Alice – 6 mg Tablet/Pcs
- Brand: Square Pharmaceuticals Ltd
Generic Name: Ivermectin BP
Therapeutic class: Anti-parasitic
Manufacturer: Square Pharmaceuticals Ltd
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.
Onchocerciasis: Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C).
Dosage & Administration
For Treatment (If COVIO Positive): 2 Tablets of Ivermectin 6 mg once daily for 5 days. (2+0+0 for 5 days).
For Prophylaxis: Single-dose as mentioned below to be taken on Day 1 & same dose on Day 7.
- Body Weight 15-24 kg: 1 Tablet of Ivermectin 3 mg
- Body Weight 25-35 kg: 1 Tablet of Ivermectin 6 mg
- Body Weight 36-50 kg: 1 Tablet of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight 51-65 kg: 2 Tablets of Ivermectin 6 mg
- Body Weight 66-79 kg: 2 Tablets of Ivermectin 6 mg + 1 Tablet of Ivermectin 3 mg
- Body Weight >80 kg: 3 Tablets of Ivermectin 6 mg
Strongyloidiasis: The recommended dosage of Ivermectin for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg/kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
Dosage Guidelines for Ivermectin for Strongyloidiasis:
- Body Weight (kg) 15-24: Dose 3 mg/kg
- Body Weight (kg) 25-35: Dose 6 mg/kg
- Body Weight (kg) 36-50: Dose 9 mg/kg
- Body Weight (kg) 51-65: Dose 12 mg/kg
- Body Weight (kg) 66-79: Dose 15 mg/kg
- Body Weight (kg) >80: Dose 200 mcg/kg
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, 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.
Dosage Guidelines for Ivermectin for Onchocerciasis:
- Body Weight (kg) 15-25: Dose 3 mg/kg
- Body Weight (kg) 26-44: Dose 6 mg/kg
- Body Weight (kg) 45-64: Dose 9 mg/kg
- Body Weight (kg) 65-84: Dose 12 mg/kg
- Body Weight (kg) >85: Dose 150 mcg/kg
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%).
Onchocerciasis: arthralgia/synovitis (19.3%), axillary lymph node enlargement and tenderness (11.0% and 4.4%, respectively), cervical lymph node enlargement and tenderness (5.3% and 1.2%, respectively), inguinal lymph node enlargement and tenderness (12.6% and 13.9%, respectively), other lymph node enlargement and tenderness (3.0% and 1.9%, respectively), pruritus (27.5%), skin involvement including edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%), abnormal sensation in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis. These have rarely been severe or associated with loss of vision and have generally resolved without corticosteroid treatment. The following adverse reactions have been reported since the drug was registered overseas: hypotension (mainly orthostatic hypotension), worsening of bronchial asthma, toxic epidermal necrolysis, and Stevens-Johnson syndrome.
Pregnancy & Lactation
Pregnancy Category C. Ivermectin does not appear to be selectively fetotoxic to the developing fetus. There are, however, no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
Nursing Mothers: Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn
Precautions & Warnings
Use in Special Populations
Pediatric Use: Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.
Geriatric Use: Clinical studies of Ivermectin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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