Dorel
Generic Name
Clopidogrel
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
dorel 75 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Dorel 75 mg Tablet contains Clopidogrel, an antiplatelet medication used to prevent blood clots in patients with heart disease, recent heart attack, stroke, or peripheral arterial disease. It helps to keep blood flowing smoothly by preventing platelets from sticking together.
Uses & Indications
Dosage
Adults
75 mg once daily with or without food. For Acute Coronary Syndrome, an initial loading dose of 300 mg or 600 mg may be given, followed by 75 mg once daily.
Elderly
No dose adjustment is generally necessary for elderly patients.
Renal_impairment
No dose adjustment is generally necessary for patients with mild to moderate renal impairment. Caution is advised in patients with severe renal impairment due to limited experience.
How to Take
Dorel 75 mg Tablet should be taken orally, with or without food. It is recommended to take the medicine at the same time each day.
Mechanism of Action
Clopidogrel is a prodrug that requires metabolic activation by CYP450 enzymes, primarily CYP2C19, to form an active thiol metabolite. The active metabolite selectively and irreversibly binds to the P2Y12 ADP receptor on platelet surfaces, thereby preventing ADP-induced platelet activation and aggregation. This inhibition is dose-dependent and lasts for the lifetime of the platelet (7-10 days).
Pharmacokinetics
Onset
Within 2 hours after a single oral dose; maximal effect observed within 3-7 days of daily dosing.
Excretion
Approximately 50% renally and 48% fecally excreted within 120 hours after dosing.
Half life
Parent drug: Approximately 6 hours. Active metabolite: Approximately 8 hours.
Absorption
Rapidly absorbed after oral administration. Mean peak plasma levels of parent drug are about 45 minutes post-dose. Bioavailability is approximately 50%.
Metabolism
Extensively metabolized in the liver. Two main metabolic pathways: one catalyzed by esterases leading to inactive carboxylic acid derivative (~85% of circulating drug), and another catalyzed by CYP450 enzymes (primarily CYP2C19) to an active thiol metabolite.
Side Effects
Contraindications
- Hypersensitivity to the active substance (Clopidogrel) or to any of the excipients.
- Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
- Severe hepatic impairment.
Drug Interactions
Warfarin and other oral anticoagulants
Increased risk of bleeding. Co-administration should be undertaken with caution.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
Increased risk of gastrointestinal bleeding. Concomitant use should be avoided.
CYP2C19 inhibitors (e.g., Omeprazole, Esomeprazole)
May reduce the antiplatelet effect of Clopidogrel. Avoid concomitant use.
SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors)
Increased risk of bleeding.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of Clopidogrel can lead to prolonged bleeding time and subsequent bleeding complications. Management of overdose should be symptomatic, including platelet transfusion if significant bleeding is observed or deemed necessary to reverse the antiplatelet effect.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Clopidogrel should be used during pregnancy only if clearly needed. It is unknown whether Clopidogrel is excreted in human milk; breastfeeding should be discontinued or the drug should be stopped, considering the benefit of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to the active substance (Clopidogrel) or to any of the excipients.
- Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
- Severe hepatic impairment.
Drug Interactions
Warfarin and other oral anticoagulants
Increased risk of bleeding. Co-administration should be undertaken with caution.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
Increased risk of gastrointestinal bleeding. Concomitant use should be avoided.
CYP2C19 inhibitors (e.g., Omeprazole, Esomeprazole)
May reduce the antiplatelet effect of Clopidogrel. Avoid concomitant use.
SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors)
Increased risk of bleeding.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of Clopidogrel can lead to prolonged bleeding time and subsequent bleeding complications. Management of overdose should be symptomatic, including platelet transfusion if significant bleeding is observed or deemed necessary to reverse the antiplatelet effect.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Clopidogrel should be used during pregnancy only if clearly needed. It is unknown whether Clopidogrel is excreted in human milk; breastfeeding should be discontinued or the drug should be stopped, considering the benefit of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials, such as CAPRIE, CURE, and COMMIT, have demonstrated the efficacy and safety of Clopidogrel in preventing atherothrombotic events in various patient populations. These trials support its use in myocardial infarction, stroke, peripheral arterial disease, and acute coronary syndromes.
Lab Monitoring
- Monitor for signs of bleeding regularly.
- Perform complete blood count (CBC) with platelet count periodically, especially if bleeding is suspected.
- Monitor liver function tests in patients with hepatic impairment.
Doctor Notes
- Counsel patients on the importance of adherence to therapy and the risk of bleeding.
- Consider alternative antiplatelet agents or a higher dose of Clopidogrel with careful monitoring for patients identified as CYP2C19 poor metabolizers.
- Evaluate bleeding risk factors before initiating therapy and regularly thereafter.
Patient Guidelines
- Take Dorel exactly as prescribed by your doctor and do not stop taking it without consulting your doctor, as this may increase your risk of a heart attack or stroke.
- Inform your doctor or dentist that you are taking Dorel before any surgery or dental procedure.
- Report any unusual bleeding or bruising immediately to your doctor.
Missed Dose Advice
If you miss a dose of Dorel, take it as soon as you remember. If it is less than 12 hours before your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Dorel is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or any other side effect that may impair your concentration, it is advisable to avoid such activities.
Lifestyle Advice
- Avoid activities that may cause significant injury to prevent bleeding.
- Maintain a healthy diet and regular exercise as advised by your doctor to manage underlying cardiovascular conditions.
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