Lopirel 75 mg Tablet

What is Lopirel?

Lopirel is an antiplatelet medication containing the generic Clopidogrel Bisulphate, manufactured by Incepta Pharmaceuticals Ltd. It is used to reduce the risk of myocardial infarction and stroke in patients with acute coronary syndrome, recent MI, recent stroke, or established peripheral arterial disease.

Indications

Acute Coronary Syndrome (ACS): Indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina/NSTEMI) and acute ST-elevation MI (STEMI).
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: Indicated to reduce the rate of MI and stroke in these patients.

Pharmacology

Clopidogrel is a prodrug that inhibits platelet activation and aggregation through irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation is seen 2 hours after a single oral dose. Repeated 75 mg daily doses inhibit ADP-induced platelet aggregation from the first day, reaching steady state between Day 3 and Day 7.

Dosage & Administration

Acute Coronary Syndrome: For patients needing an antiplatelet effect within hours, initiate with a single 300 mg (4 tablets) oral loading dose, then continue at 75 mg once daily. Without a loading dose, the antiplatelet effect is delayed by several days.
Recent MI, Recent Stroke, or Established PAD: 75 mg once daily without a loading dose.
May be taken with or without food.

Interaction

NSAIDs, Warfarin, and SSRIs/SNRIs increase the risk of bleeding. CYP2C19 inhibitors such as Omeprazole or Esomeprazole should be avoided concomitantly, as they reduce Clopidogrel's antiplatelet activity. Concomitant use with Repaglinide should be avoided as it increases Repaglinide plasma concentrations.

Contraindications

Contraindicated in hypersensitivity to the drug substance or any component of the product, and in active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Side Effects

Generally well tolerated. Common: bleeding, diarrhoea, gastrointestinal discomfort, haemorrhage, skin reactions. Rare: acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.

Pregnancy & Lactation

No adequate and well-controlled studies exist in pregnant women; use during pregnancy only if clearly needed. Unknown whether excreted in human breast milk — a decision should be made whether to discontinue nursing or the drug, weighing the importance of the drug to the mother.

Precautions & Warnings

Metabolism to the active metabolite is impaired by genetic CYP2C19 poor-metabolizer status and CYP2C19-inhibiting drugs (e.g., Omeprazole, Esomeprazole), reducing antiplatelet activity. Inhibits platelet aggregation for the platelet lifetime (7-10 days), increasing bleeding risk; platelet transfusion within 4 hours of a loading dose or 2 hours of a maintenance dose may be less effective. Discontinuation increases cardiovascular event risk — discontinue 5 days prior to elective surgery with major bleeding risk and resume once hemostasis is achieved. Thrombotic Thrombocytopenic Purpura (TTP) has been reported, requiring urgent treatment including plasmapheresis. Hypersensitivity reactions including rash, angioedema, or hematologic reactions have been reported.

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 may lead to bleeding complications. Based on biological plausibility, platelet transfusion may help restore clotting ability.

Therapeutic Class

Anti-platelet Drug

Storage Conditions

Keep below 30°C in a dry place, protected from light. Do not freeze. Keep out of reach of children.