Apt
Generic Name
Clopidogrel
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| apt 75 mg tablet | ৳ 10.03 | ৳ 100.30 |
Description
Overview of the medicine
Apt 75 mg tablet is an antiplatelet medication containing Clopidogrel, used to prevent blood clots in conditions such as heart attack, stroke, and peripheral arterial disease. It reduces the risk of further cardiovascular events.
Uses & Indications
Dosage
Adults
For MI/stroke/PAD: 75 mg once daily. For ACS: Loading dose of 300 mg (or 600 mg for PCI) followed by 75 mg once daily with aspirin.
Elderly
No dosage adjustment generally required.
Renal_impairment
No dosage adjustment required in patients with mild to moderate renal impairment. Use with caution in severe impairment.
How to Take
Administer orally, once daily, with or without food.
Mechanism of Action
Clopidogrel is a prodrug that is metabolized to an active thiol metabolite. This active metabolite selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor, thereby inhibiting ADP-mediated platelet activation and aggregation. This action is irreversible for the life of the platelet.
Pharmacokinetics
Onset
Platelet inhibition seen within 2 hours; maximal effect 3-7 days.
Excretion
Approximately 50% via urine and 48% via feces.
Half life
Active metabolite has a half-life of ~30 minutes; parent compound ~8 hours.
Absorption
Rapidly absorbed after oral administration; bioavailability is about 50%.
Metabolism
Primarily hepatic by CYP450 enzymes (mainly CYP2C19) to active and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
- Severe hepatic impairment.
Drug Interactions
NSAIDs
Increased risk of gastrointestinal bleeding.
SSRIs/SNRIs
Increased risk of bleeding.
Warfarin and other oral anticoagulants
Increased risk of bleeding.
Proton Pump Inhibitors (especially omeprazole/esomeprazole)
Can reduce the antiplatelet effect of clopidogrel due to CYP2C19 inhibition.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose with clopidogrel may lead to prolonged bleeding time and subsequent bleeding complications. Management should include supportive measures and symptomatic treatment. Platelet transfusion may be considered if rapid reversal of effects is required.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
- Severe hepatic impairment.
Drug Interactions
NSAIDs
Increased risk of gastrointestinal bleeding.
SSRIs/SNRIs
Increased risk of bleeding.
Warfarin and other oral anticoagulants
Increased risk of bleeding.
Proton Pump Inhibitors (especially omeprazole/esomeprazole)
Can reduce the antiplatelet effect of clopidogrel due to CYP2C19 inhibition.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose with clopidogrel may lead to prolonged bleeding time and subsequent bleeding complications. Management should include supportive measures and symptomatic treatment. Platelet transfusion may be considered if rapid reversal of effects is required.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA, DGDA, and other major regulatory bodies
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials (e.g., CAPRIE, CURE, COMMIT/CCS-2, CLARITY-TIMI 28) have demonstrated the efficacy and safety of clopidogrel in various cardiovascular conditions. These trials have shown its superiority over aspirin alone in reducing cardiovascular events in certain populations, and its benefit in combination with aspirin.
Lab Monitoring
- Monitor for signs of bleeding, including routine complete blood counts (CBC).
- Consider platelet function testing in selected patients (e.g., those with recurrent events).
Doctor Notes
- Counsel patients on bleeding risks and symptoms, and emphasize adherence.
- Consider CYP2C19 genetic testing in high-risk patients with recurrent events.
- Avoid concomitant use with strong CYP2C19 inhibitors where possible.
Patient Guidelines
- Take exactly as prescribed by your doctor, do not stop without consulting your doctor.
- Report any unusual bleeding or bruising immediately to your doctor.
- Inform your dentist or surgeon that you are taking this medication before any procedure.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Clopidogrel is not expected to affect the ability to drive or operate machinery. However, if you experience dizziness, avoid driving or operating machinery.
Lifestyle Advice
- Avoid activities that may cause injury or bleeding.
- Maintain a healthy lifestyle, including diet and exercise, as advised by your doctor.
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Global Brand Names
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