Noplag
Generic Name
Clopidogrel
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
noplag 60 mg tablet | ৳ 35.00 | ৳ 350.00 |
Description
Overview of the medicine
Noplag 60 mg tablet contains Clopidogrel, an antiplatelet medication used to prevent blood clots in conditions like heart attack, stroke, and peripheral arterial disease. It works by preventing platelets from clumping together, reducing the risk of cardiovascular events.
Uses & Indications
Dosage
Adults
For maintenance after a loading dose, or specific conditions like peripheral arterial disease: 60 mg once daily. For Acute Coronary Syndrome (ACS) with or without ST-segment elevation: Loading dose as prescribed by physician, followed by 60 mg once daily in combination with aspirin.
Elderly
No specific dose adjustment is generally required for elderly patients, but caution is advised due to increased risk of bleeding.
Renal_impairment
No dose adjustment necessary for mild to moderate renal impairment. Use with caution in severe renal impairment (CrCl <30 mL/min).
How to Take
Noplag 60 mg tablet should be taken orally, with or without food, at the same time each day. Swallow the tablet whole with a glass of water. Do not crush or chew.
Mechanism of Action
Clopidogrel is a prodrug that is metabolized to its active form. The active metabolite irreversibly binds to the P2Y12 adenosine diphosphate (ADP) receptor on platelets, preventing ADP-mediated platelet activation and aggregation. This inhibits the formation of blood clots.
Pharmacokinetics
Onset
Antiplatelet effect begins within 2 hours; maximal effect achieved in 3-7 days with daily dosing.
Excretion
Approximately 50% renally excreted and 48% fecally excreted within 5 days.
Half life
Parent drug: Approximately 8 hours; Active metabolite: Approximately 30 minutes.
Absorption
Rapidly absorbed after oral administration, but bioavailability is low (approx. 50%) due to extensive first-pass metabolism.
Metabolism
Extensively metabolized in the liver by CYP450 enzymes (primarily CYP2C19 and CYP3A4) to an active metabolite and an inactive carboxylic acid derivative.
Side Effects
Contraindications
- Active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage)
- Hypersensitivity to clopidogrel or any component of the tablet
- Severe hepatic impairment
Drug Interactions
SSRIs/SNRIs
Increased risk of bleeding, especially gastrointestinal bleeding.
Warfarin and other anticoagulants
Increased risk of bleeding. Co-administration should be undertaken with caution and clinical monitoring.
NSAIDs (e.g., Ibuprofen, Naproxen)
Increased risk of gastrointestinal bleeding. Concomitant use should be with caution.
Proton Pump Inhibitors (PPIs, e.g., Omeprazole, Esomeprazole)
May reduce the antiplatelet effect of clopidogrel (due to CYP2C19 inhibition). Consider alternative PPIs or H2 blockers.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach and sight of children.
Overdose
Overdose of clopidogrel may lead to prolonged bleeding time and subsequent bleeding complications. In case of suspected overdose, gastric decontamination (e.g., activated charcoal) may be considered. Platelet transfusion may be necessary if immediate reversal of antiplatelet effects is required and clinical judgment warrants it.
Pregnancy & Lactation
Pregnancy: Use only if clearly needed. Animal studies have not shown direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Lactation: It is unknown whether clopidogrel is excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Noplag therapy, considering the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Side Effects
Contraindications
- Active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage)
- Hypersensitivity to clopidogrel or any component of the tablet
- Severe hepatic impairment
Drug Interactions
SSRIs/SNRIs
Increased risk of bleeding, especially gastrointestinal bleeding.
Warfarin and other anticoagulants
Increased risk of bleeding. Co-administration should be undertaken with caution and clinical monitoring.
NSAIDs (e.g., Ibuprofen, Naproxen)
Increased risk of gastrointestinal bleeding. Concomitant use should be with caution.
Proton Pump Inhibitors (PPIs, e.g., Omeprazole, Esomeprazole)
May reduce the antiplatelet effect of clopidogrel (due to CYP2C19 inhibition). Consider alternative PPIs or H2 blockers.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach and sight of children.
Overdose
Overdose of clopidogrel may lead to prolonged bleeding time and subsequent bleeding complications. In case of suspected overdose, gastric decontamination (e.g., activated charcoal) may be considered. Platelet transfusion may be necessary if immediate reversal of antiplatelet effects is required and clinical judgment warrants it.
Pregnancy & Lactation
Pregnancy: Use only if clearly needed. Animal studies have not shown direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Lactation: It is unknown whether clopidogrel is excreted in human milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Noplag therapy, considering the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the manufacturing date when stored under recommended conditions.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA
Patent Status
Expired (Generic available)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials, including CAPRIE, CURE, and COMMIT, have demonstrated the efficacy and safety of clopidogrel in reducing atherothrombotic events in various patient populations.
Lab Monitoring
- Regular monitoring for signs of bleeding (e.g., hemoglobin, hematocrit) is important, especially during the first weeks of treatment or after invasive procedures.
- Platelet function tests (e.g., P2Y12 reaction units) may be considered in specific clinical situations (e.g., high-risk patients, stent thrombosis).
Doctor Notes
- Emphasize patient compliance, as premature discontinuation of clopidogrel significantly increases the risk of cardiovascular events, including stent thrombosis.
- Advise patients to inform all healthcare providers, including dentists and pharmacists, about clopidogrel use prior to any procedure or starting new medications.
- Be vigilant for signs and symptoms of bleeding, particularly GI bleeding and intracranial hemorrhage, and instruct patients on what to report immediately.
- Consider CYP2C19 genotyping in patients at high risk for treatment failure or adverse events, though its routine use is debated.
Patient Guidelines
- Inform your doctor about all medicines you are taking, including over-the-counter drugs, herbal supplements, and vitamins.
- Do not stop taking Noplag without consulting your doctor, even if you feel well, as this may significantly increase your risk of heart attack or stroke.
- Report any unusual bleeding or bruising (e.g., persistent nosebleeds, blood in urine/stool, severe headaches) immediately to your doctor or seek emergency medical attention.
- Be cautious with activities that may cause injury or bleeding.
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 take a double dose to make up for a missed one.
Driving Precautions
Noplag is not known to impair the ability to drive or operate machinery. However, if you experience dizziness, blurred vision, or any other side effects that affect your concentration or judgment, avoid driving or operating machinery.
Lifestyle Advice
- Avoid activities that may increase your risk of bleeding or injury, especially contact sports.
- Maintain a healthy lifestyle, including a balanced diet, regular exercise, and smoking cessation, as advised by your doctor.
- Avoid excessive alcohol consumption, as it can increase the risk of bleeding.
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