A-Mectin 12

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 

Interactions

When ivermectin was co-administered with warfarin, post-marketing complaints of elevated INR (International Normalized Ratio) were infrequent.

Contraindications

It is not recommended for those who are hypersensitive to any of the product's ingredients.

Side Effects

Strongyloidiasis: In four clinical studies in which 109 patients received one or two doses of 170 to 200 mcg/kg ivermectin, the following adverse reactions were reported as possible, likely or certain to be related to ivermectin related. 

Whole body: weakness/fatigue (0.9%), abdominal pain (0.9%)

Gastrointestinal tract: anorexia (0.9%), constipation (0.9%), diarrhea (1.8%), nausea (1.8%), vomiting (0.9%) %)

Nervous/mental system: dizziness (2.8%), drowsiness (0.9%), dizziness (0.9%), tremor (0.9%) 
 

Skin: itching (2.8%), rash (0.9%) and urticaria (0.9%) ) ).

Onchocerciasis: arthralgia/synovitis (19.3%), axillary lymphadenopathy and tenderness (11.0% and 4.4%, respectively), cervical lymphadenopathy and tenderness (5.3% and 1, 2%, respectively), Swollen and tender inguinal lymph nodes were tender (12.6%). % And 13.9%), other lymphadenopathy and tenderness (3.0% and 1.9%, respectively), itching (27.5%), skin involvement including edema, papular urticaria, pustules or obvious (22.7%) and fever (22.6%) ), eye paresthesia, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis and chorioretinitis or choroiditis. They are rarely severe or related to vision loss and usually resolve without corticosteroid treatment. Since the drug was registered abroad, the following adverse reactions have been reported: hypotension (mainly orthostatic hypotension), worsening bronchial asthma, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Pregnancy & Lactation

Pregnancy category C. Ivermectin does not appear to have selective fetal toxicity to the developing fetus. However, there are no adequate and well-controlled studies in pregnant women. Ivermectin should not be used during pregnancy because its safety during pregnancy has not been established. 

Nursing Mothers: Ivermectin is secreted in breast milk in low concentrations. Only when the risk of delaying treatment to the mother exceeds the possible risk to the newborn should mothers who intend to breastfeed should be treated.

Precautions & Warnings

Historical data indicate that microfilariat drugs, such as diethylaminomarazine citrate (DECC), can cause different severity of skin and/or systemic reactions (Mazoti reaction) and ophthalmology in patients with onchocerciasis reaction. These reactions may be due to allergic and inflammatory reactions to the death of microfilaria. Patients receiving ivermectin for onchocerciasis may have these reactions in addition to the possible, possible or certain clinical adverse reactions related to the drug itself. The treatment of severe Mazzotti reactions has not yet undergone controlled clinical trials. Oral rehydration, bedsores, intravenous saline and/or parenteral corticosteroids have been used to treat orthostatic hypotension. Most mild to moderate cases have used antihistamines and / or aspirin. After treatment with microfilariae, patients with hyperreactive dermatitis (sowda) may be more prone to serious adverse reactions than others, especially edema and dermatitis. In rare cases, patients with onchocerciasis who are severely infected with Loa loa may develop severe or even fatal encephalopathy spontaneously or after treatment with effective microfilariae drugs. Among these patients, the following adverse reactions were also reported: back pain, conjunctival hemorrhage, dyspnea, urinary incontinence and / or fecal incontinence, difficulty in standing / walking, changes in mental status, confusion, lethargy, stupor or coma.

Therapeutic Class

Anthelmintic

Storage Conditions

Keep in a dry place, below 30°C. Protect from light. Keep out of the reach of children.