
Meditex
MEDITEX INJECTION
Artemether
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NOMENCLATURE
Artemether Injection
The drug is mainly composed of Artemether. -
DESCRIPTION
A colorless or yellowish clear oily solution. -
PHARMACOLOGY AND TOXICOLOCY
Animal pharmacodynamics showed that the drug is a strong schizonticide. Parasitemia clearance occurs rapidly with stable efficacy after administration. It is also effective against chlorquine-resistant P. falciparum malaria.
Acute toxicity studies on animals showed that the Ld50 of Artemether in mice of a single i.g. administration is 895 mg/kg and a single i.m. injection is 296mg/kg: in rats, the Ld50 of a single i.m. injection is 579mg/kg. This proves the toxicity of Artemether is quite low.
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PHARMACOKINETICS
The drug is absorbed rapidly and completely after i.m. injection. The maximum blood concentration of the drug is observed in about 7 hours after i.m. injection of 10 mg/kg in human body. The peak value is about 0.8ug/ml with the plasma half-life of about 13 hours. It is widely distributed in the body with the highest level found in the brain and followed by the liver and kidney. It is mainly excreted in the feces with a part in urine. -
INDICATIONS
Antimalarial drug. For the treatment of all kinds of malaria including the chloroquine resistant P. falciparum malaria and the first aid of critical malaria. -
USAGE AND DOSAGE
The drug is used for instramuscular injection, five days course with the initial dose of 3.2mg/kg, followed by 1.6mg/kg for the following 4 days. The initial dose for adults is 160 mg (2 ampoules), followed by 80mg (1 ampoule) every time from the 2nd to 5th day.
The dose for children or overweight patients should be decreased or increased on the basis of the individual weight or under the doctor's prescription.
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ADVERSE REACTIONS
Clinical dosage exhibits slight adverse reactions. A transient low fever and reticulocytopenia may occur in individual cases. Slight rise of SGOT and SGPT may occur in individual cases. Arrhthmia may occur in rare cases(such as ventricular tachycardia). -
CONTRAINDICATIONS
None. -
PRECAUTIONS
In case of freeze due to coldness, please warm it before use. -
PREGNANCY AND LACTATION
It should be used with caution in the first trimester of pregnancy since some foetus absorption has been observed. -
DRUG INTERACTIONS
Studies and reviews in the literature demonstrated that the active substance of Artemether had no interactions with other drugs on decreasing therapeutic effects and increasing toxicity and side effects in human bodies. -
OVERDOSE
Although no case of over dosage has been documented, in case of accident, symptomatic treatment is recommended under the instruction of doctors. -
STRENGTH
I ml:80mg 0.5mg:40mg -
VALIDITY
3 years. -
STORAGE
Preserve in well closed container, protected from light and stored in a cool place. -
PACKAGE
6 ampoules in blistered aluminum foil or plastic plate, I plate to a paper box.