Revision Year: 2018 Publisher: SUBSTIPHARM DEVELOPPEMENT, 24 rue Erlanger, 75016 Parijs, Frankrijk
Official guidelines should be taken into consideration. Official guidelines will normally include WHO and public health authorities' guidelines.
The recommended dosage is one single oral dose of 200 micrograms of ivermectin per kg body weight.
For guidance, the dose, as determined by the patient’s weight, is as follows:
| _.BODY WEIGHT (kg) | DOSE (number of 3 mg tablets) |
|---|---|
| 15 to 24 | one |
| 25 to 35 | two |
| 36 to 50 | three |
| 51 to 65 | four |
| 66 to 79 | five |
| ≥80 | six |
The recommended dosage for mass distribution for the treatment of microfilaraemia caused by Wuchereria bancrofti is a single oral dose once every 6 months designed to provide approximately 150 to 200 μg/kg of body weight.
In endemic areas where treatment can only be administered once every 12 months, the recommended dosage is 300 to 400 μg/kg of body weight to maintain adequate suppression of microfilaraemia in treated patients.
For guidance, the dose, as determined by the patient’s weight, is as follows:
| BODY WEIGHT (kg) | DOSE when given once every 6 months (number of 3 mg tablets) | DOSE when given once every 12 months (number of 3 mg tablets) |
|---|---|---|
| 15 to 25 | one | two |
| 26 to 44 | two | four |
| 45 to 64 | three | six |
| 65 to 84 | four | eight |
Alternatively and if no scales are available, the dose of ivermectin for use in mass chemotherapy campaigns may be determined by the patient’s height as follows:
| HEIGHT (cm) | DOSE when given once every 6 months (number of 3 mg tablets) | DOSE when given once every 12 months (number of 3 mg tablets) |
|---|---|---|
| 90 to 119 | one | two |
| 120 to 140 | two | four |
| 141 to 158 | three | six |
| >158 | four | eight |
The recommended dosage is a single oral dose to provide ivermectin 200 μg/kg body weight.
Recovery will be considered as definite only after 4 weeks of the treatment. Persistence of pruritus or scraping lesions does not justify a second treatment before this date.
Administration of a second dose within 2 weeks after the initial dose should only be considered:
In these heavily infected forms, a second dose within 8 to 15 days of ivermectin and/or concomitant topical therapy may be necessary to obtain recovery.
Contact persons, especially family members and partners, should undergo a medical examination as soon as possible, and if necessary should be given prompt antiscabies treatment.
Hygienic measures to prevent reinfection should be taken into account (i. e. keeping fingernails short and clean) and official recommendations regarding the cleaning of clothing and bedding should be closely followed.
For all indications, safety in paediatric patients weighing less than 15 kg of body weight has not been established.
Clinical studies with ivermectin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, treatment of an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Oral route.
In children less than 6 years of age, tablets should be crushed before swallowing.
Treatment is one single oral dose taken with water on an empty stomach.
The dose may be taken at any time of the day, but no food should be taken within two hours before or after administration, as the influence of food on absorption is unknown.
Cases of accidental overdose with ivermectin have been reported, but none have resulted in fatalities. In cases of accidental intoxication with unknown doses of products destined for veterinary use (oral use, as an injection, cutaneous use), the symptoms described were: rash, contact dermatitis, oedema, headache, vertigo, asthenia, nausea, vomiting, diarrhoea and abdominal pain. Other effects have also been observed, including: seizures, ataxia, dyspnoea, paraesthesia and urticaria.
Management in case of accidental intoxication:
18 months.
Do not store above 25°C.
4, 8, 10, 12, 16 or 20 tablets in aluminium/aluminium blisters.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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