Artemether Injection 80mg/1ml

NOMENCLATURE:

English: Artemether Injection

The drug is mainly composed of Artemelher.Tlie chemical name is

(3R.5aS,6R,8aS,9R.10S,12R,12aR)- decahydro-10-methoxy-3.6,9-triinethyl-3,12-

epoxy-12H-pyrano[4,3-j]-l,2-ben-zodioxepin.

Molecular Formijla:C,ftHvalue="2" tcsc="0" unitname="F" w:st="on">2f,0,

Molecular Weight: 298.4

GMP certificate Artemether Injection

Product Description

PHARMACOLOGY AND TOXICOLOGY:

Animal pharmacodynamics showed that the drug is a strong schizonticide.Parasitemia clearance occurs rapidly with stable efficacy after administration. Tt is also effective against chloroquine-resistant P.falciparum malaria. Acute toxicity stugies on animals showed that the LD50 of Artemether in mice of a single i.g. adminnistration 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 or Arlemether is  quite low.

PHARMACOKINFTICS:

The drug is absorbed rapidly and completely alter i.m. injection. The amximum blood concenlralion of the drug is observed in about 7 hours after i.m. injection of lOmg/kg in human body. The peak value is about 0.8ug/ml with the plasma half-life of about 13hours. 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 ihe feces with a part in urine.

INDICATIONS:

Antimalarial drug. For the treatment of all kinds of malaria including the chloroqine-resislant 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 1.6nig/kg for the following 4 days. The initial dose for adults is 160mg(2 ampoules), followed by 80mg(lampoule) every lime from the 2an lo 5lh day. The dose for children or overweight patients should be decreased or increased on the basis of the individual weight or under the doctors,prescription.

ADVERSE REACTIONS:

Clinical dosage exhibits slight adverse reactions, A transieiil low fever and reticulocytopenia may occur in iiidi-vidual cases. Slight rise of SGOT and SGPT may occur in individual cases. Arrhythmia may occur in rare cases(such as ventricular tachycardia).

ConTRAINDICATIONS : None

PREGNANCY AND LACTATION

It should be used with caution in the first trimester of pregnancy since some fetus absorpLion has been observed.

ADMINISTRATION FOR CHILDREN:

For children, the dose should be chosen as follows: he dose for children should be decreased or increased on llie basis of individual weight or under the doctor's prescription.

DRUG INTERACTIONS:

Studies and reviews in the literature demonstrated that the active substance of

Artemether had no interaclions with oilier drugs on decreasing therapeutic effects

and increasing toxicity and side effects in human bodies.

OVERDOSE:

Although no case of overdosage has been documented, in case of accident,

symptomatic treatment is recommen- ded undre ihe instruction of doctors.

STRENGTH: 40mg/0.5ml, SOmg/lml

VALIDITY:

Four years.

STORAGE:

Preserve in well closed container,prolected from light and stored in a

cool place.

PACKAGE:

6 amjpoules in blistered aluminium foil or plastic plate, Iplate to a paper box.