Product Description
Compound Naphthoquine Phosphate Tablets
Composition
This product is a combination formula. Each tablet contains artemisinin 125mg, naphthoquine 50mg (equals to 78.6mg of naphthoquine phosphate).
DESCRIPTION
Film-coated, round, biconvex tablets with slight yellow cores. The tablets are engraved with A+N on one side.
TOXICOLOGY
14 days toxicology test: Safety dosage to rats is 70mg/kg· Day; Safety dosage to dogs is 17.5mg/kg· Day; Toxicity target organs are liver and bone marrow. Sensitivity parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST) and reticulocyte. All pathologic changes are reversible after stopping administration in the animals of moderate intoxication group, except those in severe intoxication animal group.
PHARMACOKINETICS
Absorption:
Both the naphthoquine phosphate and artemisinin is quickly and extensively absorbed in intestines after oral administration.
After a single dosage of 1400mg of tablet before meal, the Cmax of naphthoquine phosphate shows a value of 27.44μ G· L-1, while Artemisinin with Cmax value of 697.70μ G· L-1. Dietary taken with it reduces the absorption of naphthoquine phosphate, reducing 47%of AUC and Cmax of Naphthoquine over fasting. The tablets should be taken before meal.
INDICATIONS
For the treatment of uncomplicated P. Falciparum or/and Plasmodium vivax malaria. It is still effective in regions where amodiaquine, mefloquine is resistant.
USAGE AND DOSAGE
Orally, only single administration for adults, 8 tablets once (total dose contains naphthoquine 400mg and artemisinin 1000mg) is required. In the events of vomiting within one hour after administration, a repeat dose should be taken.
ADVERSE REACTIONS
Few side effects are reported. After administration, 5% of patient experienced of nausea and stomach discomfort; Individual patient experienced of transient elevation of ALT or AST, which reversed to normal level after stopping administration of the drug. Rare case experienced of dizziness.
CONTRAINDICATIONS
Contraindicated in the patients allergic or hypersensitive to artemisinin and naphthoquine, patients have severe impairment of liver and kidney; Women pregnant not longer than 5 months.
DRUG INTERACTIONS
The tablet is a combination formulation, containing quick-acting artemisinin and long-effecting
Naphthoquine phosphate. Combination use of the two components has synergistic effect. Synergistic index is 8.2 to resistant strains of plasmodium in animal models. No adverse reaction has been found when the tablets was used in concomitant administration of paracetamol, NSAID, vitamins, food supplements, sedatives and antibiotics.
STORAGE Preserve in well closed containers, protected from light and stored in a dry place.
PACKAGE In blistered aluminum foils, 8 tablets each, 1 sheet in a paper box.
VALIDITY Three years.
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