Clopidogrel + Aspirin Tablets

Description

Clopidogrel and Aspirin Tablets (75mg + 75mg / 150mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Clopidogrel and Aspirin Tablets in India. This fixed-dose combination provides two antiplatelet agents with complementary mechanisms and may be used as dual antiplatelet therapy for selected cardiovascular indications, including certain acute coronary syndrome and post-PCI patients, according to current clinical guidance and approved labeling.

2. Product Specifications

3. Manufacturing Technology

Clopidogrel and Aspirin require careful formulation and moisture control because both chemical compatibility and long-term stability must be demonstrated for the registered product.

• Compatibility Control: Validated formulation and, where appropriate, physical separation or coating strategies help manage interaction between the active ingredients.
• Humidity Control: Manufacturing and packaging conditions are controlled according to validated process and stability requirements.
• Release Profile: Immediate-release or modified/enteric components are used only where specifically developed and registered; not every combination product uses enteric-coated Aspirin.
• Barrier Packaging: High-barrier blister options can be used where supported by product stability requirements.

4. Quality Assurance

• Related Substances: Aspirin degradation products such as salicylic acid and relevant Clopidogrel impurities are monitored against approved limits.
• Dissolution: Each active ingredient is tested according to the release specification for the registered dosage form.
• Assay & Uniformity: Both active ingredients are tested against approved assay and dosage-unit specifications.

5. Pharmacology and Clinical Use

Aspirin irreversibly inhibits platelet COX-1 and thromboxane A2 formation, while Clopidogrel irreversibly inhibits platelet P2Y12 ADP receptors after metabolic activation. Together they produce greater platelet inhibition than either pathway alone, but also increase bleeding risk.

• Acute Coronary Syndromes: DAPT is used for selected ACS patients according to cardiology guidance.
• After PCI / Stent: Combination antiplatelet treatment is commonly prescribed for an individualized period after coronary intervention.
• Stroke/TIA: Short-term DAPT may be appropriate for selected patients in specific circumstances; prolonged routine combination therapy is not appropriate for every patient.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to destination-market requirements.

7. Frequently Asked Questions

Q: Who manufactures Clopidogrel + Aspirin Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Clopidogrel and Aspirin formulations in India.

Q: Why are Clopidogrel and Aspirin combined?
A: They inhibit platelet activation through different pathways. A fixed-dose combination can simplify prescribed DAPT, but it is suitable only when both medicines and their doses are appropriate for the patient.

Q: Is the Aspirin always enteric-coated?
A: No. The dosage form depends on the specific registered formulation. Enteric coating should only be claimed where the product is actually manufactured and registered that way.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: The dose and frequency must follow the registered formulation and treating clinician's prescription.
• Duration: DAPT duration after ACS or PCI is individualized according to ischemic risk, bleeding risk, stent/procedure factors and current clinical guidance; it should not automatically be assumed to be 12 months for every patient.
• Administration: Follow the product label. Food instructions depend on the specific formulation and patient circumstances.

9. Side Effects and Precautions

• Bleeding: Easy bruising and bleeding can occur; serious gastrointestinal, intracranial or other bleeding is possible.
• Gastrointestinal Risk: Aspirin can cause dyspepsia, ulcers and GI bleeding. Enteric coating does not eliminate systemic GI bleeding risk.
• Surgery / Dental Procedures: Do not stop Clopidogrel + Aspirin on your own. Whether and when therapy should be interrupted must be decided by the treating clinician because premature discontinuation can cause serious thrombotic events, including stent thrombosis.
• Interactions: Anticoagulants, NSAIDs and other antiplatelet drugs can further increase bleeding risk. Clopidogrel activation can also be affected by certain CYP2C19-related factors or medicines.

10. Storage Instructions

• Store below 25°C unless the registered label specifies otherwise.
• Protect from moisture.
• Keep in original protective packaging.
• Keep out of reach of children.