Audited Supplier
1ml 20mg/40mg/80mg
Internal Medicine
I.M.
Elderly, Children, Adult
Liquid
Liquid
Organic Chemicals
Chemical Synthesis
RYAN PHARMA
Carton
1ml 20mg/40mg/80mg, 6amps, 60amps/box
China
Product Description
ARTEMETHER INJECTION
NOMENCLATURE:
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-zodioxepin
CHARACTER:
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 LACTATION
It should be used with caution in the first trimester of pregnancy since some fetus absorption has been observed
ADMINISTRATION FORCHILDREN: For children, the dose should be chosen as follows:
The dose for children should be decreased or increased on the 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 interactions with other 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 recommended under the instruction of doctors.
PRESENTATION: Solution for injection, ampoule of 20mg, 40mg, 80mg/1ml, box of 6
VALIDITY: 3years.
STORAGE: Store in well closed container, protected from light and stored in a cool place.
NOMENCLATURE:
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-zodioxepin
CHARACTER:
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 LACTATION
It should be used with caution in the first trimester of pregnancy since some fetus absorption has been observed
ADMINISTRATION FORCHILDREN: For children, the dose should be chosen as follows:
| AGE(year) | WEIGHT | TOTAL DOSE | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 |
| <1 | <8kg | 75mg | 25mg | 12.5mg | 12.5mg | 12.5mg | 12.5mg |
| 1-3 | 8-12.5kg | 120mg | 40mg | 20mg | 20mg | 20mg | 20mg |
| 3-6 | 12.5-17.5kg | 150mg | 50mg | 25mg | 25mg | 25mg | 25mg |
| 6-9 | 17.5-25kg | 240mg | 80mg | 40mg | 40mg | 40mg | 40mg |
| 9-12 | 25-32kg | 300mg | 100mg | 50mg | 50mg | 50mg | 50mg |
| 12-16 | 32-47kg | 360mg | 120mg | 60mg | 60mg | 60mg | 60mg |
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 overdosage has been documented, in case of accident, symptomatic treatment is recommended under the instruction of doctors.
PRESENTATION: Solution for injection, ampoule of 20mg, 40mg, 80mg/1ml, box of 6
VALIDITY: 3years.
STORAGE: Store in well closed container, protected from light and stored in a cool place.
