Ivera 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 the 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

Interaction

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

Contraindications

It is not recommended for individuals who are allergic to any of the ingredients in this product.

Side Effects

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 percent, respectively), cervical lymph node enlargement and tenderness (5.3 and 1.2 percent, respectively), inguinal lymph node enlargement and tenderness (12.6 and 13.9 percent, respectively), other lymph node enlargement and tenderness (12.6 and 13.9 percent, respectively) (3.0 percent and 1.9 percent , respectively), Pruritus (27.5%), skin involvement (edema, papular and pustular or frank urticarial rash (22.7%), and fever (22.6%), abnormal feeling in the eyes, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis These have seldom been severe or linked with vision loss, and have typically cured without the use of corticosteroids. Since the drug's approval in other countries, the following side effects have been reported: hypotension (often orthostatic hypotension), exacerbation of bronchial asthma, toxic epidermal necrolysis, and Stevens-Johnson syndrome.

Pregnancy & Lactation

Pregnancy Type C. Ivera 12 does not appear to be fetotoxic to developing fetuses. However, no appropriate and well-controlled trials in pregnant women exist. Ivermectin should not be taken during pregnancy since its safety has not been proven.

Nursing Mothers: Ivera 12 is excreted in low quantities in human milk. Treatment of breastfeeding women should be performed only when the danger of delayed treatment to the mother surpasses the potential harm to the infant.

Precautions & Warnings

Microfilaricidal medicines, such as diethylcarbamazine citrate (DEC-C), have been found in the past to produce cutaneous and/or systemic responses of varying severity (the Mazzotti reaction) as well as ophthalmological reactions in individuals with onchocerciasis. These symptoms are most likely the result of allergic and inflammatory reactions to the demise of microfilariae. Patients receiving Ivermectin for onchocerciasis may suffer these responses in addition to clinical adverse effects that may or may not be due to the medication itself. There have been no controlled clinical trials for the treatment of severe Mazzotti responses. Postural hypotension has been treated with oral water, recumbency, intravenous normal saline, and/or parenteral corticosteroids. Most mild to severe instances have been treated with antihistamines and/or aspirin. Patients with hyperreactive onchodermatitis (sowda) may be more prone than others to have significant side effects, including edema and onchodermatitis aggravation, after therapy with microfilaricidal medicines. Patients with onchocerciasis who are also extensively infected with Loa loa may develop a significant or even deadly encephalopathy, either spontaneously or as a result of therapy with an efficient microfilaricide. Back discomfort, conjunctival bleeding, dyspnea, urine and/or fecal incontinence, difficulties standing/walking, mental status changes, disorientation, lethargy, stupor, or coma have all been recorded in these individuals.

Therapeutic Class

Anthelmintic

Storage Conditions

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