Artesunate Tablets

Artesunate Tablets

Artesunate is a water-soluble hemisuccinate derivative of artemisinin. It is unstable in neutral solution and the injectable formulation must be prepared immediately before use in 5% (w/v) sodium bicarbonate solution to produce the salt sodium artesunate.

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Details

Artesunate tablets

Indications

Product Name: Artesunate tablet

Nombre del Producto: Artesunato tableta

Specification: 50mg

Package: 10tablets/blister/box, 1blister/box, 10blister/box

Standard: CP


After parenteral administration, it is rapidly hydrolysed to the active metabolite dihydroartemisinin. The oral formulation is probably hydrolysed completely before entering the systemic circulation.

Artesunate has been reported to clear fever in patients with severe falciparum malaria 16-25 hours after parenteral administration.

Uses

Orally: treatment of uncomplicated falciparum malaria in areas where there is evidence of chloroquine, pyrimethamine/sulfadoxine, mefloquine and quinine resistance. It should always be administered together with mefloquine in full therapeutic dose.

 

Dosage and administration

Oral administration

Adults and children over 6 months: 5 mg/kg orally on the first day followed by 2.5 mg/kg on the second and third days in combination with mefloquine (15 mg/kg) in a single dose on the second day. In a few areas, a higher dose (25 mg/kg) of mefloquine may be required for a cure to be obtained.

 

Contraindications

Oral artesunate should not be used during the first trimester of pregnancy.

 

Use in pregnancy

Little experience has been gained with the use of this drug in pregnancy but the parenteral preparation should not be withheld if it is considered life-saving to the mother.

 

Adverse effects

Drug-induced fever can occur.

Neurotoxicity has been observed in animal studies but not in humans. In view of the uncertainty about toxic effects, caution should be exercised when more than one 3-day treatment is given.

Cardiotoxicity has been observed following administration of high doses.

 

Storage

Tablets and powder for injection should be stored in tightly closed containers, protected from light.


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