GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
DIRECTION OF USE:
CAUTION & SCHEDULE:
SCHEDULE: SCHEDULE ‘H’ DRUG – To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Protect from light.
Do not freeze.
DOSAGE: As directed by Physician.
α–β Arteether Injection IP 150mg/2ml (Artemotial) Taj Pharma
- Generic Name:
a) α-β Arteether Injection 75mg/1ml (Artemotial) Taj Pharma
b) α-β Arteether Injection 150mg/2ml (Artemotial) Taj Pharma
a)Each ml contains:
α-β Arteether 75mg
b)Each ml contains:
α-β Arteether 150mg
4. Clinical Particulars:
4.1 Pharmacological Category:
4.2 Pharmacological action:
α-β Arteether is a fast acting blood schizontocidal agent for P. falciparum malariae st the erythrocytic stage. α-β Arteether is concentrated in parasitized erythrocytes. The functional group responsible for antimalarial activity of α-β 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 α-β Arteether inhibits the protein synthesis and alters the ribosomal organization and endoplasmic reticulum.
α-β Arteether is transformed into dihydroartemisnin. It has a half-life of 20 hours. It is eliminated by hepatic metabolism. The elimination is much slower compared to other artemisnin compounds.
4.4 Therapeutic indications:
Severe malaria including cerebral malaria & as a second line drug in chloroquine resistant malaria cases only.
α-β Arteether injection is contraindicated in patients hypersensitive to artemisnin 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 artemisnin derivatives, but neurotoxicity has been reported in experimental animals. α-β Arteether is usually well tolerated. However, nausea, dizziness and depressed gastro-intestinal tract activity can occur. Clinical, eurological, 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 safe use of artemisnin derivatives during pregnancy are not available. Artemisnin 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 malariae 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 α-β Arteether is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised in human milk caution should be exercised while using α-β Arteether.
4.9 Drug interactions:
Prolonged QT interval has been reported in some studies with high dosage of artemisnin derivatives. The cardiac effects of artemisnin are not very important from a clinical point of view, except that caution should be exercised against combinations with other drug that prolong the QT interval, such as quinine and halofantrine.
4.10 Symptoms of over dosage and its treatment:
Overdose treatment should be symptomatic and supportive.
- Storage conditions:
Do not store above 30°C. Protect from sunlight. Keep out of reach of children.
Pack of 3X2ml
- Manufactured in India by:
TAJ PHARMACEUTICALS LTD.,
at: Survey No. 622/2/1/4, Dedhrota, Himatnagar-Vijapur Highway,
Dist: Sabarkantha – 383220, Gujarat.