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Table 4 Summary of paediatric use-relevant characteristics of oral formulations used as per WHO NTD Roadmap 2021–2030 for treatment, control and elimination of NTDs [1]

From: Drugs for neglected tropical diseases: availability of age-appropriate oral formulations for young children

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

[58,59,60]

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

[61, 62]

 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

[61, 62]

 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

[66, 67]

 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

[23, 70, 71]

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]

  1. *[Watch group antibiotic]; this is as an antibiotic recommended only for specific limited indications; for further information on categorisation of antibiotics by WHO the reader is directed to this web page: https://adoptaware.org/ (accessed July 2022)