Ivermectin

Ivermectin is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis . This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin (See CLINICAL PHARMACOLOGY, Clinical Studies ). Onchocerciasis Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus . …

• Strongyloidiasis The recommended dosage of ivermectin Tablets
• For the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight
• See Table 1 for dosage guidelines
• Patients should take tablets on an empty stomach with water (See CLINICAL PHARMACOLOGY, Pharmacokinetics )
• In general, additional doses are not necessary
• However, follow-up stool examinations should be performed to verify eradication of infection (See CLINICAL PHARMACOLOGY, Clinical Studies )
• Table 1: Dosage Guidelines for Ivermectin Tablets for Strongyloidiasis Body Weight (kg) Single Oral Dose Number of 3-mg Tablets 15-24 1 tablet 25-35 2 tablets 36-50 3 tablets 51-65 4 tablets 66-79 5 tablets ≥ 80 200 mcg/kg Onchocerciasis The recommended dosage of ivermectin Tablets
• For the treatment of onchocerciasis is a single oral dose designed to provide approximately 150 mcg of ivermectin per kg of body weight
• See Table 2 for dosage guidelines
• Patients should take tablets on an empty stomach with water (See CLINICAL PHARMACOLOGY, Pharmacokinetics )
• In mass distribution campaigns in international treatment programs, the most commonly used dose interval is 12 months
• For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months
• Table 2: Dosage Guidelines for Ivermectin Tablets for Onchocerciasis Body Weight (kg) Single Oral Dose Number of 3-mg Tablets 15-25 1 tablet 26-44 2 tablets 45-64 3 tablets 65-84 4 tablets ≥ 85 150 mcg/kg

• Safety and effectiveness
• In pediatric patients weighing less than 15 kg have not been established

Clinical studies of ivermectin did not include sufficient numbers of subjects aged 65 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. …

• Ivermectin Tablets should be taken on an empty stomach with water (See CLINICAL PHARMACOLOGY, Pharmacokinetics )
• Strongyloidiasis The patient should be reminded of the need for repeated stool examinations to document clearance of infection with Strongyloides stercoralis
• Onchocerciasis The patient should be reminded that treatment with ivermectin does not kill the adult Onchocerca parasites, and therefore repeated follow-up and retreatment is usually required

Ivermectin Tablets are contraindicated in patients who are hypersensitive to any component of this product.

Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself (See ADVERSE REACTIONS, Onchocerciasis ). The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials. …

Strongyloidiasis In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of ivermectin, the following adverse reactions were reported as possibly, probably, or definitely related to ivermectin: Body as a Whole: asthenia/fatigue (0.9%), abdominal pain (0.9%) Gastrointestinal: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) Nervous System/Psychiatric: dizziness (2.8%), somnolence (0.9%), vertigo (0.9%), tremor (0.9%) Skin: pruritus (2.8%), rash (0.9%), and urticaria (0.9%). …

Pregnancy, Teratogenic Effects Ivermectin has been shown to be teratogenic in mice, rats, and rabbits when given in repeated doses of 0.2, 8.1, and 4.5 times the maximum recommended human dose, respectively (on a mg/m2/day basis). Teratogenicity was characterized in the three species tested by cleft palate; clubbed forepaws were additionally observed in rabbits. …

Cases of neurotoxicity, including alteration of consciousness of variable severity (e.g., somnolence/drowsiness, stupor, and coma), confusion, disorientation and death have been reported with recommended dosage and overdosage of ivermectin (see WARNINGS ). Significant lethality was observed in mice and rats after single oral doses of 25 to 50 mg/kg and 40 to 50 mg/kg, respectively. No significant lethality was observed in dogs after single oral doses of up to 10 mg/kg. …

Storage Store at temperatures below 30°C (86°F).

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.