Trade Name: DOREL TABLET 75 MG
Generic Name: Clopidogrel INN 75 mg Tablet

Presentation
Dorel tablet : Each film coated tablet contains Clopidogrel bisulphate INN equivalent to Clopidogrel 75 mg.
 
Indications
Clopidogrel is indicated for the reduction of atherosclerotic events (myocardial infarction-MI, ischemic stroke and vascular death) in patients with atherosclerosis documented by recent stroke, recent myocardial infarction or established peripheral arterial disease.
 
Dosage and administration
Adults and elderly :
The recommended dose of Clopidogrel is 75 mg once daily. It can be taken with or without food. No dosage adjustment is necessary for elderly patients or patients with renal disease.
Children and adolescents :
Safety and efficacy below the age of 18 years have not been established yet.
 
Contraindications
Hypersensitivity to the drug substance or any component of the product.
Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
 
Side effects
The tolerability of Clopidogrel is similar to that of aspirin. Diarrhea, rash, or  itching occur in approximately 1 in 20 persons taking Clopidogrel. Abdominal pain also occur in about 1 in 20 persons, but it is less frequent than with aspirin.
 
Precaution
As with other antiplatelet agents, Clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions. Clopidogrel should be discontinued 7 days prior to surgery. Clopidogrel should be used with caution in patients who have ulcer or in hepatically impaired patients who may have bleeding diatheses.
 
Use in pregnancy and lactation
Pregnancy :
There are no adequate studies of Clopidogrel in pregnant women. Therefore, it can be used in pregnancy if the physician determines that it is needed.
Nursing mothers :
It is not known whether it appears in human breast milk. Because of a potential for side-effects in the nursing infant, the physician must weigh the potential benefits and possible risks before prescribing this drug in nursing mothers.
 
Drug interactions
The combination of Clopidogrel with NSAIDs, may increases the risk of stomach and intestinal bleeding. At high concentration in the blood, Clopidogrel inhibits the activity of the enzyme which metabolizes Warfarin and increase the risk of bleeding due to over-thinning of the blood.

Overdosage
No adverse events were reported.
 
Commercial pack
Dorel tablet : Each box contains 3x10 tablets in blister strip.