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Clopix

Clopix

clopidogrel

Manufacturer:

Medhaus

Distributor:

Medhaus
Full Prescribing Info
Contents
Clopidogrel bisulfate.
Description
Each film-coated tablet contains: Clopidogrel (as bisulfate) 75 mg.
Action
Pharmacology:  Pharmacokinetics: After repeated 75 mg oral doses of Clopidogrel, plasma concentrations of the parent compound, which has no platelet inhibiting effect, are very low and are generally below the quantification limit (0.00025 mg/L) beyond 2 hours after dosing. Clopidogrel is extensively metabolized by the liver. The main circulating metabolite is the carboxylic acid derivative and it too has no effect on platelet aggregation. it represents about 85% of the circulating drug-related compounds in plasma.
Following an oral dose of 14C-labeled clopidogrel in humans, approximately 50% was excreted in the urine and approximately 46% in the feces in the 5 days after dosing. The elimination half-life of the main circulating metabolite was 8 hours after single and repeated administration. Covalent binding to platelets accounted for 2 % of radiolabel with a half-life of 11 days.
Indications/Uses
Used in thromboembolic disorders. It is given prophylactically as an alternative to aspirin in patients with atheroscelorosis who are at risk of thromboembolic disorders such as myocardial infarction, peripheral arterial disease and stroke.
Dosage/Direction for Use
Recent Myocardial Infarction/Recent Stroke/Established Peripheral Arterial Disease: Recommended Daily Dose: 75 mg once daily.
Acute Coronary Syndrome: Initial dose: single 300 mg loading dose and then continued at 75 mg once daily.
Clopidogrel tablets can be administered with or without food. No dosage adjustment is necessary for elderly patients or patients with renal disease.
Contraindications
Hypersensitivity to the drug. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage. Pregnant and nursing mothers.
Special Precautions
In patients taking medications that increase the risk of bleeding, such as non-steroidal anti-inflammatory agents or aspirin, discontinue Clopidogrel 7 days prior to surgery or any event when a normal platelet effect is needed. Clopidogrel should be used with caution in patients with active hepatic disease.
Adverse Reactions
Headache, dizziness, depression, dyspnea, rhinitis, bronchitis, coughing, edema, hypertension, abdominal pain, diarrhea, nausea, arthralgia, back pain, fatigue & hypercholesterolemia.
Drug Interactions
Warfarin: The concomitant administration of clopidogrel with warfarin is not recommended since it may increase the intensity of bleeding.
Aspirin: Clopidogrel potentiated the effect of aspirin on a collagen-induced platelet aggregation. A pharmacodynamic interaction between clopidogrel and aspirin is possible leading to increased risk of bleeding therefore concomitant use should be undertaken with caution.
Heparin: Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Thrombolytics: The safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
NSAlDs: The concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Clopix FC tab 75 mg
Packing/Price
30's (P1,080/pack)
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