Drug | Regulatory indication(s) [8th EMLc indication(s)] | Formulations(s) | Instructions for administration to children in regulatory label | References |
---|---|---|---|---|
Anthelminthics | ||||
 Albendazole | Lymphatic filariasis and the control of soil-transmitted helminthiasis (= 400 mg for children > 2 years; 200 mg for children aged 1–2 years) [Intestinal anthelminthic, antifilarial, cysticidal] | 400 mg tablet scored oval tablet 19 mm x9mm x6mm 400 mg chewable tablet | The tablets should be taken with water on an empty stomach The tablets can be chewed or taken with water. Some people, particularly young children, may experience difficulties swallowing the tablets whole and should be encouraged to chew the tablets with a little water, alternatively the tablets may be crushed | [56] [57] |
 Mebendazole | Gastrointestinal infections caused by Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Necator americanus and Ancylostoma duodenale (hookworms) (500 mg for children ≥ 1 year) [Intestinal anthelminthic, cysticidal] | 100 mg, 500 mg chewable tablet 500 mg scored chewable tablet: round, 16 mm diameter | Chew tablet completely before swallowing For subjects who have difficulty chewing the tablet, approximately 2 ml to 3 ml of drinking water can be added to a suitably sized spoon and the tablet placed into the water Within 2 min, the tablet absorbs water and turns into a soft mass with semi-solid consistency, which can then be swallowed | |
Antischistosomals and other antitrematode medicines | ||||
 Praziquantel | Preventive chemotherapy interventions for the control of schistosoma infections (600 mg for children ≥ 6 years) [Intestinal anthelminthic, antischistosomals and other antitrematode, cysticidal] | 150 mg, 500 mg, 600 mg tablet 600 mg scored oval tablet 21 mm × 9 mm × 7 mm | Tablets should be swallowed whole with some liquid, preferably during or after meals | |
 Triclabendazole | Treatment of fascioliasis (10 mg/kg for children ≥ 6 years)[treatment of fascioliasis] | 250 mg scored capsule shaped biconvex tablet | Swallow tablets whole or divide in half and take with water or crush and administer with applesauce | [63] |
Antibiotics | ||||
 Azithromycin | Antibiotic for systemic use (10 mg/kg/day in infants > 1 year) [Watch group antibiotic]* [First choice: cholera; enteric fever; trachoma; yaws. Second choice: acute invasive bacterial diarrhoea /dysentery] | 250 mg capsule. Capsules are not suitable for children < 45 kg Powder for oral suspension (when reconstituted with water, one bottle of POS contains 1200 mg in 30 ml (200 mg/5 ml) | Capsules should be taken at least 1 h before or 2 h after food | [64] [65] |
 Rifampicin | Tuberculosis (300 mg for children > 21–30 kg) [Antileprosy, antituberculosis] | 150 mg capsule size 2, 17.6 mm × 6.39 mm 300 mg capsule size 0, 21.6 mm × 7.64 mm 20 mg/ml Oral liquid | Capsules should be taken on an empty stomach (at least 1 h prior to or 2 h after a meal) to ensure rapid and complete absorption | |
 Dapsone | Multibacillary leprosy Paucibacillary leprosy (100 mg for children ≥ 6 years) [Antileprosy] | 25 mg, 50 mg, 100 mg tablet 100 mg scored round, 8 mm diameter | For oral administration | |
 Clofazimine | Tuberculosis (100 mg in adolescents 15 years or older weighing ≥ 30 kg) [Antileprosy, multidrug-resistant tuberculosis] | 50 mg, 100 mg capsule 100 mg soft capsule | Should be taken with water and swallowed whole Should be taken with food to avoid stomach upset and improve absorption | [68] |
 Clarithromycin | Antibiotic for systemic use (7.5 mg/kg for infants > 6 months) [Watch group antibiotic]* [Second choice: Pharyngitis] | 500 mg solid oral dosage form 500 mg film-coated oval tablet 18.5 mm × 8.1 mm 125 mg/5 ml, 250 mg/ml powder for oral liquid | The tablet should be swallowed whole with a sufficient amount of fluid (e.g. one glass of water) Clarithromycin film-coated tablets may be given irrespective of food intake | [69] |
 Moxifloxacin | Pneumonia, skin and abdominal (stomach area) infections (100 mg for infants > 5 kg) [Multidrug-resistant tuberculosis] | 400 mg tablet 100 mg dispersible tablet, scored round 10 mm diameter (Micro Labs Ltd); caplet shape, scored 19 mm × 8 mm (Macleods Pharmaceuticals Ltd) | Dispersible tablet: Patients weighing ≥ 7 kg: The required number of tablets should be dispersed in approximately 10 ml of drinking water and the entire mixture should be swallowed. The mixture (tablets dispersed in water) should be used within 10 min. An additional volume of water should then be consumed immediately Patients weighing 5–6 kg: For administration of the correct dose, an oral syringe of 10 ml with 1 ml markings is needed. One tablet should be dispersed in exactly 10 ml of drinking water and mixed carefully; 8 ml of the mixture should be drawn up in the syringe and administered to the child | |
Antitrypanosomal | ||||
 Fexinidazole | First-stage (haemo-lymphatic) and second stage (meningo-encephalitic) of human African trypanosomiasis (600 mg for children ≥ 6 years and weighing ≥ 20 kg) [African trypanosomiasis] | 600 mg tablet, round 13 mm diameter | Must be taken with food Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water) Do not break or crush the tablets | [72] |
 Benznidazole | Chagas disease (5 mg/kg for children > 2 years) [American trypanosomiasis] | 12.5 mg tablet round, 5 mm diameter; 100 mg tablet scored, round 10 mm diameter | May be taken with or without food Tablets may be made into slurry in a specified volume of water where the slurry must be drunk immediately following preparation and the cup used to prepare the slurry should be rinsed with additional water | [73] |
 Nifurtimox | Chagas disease (10 mg/kg in babies > 2.5 kg) [African trypanosomiasis, American trypanosomiasis] | 30 mg round, scored tablet, 120 mg round, scored tablet | Must be taken with food Tablets can be made into a slurry as an alternative method of administration for patients who cannot swallow the tablet | [74] |
Antiprotozoal drugs | ||||
 Miltefosine | Visceral leishmaniasis, cutaneous leishmaniasis (1.5 mg/kg for children ≥ 3 years) [Antileishmaniasis] | 10 mg capsule size 3, 15.7 mm × 5.85 mm 50 mg capsule size 2, 17.6 mm × 6.39 mm | Administer with food to ameliorate gastrointestinal adverse reactions Swallow the capsule whole and do not chew it or break it apart | [75] |
Antifungal drugs | ||||
 Itraconazole | Local and systemic candidiasis (3 mg/kg in infants > 1 month) [Chronic pulmonary aspergillosis, acute invasive aspergillosis, histoplasmosis, sporotrichosis, paracoccidiodomycosis, mycoses caused by T marneffei and chromoblastomycosis and prophylaxis of histoplasmosis and infections caused by T. marneffei in AIDS patients] | 100 mg capsule size 0, 21.6 mm × 7.64 mm 10 mg/ml liquid | Must be taken immediately after a meal for maximal absorption Capsules must be swallowed whole with a small amount of water | [76] |
 Fluconazole | Local and systemic fungal infections: Mucosal candidiasis, invasive candidiasis, cryptococcal meningitis (6 mg/kg in infants > 1 month) [Antifungal] | 50 mg capsule size 4, 14.3 mm × 5.33 mm 50 mg/5 ml oral liquid | The capsules should be swallowed whole and independent of food intake | [77] |
Antifilarial drugs | ||||
 Ivermectin | Soil-transmitted helminthiasis, strongyloidiasis, onchocerciasis, lymphatic filariasis and scabies (3 mg in children > 15 kg) [Intestinal anthelminthic, Antifilarial, ectoparasitic infection] | 3 mg scored tablet round, 6 mm diameter | The tablets should be taken with some water on an empty stomach. Do not eat any food within 2 h before or after taking this medicine In children < 6 years of age, the tablets should be crushed before swallowing | [78] |
 Diethylcarbamazine | Filarial infections due to Wuchereria bancrofti, Loa loa, Brugia malayi and Brugia timori, tropical eosinophilia, toxocariasis, 6—9 mg/kg daily in 3 divided doses [Antifilarial] | 50 mg tablet scored tablet round 8 mm diameter 100 mg scored tablet round 12 mm diameter | Diethylcarbamazine should be administered after meals | [79] |