Description
The report explains the model list given by World Health Organisation WHO on essential medicines used for children.
WHO Model List of Essential Medicines for Children
First List, October 2007 Status of this document This is a reprint of the text on the WHO Medicines web site http://www.who.int/medicines/publications/essentialmedicines/en/index.html
WHO Model List of Essential Medicines for Children Explanatory Notes
This Model List is intended for use for children up to 12 years of age. The core list presents a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost?effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost?effective treatment. The complementary list presents essential medicines for priority diseases, for which specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training are needed. In case of doubt medicines may also be listed as complementary on the basis of consistent higher costs or less attractive cost?effectiveness in a variety of settings. The square box symbol ( ) is primarily intended to indicate similar clinical performance within a pharmacological class. The listed medicine should be the example of the class for which there is the best evidence for effectiveness and safety. In some cases, this may be the first medicine that is licensed for marketing; in other instances, subsequently licensed compounds may be safer or more effective. Where there is no difference in terms of efficacy and safety data, the listed medicine should be the one that is generally available at the lowest price, based on international drug price information sources. Therapeutic equivalence is only indicated on the basis of reviews of efficacy and safety and when consistent with WHO clinical guidelines. National lists should not use a similar symbol and should be specific in their final selection, which would depend on local availability and price. Medicines are listed in alphabetical order, within sections. The format and numbering of the 15th WHO Model List of Essential Medicines have been retained but, as indicated in the text, some sections have been deleted because they contain medicines that are not relevant for children. In the List of Essential Medicines for Children, two additional symbols are used.
a indicates that there is an age restriction on use of the medicines; the details for each
medicine are in Table 1. R indicates that the Subcommittee has endorsed the medicine as essential but has requested a review of the efficacy and safety to confirm this decision, or to expand use to additional age groups.
WHO Model List of Essential Medicines for Children (October 2007) -- page 1
The listing of a medicine on the Essential Medicines List carries no assurance as to pharmaceutical quality of an individual product. It is the responsibility of each local regulatory authority to ensure that each brand is of appropriate pharmaceutical quality (including stability) and that, when relevant, different brands are interchangeable. Dosage forms of medicines are listed in alphabetical order and there is no implication of preference for one form over another. Standard treatment guidelines should be consulted for information on appropriate dosage forms. Entries of the type oral liquid are intended to permit any solution, suspension or other form of liquid. Granules or powder for reconstitution as an oral liquid may substitute for oral liquids, and typically carry benefits in the form of better stability and lower transport costs. If more than one type of oral liquid is available on the same market (e.g. solution, suspension, granules or powder for reconstitution), they may be interchanged and in such cases should be bioequivalent. It is preferable that oral liquids do not contain sugar and that solutions for children do not contain alcohol. Entries of the type tablet are intended to allow various forms of immediate?release tablet such as scored, uncoated, film?coated, crushable, chewable, dispersible etc. Enteric coating, on the other hand, modifies drug release, and enteric?coated products are a modified?release dosage form. Crushable, chewable and dispersible tablets may be easier to administer to paediatric populations and to the elderly.
WHO Model List of Essential Medicines for Children (October 2007) -- page 2
1. ANAESTHETICS
1.1 General anaesthetics and oxygen
halothane R
Inhalation. R Review for alternative inhalational agents. Injection: 50 mg (as hydrochloride)/ml in 10?ml vial. Inhalation. Inhalation (medicinal gas). Powder for injection: 0.5 g; 1.0 g (sodium salt) in ampoule.
ketamine nitrous oxide oxygen thiopental 1.2 Local anaesthetics
Injection: 0.25%; 0.5% (hydrochloride) in vial.
bupivacaine
Injection for spinal anaesthesia: 0.5% (hydrochloride) in 4?ml ampoule to be mixed with 7.5% glucose solution. Injection: 1%; 2% (hydrochloride) in vial.
lidocaine
Injection for spinal anaesthesia: 5% (hydrochloride) in 2?ml ampoule to be mixed with 7.5% glucose solution. Topical forms: 2% to 4% (hydrochloride).
lidocaine + epinephrine (adrenaline)
Dental cartridge: 2% (hydrochloride) + epinephrine 1:80 000. Injection: 1%; 2% (hydrochloride) + epinephrine 1:200 000 in vial.
1.3 Preoperative medication and sedation for short-term procedures atropine R Injection: 1 mg (sulfate) in 1?ml ampoule. R
Relevance to current clinical practice?
Injection: 5 mg/ml in 2?ml ampoule.
diazepam R
Tablet: 5 mg. R
Alternatives such as midazolam preferable?
morphine R
Injection: 10 mg (sulfate or hydrochloride) in 1?ml ampoule. R
Need for review for the next meeting.
2. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY MEDICINES (NSAIMs), MEDICINES USED TO TREAT GOUT AND DISEASE MODIFYING AGENTS IN RHEUMATOID DISORDERS (DMARDs)
2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) Tablet: 200 mg; 400 mg. ibuprofen a R a >3 months. R Use in children, focusing on comparative analgesic efficacy and
safety, include role of injection form in patent ductus arteriosus.
Oral liquid: 125 mg/5 ml. Suppository: 100 mg. paracetamol* Tablet: 100 mg to 500 mg. * Not recommended for anti?inflammatory use due to lack of proven benefit to that effect.
WHO Model List of Essential Medicines for Children (October 2007) -- page 3
Complementary List Suppository: 50 mg to 150 mg. acetylsalicylic acid* Tablet: 100 mg to 500 mg. * For use for rheumatic fever, juvenile arthritis, Kawasaki disease. 2.2 Opioid analgesics codeine Tablet: 15 mg (phosphate). Injection: 10 mg (morphine hydrochloride or morphine sulfate) in 1?ml ampoule. Oral liquid: 10 mg (morphine hydrochloride or morphine sulfate)/5 ml. Tablet: 10 mg (morphine sulfate). Tablet (prolonged release): 10 mg; 30 mg; 60 mg (morphine sulfate). 2.3 Medicines used to treat gout 2.4 Disease modifying agents used in rheumatoid disorders (DMARDs)R R The Subcommittee noted that there is a need for medicines for the treatment of juvenile arthritis but did not endorse any of the currently listed medicines at this time, requesting a review of this section.
morphine
3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS
Injection: 10 mg (hydrogen maleate) in 1?ml ampoule. Oral liquid: 2 mg/5 ml.
chlorphenamine a R
Tablet: 4 mg (hydrogen maleate). a >1 year. R Review of diphenhydramine to assess comparative efficacy and safety
with chlorphenamine as a possible preferable alternative.
dexamethasone epinephrine (adrenaline) hydrocortisone
prednisolone
Injection: 4 mg dexamethasone phosphate (as disodium salt) in 1?ml ampoule. Injection: 1 mg (as hydrochloride or hydrogen tartrate) in 1?ml ampoule. Powder for injection: 100 mg (as sodium succinate) in vial. Oral liquid: 5mg/ml. Tablet: 5 mg; 25 mg.
4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS
4.1 Non-specific charcoal, activated 4.2 Specific R R The Subcommittee recommended that this section be reviewed for its next meeting. acetylcysteine atropine calcium gluconate Injection: 200 mg/ml in 10?ml ampoule. Injection: 1 mg (sulfate) in 1?ml ampoule. Injection: 100 mg/ml in 10?ml ampoule. Powder.
WHO Model List of Essential Medicines for Children (October 2007) -- page 4
deferoxamine dimercaprol naloxone penicillamine R
Powder for injection: 500 mg (mesilate) in vial. Injection in oil: 50 mg/ml in 2?ml ampoule. Injection: 400 micrograms (hydrochloride) in 1?ml ampoule. Capsule or tablet: 250 mg. R
Comparative effectiveness and safety versus sodium calcium edetate.
sodium calcium edetate R
Injection: 200 mg/ml in 5?ml ampoule. R
Comparative effectiveness and safety versus penicillamine.
5. ANTICONVULSANTS/ANTIEPILEPTICS
Oral liquid: 100 mg/5 ml. carbamazepine Tablet (chewable): 100 mg; 200 mg. Tablet (scored): 100 mg; 200 mg. Injection: 5 mg/ml in 2?ml ampoule (intravenous or rectal).
diazepam R
R
Review of benzodiazepines as alternative to diazepam (specifically consider comparative efficacy and safety of lorazepam and midazolam in relation to diazepam).
Injection: 200 mg/ml (phenobarbital sodium). phenobarbital Oral liquid: 15 mg/5 ml (phenobarbital) or 5 ml (phenobarbital sodium). Tablet: 15 mg to 100 mg (phenobarbital). Capsule: 25 mg; 50 mg; 100 mg (sodium salt). Injection: 50 mg/ml in 5?ml vial (sodium salt). Oral liquid: 25 mg to 30 mg/5 ml.* phenytoin Tablet: 25 mg; 50 mg; 100 mg (sodium salt). Tablet (chewable): 50 mg. * The presence of both 25 mg/5 ml and 30 mg/5 ml strengths on the same market would cause confusion in prescribing and dispensing and should be avoided. Oral liquid: 200 mg/5 ml. valproic acid (sodium valproate) Tablet (crushable): 100 mg. Tablet (enteric?coated): 200 mg; 500 mg (sodium salt). Complementary List ethosuximide Capsule: 250 mg. Oral liquid: 250 mg/5 ml.
6. ANTI-INFECTIVE MEDICINES
6.1 Anthelminthics R R
Review evidence of efficacy and safety of use of anthelminth/antifilarial/antischistosomal and antitrematode medicines in children below the specified age in current licences.
6.1.1 Intestinal anthelminthics R albendazole Tablet (chewable): 400 mg.
WHO Model List of Essential Medicines for Children (October 2007) -- page 5
levamisole
mebendazole
Tablet: 50 mg; 150 mg (as hydrochloride). Tablet (chewable): 100 mg; 500 mg. Tablet (chewable): 500 mg. * Niclosamide is listed for use when praziquantel treatment fails. Tablet: 150 mg; 600 mg. Oral liquid: 50 mg (as embonate)/ml. Tablet (chewable): 250 mg (as embonate).
niclosamide* praziquantel pyrantel 6.1.2 Antifilarials R ivermectin Complementary List diethylcarbamazine
Tablet (scored): 3 mg; 6 mg.
Tablet: 50 mg; 100 mg (dihydrogen citrate).
6.1.3 Antischistosomals and antitrematode medicine R praziquantel triclabendazole Complementary List Capsule: 250 mg. oxamniquine* Oral liquid: 250 mg/5 ml. * Oxamniquine is listed for use when praziquantel treatment fails. 6.2 Antibacterials 6.2.1 Beta Lactam medicines Capsule or tablet: 250 mg; 500 mg (anhydrous). amoxicillin Powder for oral liquid: 125 mg (anhydrous)/5 ml; 250 mg (anhydrous)/5 ml. Oral liquid: 125 mg amoxicillin + 31.25 mg clavulanic acid/5 ml AND 250 mg amoxicillin + 62.5 mg clavulanic acid/5 ml. Tablet: 500 mg + 125 mg. ampicillin benzathine benzylpenicillin benzylpenicillin Powder for injection: 500 mg; 1 g (as sodium salt) in vial. Powder for injection: 900 mg benzylpenicillin (=1.2 million IU) in 5?ml vial; 1.44 g benzylpenicillin (=2.4 million IU) in 5?ml vial. Powder for injection: 600 mg (= 1 million IU); 3 g (= 5 million IU) (sodium or potassium salt) in vial. Powder for injection: 1 g (as sodium salt) in vial. cefazolin* a * For surgical prophylaxis. a ceftriaxone R
>1 month.
Tablet: 600 mg. Tablet: 250 mg.
amoxicillin + clavulanic acid
Powder for injection: 250 mg, 1 g (as sodium salt) in vial. R Review for safety of use in neonates.
WHO Model List of Essential Medicines for Children (October 2007) -- page 6
Capsule: 500 mg; 1 g (as sodium salt).
cloxacillin
Powder for injection: 500 mg (as sodium salt) in vial. Powder for oral liquid: 125 mg (as sodium salt)/5 ml.
phenoxymethylpenicillin
Powder for oral liquid: 250 mg (as potassium salt)/5 ml. Tablet: 250 mg (as potassium salt). Powder for injection: 1 g (=1 million IU); 3 g (=3 million IU) in vial. a Not in neonates />1 month. R Review use of procaine penicillin in neonates.
procaine benzylpenicillin a R
Complementary List Powder for injection: 250 mg (as pentahydrate) in vial. ceftazidime R R Review the use of ceftazidime (predominantly for pseudomonas infections) - are there preferred alternatives for use in children? Powder for injection: 250 mg (as monohydrate) + 250 mg (as sodium salt); 500 mg (as monohydrate) + 500 mg (as sodium salt) in vial. imipenem* + cilastatin* R * Only listed for the treatment of life?threatening hospital?based infection due to suspected or proven multidrug?resistant infection. R 6.2.2 Other antibacterials Capsule: 250 mg or 500 mg. azithromycin* a Oral liquid: 200 mg/5 ml. * Only listed for trachoma. a
>6 months. Review the use of meropenem and other penems as alternative to imipenem, specifically identifying agents useful in all age groups.
Capsule: 250 mg. Oily suspension for injection*: 0.5 g (as sodium succinate)/ml in 2?ml ampoule chloramphenicol * Only for the presumptive treatment of epidemic meningitis in children older than 2 years. Oral liquid: 150 mg (as palmitate)/5 ml. Powder for injection: 1 g (sodium succinate) in vial. Tablet: 250 mg (as hydrochloride). ciprofloxacin* R * Only for treatment of Shigella infections. R
Review of appropriate use of fluroquinolones in children.
Capsule or tablet: 100 mg (hydrochloride). doxycycline* R * For the treatment of cholera. R
Review comparative safety and efficacy of tetracyclines (are tetracyclines other than doxycycline appropriate for this indication and therefore a square box listing is appropriate?).
WHO Model List of Essential Medicines for Children (October 2007) -- page 7
Capsule or tablet: 250 mg (as stearate or ethyl succinate). Powder for injection: 500 mg (as lactobionate) in vial. erythromycin R Powder for oral liquid: 125 mg (as stearate or ethyl succinate). R
Review macrolides used in children for specific indications and whether erythromycin is the appropriate listed medicine. Review to consider use in neonates (risk of pyloric stenosis with erythromycin), relative toxicity and dosing compared to other macrolides. Include consideration of use of other macrolides for rheumatic fever.
gentamicin R
Injection: 10 mg; 40 mg (as sulfate)/ml in 2?ml vial. R
Review of evidence on ototoxicity for the next meeting.
Injection: 500 mg in 100?ml vial. metronidazole Oral liquid: 200 mg (as benzoate)/5 ml. Tablet: 200 mg to 500 mg. nitrofurantoin Oral liquid: 25 mg/5 ml. Tablet: 100 mg. Injection: 80 mg + 16 mg/ml in 5?ml and 10?ml ampoules. sulfamethoxazole + trimethoprim Oral liquid: 200 mg + 40 mg/5 ml. Tablet: 100 mg + 20 mg; 400 mg + 80 mg. Oral liquid: 50 mg/5 ml. trimethoprim a Tablet: 100 mg; 200 mg. a Complementary List Capsule: 150 mg. clindamycin a Injection: 150 mg (as phosphate)/ml. Oral liquid: 75 mg/5 ml. a
>1 month. >6 months.
Injection: 250 mg (sodium salt) in 4?ml ampoule. sulfadiazine R Tablet: 500 mg. R vancomycin 6.2.3 Antileprosy medicines Medicines used in the treatment of leprosy should never be used except in combination. Combination therapy is essential to prevent the emergence of drug resistance. Colour coded blister packs (MDT blister packs) containing standard two medicine (paucibacillary leprosy) or three medicine (multibacillary leprosy) combinations for adult and childhood leprosy should be used. MDT blister packs can be supplied free of charge through WHO. clofazimine dapsone rifampicin Capsule: 50 mg; 100 mg. Tablet: 25 mg; 50 mg; 100 mg. Capsule or tablet: 150 mg; 300 mg.
Review on use of sulfadiazine in children - especially safety, efficacy and dosing in toxoplasmosis.
Powder for injection: 250 mg (as hydrochloride) in vial.
WHO Model List of Essential Medicines for Children (October 2007) -- page 8
6.2.4 Antituberculosis medicines R R
The Subcommittee requested a review of medicines used for TB in children, including evidence regarding dose, and alternatives for streptomycin.
ethambutol
Oral liquid: 25 mg/ml. Tablet: 100 mg; 400 mg (hydrochloride). Oral liquid: 50 mg/5 ml.
isoniazid
Tablet: 100 mg; 300 mg. Tablet (scored): 50 mg. Oral liquid: 30 mg/ml.
pyrazinamide
Tablet: 400 mg. Tablet (dispersible): 150 mg. Tablet (scored): 150 mg.
rifampicin
Capsule or tablet: 150 mg; 300 mg. Oral liquid: 20 mg/ml. Tablet:
rifampicin + isoniazid
60 mg + 30 mg. 60 mg + 60 mg (For intermittent use three times weekly).
rifampicin + isoniazid + pyrazinamide streptomycin Complementary List
Tablet: 60 mg + 30 mg + 150 mg. Powder for injection: 1 g (as sulfate) in vial.
Reserve second?line drugs for the treatment of multidrug?resistant tuberculosis (MDR?TB) should be used in specialized centres adhering to WHO standards for TB control. R R The Subcommittee has included these in recognition of the need for medicines for MDR-TB in children, but
has not reviewed evidence at this meeting and therefore the section should be reviewed for the next meeting.
amikacin capreomycin cycloserine ethionamide kanamycin
Powder for injection: 1000 mg in vial. Powder for injection: 1000 mg in vial. Capsule or tablet: 250 mg. Tablet: 125 mg; 250 mg. Powder for injection: 1000 mg in vial. Tablet: 200 mg; 400 mg.
ofloxacin*
* Levofloxacin may be an alternative based on availability and programme considerations. Granules: 4 g in sachet. Tablet: 500 mg.
p?aminosalicylic acid
WHO Model List of Essential Medicines for Children (October 2007) -- page 9
6.3 Antifungal medicines Capsule: 50 mg. fluconazole Injection: 2 mg/ml in vial. Oral liquid: 50 mg/5 ml. griseofulvin Capsule or tablet: 125 mg; 250 mg. Oral liquid: 125 mg/5ml. Lozenge: 100 000 IU. nystatin Oral liquid: 50 mg/5 ml; 100 000 IU/ml. Tablet: 100 000 IU; 500 000 IU. Complementary List amphotericin B flucytosine potassium iodide 6.4 Antiviral medicines 6.4.1 Antiherpes medicines Oral liquid: 200 mg/5 ml. aciclovir Powder for injection: 250 mg (as sodium salt) in vial. Tablet: 200 mg. 6.4.2 Antiretrovirals Based on current evidence and experience of use, medicines in the following three classes of antiretrovirals are included as essential medicines for treatment and prevention of HIV (prevention of mother?to?child transmission and post exposure prophylaxis). The Subcommittee emphasizes the importance of using these products in accordance with global and national guidelines. The Subcommittee recommends and endorses the use of fixed?dose combinations and the development of appropriate new fixed?dose combinations, including modified dosage forms, non?refrigerated products and paediatric dosage forms with assured pharmaceutical quality. The Subcommittee notes that scored tablets can be used in children and therefore can be considered for inclusion in the listing of tablets, provided adequate quality products are available. 6.4.2.1 Nucleoside/Nucleotide reverse transcriptase inhibitors abacavir (ABC) Oral liquid: 100 mg (as sulfate)/5 ml. Tablet: 300 mg (as sulfate). Buffered powder for oral liquid: 100 mg; 167 mg; 250 mg packets. didanosine (ddI) Capsule (unbuffered enteric?coated): 125 mg; 200 mg; 250 mg; 400 mg. Tablet (buffered chewable, dispersible): 25 mg; 50 mg; 100 mg; 150 mg; 200 mg. Powder for injection: 50 mg in vial. Capsule: 250 mg. Infusion: 2.5 g in 250 ml. Saturated solution.
WHO Model List of Essential Medicines for Children (October 2007) -- page 10
Capsule: 200 mg. Oral liquid: 10 mg/ml. emtricitabine (FTC)* a * FTC is an acceptable alternative to 3TC, based on knowledge of the pharmacology, the resistance patterns and clinical trials of antiretrovirals. a lamivudine (3TC)
>3 months.
Oral liquid: 50 mg/5 ml. Tablet: 150 mg. Capsule: 15 mg; 20 mg; 30 mg. Powder for oral liquid: 5 mg/5 ml. Capsule: 100 mg; 250 mg.
stavudine (d4T)
zidovudine (ZDV or AZT)
Oral liquid: 50 mg/5 ml. Solution for IV infusion injection: 10 mg/ml in 20?ml vial. Tablet: 300 mg.
6.4.2.2 Non-nucleoside reverse transcriptase inhibitors Capsule: 50 mg; 100 mg; 200 mg. efavirenz (EFV or EFZ) a Oral liquid: 150 mg/5 ml. Tablet: 600 mg. a nevirapine (NVP) 6.4.2.3 Protease inhibitors Selection of protease inhibitor(s) from the Model List will need to be determined by each country after consideration of international and national treatment guidelines and experience. Ritonavir is recommended for use in combination as a pharmacological booster, and not as an antiretroviral in its own right. This section will be reviewed. It is expected that application for a heat?stable tablet formulation containing 200/50 mg lopinavir + ritonavir will be submitted for the next meeting. lopinavir + ritonavir (LPV/r) Capsule: 133.3 mg + 33.3 mg. Oral liquid: 400 mg + 100 mg/5 ml. Oral powder: 50 mg/g. Tablet: 250 mg (as mesilate). Oral liquid: 400 mg/5 ml. Oral solid dosage form: 100 mg. Capsule: 200 mg. a
>25 kg weight. >3 years or >10 kg weight.
Oral liquid: 50 mg/5 ml. Tablet: 200 mg.
nelfinavir (NFV)
ritonavir
saquinavir (SQV) a
WHO Model List of Essential Medicines for Children (October 2007) -- page 11
FIXED-DOSE COMBINATIONS stavudine + lamivudine + nevirapine zidovudine + lamivudine zidovudine + lamivudine + nevirapine 6.4.3 Other antivirals Injection for intravenous administration: 800 mg and 1000 mg in 10?ml phosphate buffer solution. ribavirin* Oral solid dosage forms: 200 mg; 400 mg; 600 mg. * For the treatment of viral haemorrhagic fevers only. 6.5 Antiprotozoal medicines 6.5.1 Antiamoebic and antigiardiasis medicines Tablet: 500 mg (furoate). diloxanide a R a
>25 kg weight.
Tablet: 30 mg + 150 mg + 200 mg. Tablet: 300 mg + 150 mg. Tablet: 300 mg + 150 mg + 200 mg.
R Review of effectiveness and safety for amoebiasis, with emphasis on
comparative efficacy, safety, and age limits compared with oral paromomycin.
Injection: 500 mg in 100?ml vial.
metronidazole
Oral liquid: 200 mg (as benzoate)/5 ml. Tablet: 200 mg to 500 mg.
6.5.2 Antileishmaniasis medicines paromomycin sodium stibogluconate or meglumine antimoniate Complementary List amphotericin B Powder for injection: 50 mg in vial. Solution for intramuscular injection: 750 mg of paromomycin base present as the sulfate. Injection: 100 mg/ml, 1 vial = 30 ml or 30%, equivalent to approximately 8.1% antimony in 5?ml ampoule.
6.5.3 Antimalarial medicines 6.5.3.1 For curative treatment Medicines for the treatment of P. falciparum malaria cases should be used in combination. The list currently recommends combinations according to treatment guidelines. The Subcommittee recognizes that not all of these FDCs exist and encourages their development and rigorous testing. The Subcommittee also encourages development and testing of rectal dosage formulations. Tablet: 153 mg or 200 mg (as hydrochloride). amodiaquine* * To be used (a) in combination with artesunate 50 mg OR (b) may be used alone for the treatment of P.vivax, P.ovale and P.malariae infections. Oily injection: 80 mg/ml in 1?ml ampoule. For use in the management of severe malaria.
WHO Model List of Essential Medicines for Children (October 2007) -- page 12
artemether
Tablet: 20 mg + 120 mg. artemether + lumefantrine* * Not recommended in the first trimester of pregnancy or in children below 5 kg. Injection: ampoules, containing 60 mg anhydrous artesunic acid with a separate ampoule of 5% sodium bicarbonate solution. For use in the management of severe malaria. artesunate* Rectal dosage form: 50 mg; 200 mg capsules (for pre?referral treatment of severe malaria only; patients should be taken to an appropriate health facility for follow?up care). Tablet: 50 mg. * To be used in combination with either amodiaquine, mefloquine or sulfadoxine + pyrimethamine. Oral liquid: 50 mg (as phosphate or sulfate)/5 ml. chloroquine* Tablet: 100 mg; 150 mg (as phosphate or sulfate). * For use only in central American regions, for use for P.vivax. Capsule: 100 mg (as hydrochloride). doxycycline* Tablet (dispersible): 100 mg (as monohydrate). * For use only in combination with quinine. mefloquine* Tablet: 250 mg (as hydrochloride). * To be used in combination with artesunate 50 mg. Tablet: 7.5 mg; 15 mg (as diphosphate). primaquine* * Only for use to achieve radical cure of P.vivax and P.ovale infections, given for 14 days. Injection: 300 mg quinine hydrochloride/ml in 2?ml ampoule. quinine* Tablet: 300 mg (quinine sulfate) or 300 mg (quinine bisulfate). * For use only in the management of severe malaria, and should be used in combination with doxycycline. sulfadoxine + pyrimethamine* 6.5.3.2 For prophylaxis Oral liquid: 50 mg (as phosphate or sulfate)/5 ml. chloroquine* Tablet: 150 mg (as phosphate or sulfate). * For use only in central American regions, for use for P.vivax. doxycycline a Capsule or tablet: 100 mg (as hydrochloride). a
>8 years.
Tablet: 500 mg + 25 mg. * Only in combination with artesunate 50 mg.
mefloquine a
Tablet: 250 mg (as hydrochloride). a
>5 kg or >3 months.
proguanil*
Tablet: 100 mg (as hydrochloride). * For use only in combination with chloroquine.
WHO Model List of Essential Medicines for Children (October 2007) -- page 13
6.5.4 Anti-pneumocystosis and antitoxoplasmosis medicines pyrimethamine Tablet: 25 mg. Injection: 80 mg + 16 mg/ml in 5?ml ampoule; 80 mg + 16 mg/ml in 10?ml ampoule. sulfamethoxazole + trimethoprim Oral liquid: 200 mg + 40 mg/5 ml. Tablet: 100 mg + 20 mg; 400 mg + 80 mg. 6.5.5 Antitrypanosomal medicines R R The Subcommittee requested a review of evidence for effectiveness and safety for medicines for trypanosomiasis in children for the next meeting. 6.5.5.1 African trypanosomiasis Medicines for the treatment of 1st stage African trypanosomiasis Powder for injection: 200 mg (pentamidine isetionate) in vial. pentamidine* * To be used for the treatment of Trypanosoma brucei gambiense infection. Powder for injection: 1 g in vial. * To be used for the treatment of the initial phase of Trypanosoma brucei rhodesiense infection. Medicines for the treatment of 2nd stage African trypanosomiasis eflornithine melarsoprol Injection: 200 mg (hydrochloride)/ml in 100?ml bottle. Injection: 3.6% solution, 5?ml ampoules (180 mg of active compound).
suramin sodium*
6.5.5.2 American trypanosomiasis benznidazole nifurtimox Tablet: 100 mg. Tablet: 30 mg; 120 mg; 250 mg.
7. ANTIMIGRAINE MEDICINES
7.1 For treatment of acute attack ibuprofen paracetamol 7.2 For prophylaxis propranolol Tablet: 20 mg; 40 mg (hydrochloride). Tablet: 200 mg; 400 mg. Syrup: 125 mg/5 ml. Tablet: 300 mg to 500 mg.
WHO Model List of Essential Medicines for Children (October 2007) -- page 14
8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES AND MEDICINES USED IN PALLIATIVE CARE R
R
The Subcommittee noted that these immunosuppressives and cytotoxics are essential for children but requested that these medicines be reviewed for the next meeting.
8.1 Immunosuppressive medicines Complementary List azathioprine Powder for injection: 100 mg (as sodium salt) in vial. Tablet: 50 mg. Capsule: 25 mg. ciclosporin 8.2 Cytotoxic medicines Complementary List allopurinol asparaginase bleomycin calcium folinate chlorambucil cisplatin cyclophosphamide cytarabine dacarbazine dactinomycin daunorubicin doxorubicin etoposide fluorouracil mercaptopurine methotrexate procarbazine vinblastine vincristine Tablet: 100 mg to 300 mg. Powder for injection: 10 000 IU in vial. Powder for injection: 15 mg (as sulfate) in vial. Injection: 3 mg/ml in 10?ml ampoule. Tablet: 15 mg. Tablet: 2 mg. Powder for injection: 10 mg; 50 mg in vial. Powder for injection: 500 mg in vial. Tablet: 25 mg. Powder for injection: 100 mg in vial. Powder for injection: 100 mg in vial. Powder for injection: 500 micrograms in vial. Powder for injection: 50 mg (as hydrochloride). Powder for injection: 10 mg; 50 mg (hydrochloride) in vial. Capsule: 100 mg. Injection: 20 mg/ml in 5?ml ampoule. Injection: 50 mg/ml in 5?ml ampoule. Tablet: 50 mg. Powder for injection: 50 mg (as sodium salt) in vial. Tablet: 2.5 mg (as sodium salt). Capsule: 50 mg (as hydrochloride). Powder for injection: 10 mg (sulfate) in vial. Powder for injection: 1 mg; 5 mg (sulfate) in vial. Concentrate for injection: 50 mg/ml in 1?ml ampoule for organ transplantation.
WHO Model List of Essential Medicines for Children (October 2007) -- page 15
8.3 Hormones and antihormones Complementary List dexamethasone hydrocortisone Injection: 4 mg dexamethasone phosphate (as disodium salt) in 1?ml ampoule. Powder for injection: 100 mg (as sodium succinate) in vial. Oral liquid: 5 mg/ml. prednisolone* Tablet: 5 mg; 25 mg. * Prednisone should be considered equivalent to prednisolone. 8.4 Medicines used in palliative care The WHO Expert Committee recognizes the importance of listing specific medicines in the Palliative Care Section. Some medicines currently used in palliative care are included in the relevant sections of the Model List, according to their therapeutic use, e.g. analgesics. The Guidelines for Palliative Care that were referenced in the previous list are in need of update. The Expert Committee expects applications for medicines needed for palliative care to be submitted for the next meeting.
9. ANTIPARKINSONISM MEDICINES 10. MEDICINES AFFECTING THE BLOOD
10.1 Antianaemia medicines The Subcommittee proposed a review of the evidence for appropriate dose combinations of iron and folic acid for children for consideration at its next meeting. ferrous salt folic acid hydroxocobalamin Oral liquid: equivalent to 25 mg elemental iron/ml. Tablet: equivalent to 60 mg iron. Tablet: 1 mg; 5 mg. Injection: 1 mg in 1?ml ampoule.
10.2 Medicines affecting coagulation phytomenadione Complementary List heparin sodium protamine sulfate warfarin Injection: 1000 IU/ml; 5000 IU/ml; 20,000 IU/ml in 1?ml ampoule. Injection: 10 mg/ml in 5?ml ampoule. Tablet: 0.5 mg; 1.0 mg; 2.0 mg; 5.0 mg (sodium salt). Injection: 1 mg/ml; 10 mg/ml in 5?ml ampoule. Tablet: 10 mg.
11. BLOOD PRODUCTS AND PLASMA SUBSTITUTES
11.1 Plasma substitutes R R The Subcommittee requested a review to determine whether these medicines are essential for children.
WHO Model List of Essential Medicines for Children (October 2007) -- page 16
11.2 Plasma fractions for specific use All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992). (WHO Technical Report Series, No. 840, 1994, Annex 2). Complementary List Intramuscular administration: 16% protein solution.* Intravenous administration: 5%; 10% protein solution.** human normal immunoglobulin Subcutaneous administration: 15%; 16% protein solution.* * Indicated for primary immune deficiency. **Indicated for primary immune deficiency and Kawasaki disease. factor VIII concentrate factor IX complex (coagulation factors, II, VII, IX, X) concentrate Dried. Dried.
12. CARDIOVASCULAR MEDICINES
12.1 Antianginal medicines 12.2 Antiarrhythmic medicines R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 12.3 Antihypertensive medicines R R The Subcommittee noted the potential importance of these medicines in children but requested a review of
the section before endorsing any medicine as essential.
12.4 Medicines used in heart failure R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section for the next meeting. Injection: 250 micrograms/ml in 2?ml ampoule. digoxin Oral liquid: 50 micrograms/ml. Tablet: 62.5 micrograms; 250 micrograms. Injection: 10 mg/ml in 2?ml ampoule. furosemide Oral liquid: 20 mg/5 ml. Tablet: 40 mg. Complementary List Injection: 40 mg (hydrochloride)in 5?ml vial. dopamine R R
Review of safety and efficacy and place in therapy of dopamine in children.
12.5 Antithrombotic medicines R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 12.6 Lipid-lowering agents R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential.
WHO Model List of Essential Medicines for Children (October 2007) -- page 17
13. DERMATOLOGICAL MEDICINES (topical) R
R
The Subcommittee noted the need for a review of this section with alternative possible additions to the list.
13.1 Antifungal medicines benzoic acid + salicylic acid
miconazole
Ointment or cream: 6% + 3%. Ointment or cream: 2% (nitrate).
Complementary List selenium sulfide Detergent?based suspension: 2%.
13.2 Anti-infective medicines Aqueous solution: 0.5%.
methylrosanilinium chloride
(gentian violet) R neomycin sulfate + bacitracin potassium permanganate silver sulfadiazine a
Tincture: 0.5%. R
Review of new evidence from ongoing trials.
Ointment: 5 mg neomycin sulfate + 250 IU bacitracin zinc/g. Aqueous solution: 1:10 000. Cream: 1%, in 500?g container. a
>2 months.
13.3 Anti-inflammatory and antipruritic medicines
betamethasone a
Cream or ointment: 0.1% (as valerate). a
Hydrocortisone preferred in neonates.
calamine lotion hydrocortisone
Lotion. Cream or ointment: 1% (acetate).
13.4 Astringent medicines R R
The Subcommittee requested a review to determine whether these medicines are essential for children.
13.5 Medicines affecting skin differentiation and proliferation benzoyl peroxide coal tar dithranol podophyllum resin salicylic acid urea Cream or lotion: 5%. Solution: 5%. Ointment: 0.1% to 2.0%. Solution: 10% to 25%. Solution: 5%. Cream or ointment: 10%.
13.6 Scabicides and pediculicides Lotion: 25%.
benzyl benzoate a R
a >2 years. R Review of alternatives to benzyl benzoate for use in younger children
(possible role for sulphur-based preparations in younger children).
permethrin
Cream: 5%. Lotion: 1%.
WHO Model List of Essential Medicines for Children (October 2007) -- page 18
14. DIAGNOSTIC AGENTS
14.1 Ophthalmic medicines fluorescein
tropicamide
Eye drops: 1% (sodium salt). Eye drops: 0.5%.
14.2 Radiocontrast media R R The Subcommittee requested a review of possible alternative contrast agents for use in children. Complementary List barium sulfate Aqueous suspension.
15. DISINFECTANTS AND ANTISEPTICS
15.1 Antiseptics
chlorhexidine ethanol polyvidone iodine
Solution: 5% (digluconate) for dilution. Solution: 70% (denatured). Solution: 10%.
15.2 Disinfectants
chlorine base compound chloroxylenol
Powder: (0.1% available chlorine) for solution. Solution: 4.8%. Solution: 2%.
glutaral
16. DIURETICS
Injection: 10 mg/ml in 2?ml ampoule. furosemide Oral liquid: 20 mg/5 ml. Tablet: 10 mg; 20 mg; 40 mg. Complementary List
hydrochlorothiazide
Tablet (scored): 25 mg. Injectable solution: 10%; 20%.
mannitol R
R
Review of comparative efficacy, safety and place in therapy of mannitol in children.
Oral liquid: 1 to 20 mg/ml. spironolactone R Tablet: 25 mg. R
Review of comparative efficacy, safety and place in therapy of spironolactone in children.
17. GASTROINTESTINAL MEDICINES
17.1 Antacids and other antiulcer medicines aluminium hydroxide magnesium hydroxide Oral liquid: 320 mg/5 ml. Tablet: 500 mg. Oral liquid: equivalent to 550 mg magnesium oxide/10 ml.
WHO Model List of Essential Medicines for Children (October 2007) -- page 19
Injection: 25 mg/ml in 2?ml ampoule.
ranitidine
Oral liquid: 75 mg/5 ml. Tablet: 150 mg (as hydrochloride).
17.2 Antiemetic medicines Injection: 5 mg (hydrochloride)/ml in 2?ml ampoule. metoclopramide a
Oral liquid: 5 mg/5 ml. Tablet: 10 mg (hydrochloride). a
Not in neonates.
Injection: 25 mg (hydrochloride)/ml in 2?ml ampoule. promethazine a
Oral liquid: 5 mg (hydrochloride)/5 ml. Tablet: 10 mg; 25 mg (hydrochloride). a
>2 years.
17.3 Anti-inflammatory medicines 17.4 Laxatives R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 17.5 Medicines used in diarrhoea 17.5.1 Oral rehydration glucose: sodium: chloride: potassium: citrate: osmolarity: glucose: sodium chloride: potassium chloride: trisodium citrate dihydrate+: 75 mEq 75 mEq or mmol/l 65 mEq or mmol/l 20 mEq or mmol/l 10 mmol/l 245 mOsm/l 13.5 g/l 2.6 g/l 1.5 g/l 2.9 g/l
oral rehydration salts
+ trisodium citrate dihydrate may be replaced by sodium hydrogen carbonate (sodium bicarbonate) 2.5 g/l. However, as the stability of this latter formulation is very poor under tropical conditions, it is only recommended when manufactured for immediate use.
17.5.2 Medicines for diarrhoea in children Oral liquid: in 10 mg per unit dosage forms. Tablet: in 10 mg per unit dosage forms. zinc sulfate* R * In acute diarrhoea zinc sulfate should be used as an adjunct to oral rehydration salts. R Review of availability of appropriate dosage forms. 17.5.3 Antidiarrhoeal (symptomatic) medicines in adults
WHO Model List of Essential Medicines for Children (October 2007) -- page 20
18. HORMONES, OTHER ENDOCRINE MEDICINES AND CONTRACEPTIVES
18.1 Adrenal hormones and synthetic substitutes R R The Subcommittee noted the need for adrenal hormones and requested that appropriate products be reviewed for possible inclusion. 18.2 Androgens 18.3 Contraceptives 18.3.1 Oral hormonal contraceptives 18.3.2 Injectable hormonal contraceptives 18.3.3 Intrauterine devices 18.3.4 Barrier methods 18.3.5 Implantable contraceptives 18.4 Estrogens 18.5 Insulins and other antidiabetic agents insulin injection (soluble) intermediate?acting insulin Complementary List metformin R 18.6 Ovulation inducers 18.7 Progestogens 18.8 Thyroid hormones and antithyroid medicines levothyroxine Complementary List Lugol?s solution potassium iodide propylthiouracil R Oral liquid: about 130 mg total iodine/ml. Tablet: 60 mg. Tablet: 50 mg. R Review of use of propylthiouracil in children and appropriateness of carbimazole as an alternative. Tablet: 25 micrograms; 50 micrograms; 100 micrograms (sodium salt). Injection: 40 IU/ml in 10?ml vial; 100 IU/ml in 10?ml vial. Injection: 40 IU/ml in 10?ml vial; 100 IU/ml in 10?ml vial (as compound insulin zinc suspension or isophane insulin). Tablet: 500 mg (hydrochloride). R
Review of public health relevance of this medicine in children.
19. IMMUNOLOGICALS
19.1 Diagnostic agents All tuberculins should comply with the WHO Requirements for Tuberculins (Revised 1985). WHO Expert Committee on Biological Standardization. Thirty?sixth report. (WHO Technical Report Series, No. 745, 1987, Annex 1). tuberculin, purified protein derivative (PPD) Injection.
WHO Model List of Essential Medicines for Children (October 2007) -- page 21
19.2 Sera and immunoglobulins All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992). WHO Expert Committee on Biological Standardization. Forty?third report. (WHO Technical Report Series, No. 840, 1994, Annex 2). antitetanus immunoglobulin (human) antivenom immunoglobulin* diphtheria antitoxin
rabies immunoglobulin
Injection: 500 IU in vial. Injection. * Exact type to be defined locally. Injection: 10 000 IU; 20 000 IU in vial. Injection: 150 IU/ml in vial.
19.3 Vaccines
Selection of vaccines from the Model List will need to be determined by each country after consideration of international recommendations, epidemiology and national priorities. The list below details the vaccines for which there is either a recommendation from the Strategic Advisory Group of Experts on Immunization (SAGE) (http://www.who.int/immunization/sage_conclusions/en/index.html) and/or a WHO position paper (http://www.who.int/immunization/documents/positionpapers/en/index.html). This site will be updated as new position papers are published and contains the most recent information and recommendations. All vaccines should comply with the WHO Requirements for Biological Substances. The Subcommittee noted the need for vaccines used in children to be polyvalent. BCG vaccine cholera vaccine diphtheria vaccine hepatitis A vaccine hepatitis B vaccine Haemophilus influenzae type b vaccine influenza vaccine Japanese encephalitis vaccine measles vaccine meningococcal meningitis vaccine mumps vaccine pertussis vaccine pneumococcal vaccine poliomyelitis vaccine rabies vaccine rotavirus vaccine
WHO Model List of Essential Medicines for Children (October 2007) -- page 22
rubella vaccine tetanus vaccine typhoid vaccine varicella vaccine yellow fever vaccine
20. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) AND CHOLINESTERASE INHIBITORS R
R
The Subcommittee recommended a review of the alternatives available for use in children.
neostigmine
Injection: 500 micrograms in 1?ml ampoule; 2.5 mg (metilsulfate) in 1?ml ampoule. Tablet: 15 mg (bromide).
suxamethonium
vecuronium
Injection: 50 mg (chloride)/ml in 2?ml ampoule. Powder for injection: (chloride), in vial. Powder for injection: 10 mg (bromide) in vial.
Complementary List pyridostigmine Injection: 1 mg in 1?ml ampoule. Tablet: 60 mg (bromide).
21. OPHTHALMOLOGICAL PREPARATIONS R
R The Subcommittee requested a review of newer medicines for potential additions to this list. 21.1 Anti-infective agents aciclovir
gentamicin tetracycline
Ointment: 3% W/W. Solution (eye drops): 0.3% (sulfate). Eye ointment: 1% (hydrochloride).
21.2 Anti-inflammatory agents
prednisolone
Solution (eye drops): 0.5% (sodium phosphate).
21.3 Local anaesthetics
tetracaine a
Solution (eye drops): 0.5% (hydrochloride). a
Not in preterm neonates.
21.4 Miotics and antiglaucoma medicines 21.5 Mydriatics Solution (eye drops): 0.1%; 0.5%; 1% (sulfate). atropine* a * OR homatropine or cyclopentolate. a Complementary List Solution (eye drops): 2% (as hydrochloride). epinephrine (adrenaline) R R Review of anti-infective eye drops, identifying which are most appropriate for use in children.
>3 months.
WHO Model List of Essential Medicines for Children (October 2007) -- page 23
22. OXYTOCICS AND ANTIOXYTOCICS
22.1 Oxytocics 22.2 Antioxytocics (tocolytics)
23. PERITONEAL DIALYSIS SOLUTION
Complementary List intraperitoneal dialysis solution (of appropriate composition) Parenteral solution.
24. PSYCHOTHERAPEUTIC MEDICINES
24.1 Medicines used in psychotic disorders R R
The Subcommittee requested a review of appropriate antipsychotics for use in children.
Injection: 25 mg (hydrochloride)/ml in 2?ml ampoule. chlorpromazine Oral liquid: 25 mg (hydrochloride)/5 ml. Tablet: 10 mg; 25 mg; 50 mg; 100 mg (hydrochloride). Injection: 5 mg in 1?ml ampoule. haloperidol Oral liquid: 2 mg/ml. Oral solid dosage form: 0.5 mg; 2.0 mg; 5.0 mg. 24.2 Medicines used in mood disorders 24.2.1 Medicines used in depressive disorders Complementary List fluoxetine a Capsule or tablet: 20 mg (present as hydrochloride). a
>8 years.
24.2.2 Medicines used in bipolar disorders R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 24.3 Medicines used in generalized anxiety and sleep disorders R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 24.4 Medicines used for obsessive compulsive disorders and panic attacks R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 24.5 Medicines used in substance dependence programmes R R The Subcommittee noted the potential importance of these medicines, particularly in neonates, but
requested an assessment of the evidence before endorsing any medicine as essential.
25. MEDICINES ACTING ON THE RESPIRATORY TRACT
25.1 Antiasthmatic and medicines for chronic obstructive pulmonary disease
budesonide
Inhalation (aerosol): 50 micrograms per dose (dipropionate); 250 micrograms (dipropionate) per dose. Injection: 1 mg (as hydrochloride or hydrogen tartrate) in 1?ml ampoule.
epinephrine (adrenaline)
WHO Model List of Essential Medicines for Children (October 2007) -- page 24
Injection: 50 micrograms (as sulfate)/ml in 5?ml ampoule. Metered dose inhaler (aerosol): 100 micrograms (as sulfate) per dose. Oral liquid: 2 mg/5 ml.
salbutamol
R Review of the place in therapy of oral salbutamol preparations in children, with particular emphasis on efficacy and safety in asthma and in the wheezy child with acute respiratory tract infection. Respirator solution for use in nebulizers: 5 mg (as sulfate)/ml. Tablet: 2 mg; 4 mg (as sulfate). R As for oral liquid.
25.2 Other medicines acting on the respiratory tract caffeine citrate Injection: 20 mg/ml (equivalent to 10 mg caffeine base/ml). Oral liquid: 20 mg/ml (equivalent to 10 mg caffeine base/ml).
26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID-BASE DISTURBANCES
26.1 Oral oral rehydration salts potassium chloride 26.2 Parenteral glucose Injectable solution: 5%; 10% isotonic; 50% hypertonic. Injectable solution: 4% glucose, 0.18% sodium chloride (equivalent to Na+ 30 mmol/l, Cl? 30 mmol/l); 5% glucose, 0.9% sodium chloride (equivalent to 150 mmol/l Na+ and 150 mmol/l Cl?); 5% glucose, 0.45% sodium chloride (equivalent to 75 mmol/l Na+ and 75 mmol/l Cl?). Solution: 11.2% in 20?ml ampoule (equivalent to K+ 1.5 mmol/ml, Cl? 1.5 mmol/ml). Injectable solution: 0.9% isotonic (equivalent to Na+ 154 mmol/l, Cl? 154 mmol/l). Injectable solution: 1.4% isotonic (equivalent to Na+ 167 mmol/l, HCO3? 167 mmol/l). Solution: 8.4% in 10?ml ampoule (equivalent to Na+ 1000 mmol/l, HCO3?1000 mmol/l). Injectable solution. See section 17.5.1. Powder for solution.
glucose with sodium chloride
potassium chloride sodium chloride
sodium hydrogen carbonate
sodium lactate, compound
solution 26.3 Miscellaneous water for injection
2?ml; 5?ml; 10?ml ampoules.
27. VITAMINS AND MINERALS R
R The Subcommittee noted the need for a review of this section of the list to meet public health needs in children. ascorbic acid Tablet: 50 mg.
WHO Model List of Essential Medicines for Children (October 2007) -- page 25
Capsule or tablet: 400 IU; 1000 IU. cholecalciferol* Oral liquid: 400 IU/ml. * Ergocalciferol can be used as an alternative. Capsule: 200 mg. iodine Iodized oil: 1 ml (480 mg iodine); 0.5 ml (240 mg iodine) in ampoule (oral or injectable); 0.57 ml (308 mg iodine) in dispenser bottle. Tablet: 25 mg (hydrochloride). Capsule: 50 000 IU; 100 000 IU; 200 000 IU (as palmitate). Oral oily solution: 100 000 IU (as palmitate)/ml in multidose dispenser. Tablet (sugar?coated): 10 000 IU (as palmitate). Water?miscible injection: 100 000 IU (as palmitate) in 2?ml ampoule. riboflavin sodium fluoride thiamine Complementary List calcium gluconate Injection: 100 mg/ml in 10?ml ampoule. Tablet: 5 mg. In any appropriate topical formulation. Tablet: 50 mg (hydrochloride).
pyridoxine
retinol
WHO Model List of Essential Medicines for Children (October 2007) -- page 26
Table 1: Medicines with age restrictions
atropine azithromycin benzyl benzoate betamethasone topical preparations cefazolin chlorphenamine clindamycin diloxanide doxycyline efavirenz emtricitabine fluoxetine ibuprofen mefloquine metoclopramide procaine benzylpenicillin promethazine saquinavir silver sulfadiazine tetracaine trimethoprim >3 months >6 months >2 years Hydrocortisone preferred in neonates >1 month >1 year >1 month >25 kg weight >8 years >3 years or >10 kg weight >3 months >8 years >3 months >5 kg or >3 months Not in neonates Not in neonates />1 month >2 years >25 kg weight >2 months Not in preterm neonates >6 months
WHO Model List of Essential Medicines for Children (October 2007) -- page 27
INDEX
abacavir (ABC)................................................... 10 acetylcysteine....................................................... 4 acetylsalicylic acid.................................................. 4 aciclovir ........................................................ 10, 23 albendazole .......................................................... 5 allopurinol............................................................ 15 aluminium hydroxide....................................... 19 amikacin ................................................................. 9 amodiaquine ...................................................... 12 amoxicillin............................................................ 6 amoxicillin + clavulanic acid.............................. 6 amphotericin B ............................................... 10, 12 ampicillin.............................................................. 6 antitetanus immunoglobulin (human)........... 22 antivenom immunoglobulin............................ 22 artemether .......................................................... 12 artemether + lumefantrine ............................... 13 artesunate ........................................................... 13 ascorbic acid....................................................... 25 asparaginase......................................................... 15 atropine....................................................... 3, 4, 23 azathioprine.......................................................... 15 azithromycin ........................................................ 7 barium sulfate ...................................................... 19 BCG vaccine ....................................................... 22 benzathine benzylpenicillin............................... 6 benznidazole...................................................... 14 benzoic acid + salicylic acid ............................. 18 benzoyl peroxide............................................... 18 benzyl benzoate................................................. 18 benzylpenicillin ................................................... 6 betamethasone ................................................... 18 bleomycin ............................................................. 15 budesonide......................................................... 24 bupivacaine.......................................................... 3 caffeine citrate.................................................... 25 calamine lotion .................................................. 18 calcium folinate .................................................... 15 calcium gluconate ......................................... 4, 26 capreomycin ........................................................... 9 carbamazepine..................................................... 5 cefazolin................................................................ 6 ceftazidime ............................................................. 7 ceftriaxone ............................................................ 6 charcoal, activated............................................... 4 chlorambucil......................................................... 15 chloramphenicol.................................................. 7 chlorhexidine ..................................................... 19 chlorine base compound .................................. 19 chloroquine ........................................................ 13 chloroxylenol ..................................................... 19 chlorphenamine................................................... 4 chlorpromazine ................................................. 24 cholecalciferol .................................................... 26 cholera vaccine .................................................. 22 ciclosporin............................................................ 15 ciprofloxacin ........................................................ 7 cisplatin................................................................ 15 clindamycin ........................................................... 8 clofazimine........................................................... 8 cloxacillin ............................................................. 7 coal tar ................................................................ 18 codeine.................................................................. 4 cyclophosphamide ................................................ 15 cycloserine.............................................................. 9 cytarabine............................................................. 15 dacarbazine .......................................................... 15 dactinomycin........................................................ 15 dapsone ................................................................ 8 daunorubicin........................................................ 15 deferoxamine ....................................................... 5 dexamethasone.............................................. 4, 16 diazepam.......................................................... 3, 5 didanosine (ddI) ................................................ 10 diethylcarbamazine ................................................ 6 digoxin................................................................ 17 diloxanide........................................................... 12 dimercaprol.......................................................... 5 diphtheria antitoxin .......................................... 22 diphtheria vaccine............................................. 22 dithranol............................................................. 18 dopamine.............................................................. 17 doxorubicin .......................................................... 15 doxycycline .................................................... 7, 13 efavirenz (EFV or EFZ)..................................... 11 eflornithine......................................................... 14 emtricitabine (FTC) ........................................... 11 epinephrine (adrenaline).........................4, 23, 24 erythromycin ....................................................... 8 ethambutol ........................................................... 9 ethanol ................................................................ 19 ethionamide............................................................ 9 ethosuximide .......................................................... 5 etoposide............................................................... 15 factor IX complex (coagulation factors, II, VII, IX, X) concentrate................................................. 17 factor VIII concentrate ......................................... 17 ferrous salt.......................................................... 16 fluconazole ......................................................... 10 flucytosine............................................................ 10 fluorescein .......................................................... 19 fluorouracil .......................................................... 15 fluoxetine ............................................................. 24 folic acid ............................................................. 16
WHO Model List of Essential Medicines for Children (October 2007) -- page 28
furosemide ................................................... 17, 19 gentamicin...................................................... 8, 23 glucose ................................................................ 25 glucose with sodium chloride ......................... 25 glutaral................................................................ 19 griseofulvin ........................................................ 10 Haemophilus influenzae type b vaccine............. 22 haloperidol ......................................................... 24 halothane .............................................................. 3 heparin sodium..................................................... 16 hepatitis A vaccine ............................................ 22 hepatitis B vaccine............................................. 22 human normal immunoglobulin .......................... 17 hydrochlorothiazide.............................................. 19 hydrocortisone......................................... 4, 16, 18 hydroxocobalamin ............................................ 16 ibuprofen ........................................................ 3, 14 imipenem + cilastatin............................................. 7 influenza vaccine............................................... 22 insulin injection (soluble) ................................. 21 intermediate?acting insulin.............................. 21 intraperitoneal dialysis solution (of appropriate composition) .................................................... 24 iodine .................................................................. 26 isoniazid ............................................................... 9 ivermectin............................................................. 6 Japanese encephalitis vaccine.......................... 22 kanamycin.............................................................. 9 ketamine ............................................................... 3 lamivudine (3TC) .............................................. 11 levamisole............................................................. 6 levothyroxine ..................................................... 21 lidocaine ............................................................... 3 lidocaine + epinephrine (adrenaline)................ 3 lopinavir + ritonavir (LPV/r)............................ 11 Lugol?s solution ................................................... 21 magnesium hydroxide...................................... 19 mannitol............................................................... 19 measles vaccine ................................................. 22 mebendazole ........................................................ 6 mefloquine ......................................................... 13 melarsoprol ........................................................ 14 meningococcal meningitis vaccine ................. 22 mercaptopurine .................................................... 15 metformin............................................................. 21 methotrexate......................................................... 15 methylrosanilinium chloride (gentian violet) 18 metoclopramide................................................. 20 metronidazole................................................ 8, 12 miconazole ......................................................... 18 morphine .......................................................... 3, 4 mumps vaccine.................................................. 22 naloxone ............................................................... 5 nelfinavir (NFV) ................................................ 11
neomycin sulfate + bacitracin .......................... 18 neostigmine........................................................ 23 nevirapine (NVP) .............................................. 11 niclosamide .......................................................... 6 nifurtimox .......................................................... 14 nitrofurantoin ...................................................... 8 nitrous oxide ........................................................ 3 nystatin ............................................................... 10 ofloxacin................................................................. 9 oral rehydration salts.................................. 20, 25 oxamniquine .......................................................... 6 oxygen .................................................................. 3 p?aminosalicylic acid.............................................. 9 paracetamol.................................................... 3, 14 paromomycin..................................................... 12 penicillamine ....................................................... 5 pentamidine ....................................................... 14 permethrin ......................................................... 18 pertussis vaccine ............................................... 22 phenoxymethylpenicillin ................................... 7 phenytoin ............................................................. 5 phytomenadione ............................................... 16 pneumococcal vaccine...................................... 22 podophyllum resin ........................................... 18 poliomyelitis vaccine ........................................ 22 polyvidone iodine ............................................. 19 potassium chloride............................................ 25 potassium iodide ............................................ 10, 21 potassium permanganate................................. 18 praziquantel......................................................... 6 prednisolone .............................................4, 16, 23 primaquine......................................................... 13 procaine benzylpenicillin................................... 7 procarbazine......................................................... 15 proguanil............................................................ 13 promethazine..................................................... 20 propranolol ........................................................ 14 propylthiouracil ................................................... 21 protamine sulfate ................................................. 16 pyrantel ................................................................ 6 pyrazinamide....................................................... 9 pyridostigmine ..................................................... 23 pyridoxine .......................................................... 26 pyrimethamine .................................................. 14 quinine................................................................ 13 rabies immunoglobulin .................................... 22 rabies vaccine..................................................... 22 ranitidine ............................................................ 20 retinol.................................................................. 26 ribavirin.............................................................. 12 riboflavin ............................................................ 26 rifampicin ......................................................... 8, 9 rifampicin + isoniazid ......................................... 9 rifampicin + isoniazid + pyrazinamide ............ 9
WHO Model List of Essential Medicines for Children (October 2007) -- page 29
ritonavir .............................................................. 11 rotavirus vaccine ............................................... 22 rubella vaccine ................................................... 23 salbutamol.......................................................... 25 salicylic acid ....................................................... 18 saquinavir (SQV) ............................................... 11 selenium sulfide ................................................... 18 silver sulfadiazine ............................................. 18 sodium calcium henobar .................................... 5 sodium chloride................................................. 25 sodium fluoride ................................................. 26 sodium hydrogen carbonate............................ 25 sodium lactate, compound solution ............... 25 sodium stibogluconate or meglumine antimoniate.................................................... 12 spironolactone ...................................................... 19 stavudine (d4T).................................................. 11 stavudine + lamivudine + nevirapine ............. 12 streptomycin ........................................................ 9 sulfadiazine ............................................................ 8 sulfadoxine + pyrimethamine.......................... 13 sulfamethoxazole + trimethoprim............... 8, 14 suramin sodium ................................................ 14 suxamethonium................................................. 23
tetanus vaccine .................................................. 23 tetracaine ............................................................ 23 tetracycline ......................................................... 23 thiamine.............................................................. 26 thiopental ............................................................. 3 triclabendazole .................................................... 6 trimethoprim ....................................................... 8 tropicamide ........................................................ 19 tuberculin, purified protein derivative (PPD)21 typhoid vaccine ................................................. 23 urea ..................................................................... 18 valproic acid (sodium valproate)...................... 5 vancomycin ............................................................ 8 varicella vaccine ................................................ 23 vecuronium........................................................ 23 vinblastine............................................................ 15 vincristine ............................................................ 15 warfarin ............................................................... 16 water for injection ............................................. 25 yellow fever vaccine ......................................... 23 zidovudine (ZDV or AZT) ............................... 11 zidovudine + lamivudine................................. 12 zidovudine + lamivudine + nevirapine .......... 12 zinc sulfate ......................................................... 20
WHO Model List of Essential Medicines for Children (October 2007) -- page 30
doc_269673018.pdf
The report explains the model list given by World Health Organisation WHO on essential medicines used for children.
WHO Model List of Essential Medicines for Children
First List, October 2007 Status of this document This is a reprint of the text on the WHO Medicines web site http://www.who.int/medicines/publications/essentialmedicines/en/index.html
WHO Model List of Essential Medicines for Children Explanatory Notes
This Model List is intended for use for children up to 12 years of age. The core list presents a list of minimum medicine needs for a basic health care system, listing the most efficacious, safe and cost?effective medicines for priority conditions. Priority conditions are selected on the basis of current and estimated future public health relevance, and potential for safe and cost?effective treatment. The complementary list presents essential medicines for priority diseases, for which specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training are needed. In case of doubt medicines may also be listed as complementary on the basis of consistent higher costs or less attractive cost?effectiveness in a variety of settings. The square box symbol ( ) is primarily intended to indicate similar clinical performance within a pharmacological class. The listed medicine should be the example of the class for which there is the best evidence for effectiveness and safety. In some cases, this may be the first medicine that is licensed for marketing; in other instances, subsequently licensed compounds may be safer or more effective. Where there is no difference in terms of efficacy and safety data, the listed medicine should be the one that is generally available at the lowest price, based on international drug price information sources. Therapeutic equivalence is only indicated on the basis of reviews of efficacy and safety and when consistent with WHO clinical guidelines. National lists should not use a similar symbol and should be specific in their final selection, which would depend on local availability and price. Medicines are listed in alphabetical order, within sections. The format and numbering of the 15th WHO Model List of Essential Medicines have been retained but, as indicated in the text, some sections have been deleted because they contain medicines that are not relevant for children. In the List of Essential Medicines for Children, two additional symbols are used.
a indicates that there is an age restriction on use of the medicines; the details for each
medicine are in Table 1. R indicates that the Subcommittee has endorsed the medicine as essential but has requested a review of the efficacy and safety to confirm this decision, or to expand use to additional age groups.
WHO Model List of Essential Medicines for Children (October 2007) -- page 1
The listing of a medicine on the Essential Medicines List carries no assurance as to pharmaceutical quality of an individual product. It is the responsibility of each local regulatory authority to ensure that each brand is of appropriate pharmaceutical quality (including stability) and that, when relevant, different brands are interchangeable. Dosage forms of medicines are listed in alphabetical order and there is no implication of preference for one form over another. Standard treatment guidelines should be consulted for information on appropriate dosage forms. Entries of the type oral liquid are intended to permit any solution, suspension or other form of liquid. Granules or powder for reconstitution as an oral liquid may substitute for oral liquids, and typically carry benefits in the form of better stability and lower transport costs. If more than one type of oral liquid is available on the same market (e.g. solution, suspension, granules or powder for reconstitution), they may be interchanged and in such cases should be bioequivalent. It is preferable that oral liquids do not contain sugar and that solutions for children do not contain alcohol. Entries of the type tablet are intended to allow various forms of immediate?release tablet such as scored, uncoated, film?coated, crushable, chewable, dispersible etc. Enteric coating, on the other hand, modifies drug release, and enteric?coated products are a modified?release dosage form. Crushable, chewable and dispersible tablets may be easier to administer to paediatric populations and to the elderly.
WHO Model List of Essential Medicines for Children (October 2007) -- page 2
1. ANAESTHETICS
1.1 General anaesthetics and oxygen
halothane R
Inhalation. R Review for alternative inhalational agents. Injection: 50 mg (as hydrochloride)/ml in 10?ml vial. Inhalation. Inhalation (medicinal gas). Powder for injection: 0.5 g; 1.0 g (sodium salt) in ampoule.
ketamine nitrous oxide oxygen thiopental 1.2 Local anaesthetics
Injection: 0.25%; 0.5% (hydrochloride) in vial.
bupivacaine
Injection for spinal anaesthesia: 0.5% (hydrochloride) in 4?ml ampoule to be mixed with 7.5% glucose solution. Injection: 1%; 2% (hydrochloride) in vial.
lidocaine
Injection for spinal anaesthesia: 5% (hydrochloride) in 2?ml ampoule to be mixed with 7.5% glucose solution. Topical forms: 2% to 4% (hydrochloride).
lidocaine + epinephrine (adrenaline)
Dental cartridge: 2% (hydrochloride) + epinephrine 1:80 000. Injection: 1%; 2% (hydrochloride) + epinephrine 1:200 000 in vial.
1.3 Preoperative medication and sedation for short-term procedures atropine R Injection: 1 mg (sulfate) in 1?ml ampoule. R
Relevance to current clinical practice?
Injection: 5 mg/ml in 2?ml ampoule.
diazepam R
Tablet: 5 mg. R
Alternatives such as midazolam preferable?
morphine R
Injection: 10 mg (sulfate or hydrochloride) in 1?ml ampoule. R
Need for review for the next meeting.
2. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY MEDICINES (NSAIMs), MEDICINES USED TO TREAT GOUT AND DISEASE MODIFYING AGENTS IN RHEUMATOID DISORDERS (DMARDs)
2.1 Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) Tablet: 200 mg; 400 mg. ibuprofen a R a >3 months. R Use in children, focusing on comparative analgesic efficacy and
safety, include role of injection form in patent ductus arteriosus.
Oral liquid: 125 mg/5 ml. Suppository: 100 mg. paracetamol* Tablet: 100 mg to 500 mg. * Not recommended for anti?inflammatory use due to lack of proven benefit to that effect.
WHO Model List of Essential Medicines for Children (October 2007) -- page 3
Complementary List Suppository: 50 mg to 150 mg. acetylsalicylic acid* Tablet: 100 mg to 500 mg. * For use for rheumatic fever, juvenile arthritis, Kawasaki disease. 2.2 Opioid analgesics codeine Tablet: 15 mg (phosphate). Injection: 10 mg (morphine hydrochloride or morphine sulfate) in 1?ml ampoule. Oral liquid: 10 mg (morphine hydrochloride or morphine sulfate)/5 ml. Tablet: 10 mg (morphine sulfate). Tablet (prolonged release): 10 mg; 30 mg; 60 mg (morphine sulfate). 2.3 Medicines used to treat gout 2.4 Disease modifying agents used in rheumatoid disorders (DMARDs)R R The Subcommittee noted that there is a need for medicines for the treatment of juvenile arthritis but did not endorse any of the currently listed medicines at this time, requesting a review of this section.
morphine
3. ANTIALLERGICS AND MEDICINES USED IN ANAPHYLAXIS
Injection: 10 mg (hydrogen maleate) in 1?ml ampoule. Oral liquid: 2 mg/5 ml.
chlorphenamine a R
Tablet: 4 mg (hydrogen maleate). a >1 year. R Review of diphenhydramine to assess comparative efficacy and safety
with chlorphenamine as a possible preferable alternative.
dexamethasone epinephrine (adrenaline) hydrocortisone
prednisolone
Injection: 4 mg dexamethasone phosphate (as disodium salt) in 1?ml ampoule. Injection: 1 mg (as hydrochloride or hydrogen tartrate) in 1?ml ampoule. Powder for injection: 100 mg (as sodium succinate) in vial. Oral liquid: 5mg/ml. Tablet: 5 mg; 25 mg.
4. ANTIDOTES AND OTHER SUBSTANCES USED IN POISONINGS
4.1 Non-specific charcoal, activated 4.2 Specific R R The Subcommittee recommended that this section be reviewed for its next meeting. acetylcysteine atropine calcium gluconate Injection: 200 mg/ml in 10?ml ampoule. Injection: 1 mg (sulfate) in 1?ml ampoule. Injection: 100 mg/ml in 10?ml ampoule. Powder.
WHO Model List of Essential Medicines for Children (October 2007) -- page 4
deferoxamine dimercaprol naloxone penicillamine R
Powder for injection: 500 mg (mesilate) in vial. Injection in oil: 50 mg/ml in 2?ml ampoule. Injection: 400 micrograms (hydrochloride) in 1?ml ampoule. Capsule or tablet: 250 mg. R
Comparative effectiveness and safety versus sodium calcium edetate.
sodium calcium edetate R
Injection: 200 mg/ml in 5?ml ampoule. R
Comparative effectiveness and safety versus penicillamine.
5. ANTICONVULSANTS/ANTIEPILEPTICS
Oral liquid: 100 mg/5 ml. carbamazepine Tablet (chewable): 100 mg; 200 mg. Tablet (scored): 100 mg; 200 mg. Injection: 5 mg/ml in 2?ml ampoule (intravenous or rectal).
diazepam R
R
Review of benzodiazepines as alternative to diazepam (specifically consider comparative efficacy and safety of lorazepam and midazolam in relation to diazepam).
Injection: 200 mg/ml (phenobarbital sodium). phenobarbital Oral liquid: 15 mg/5 ml (phenobarbital) or 5 ml (phenobarbital sodium). Tablet: 15 mg to 100 mg (phenobarbital). Capsule: 25 mg; 50 mg; 100 mg (sodium salt). Injection: 50 mg/ml in 5?ml vial (sodium salt). Oral liquid: 25 mg to 30 mg/5 ml.* phenytoin Tablet: 25 mg; 50 mg; 100 mg (sodium salt). Tablet (chewable): 50 mg. * The presence of both 25 mg/5 ml and 30 mg/5 ml strengths on the same market would cause confusion in prescribing and dispensing and should be avoided. Oral liquid: 200 mg/5 ml. valproic acid (sodium valproate) Tablet (crushable): 100 mg. Tablet (enteric?coated): 200 mg; 500 mg (sodium salt). Complementary List ethosuximide Capsule: 250 mg. Oral liquid: 250 mg/5 ml.
6. ANTI-INFECTIVE MEDICINES
6.1 Anthelminthics R R
Review evidence of efficacy and safety of use of anthelminth/antifilarial/antischistosomal and antitrematode medicines in children below the specified age in current licences.
6.1.1 Intestinal anthelminthics R albendazole Tablet (chewable): 400 mg.
WHO Model List of Essential Medicines for Children (October 2007) -- page 5
levamisole
mebendazole
Tablet: 50 mg; 150 mg (as hydrochloride). Tablet (chewable): 100 mg; 500 mg. Tablet (chewable): 500 mg. * Niclosamide is listed for use when praziquantel treatment fails. Tablet: 150 mg; 600 mg. Oral liquid: 50 mg (as embonate)/ml. Tablet (chewable): 250 mg (as embonate).
niclosamide* praziquantel pyrantel 6.1.2 Antifilarials R ivermectin Complementary List diethylcarbamazine
Tablet (scored): 3 mg; 6 mg.
Tablet: 50 mg; 100 mg (dihydrogen citrate).
6.1.3 Antischistosomals and antitrematode medicine R praziquantel triclabendazole Complementary List Capsule: 250 mg. oxamniquine* Oral liquid: 250 mg/5 ml. * Oxamniquine is listed for use when praziquantel treatment fails. 6.2 Antibacterials 6.2.1 Beta Lactam medicines Capsule or tablet: 250 mg; 500 mg (anhydrous). amoxicillin Powder for oral liquid: 125 mg (anhydrous)/5 ml; 250 mg (anhydrous)/5 ml. Oral liquid: 125 mg amoxicillin + 31.25 mg clavulanic acid/5 ml AND 250 mg amoxicillin + 62.5 mg clavulanic acid/5 ml. Tablet: 500 mg + 125 mg. ampicillin benzathine benzylpenicillin benzylpenicillin Powder for injection: 500 mg; 1 g (as sodium salt) in vial. Powder for injection: 900 mg benzylpenicillin (=1.2 million IU) in 5?ml vial; 1.44 g benzylpenicillin (=2.4 million IU) in 5?ml vial. Powder for injection: 600 mg (= 1 million IU); 3 g (= 5 million IU) (sodium or potassium salt) in vial. Powder for injection: 1 g (as sodium salt) in vial. cefazolin* a * For surgical prophylaxis. a ceftriaxone R
>1 month.
Tablet: 600 mg. Tablet: 250 mg.
amoxicillin + clavulanic acid
Powder for injection: 250 mg, 1 g (as sodium salt) in vial. R Review for safety of use in neonates.
WHO Model List of Essential Medicines for Children (October 2007) -- page 6
Capsule: 500 mg; 1 g (as sodium salt).
cloxacillin
Powder for injection: 500 mg (as sodium salt) in vial. Powder for oral liquid: 125 mg (as sodium salt)/5 ml.
phenoxymethylpenicillin
Powder for oral liquid: 250 mg (as potassium salt)/5 ml. Tablet: 250 mg (as potassium salt). Powder for injection: 1 g (=1 million IU); 3 g (=3 million IU) in vial. a Not in neonates />1 month. R Review use of procaine penicillin in neonates.
procaine benzylpenicillin a R
Complementary List Powder for injection: 250 mg (as pentahydrate) in vial. ceftazidime R R Review the use of ceftazidime (predominantly for pseudomonas infections) - are there preferred alternatives for use in children? Powder for injection: 250 mg (as monohydrate) + 250 mg (as sodium salt); 500 mg (as monohydrate) + 500 mg (as sodium salt) in vial. imipenem* + cilastatin* R * Only listed for the treatment of life?threatening hospital?based infection due to suspected or proven multidrug?resistant infection. R 6.2.2 Other antibacterials Capsule: 250 mg or 500 mg. azithromycin* a Oral liquid: 200 mg/5 ml. * Only listed for trachoma. a
>6 months. Review the use of meropenem and other penems as alternative to imipenem, specifically identifying agents useful in all age groups.
Capsule: 250 mg. Oily suspension for injection*: 0.5 g (as sodium succinate)/ml in 2?ml ampoule chloramphenicol * Only for the presumptive treatment of epidemic meningitis in children older than 2 years. Oral liquid: 150 mg (as palmitate)/5 ml. Powder for injection: 1 g (sodium succinate) in vial. Tablet: 250 mg (as hydrochloride). ciprofloxacin* R * Only for treatment of Shigella infections. R
Review of appropriate use of fluroquinolones in children.
Capsule or tablet: 100 mg (hydrochloride). doxycycline* R * For the treatment of cholera. R
Review comparative safety and efficacy of tetracyclines (are tetracyclines other than doxycycline appropriate for this indication and therefore a square box listing is appropriate?).
WHO Model List of Essential Medicines for Children (October 2007) -- page 7
Capsule or tablet: 250 mg (as stearate or ethyl succinate). Powder for injection: 500 mg (as lactobionate) in vial. erythromycin R Powder for oral liquid: 125 mg (as stearate or ethyl succinate). R
Review macrolides used in children for specific indications and whether erythromycin is the appropriate listed medicine. Review to consider use in neonates (risk of pyloric stenosis with erythromycin), relative toxicity and dosing compared to other macrolides. Include consideration of use of other macrolides for rheumatic fever.
gentamicin R
Injection: 10 mg; 40 mg (as sulfate)/ml in 2?ml vial. R
Review of evidence on ototoxicity for the next meeting.
Injection: 500 mg in 100?ml vial. metronidazole Oral liquid: 200 mg (as benzoate)/5 ml. Tablet: 200 mg to 500 mg. nitrofurantoin Oral liquid: 25 mg/5 ml. Tablet: 100 mg. Injection: 80 mg + 16 mg/ml in 5?ml and 10?ml ampoules. sulfamethoxazole + trimethoprim Oral liquid: 200 mg + 40 mg/5 ml. Tablet: 100 mg + 20 mg; 400 mg + 80 mg. Oral liquid: 50 mg/5 ml. trimethoprim a Tablet: 100 mg; 200 mg. a Complementary List Capsule: 150 mg. clindamycin a Injection: 150 mg (as phosphate)/ml. Oral liquid: 75 mg/5 ml. a
>1 month. >6 months.
Injection: 250 mg (sodium salt) in 4?ml ampoule. sulfadiazine R Tablet: 500 mg. R vancomycin 6.2.3 Antileprosy medicines Medicines used in the treatment of leprosy should never be used except in combination. Combination therapy is essential to prevent the emergence of drug resistance. Colour coded blister packs (MDT blister packs) containing standard two medicine (paucibacillary leprosy) or three medicine (multibacillary leprosy) combinations for adult and childhood leprosy should be used. MDT blister packs can be supplied free of charge through WHO. clofazimine dapsone rifampicin Capsule: 50 mg; 100 mg. Tablet: 25 mg; 50 mg; 100 mg. Capsule or tablet: 150 mg; 300 mg.
Review on use of sulfadiazine in children - especially safety, efficacy and dosing in toxoplasmosis.
Powder for injection: 250 mg (as hydrochloride) in vial.
WHO Model List of Essential Medicines for Children (October 2007) -- page 8
6.2.4 Antituberculosis medicines R R
The Subcommittee requested a review of medicines used for TB in children, including evidence regarding dose, and alternatives for streptomycin.
ethambutol
Oral liquid: 25 mg/ml. Tablet: 100 mg; 400 mg (hydrochloride). Oral liquid: 50 mg/5 ml.
isoniazid
Tablet: 100 mg; 300 mg. Tablet (scored): 50 mg. Oral liquid: 30 mg/ml.
pyrazinamide
Tablet: 400 mg. Tablet (dispersible): 150 mg. Tablet (scored): 150 mg.
rifampicin
Capsule or tablet: 150 mg; 300 mg. Oral liquid: 20 mg/ml. Tablet:
rifampicin + isoniazid
60 mg + 30 mg. 60 mg + 60 mg (For intermittent use three times weekly).
rifampicin + isoniazid + pyrazinamide streptomycin Complementary List
Tablet: 60 mg + 30 mg + 150 mg. Powder for injection: 1 g (as sulfate) in vial.
Reserve second?line drugs for the treatment of multidrug?resistant tuberculosis (MDR?TB) should be used in specialized centres adhering to WHO standards for TB control. R R The Subcommittee has included these in recognition of the need for medicines for MDR-TB in children, but
has not reviewed evidence at this meeting and therefore the section should be reviewed for the next meeting.
amikacin capreomycin cycloserine ethionamide kanamycin
Powder for injection: 1000 mg in vial. Powder for injection: 1000 mg in vial. Capsule or tablet: 250 mg. Tablet: 125 mg; 250 mg. Powder for injection: 1000 mg in vial. Tablet: 200 mg; 400 mg.
ofloxacin*
* Levofloxacin may be an alternative based on availability and programme considerations. Granules: 4 g in sachet. Tablet: 500 mg.
p?aminosalicylic acid
WHO Model List of Essential Medicines for Children (October 2007) -- page 9
6.3 Antifungal medicines Capsule: 50 mg. fluconazole Injection: 2 mg/ml in vial. Oral liquid: 50 mg/5 ml. griseofulvin Capsule or tablet: 125 mg; 250 mg. Oral liquid: 125 mg/5ml. Lozenge: 100 000 IU. nystatin Oral liquid: 50 mg/5 ml; 100 000 IU/ml. Tablet: 100 000 IU; 500 000 IU. Complementary List amphotericin B flucytosine potassium iodide 6.4 Antiviral medicines 6.4.1 Antiherpes medicines Oral liquid: 200 mg/5 ml. aciclovir Powder for injection: 250 mg (as sodium salt) in vial. Tablet: 200 mg. 6.4.2 Antiretrovirals Based on current evidence and experience of use, medicines in the following three classes of antiretrovirals are included as essential medicines for treatment and prevention of HIV (prevention of mother?to?child transmission and post exposure prophylaxis). The Subcommittee emphasizes the importance of using these products in accordance with global and national guidelines. The Subcommittee recommends and endorses the use of fixed?dose combinations and the development of appropriate new fixed?dose combinations, including modified dosage forms, non?refrigerated products and paediatric dosage forms with assured pharmaceutical quality. The Subcommittee notes that scored tablets can be used in children and therefore can be considered for inclusion in the listing of tablets, provided adequate quality products are available. 6.4.2.1 Nucleoside/Nucleotide reverse transcriptase inhibitors abacavir (ABC) Oral liquid: 100 mg (as sulfate)/5 ml. Tablet: 300 mg (as sulfate). Buffered powder for oral liquid: 100 mg; 167 mg; 250 mg packets. didanosine (ddI) Capsule (unbuffered enteric?coated): 125 mg; 200 mg; 250 mg; 400 mg. Tablet (buffered chewable, dispersible): 25 mg; 50 mg; 100 mg; 150 mg; 200 mg. Powder for injection: 50 mg in vial. Capsule: 250 mg. Infusion: 2.5 g in 250 ml. Saturated solution.
WHO Model List of Essential Medicines for Children (October 2007) -- page 10
Capsule: 200 mg. Oral liquid: 10 mg/ml. emtricitabine (FTC)* a * FTC is an acceptable alternative to 3TC, based on knowledge of the pharmacology, the resistance patterns and clinical trials of antiretrovirals. a lamivudine (3TC)
>3 months.
Oral liquid: 50 mg/5 ml. Tablet: 150 mg. Capsule: 15 mg; 20 mg; 30 mg. Powder for oral liquid: 5 mg/5 ml. Capsule: 100 mg; 250 mg.
stavudine (d4T)
zidovudine (ZDV or AZT)
Oral liquid: 50 mg/5 ml. Solution for IV infusion injection: 10 mg/ml in 20?ml vial. Tablet: 300 mg.
6.4.2.2 Non-nucleoside reverse transcriptase inhibitors Capsule: 50 mg; 100 mg; 200 mg. efavirenz (EFV or EFZ) a Oral liquid: 150 mg/5 ml. Tablet: 600 mg. a nevirapine (NVP) 6.4.2.3 Protease inhibitors Selection of protease inhibitor(s) from the Model List will need to be determined by each country after consideration of international and national treatment guidelines and experience. Ritonavir is recommended for use in combination as a pharmacological booster, and not as an antiretroviral in its own right. This section will be reviewed. It is expected that application for a heat?stable tablet formulation containing 200/50 mg lopinavir + ritonavir will be submitted for the next meeting. lopinavir + ritonavir (LPV/r) Capsule: 133.3 mg + 33.3 mg. Oral liquid: 400 mg + 100 mg/5 ml. Oral powder: 50 mg/g. Tablet: 250 mg (as mesilate). Oral liquid: 400 mg/5 ml. Oral solid dosage form: 100 mg. Capsule: 200 mg. a
>25 kg weight. >3 years or >10 kg weight.
Oral liquid: 50 mg/5 ml. Tablet: 200 mg.
nelfinavir (NFV)
ritonavir
saquinavir (SQV) a
WHO Model List of Essential Medicines for Children (October 2007) -- page 11
FIXED-DOSE COMBINATIONS stavudine + lamivudine + nevirapine zidovudine + lamivudine zidovudine + lamivudine + nevirapine 6.4.3 Other antivirals Injection for intravenous administration: 800 mg and 1000 mg in 10?ml phosphate buffer solution. ribavirin* Oral solid dosage forms: 200 mg; 400 mg; 600 mg. * For the treatment of viral haemorrhagic fevers only. 6.5 Antiprotozoal medicines 6.5.1 Antiamoebic and antigiardiasis medicines Tablet: 500 mg (furoate). diloxanide a R a
>25 kg weight.
Tablet: 30 mg + 150 mg + 200 mg. Tablet: 300 mg + 150 mg. Tablet: 300 mg + 150 mg + 200 mg.
R Review of effectiveness and safety for amoebiasis, with emphasis on
comparative efficacy, safety, and age limits compared with oral paromomycin.
Injection: 500 mg in 100?ml vial.
metronidazole
Oral liquid: 200 mg (as benzoate)/5 ml. Tablet: 200 mg to 500 mg.
6.5.2 Antileishmaniasis medicines paromomycin sodium stibogluconate or meglumine antimoniate Complementary List amphotericin B Powder for injection: 50 mg in vial. Solution for intramuscular injection: 750 mg of paromomycin base present as the sulfate. Injection: 100 mg/ml, 1 vial = 30 ml or 30%, equivalent to approximately 8.1% antimony in 5?ml ampoule.
6.5.3 Antimalarial medicines 6.5.3.1 For curative treatment Medicines for the treatment of P. falciparum malaria cases should be used in combination. The list currently recommends combinations according to treatment guidelines. The Subcommittee recognizes that not all of these FDCs exist and encourages their development and rigorous testing. The Subcommittee also encourages development and testing of rectal dosage formulations. Tablet: 153 mg or 200 mg (as hydrochloride). amodiaquine* * To be used (a) in combination with artesunate 50 mg OR (b) may be used alone for the treatment of P.vivax, P.ovale and P.malariae infections. Oily injection: 80 mg/ml in 1?ml ampoule. For use in the management of severe malaria.
WHO Model List of Essential Medicines for Children (October 2007) -- page 12
artemether
Tablet: 20 mg + 120 mg. artemether + lumefantrine* * Not recommended in the first trimester of pregnancy or in children below 5 kg. Injection: ampoules, containing 60 mg anhydrous artesunic acid with a separate ampoule of 5% sodium bicarbonate solution. For use in the management of severe malaria. artesunate* Rectal dosage form: 50 mg; 200 mg capsules (for pre?referral treatment of severe malaria only; patients should be taken to an appropriate health facility for follow?up care). Tablet: 50 mg. * To be used in combination with either amodiaquine, mefloquine or sulfadoxine + pyrimethamine. Oral liquid: 50 mg (as phosphate or sulfate)/5 ml. chloroquine* Tablet: 100 mg; 150 mg (as phosphate or sulfate). * For use only in central American regions, for use for P.vivax. Capsule: 100 mg (as hydrochloride). doxycycline* Tablet (dispersible): 100 mg (as monohydrate). * For use only in combination with quinine. mefloquine* Tablet: 250 mg (as hydrochloride). * To be used in combination with artesunate 50 mg. Tablet: 7.5 mg; 15 mg (as diphosphate). primaquine* * Only for use to achieve radical cure of P.vivax and P.ovale infections, given for 14 days. Injection: 300 mg quinine hydrochloride/ml in 2?ml ampoule. quinine* Tablet: 300 mg (quinine sulfate) or 300 mg (quinine bisulfate). * For use only in the management of severe malaria, and should be used in combination with doxycycline. sulfadoxine + pyrimethamine* 6.5.3.2 For prophylaxis Oral liquid: 50 mg (as phosphate or sulfate)/5 ml. chloroquine* Tablet: 150 mg (as phosphate or sulfate). * For use only in central American regions, for use for P.vivax. doxycycline a Capsule or tablet: 100 mg (as hydrochloride). a
>8 years.
Tablet: 500 mg + 25 mg. * Only in combination with artesunate 50 mg.
mefloquine a
Tablet: 250 mg (as hydrochloride). a
>5 kg or >3 months.
proguanil*
Tablet: 100 mg (as hydrochloride). * For use only in combination with chloroquine.
WHO Model List of Essential Medicines for Children (October 2007) -- page 13
6.5.4 Anti-pneumocystosis and antitoxoplasmosis medicines pyrimethamine Tablet: 25 mg. Injection: 80 mg + 16 mg/ml in 5?ml ampoule; 80 mg + 16 mg/ml in 10?ml ampoule. sulfamethoxazole + trimethoprim Oral liquid: 200 mg + 40 mg/5 ml. Tablet: 100 mg + 20 mg; 400 mg + 80 mg. 6.5.5 Antitrypanosomal medicines R R The Subcommittee requested a review of evidence for effectiveness and safety for medicines for trypanosomiasis in children for the next meeting. 6.5.5.1 African trypanosomiasis Medicines for the treatment of 1st stage African trypanosomiasis Powder for injection: 200 mg (pentamidine isetionate) in vial. pentamidine* * To be used for the treatment of Trypanosoma brucei gambiense infection. Powder for injection: 1 g in vial. * To be used for the treatment of the initial phase of Trypanosoma brucei rhodesiense infection. Medicines for the treatment of 2nd stage African trypanosomiasis eflornithine melarsoprol Injection: 200 mg (hydrochloride)/ml in 100?ml bottle. Injection: 3.6% solution, 5?ml ampoules (180 mg of active compound).
suramin sodium*
6.5.5.2 American trypanosomiasis benznidazole nifurtimox Tablet: 100 mg. Tablet: 30 mg; 120 mg; 250 mg.
7. ANTIMIGRAINE MEDICINES
7.1 For treatment of acute attack ibuprofen paracetamol 7.2 For prophylaxis propranolol Tablet: 20 mg; 40 mg (hydrochloride). Tablet: 200 mg; 400 mg. Syrup: 125 mg/5 ml. Tablet: 300 mg to 500 mg.
WHO Model List of Essential Medicines for Children (October 2007) -- page 14
8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES AND MEDICINES USED IN PALLIATIVE CARE R
R
The Subcommittee noted that these immunosuppressives and cytotoxics are essential for children but requested that these medicines be reviewed for the next meeting.
8.1 Immunosuppressive medicines Complementary List azathioprine Powder for injection: 100 mg (as sodium salt) in vial. Tablet: 50 mg. Capsule: 25 mg. ciclosporin 8.2 Cytotoxic medicines Complementary List allopurinol asparaginase bleomycin calcium folinate chlorambucil cisplatin cyclophosphamide cytarabine dacarbazine dactinomycin daunorubicin doxorubicin etoposide fluorouracil mercaptopurine methotrexate procarbazine vinblastine vincristine Tablet: 100 mg to 300 mg. Powder for injection: 10 000 IU in vial. Powder for injection: 15 mg (as sulfate) in vial. Injection: 3 mg/ml in 10?ml ampoule. Tablet: 15 mg. Tablet: 2 mg. Powder for injection: 10 mg; 50 mg in vial. Powder for injection: 500 mg in vial. Tablet: 25 mg. Powder for injection: 100 mg in vial. Powder for injection: 100 mg in vial. Powder for injection: 500 micrograms in vial. Powder for injection: 50 mg (as hydrochloride). Powder for injection: 10 mg; 50 mg (hydrochloride) in vial. Capsule: 100 mg. Injection: 20 mg/ml in 5?ml ampoule. Injection: 50 mg/ml in 5?ml ampoule. Tablet: 50 mg. Powder for injection: 50 mg (as sodium salt) in vial. Tablet: 2.5 mg (as sodium salt). Capsule: 50 mg (as hydrochloride). Powder for injection: 10 mg (sulfate) in vial. Powder for injection: 1 mg; 5 mg (sulfate) in vial. Concentrate for injection: 50 mg/ml in 1?ml ampoule for organ transplantation.
WHO Model List of Essential Medicines for Children (October 2007) -- page 15
8.3 Hormones and antihormones Complementary List dexamethasone hydrocortisone Injection: 4 mg dexamethasone phosphate (as disodium salt) in 1?ml ampoule. Powder for injection: 100 mg (as sodium succinate) in vial. Oral liquid: 5 mg/ml. prednisolone* Tablet: 5 mg; 25 mg. * Prednisone should be considered equivalent to prednisolone. 8.4 Medicines used in palliative care The WHO Expert Committee recognizes the importance of listing specific medicines in the Palliative Care Section. Some medicines currently used in palliative care are included in the relevant sections of the Model List, according to their therapeutic use, e.g. analgesics. The Guidelines for Palliative Care that were referenced in the previous list are in need of update. The Expert Committee expects applications for medicines needed for palliative care to be submitted for the next meeting.
9. ANTIPARKINSONISM MEDICINES 10. MEDICINES AFFECTING THE BLOOD
10.1 Antianaemia medicines The Subcommittee proposed a review of the evidence for appropriate dose combinations of iron and folic acid for children for consideration at its next meeting. ferrous salt folic acid hydroxocobalamin Oral liquid: equivalent to 25 mg elemental iron/ml. Tablet: equivalent to 60 mg iron. Tablet: 1 mg; 5 mg. Injection: 1 mg in 1?ml ampoule.
10.2 Medicines affecting coagulation phytomenadione Complementary List heparin sodium protamine sulfate warfarin Injection: 1000 IU/ml; 5000 IU/ml; 20,000 IU/ml in 1?ml ampoule. Injection: 10 mg/ml in 5?ml ampoule. Tablet: 0.5 mg; 1.0 mg; 2.0 mg; 5.0 mg (sodium salt). Injection: 1 mg/ml; 10 mg/ml in 5?ml ampoule. Tablet: 10 mg.
11. BLOOD PRODUCTS AND PLASMA SUBSTITUTES
11.1 Plasma substitutes R R The Subcommittee requested a review to determine whether these medicines are essential for children.
WHO Model List of Essential Medicines for Children (October 2007) -- page 16
11.2 Plasma fractions for specific use All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992). (WHO Technical Report Series, No. 840, 1994, Annex 2). Complementary List Intramuscular administration: 16% protein solution.* Intravenous administration: 5%; 10% protein solution.** human normal immunoglobulin Subcutaneous administration: 15%; 16% protein solution.* * Indicated for primary immune deficiency. **Indicated for primary immune deficiency and Kawasaki disease. factor VIII concentrate factor IX complex (coagulation factors, II, VII, IX, X) concentrate Dried. Dried.
12. CARDIOVASCULAR MEDICINES
12.1 Antianginal medicines 12.2 Antiarrhythmic medicines R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 12.3 Antihypertensive medicines R R The Subcommittee noted the potential importance of these medicines in children but requested a review of
the section before endorsing any medicine as essential.
12.4 Medicines used in heart failure R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section for the next meeting. Injection: 250 micrograms/ml in 2?ml ampoule. digoxin Oral liquid: 50 micrograms/ml. Tablet: 62.5 micrograms; 250 micrograms. Injection: 10 mg/ml in 2?ml ampoule. furosemide Oral liquid: 20 mg/5 ml. Tablet: 40 mg. Complementary List Injection: 40 mg (hydrochloride)in 5?ml vial. dopamine R R
Review of safety and efficacy and place in therapy of dopamine in children.
12.5 Antithrombotic medicines R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 12.6 Lipid-lowering agents R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential.
WHO Model List of Essential Medicines for Children (October 2007) -- page 17
13. DERMATOLOGICAL MEDICINES (topical) R
R
The Subcommittee noted the need for a review of this section with alternative possible additions to the list.
13.1 Antifungal medicines benzoic acid + salicylic acid
miconazole
Ointment or cream: 6% + 3%. Ointment or cream: 2% (nitrate).
Complementary List selenium sulfide Detergent?based suspension: 2%.
13.2 Anti-infective medicines Aqueous solution: 0.5%.
methylrosanilinium chloride
(gentian violet) R neomycin sulfate + bacitracin potassium permanganate silver sulfadiazine a
Tincture: 0.5%. R
Review of new evidence from ongoing trials.
Ointment: 5 mg neomycin sulfate + 250 IU bacitracin zinc/g. Aqueous solution: 1:10 000. Cream: 1%, in 500?g container. a
>2 months.
13.3 Anti-inflammatory and antipruritic medicines
betamethasone a
Cream or ointment: 0.1% (as valerate). a
Hydrocortisone preferred in neonates.
calamine lotion hydrocortisone
Lotion. Cream or ointment: 1% (acetate).
13.4 Astringent medicines R R
The Subcommittee requested a review to determine whether these medicines are essential for children.
13.5 Medicines affecting skin differentiation and proliferation benzoyl peroxide coal tar dithranol podophyllum resin salicylic acid urea Cream or lotion: 5%. Solution: 5%. Ointment: 0.1% to 2.0%. Solution: 10% to 25%. Solution: 5%. Cream or ointment: 10%.
13.6 Scabicides and pediculicides Lotion: 25%.
benzyl benzoate a R
a >2 years. R Review of alternatives to benzyl benzoate for use in younger children
(possible role for sulphur-based preparations in younger children).
permethrin
Cream: 5%. Lotion: 1%.
WHO Model List of Essential Medicines for Children (October 2007) -- page 18
14. DIAGNOSTIC AGENTS
14.1 Ophthalmic medicines fluorescein
tropicamide
Eye drops: 1% (sodium salt). Eye drops: 0.5%.
14.2 Radiocontrast media R R The Subcommittee requested a review of possible alternative contrast agents for use in children. Complementary List barium sulfate Aqueous suspension.
15. DISINFECTANTS AND ANTISEPTICS
15.1 Antiseptics
chlorhexidine ethanol polyvidone iodine
Solution: 5% (digluconate) for dilution. Solution: 70% (denatured). Solution: 10%.
15.2 Disinfectants
chlorine base compound chloroxylenol
Powder: (0.1% available chlorine) for solution. Solution: 4.8%. Solution: 2%.
glutaral
16. DIURETICS
Injection: 10 mg/ml in 2?ml ampoule. furosemide Oral liquid: 20 mg/5 ml. Tablet: 10 mg; 20 mg; 40 mg. Complementary List
hydrochlorothiazide
Tablet (scored): 25 mg. Injectable solution: 10%; 20%.
mannitol R
R
Review of comparative efficacy, safety and place in therapy of mannitol in children.
Oral liquid: 1 to 20 mg/ml. spironolactone R Tablet: 25 mg. R
Review of comparative efficacy, safety and place in therapy of spironolactone in children.
17. GASTROINTESTINAL MEDICINES
17.1 Antacids and other antiulcer medicines aluminium hydroxide magnesium hydroxide Oral liquid: 320 mg/5 ml. Tablet: 500 mg. Oral liquid: equivalent to 550 mg magnesium oxide/10 ml.
WHO Model List of Essential Medicines for Children (October 2007) -- page 19
Injection: 25 mg/ml in 2?ml ampoule.
ranitidine
Oral liquid: 75 mg/5 ml. Tablet: 150 mg (as hydrochloride).
17.2 Antiemetic medicines Injection: 5 mg (hydrochloride)/ml in 2?ml ampoule. metoclopramide a
Oral liquid: 5 mg/5 ml. Tablet: 10 mg (hydrochloride). a
Not in neonates.
Injection: 25 mg (hydrochloride)/ml in 2?ml ampoule. promethazine a
Oral liquid: 5 mg (hydrochloride)/5 ml. Tablet: 10 mg; 25 mg (hydrochloride). a
>2 years.
17.3 Anti-inflammatory medicines 17.4 Laxatives R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 17.5 Medicines used in diarrhoea 17.5.1 Oral rehydration glucose: sodium: chloride: potassium: citrate: osmolarity: glucose: sodium chloride: potassium chloride: trisodium citrate dihydrate+: 75 mEq 75 mEq or mmol/l 65 mEq or mmol/l 20 mEq or mmol/l 10 mmol/l 245 mOsm/l 13.5 g/l 2.6 g/l 1.5 g/l 2.9 g/l
oral rehydration salts
+ trisodium citrate dihydrate may be replaced by sodium hydrogen carbonate (sodium bicarbonate) 2.5 g/l. However, as the stability of this latter formulation is very poor under tropical conditions, it is only recommended when manufactured for immediate use.
17.5.2 Medicines for diarrhoea in children Oral liquid: in 10 mg per unit dosage forms. Tablet: in 10 mg per unit dosage forms. zinc sulfate* R * In acute diarrhoea zinc sulfate should be used as an adjunct to oral rehydration salts. R Review of availability of appropriate dosage forms. 17.5.3 Antidiarrhoeal (symptomatic) medicines in adults
WHO Model List of Essential Medicines for Children (October 2007) -- page 20
18. HORMONES, OTHER ENDOCRINE MEDICINES AND CONTRACEPTIVES
18.1 Adrenal hormones and synthetic substitutes R R The Subcommittee noted the need for adrenal hormones and requested that appropriate products be reviewed for possible inclusion. 18.2 Androgens 18.3 Contraceptives 18.3.1 Oral hormonal contraceptives 18.3.2 Injectable hormonal contraceptives 18.3.3 Intrauterine devices 18.3.4 Barrier methods 18.3.5 Implantable contraceptives 18.4 Estrogens 18.5 Insulins and other antidiabetic agents insulin injection (soluble) intermediate?acting insulin Complementary List metformin R 18.6 Ovulation inducers 18.7 Progestogens 18.8 Thyroid hormones and antithyroid medicines levothyroxine Complementary List Lugol?s solution potassium iodide propylthiouracil R Oral liquid: about 130 mg total iodine/ml. Tablet: 60 mg. Tablet: 50 mg. R Review of use of propylthiouracil in children and appropriateness of carbimazole as an alternative. Tablet: 25 micrograms; 50 micrograms; 100 micrograms (sodium salt). Injection: 40 IU/ml in 10?ml vial; 100 IU/ml in 10?ml vial. Injection: 40 IU/ml in 10?ml vial; 100 IU/ml in 10?ml vial (as compound insulin zinc suspension or isophane insulin). Tablet: 500 mg (hydrochloride). R
Review of public health relevance of this medicine in children.
19. IMMUNOLOGICALS
19.1 Diagnostic agents All tuberculins should comply with the WHO Requirements for Tuberculins (Revised 1985). WHO Expert Committee on Biological Standardization. Thirty?sixth report. (WHO Technical Report Series, No. 745, 1987, Annex 1). tuberculin, purified protein derivative (PPD) Injection.
WHO Model List of Essential Medicines for Children (October 2007) -- page 21
19.2 Sera and immunoglobulins All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992). WHO Expert Committee on Biological Standardization. Forty?third report. (WHO Technical Report Series, No. 840, 1994, Annex 2). antitetanus immunoglobulin (human) antivenom immunoglobulin* diphtheria antitoxin
rabies immunoglobulin
Injection: 500 IU in vial. Injection. * Exact type to be defined locally. Injection: 10 000 IU; 20 000 IU in vial. Injection: 150 IU/ml in vial.
19.3 Vaccines
Selection of vaccines from the Model List will need to be determined by each country after consideration of international recommendations, epidemiology and national priorities. The list below details the vaccines for which there is either a recommendation from the Strategic Advisory Group of Experts on Immunization (SAGE) (http://www.who.int/immunization/sage_conclusions/en/index.html) and/or a WHO position paper (http://www.who.int/immunization/documents/positionpapers/en/index.html). This site will be updated as new position papers are published and contains the most recent information and recommendations. All vaccines should comply with the WHO Requirements for Biological Substances. The Subcommittee noted the need for vaccines used in children to be polyvalent. BCG vaccine cholera vaccine diphtheria vaccine hepatitis A vaccine hepatitis B vaccine Haemophilus influenzae type b vaccine influenza vaccine Japanese encephalitis vaccine measles vaccine meningococcal meningitis vaccine mumps vaccine pertussis vaccine pneumococcal vaccine poliomyelitis vaccine rabies vaccine rotavirus vaccine
WHO Model List of Essential Medicines for Children (October 2007) -- page 22
rubella vaccine tetanus vaccine typhoid vaccine varicella vaccine yellow fever vaccine
20. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) AND CHOLINESTERASE INHIBITORS R
R
The Subcommittee recommended a review of the alternatives available for use in children.
neostigmine
Injection: 500 micrograms in 1?ml ampoule; 2.5 mg (metilsulfate) in 1?ml ampoule. Tablet: 15 mg (bromide).
suxamethonium
vecuronium
Injection: 50 mg (chloride)/ml in 2?ml ampoule. Powder for injection: (chloride), in vial. Powder for injection: 10 mg (bromide) in vial.
Complementary List pyridostigmine Injection: 1 mg in 1?ml ampoule. Tablet: 60 mg (bromide).
21. OPHTHALMOLOGICAL PREPARATIONS R
R The Subcommittee requested a review of newer medicines for potential additions to this list. 21.1 Anti-infective agents aciclovir
gentamicin tetracycline
Ointment: 3% W/W. Solution (eye drops): 0.3% (sulfate). Eye ointment: 1% (hydrochloride).
21.2 Anti-inflammatory agents
prednisolone
Solution (eye drops): 0.5% (sodium phosphate).
21.3 Local anaesthetics
tetracaine a
Solution (eye drops): 0.5% (hydrochloride). a
Not in preterm neonates.
21.4 Miotics and antiglaucoma medicines 21.5 Mydriatics Solution (eye drops): 0.1%; 0.5%; 1% (sulfate). atropine* a * OR homatropine or cyclopentolate. a Complementary List Solution (eye drops): 2% (as hydrochloride). epinephrine (adrenaline) R R Review of anti-infective eye drops, identifying which are most appropriate for use in children.
>3 months.
WHO Model List of Essential Medicines for Children (October 2007) -- page 23
22. OXYTOCICS AND ANTIOXYTOCICS
22.1 Oxytocics 22.2 Antioxytocics (tocolytics)
23. PERITONEAL DIALYSIS SOLUTION
Complementary List intraperitoneal dialysis solution (of appropriate composition) Parenteral solution.
24. PSYCHOTHERAPEUTIC MEDICINES
24.1 Medicines used in psychotic disorders R R
The Subcommittee requested a review of appropriate antipsychotics for use in children.
Injection: 25 mg (hydrochloride)/ml in 2?ml ampoule. chlorpromazine Oral liquid: 25 mg (hydrochloride)/5 ml. Tablet: 10 mg; 25 mg; 50 mg; 100 mg (hydrochloride). Injection: 5 mg in 1?ml ampoule. haloperidol Oral liquid: 2 mg/ml. Oral solid dosage form: 0.5 mg; 2.0 mg; 5.0 mg. 24.2 Medicines used in mood disorders 24.2.1 Medicines used in depressive disorders Complementary List fluoxetine a Capsule or tablet: 20 mg (present as hydrochloride). a
>8 years.
24.2.2 Medicines used in bipolar disorders R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 24.3 Medicines used in generalized anxiety and sleep disorders R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 24.4 Medicines used for obsessive compulsive disorders and panic attacks R R The Subcommittee noted the potential importance of these medicines in children but requested a review of the section before endorsing any medicine as essential. 24.5 Medicines used in substance dependence programmes R R The Subcommittee noted the potential importance of these medicines, particularly in neonates, but
requested an assessment of the evidence before endorsing any medicine as essential.
25. MEDICINES ACTING ON THE RESPIRATORY TRACT
25.1 Antiasthmatic and medicines for chronic obstructive pulmonary disease
budesonide
Inhalation (aerosol): 50 micrograms per dose (dipropionate); 250 micrograms (dipropionate) per dose. Injection: 1 mg (as hydrochloride or hydrogen tartrate) in 1?ml ampoule.
epinephrine (adrenaline)
WHO Model List of Essential Medicines for Children (October 2007) -- page 24
Injection: 50 micrograms (as sulfate)/ml in 5?ml ampoule. Metered dose inhaler (aerosol): 100 micrograms (as sulfate) per dose. Oral liquid: 2 mg/5 ml.
salbutamol
R Review of the place in therapy of oral salbutamol preparations in children, with particular emphasis on efficacy and safety in asthma and in the wheezy child with acute respiratory tract infection. Respirator solution for use in nebulizers: 5 mg (as sulfate)/ml. Tablet: 2 mg; 4 mg (as sulfate). R As for oral liquid.
25.2 Other medicines acting on the respiratory tract caffeine citrate Injection: 20 mg/ml (equivalent to 10 mg caffeine base/ml). Oral liquid: 20 mg/ml (equivalent to 10 mg caffeine base/ml).
26. SOLUTIONS CORRECTING WATER, ELECTROLYTE AND ACID-BASE DISTURBANCES
26.1 Oral oral rehydration salts potassium chloride 26.2 Parenteral glucose Injectable solution: 5%; 10% isotonic; 50% hypertonic. Injectable solution: 4% glucose, 0.18% sodium chloride (equivalent to Na+ 30 mmol/l, Cl? 30 mmol/l); 5% glucose, 0.9% sodium chloride (equivalent to 150 mmol/l Na+ and 150 mmol/l Cl?); 5% glucose, 0.45% sodium chloride (equivalent to 75 mmol/l Na+ and 75 mmol/l Cl?). Solution: 11.2% in 20?ml ampoule (equivalent to K+ 1.5 mmol/ml, Cl? 1.5 mmol/ml). Injectable solution: 0.9% isotonic (equivalent to Na+ 154 mmol/l, Cl? 154 mmol/l). Injectable solution: 1.4% isotonic (equivalent to Na+ 167 mmol/l, HCO3? 167 mmol/l). Solution: 8.4% in 10?ml ampoule (equivalent to Na+ 1000 mmol/l, HCO3?1000 mmol/l). Injectable solution. See section 17.5.1. Powder for solution.
glucose with sodium chloride
potassium chloride sodium chloride
sodium hydrogen carbonate
sodium lactate, compound
solution 26.3 Miscellaneous water for injection
2?ml; 5?ml; 10?ml ampoules.
27. VITAMINS AND MINERALS R
R The Subcommittee noted the need for a review of this section of the list to meet public health needs in children. ascorbic acid Tablet: 50 mg.
WHO Model List of Essential Medicines for Children (October 2007) -- page 25
Capsule or tablet: 400 IU; 1000 IU. cholecalciferol* Oral liquid: 400 IU/ml. * Ergocalciferol can be used as an alternative. Capsule: 200 mg. iodine Iodized oil: 1 ml (480 mg iodine); 0.5 ml (240 mg iodine) in ampoule (oral or injectable); 0.57 ml (308 mg iodine) in dispenser bottle. Tablet: 25 mg (hydrochloride). Capsule: 50 000 IU; 100 000 IU; 200 000 IU (as palmitate). Oral oily solution: 100 000 IU (as palmitate)/ml in multidose dispenser. Tablet (sugar?coated): 10 000 IU (as palmitate). Water?miscible injection: 100 000 IU (as palmitate) in 2?ml ampoule. riboflavin sodium fluoride thiamine Complementary List calcium gluconate Injection: 100 mg/ml in 10?ml ampoule. Tablet: 5 mg. In any appropriate topical formulation. Tablet: 50 mg (hydrochloride).
pyridoxine
retinol
WHO Model List of Essential Medicines for Children (October 2007) -- page 26
Table 1: Medicines with age restrictions
atropine azithromycin benzyl benzoate betamethasone topical preparations cefazolin chlorphenamine clindamycin diloxanide doxycyline efavirenz emtricitabine fluoxetine ibuprofen mefloquine metoclopramide procaine benzylpenicillin promethazine saquinavir silver sulfadiazine tetracaine trimethoprim >3 months >6 months >2 years Hydrocortisone preferred in neonates >1 month >1 year >1 month >25 kg weight >8 years >3 years or >10 kg weight >3 months >8 years >3 months >5 kg or >3 months Not in neonates Not in neonates />1 month >2 years >25 kg weight >2 months Not in preterm neonates >6 months
WHO Model List of Essential Medicines for Children (October 2007) -- page 27
INDEX
abacavir (ABC)................................................... 10 acetylcysteine....................................................... 4 acetylsalicylic acid.................................................. 4 aciclovir ........................................................ 10, 23 albendazole .......................................................... 5 allopurinol............................................................ 15 aluminium hydroxide....................................... 19 amikacin ................................................................. 9 amodiaquine ...................................................... 12 amoxicillin............................................................ 6 amoxicillin + clavulanic acid.............................. 6 amphotericin B ............................................... 10, 12 ampicillin.............................................................. 6 antitetanus immunoglobulin (human)........... 22 antivenom immunoglobulin............................ 22 artemether .......................................................... 12 artemether + lumefantrine ............................... 13 artesunate ........................................................... 13 ascorbic acid....................................................... 25 asparaginase......................................................... 15 atropine....................................................... 3, 4, 23 azathioprine.......................................................... 15 azithromycin ........................................................ 7 barium sulfate ...................................................... 19 BCG vaccine ....................................................... 22 benzathine benzylpenicillin............................... 6 benznidazole...................................................... 14 benzoic acid + salicylic acid ............................. 18 benzoyl peroxide............................................... 18 benzyl benzoate................................................. 18 benzylpenicillin ................................................... 6 betamethasone ................................................... 18 bleomycin ............................................................. 15 budesonide......................................................... 24 bupivacaine.......................................................... 3 caffeine citrate.................................................... 25 calamine lotion .................................................. 18 calcium folinate .................................................... 15 calcium gluconate ......................................... 4, 26 capreomycin ........................................................... 9 carbamazepine..................................................... 5 cefazolin................................................................ 6 ceftazidime ............................................................. 7 ceftriaxone ............................................................ 6 charcoal, activated............................................... 4 chlorambucil......................................................... 15 chloramphenicol.................................................. 7 chlorhexidine ..................................................... 19 chlorine base compound .................................. 19 chloroquine ........................................................ 13 chloroxylenol ..................................................... 19 chlorphenamine................................................... 4 chlorpromazine ................................................. 24 cholecalciferol .................................................... 26 cholera vaccine .................................................. 22 ciclosporin............................................................ 15 ciprofloxacin ........................................................ 7 cisplatin................................................................ 15 clindamycin ........................................................... 8 clofazimine........................................................... 8 cloxacillin ............................................................. 7 coal tar ................................................................ 18 codeine.................................................................. 4 cyclophosphamide ................................................ 15 cycloserine.............................................................. 9 cytarabine............................................................. 15 dacarbazine .......................................................... 15 dactinomycin........................................................ 15 dapsone ................................................................ 8 daunorubicin........................................................ 15 deferoxamine ....................................................... 5 dexamethasone.............................................. 4, 16 diazepam.......................................................... 3, 5 didanosine (ddI) ................................................ 10 diethylcarbamazine ................................................ 6 digoxin................................................................ 17 diloxanide........................................................... 12 dimercaprol.......................................................... 5 diphtheria antitoxin .......................................... 22 diphtheria vaccine............................................. 22 dithranol............................................................. 18 dopamine.............................................................. 17 doxorubicin .......................................................... 15 doxycycline .................................................... 7, 13 efavirenz (EFV or EFZ)..................................... 11 eflornithine......................................................... 14 emtricitabine (FTC) ........................................... 11 epinephrine (adrenaline).........................4, 23, 24 erythromycin ....................................................... 8 ethambutol ........................................................... 9 ethanol ................................................................ 19 ethionamide............................................................ 9 ethosuximide .......................................................... 5 etoposide............................................................... 15 factor IX complex (coagulation factors, II, VII, IX, X) concentrate................................................. 17 factor VIII concentrate ......................................... 17 ferrous salt.......................................................... 16 fluconazole ......................................................... 10 flucytosine............................................................ 10 fluorescein .......................................................... 19 fluorouracil .......................................................... 15 fluoxetine ............................................................. 24 folic acid ............................................................. 16
WHO Model List of Essential Medicines for Children (October 2007) -- page 28
furosemide ................................................... 17, 19 gentamicin...................................................... 8, 23 glucose ................................................................ 25 glucose with sodium chloride ......................... 25 glutaral................................................................ 19 griseofulvin ........................................................ 10 Haemophilus influenzae type b vaccine............. 22 haloperidol ......................................................... 24 halothane .............................................................. 3 heparin sodium..................................................... 16 hepatitis A vaccine ............................................ 22 hepatitis B vaccine............................................. 22 human normal immunoglobulin .......................... 17 hydrochlorothiazide.............................................. 19 hydrocortisone......................................... 4, 16, 18 hydroxocobalamin ............................................ 16 ibuprofen ........................................................ 3, 14 imipenem + cilastatin............................................. 7 influenza vaccine............................................... 22 insulin injection (soluble) ................................. 21 intermediate?acting insulin.............................. 21 intraperitoneal dialysis solution (of appropriate composition) .................................................... 24 iodine .................................................................. 26 isoniazid ............................................................... 9 ivermectin............................................................. 6 Japanese encephalitis vaccine.......................... 22 kanamycin.............................................................. 9 ketamine ............................................................... 3 lamivudine (3TC) .............................................. 11 levamisole............................................................. 6 levothyroxine ..................................................... 21 lidocaine ............................................................... 3 lidocaine + epinephrine (adrenaline)................ 3 lopinavir + ritonavir (LPV/r)............................ 11 Lugol?s solution ................................................... 21 magnesium hydroxide...................................... 19 mannitol............................................................... 19 measles vaccine ................................................. 22 mebendazole ........................................................ 6 mefloquine ......................................................... 13 melarsoprol ........................................................ 14 meningococcal meningitis vaccine ................. 22 mercaptopurine .................................................... 15 metformin............................................................. 21 methotrexate......................................................... 15 methylrosanilinium chloride (gentian violet) 18 metoclopramide................................................. 20 metronidazole................................................ 8, 12 miconazole ......................................................... 18 morphine .......................................................... 3, 4 mumps vaccine.................................................. 22 naloxone ............................................................... 5 nelfinavir (NFV) ................................................ 11
neomycin sulfate + bacitracin .......................... 18 neostigmine........................................................ 23 nevirapine (NVP) .............................................. 11 niclosamide .......................................................... 6 nifurtimox .......................................................... 14 nitrofurantoin ...................................................... 8 nitrous oxide ........................................................ 3 nystatin ............................................................... 10 ofloxacin................................................................. 9 oral rehydration salts.................................. 20, 25 oxamniquine .......................................................... 6 oxygen .................................................................. 3 p?aminosalicylic acid.............................................. 9 paracetamol.................................................... 3, 14 paromomycin..................................................... 12 penicillamine ....................................................... 5 pentamidine ....................................................... 14 permethrin ......................................................... 18 pertussis vaccine ............................................... 22 phenoxymethylpenicillin ................................... 7 phenytoin ............................................................. 5 phytomenadione ............................................... 16 pneumococcal vaccine...................................... 22 podophyllum resin ........................................... 18 poliomyelitis vaccine ........................................ 22 polyvidone iodine ............................................. 19 potassium chloride............................................ 25 potassium iodide ............................................ 10, 21 potassium permanganate................................. 18 praziquantel......................................................... 6 prednisolone .............................................4, 16, 23 primaquine......................................................... 13 procaine benzylpenicillin................................... 7 procarbazine......................................................... 15 proguanil............................................................ 13 promethazine..................................................... 20 propranolol ........................................................ 14 propylthiouracil ................................................... 21 protamine sulfate ................................................. 16 pyrantel ................................................................ 6 pyrazinamide....................................................... 9 pyridostigmine ..................................................... 23 pyridoxine .......................................................... 26 pyrimethamine .................................................. 14 quinine................................................................ 13 rabies immunoglobulin .................................... 22 rabies vaccine..................................................... 22 ranitidine ............................................................ 20 retinol.................................................................. 26 ribavirin.............................................................. 12 riboflavin ............................................................ 26 rifampicin ......................................................... 8, 9 rifampicin + isoniazid ......................................... 9 rifampicin + isoniazid + pyrazinamide ............ 9
WHO Model List of Essential Medicines for Children (October 2007) -- page 29
ritonavir .............................................................. 11 rotavirus vaccine ............................................... 22 rubella vaccine ................................................... 23 salbutamol.......................................................... 25 salicylic acid ....................................................... 18 saquinavir (SQV) ............................................... 11 selenium sulfide ................................................... 18 silver sulfadiazine ............................................. 18 sodium calcium henobar .................................... 5 sodium chloride................................................. 25 sodium fluoride ................................................. 26 sodium hydrogen carbonate............................ 25 sodium lactate, compound solution ............... 25 sodium stibogluconate or meglumine antimoniate.................................................... 12 spironolactone ...................................................... 19 stavudine (d4T).................................................. 11 stavudine + lamivudine + nevirapine ............. 12 streptomycin ........................................................ 9 sulfadiazine ............................................................ 8 sulfadoxine + pyrimethamine.......................... 13 sulfamethoxazole + trimethoprim............... 8, 14 suramin sodium ................................................ 14 suxamethonium................................................. 23
tetanus vaccine .................................................. 23 tetracaine ............................................................ 23 tetracycline ......................................................... 23 thiamine.............................................................. 26 thiopental ............................................................. 3 triclabendazole .................................................... 6 trimethoprim ....................................................... 8 tropicamide ........................................................ 19 tuberculin, purified protein derivative (PPD)21 typhoid vaccine ................................................. 23 urea ..................................................................... 18 valproic acid (sodium valproate)...................... 5 vancomycin ............................................................ 8 varicella vaccine ................................................ 23 vecuronium........................................................ 23 vinblastine............................................................ 15 vincristine ............................................................ 15 warfarin ............................................................... 16 water for injection ............................................. 25 yellow fever vaccine ......................................... 23 zidovudine (ZDV or AZT) ............................... 11 zidovudine + lamivudine................................. 12 zidovudine + lamivudine + nevirapine .......... 12 zinc sulfate ......................................................... 20
WHO Model List of Essential Medicines for Children (October 2007) -- page 30
doc_269673018.pdf