Clopilet A 75 mg+75 mg (Tablet)

Title

• Clopilet A

Category

• Medicine
• Anti-Platelet Drug

Description

• Clopilet A is indicated for reducing the rate of Myocardial Infarction (MI) and Stroke in patients with acute coronary syndrome (ACS), recent MI, recent stroke, or established peripheral arterial disease. It is a prodrug that inhibits platelet activation and aggregation through irreversible binding to P2Y12 class of ADP receptors on platelets. The recommended daily dose is 75 mg once daily with or without food. It is contraindicated in hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage.

Color Options

• NA

Dimensions

• NA

Weight

• NA

Materials

• NA

Function

• Reducing the rate of Myocardial Infarction (MI) and Stroke
• Inhibits platelet activation and aggregation
• Irreversible binding to P2Y12 class of ADP receptors on platelets

Technical Specifications

• Recommended daily dose: 75 mg once daily
• Plasma concentrations of the parent compound are very low and generally below the quantification limit (0.00025 mg/L) beyond 2 hours after dosing
• Approximately 50% of the drug is excreted in urine and approximately 46% in faeces in 5 days after dosing
• The elimination half-life of the main circulating metabolite is 8 hours after single and repeated administration
• Absorption is at least 50% based on urinary excretion of Clopidogrel-related metabolites
• Main circulating metabolite binds reversibly in vitro to human plasma proteins (94%)

Design Elements

• NA

Usability Features

• Indicated for acute coronary syndrome (ACS), recent MI, recent stroke, or established peripheral arterial disease

Dosage and Administration

• Recommended daily dose: 75 mg once daily with or without food
• For patients with acute coronary syndrome, should be initiated with a single 300 mg loading dose and then continued at 75 mg once daily
• Aspirin should be initiated and continued in combination with Clopidogrel

Interactions

• Interacts with aspirin, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs), and warfarin

Contraindications

• Hypersensitivity to the drug substance or any component of the product
• Active pathological bleeding such as peptic ulcer or intracranial hemorrhage

Side Effects

• Generally well tolerated

Pregnancy & Lactation

• Should be used during the first and second trimesters of pregnancy only if clearly needed
• Contraindicated during the third trimester of pregnancy
• Unknown whether Clopidogrel is excreted in human breast milk but Aspirin is excreted in human milk
• Drug should be discontinued during breastfeeding

Precautions & Warnings

• May prolong bleeding time
• Rare reports of Thrombotic thrombocytopenic purpura (TTP)
• Reye's syndrome may develop in individuals with chicken pox, influenza or flu symptoms
• Hypersensitivity reactions reported

Use in Special Populations

• Should not be given to children, particularly those under 12 years, unless the expected benefits outweigh the possible risks

Overdose Effects

• Clopidogrel overdose may lead to bleeding complications
• In moderate aspirin intoxication, symptoms may include dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms
• Severe aspirin intoxication can result in respiratory and metabolic issues
• Can be treated with platelet transfusion, vomiting induction, gastric lavage, haemodialysis, and symptomatic treatment

Therapeutic Class

• Anti-platelet drugs

Storage Conditions

• Keep in a cool & dry place (below 30°C)
• Protected from light & moisture
• Keep out of the reach of children

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