Ivermectin Capsules

1. Pharmacological action This product is a derivative of avermectin, which is an oral semi-synthetic broad-spectrum antiparasitic drug. This product has effects on most nematodes (but not all nematodes) of various life cycles; it is effective against microfilariae of Onchocerca volvulus, but not against adults; it is also effective against Strongyloides that are only in the intestine. This product has a selective inhibitory effect, which increases the permeability of cell membranes to chloride ions by binding with high affinity to chloride ion channels with glutamate as valves in nerve cells and muscle cells of invertebrates, causing hyperpolarization of nerve cells or muscle cells, paralysis or death of parasites. This product can also interact with chloride ion channels of other ligand valves (such as neurotransmitter γ-aminobutyric acid (GABA)). The selectivity of this product is because some mammals do not have glutamate-chloride ion channels in their bodies, and avermectin has only low affinity for mammalian ligand-chloride ion channels. This product cannot penetrate the human blood-brain barrier. 2. Toxicological studies Genetic toxicity: Only in vitro mutagenicity tests were conducted, and the results did not find that this product was genetically toxic. Reproductive toxicity: When the rats were repeatedly administered at doses up to 3 times the maximum clinically recommended dose (based on body surface area), no effect on animal fertility was observed. When mice, rats and rabbits were repeatedly administered at doses up to 0.2, 8.1 and 4.5 times the maximum clinically recommended dose (based on body surface area), respectively, this product showed teratogenic effects. Both animals developed cleft palates, and the rabbits also developed clubbed forepaws. These effects occurred at doses close to maternal toxicity. Therefore, this product is clearly not selective fetotoxic, but there is no sufficient and rigorous research data on pregnant women to confirm the safety of using this product during pregnancy, so it should not be used during pregnancy.

The main ingredients of this product are ivermectin B1a and ivermectin B1b. The chemical name of ivermectin B1a is (5-O-demethyl-22,23-dihydroavermectin A1a); the chemical name of ivermectin B1b is (5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-avermectin A1a).

This product is white or off-white granules.

It is suitable for onchocerciasis, strongyloidiasis, and infections caused by hookworms, ascaris, whipworms, and pinworms.

The recommended dose for strongyloidiasis is a single oral dose of 200μg/kg, taken with water. Usually, no additional dose is required, but follow-up is required to ensure cure. The common doses are as follows: for 15-24kg, the dose is half a tablet (about 3mg); for 25-34kg, the dose is 1 tablet (about 6mg); for 35-50kg, the dose is 1 and a half tablets (about 9mg); for 51-65kg, the dose is 2 tablets (about 12mg); for 66-79kg, the dose is 2 and a half tablets (about 15mg); for those over 80kg, 200μg/kg. The recommended dose for onchocerciasis is a single oral dose of 150μg/kg, taken with water. The commonly used doses are as follows: for those weighing 15-24g, the dose is half a tablet (about 3mg); for those weighing 25-44kg, the dose is 1 tablet (about 6mg); for those weighing 45-64kg, the dose is 1.5 tablets (about 9mg); for those weighing 65-84kg, the dose is 2 tablets (about 12mg); for those weighing more than 80kg, 150μg/kg. For hookworm infection, a single oral dose of 12mg (equivalent to 0.2mg/kg) is given to patients over 14 years old; a single oral dose of 6mg is given to patients under 14 years old. For ascaris infection, a single oral dose of 6mg (equivalent to 0.1mg/kg) is given to patients over 14 years old; a single oral dose of 3mg is given to patients under 14 years old. For whipworm infection, a single oral dose of 12mg (equivalent to 0.2mg/kg) is given to patients over 14 years old; a single oral dose of 6mg is given to patients under 14 years old. For pinworm infection, a single oral dose of 12mg (equivalent to 0.2mg/kg) is given to patients over 14 years old; a single oral dose of 6mg is given to patients under 14 years old.

Systemic reactions: including weakness, asthenia, abdominal pain, and fever; Gastrointestinal reactions: including anorexia, constipation, diarrhea, nausea, and vomiting; Nervous system reactions: including dizziness, drowsiness, vertigo, and tremors; Skin: including itching, rash, papules, urticaria, and small pustules; Ophthalmology: The following ophthalmic adverse reactions are caused by the disease itself, but there are also reports of them occurring after treatment with ivermectin. Some adverse reactions include visual abnormalities, eyelid edema, anterior uveitis, conjunctivitis, Limbitis, keratitis, chorioretinitis, or choroiditis. The above symptoms are generally mild symptoms, do not cause blindness, and generally resolve on their own without corticosteroid treatment. Others: including joint pain, synovitis, enlarged and tender axillary lymph nodes, enlarged and tender cervical lymph nodes, and swollen inguinal lymph nodes.

It is contraindicated for patients with severe liver, kidney or heart dysfunction, allergy to the product or mental disorders.

Precautions for children: A similar safety range was observed in open trials on pediatric patients aged 6 to 13 years. The safety and effectiveness for children weighing less than 15 kg have not been determined, and these children should use it with caution. Precautions for pregnancy and lactation: There is currently a lack of clinical research data on the use of this product by pregnant women. The safety of this product during pregnancy has not been determined. Therefore, pregnant women should not use this product. This product is secreted from breast milk at low concentrations, and breastfeeding women should weigh the pros and cons. This product should only be considered for use when the harm to the mother of delayed treatment exceeds the possible harm to the newborn. Precautions for the elderly: There is currently a lack of detailed research data on this product.

Not yet clear.

Keep in a light-proof, sealed, dry place. The validity period is tentatively 2 years.

3mg

24 months

Zhejiang Hisun Pharmaceutical Co., Ltd.

• Founded in:

  1998-02-11

• Address:

  No. 46, Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province

• Tax NO.:

  91330000704676287N

• Registered Funds:

  1,207,873,716 yuan

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