1. Generic Name:
?-?
Arteether Injection 150mg/2ml (Artemotial)
2. Composition:
?-?
Arteether Injection 150mg/2ml (Artemotial)
Each ml contains 75mg of ?-?
Arteether.
3. Dosage Form:
Liquid Injection
4. Clinical
Particulars:
4.1 Pharmacological Category:
Anti-malarial
4.2 Pharmacological action:
?-? Arteether is a fast-acting blood schizontocidal agent for P. falciparum malaria st the erythrocytic stage. ?-? Arteether is concentrated in parasitized erythrocytes. The functional group responsible for antimalarial activity of ?-? Arteether is endoperoxide bridge. Iron from the digested haemoglobin of the parasite?s victim reduces this bridge releasing a highly reactive free radical iron species which causes lysis of the parasitic cell. It is also proposed that ?-? Arteether inhibits the protein synthesis and alters the ribosomal organization and endoplasmic reticulum.
4.3 Pharmacokinetics:
?-? Arteether is transformed into dihydroartemisinin. It has a half-life of 20 hours. It is eliminated by hepatic metabolism. The elimination is much slower compared to other artemisinin compounds.
4.4 Therapeutic indications:
Severe malaria including cerebral malaria & as a second-line drug in chloroquine-resistant malaria cases only.
4.5 Contraindications:
?-? Arteether injection is contraindicated in patients hypersensitive to artemisinin derivatives.
4.6 Dosage &
directions for use:
Adult: 1 ampoule per day
administered by IM injection for a period of 3 days.
Children: 3mg/kg per day
administered by IM injection for a period of 3 days.
Directions of use: The injection must be given under aseptic conditions, deep intramuscularly
in the upper lateral quadrant of the buttock. No other drug should be mixed in
the same syringe.
4.7 Adverse reactions:
There is no evidence of neurotoxicity in human beings with artemisinin derivatives, but neurotoxicity has been reported in experimental animals. ?-? Arteether is usually well tolerated. However, nausea, dizziness and depressed gastrointestinal tract activity can occur. Clinical, urological, electrocardiographic and biochemical monitoring did not reveal significant toxicity. Apart from some increase in eosinophil numbers, no haematological abnormality was seen.
4.8 Warnings & precautions for use in special populations:
When treating children, particular care should be taken to ensure the correct doses are given and retained.
Pregnancy ? Adequate studies regarding the safe use of artemisinin derivatives during pregnancy are not available. Artemisinin derivatives should not be used in pregnancy as primary drugs for uncomplicated malaria cases but these can be used for the treatment of severe or uncomplicated P. falciparum malaria infection in patients of multiple drug resistance if the potential benefit justifies the potential risk to the fetus.
Nursing mothers ? It is not known whether ?-? Arteether is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised while using ?-? Arteether.
4.9 Drug interactions:
Prolonged QT interval has been reported in some studies with a high dosage of artemisinin derivatives. The cardiac effects of artemisinin are not very important from a clinical point of view, except that caution should be exercised against combinations with other drugs that prolong the QT interval, such as quinine and halofantrine.
4.10 Symptoms of overdosage and its treatment:
Overdose treatment should be symptomatic and supportive.
5. Storage
conditions:
Do not store above 30?C. Protect from sunlight. Keep out
of reach of children.
6. Packing:
Pack of 3X2ml
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)