ARTEMETHER INJECTIONNOMENCLATURE:The drug is mainly composed of
Artemether. The chemical name is (3R, 5aS, 6R, 8aS, 9R, 10S, 12R,
12aR)-decahydro-10-methoxy-3,6,9-trimethy1-3,12-epoxy-12H-pyrano[4,3-j]-1,2-ben-zodioxepinCHARACTER:A
colorless or yellowish clear oily solution.PHARMACOLOGY AND
TOXICOLOGY:Animal pharmacodynamics showed that the drug isa strong
schizonticide. Parasitemia clearance occurs rapidly with stable
efficacy after administration. It is also effective against
chloroquine-resistant P. falciparum malaria. Acute toxicity studies
on animals showed that the LD50 of Artemether in mice of a single
i.g. administration is 895mg/kg and a single i.m. injection is
296mg/kg; in rats, the LD50 of a single i.m. injection is 597mg/kg.
This proves the toxicity of Artemether is quite
low.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 10mg/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 intramuscular 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 160mg, followed by 80mg every
time from the 2nd to 5nd 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.ADVERSE
REACTIONS:Clinical dosage exhibits slight adverse reactions. A
transient low fever and reticulocytopenia may occur individual
cases. Slight rise of SGOT and SGPT may occur in individual cases.
Arrhythmia may occur in rare cases (such as ventricular
tachycardia).CONTRAINDICATIONS: Hypersensibility to any one of
constituents.PRECAUTIONS: In case of freeze due to coldness, please
warm it before use.PREGNANCY AND LACTATIONIt should be used with
caution in the first trimester of pregnancy since some fetus
absorption has been observedADMINISTRATION FORCHILDREN: For
children, the dose should be chosen as follows:AGE(year)WEIGHTTOTAL
DOSEDay 1Day 2Day 3Day 4Day 5
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