Clorel 75 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Clopidogrel bisulphate |
| Company | Aci limited |
Indications
- Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)].
- Recent MI, recent Stroke, or established Peripheral Arterial Disease: It is indicated to reduce the rate of MI and stroke.
Pharmacology
Clopidogrel inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.
Dosage & Administration
- Acute Coronary Syndrome: Initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily.
- Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
- It is given orally with or without food.
Interaction
- NSAIDs, warfarin, SSRIs, SNRIs: Increases risk of bleeding
- CYP2C19 inhibitors (omeprazole or esomeprazole): Avoid concomitant use of omeprazole or esomeprazole
- Repaglinide (CYP2C8 substrates): Avoid concomitant use of Clorel with Repaglinide as it increases plasma concentrations of Repaglinide
Contraindications
Clopidogrel is contraindicated in conditions such as hypersensitivity to the drug substance or any component of the product, and active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
Side Effects
- Bleeding
- Diarrhoea
- Gastrointestinal discomfort
- Haemorrhage
- Skin reactions
- Acquired haemophilia
- Anaemia
- Angioedema
- Arthralgia
- Arthritis
- Bone marrow disorders
Pregnancy & Lactation
There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Precautions & Warnings
- Metabolism to its active metabolite is impaired by genetic variations in CYP2C19 and by the drugs that inhibit CYP2C19 such as Omeprazole and Esomeprazole.
- It inhibits platelet aggregation for the lifetime of the platelet (7-10 days), and the risk of bleeding may increase.
- Discontinuation of Clorel increases the risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Resume Clorel as soon as hemostasis is achieved.
- Thrombotic Thrombocytopenic Purpura (TTP) has been reported that requires urgent treatment including plasmapheresis (plasma exchange).
- Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel or history of hypersensitivity to other thienopyridines.
Use in Special Populations
Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.
Overdose Effects
Overdose following clopidogrel administration may lead to bleeding complications. Platelet transfusion may restore clotting ability based on biological plausibility.
Therapeutic Class
Anti-platelet drugs
Storage Conditions
Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.