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Tel: 01-737-8991; 01-871-3181; 0803-343-1338; 0803-569-9324
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablets (NRN: 04-7255): Each kit contains: 3 tablets of Artesunate 200 mg and 3 tablets of Amodiaquine BP 60 mg base.
Pack size: A blister pack contains: 3 tablets of Artesunate 200 mg + 3 tablets of Amodiaquine BP 600 mg base.
Amodiaquine is an antimalarial with schizonticidal activity. It is effective against the erythrocytic stages of all 4 species of Plasmodium falciparum. It is as effective as Chloroquine against Chloroquine-sensitive strains of Plasmodium falciparum and is also effective against some Chloroquine-resistant strains. Amodiaquine accumulates in the lysosomes and brings about loss of function. The parasite is unable to digest haemoglobin on which it depends for its energy.
In general, 4-aminoquinolones derivatives appear to bind to nucleoproteins and inhibit DNA polymerase. High drug concentrations are found in the malaria parasite's digestive vacuoles.
Artesunate is a potent blood schizonticide agent for P. falciparum. Artesunate binds tightly to parasitized erythrocyte membranes. The functional group responsible for antimalarial activity of Artesunate is endoperoxide bond. Release of an active oxygen species from this bond kills the parasite if accumulated in the erythrocytic cells.
It also suppresses the production or activity of antioxidant enzymes in the erythrocytes, causing lysis of the parasitic cell due to the highly reactive free oxygen radicals. It reduces gametocyte carriage rate.
Treatment of uncomplicated cases of malaria caused by Plasmodium falciparum.
Known hypersensitivity to Amodiaquine or 4-aminoquinolones and Artesunate or artemisinin derivatives. Because of resistance and risk of major toxicity, Amodiaquine is not recommended for the prophylaxis of malaria.
Amodiaquine is also contraindicated in patients with hepatic disorders.
They are mainly pertaining to Amodiaquine-Artesunate combination kit. Amodiaquine is no longer recommended for chemoprophylaxis of falciparum malaria because its use is associated with hepatic toxicity and agranulocytosis.
Severe neutropenia can occur. Large doses of Amodiaquine have been reported to produce syncope, spasticity, convulsions and involuntary movements.
Amodiaquine may cause blood dyscrasias, hepatitis, peripheral neuropathy and haemolytic anaemia. If long term therapy is given, regular ophthalmic examination is recommended.
Because Amodiaquine may concentrate in the liver, the drug should be used with caution in patients with alcoholism and in patients receiving hepatotoxic drugs.
Since hemolysis and acute renal failure have been reported to occur in a few patients with glucose 6-phosphate dehydrogenase deficiency receiving Chloroquine, this should also be considered when using Amodiaquine.
Risk benefit ratio should be considered before administering Amodiaquine-Artesunate combination kit in pregnancy as enough safety data is not available.
Dosage & Administration
Artesunate Tablet: 1 tablet every day for 3 days
Amodiaquine Tablet: 1 tablet every day for 3 days.
Store below 25oC.