Corplet

Corplet

clopidogrel

Manufacturer:

Mepro Pharmaceutical

Distributor:

Mc Graw Pharma

Marketer:

MedEthix
Full Prescribing Info
Contents
Clopidogrel bisulfate.
Description
Each film coated tablet contains: Clopidogrel (as bisulfate) 75 mg.
Clopidogrel is a thienopyridine platelet aggregation inhibitor. It is used for the prevention of ischemic events in patients at risk, i.e. recent stroke, myocardial infarction or peripheral arterial disease.
Action
Pharmacology: Mechanism of Action: Clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation. Biotransformation of clopidogrel is necessary to produce inhibition of platelet aggregation, but an active metabolite responsible for the activity of the drug has not been isolated. Clopidogrel also inhibits platelet aggregation induced by agonists other than ADP by blocking the amplification of platelet activation by released ADP. Clopidogrel does not inhibit phosphodiesterase activity. Clopidogrel acts by irreversibly modifying the platelet ADP receptor and platelets exposed to clopidogrel are affected for the remainder of their lifespan.
Pharmacokinetics: Absorption and Distribution: Clopidogrel is rapidly absorbed after oral administration of repeated doses of 75 mg clopidogrel, with peak plasma levels (3 mg/L) of the main circulating metabolite occurring approximately 1 hour after dosing. The pharmacokinetics of the main circulating metabolite is linear in the dose range of 50 to 150 mg of clopidogrel. Absorption is at least 50% based on urinary excretion of clopidogrel-related metabolites. Total protein binding of clopidogrel and the main circulating metabolite is about 98% and 94%, respectively.
Effect of Food: Bioavailability of clopidogrel was not significantly modified when it was administered with food as assessed by the pharmacokinetics of the main circulating metabolite.
Metabolism and Elimination: Clopidogrel is extensively metabolized in the liver, mainly to the inactive carboxylic acid derivative. In plasma and urine, the glucuronide of the carboxylic acid derivative is also observed. The elimination half-life of the main circulating metabolite was 8 hours after single and repeated administration. After oral administration about 50% of dose is excreted in the urine and about 46% in the feces.
Indications/Uses
It is given prophylactically as an alternative to aspirin in patients with atherosclerosis who are at risk of thromboembolic disorders such as myocardial infarction, peripheral arterial disease, and stroke.
Dosage/Direction for Use
Clopidogrel can be administered with or without food.
The recommended daily dose of clopidogrel is 75 mg once daily for the treatment of recent MI, recent stroke, or established peripheral arterial disease.
In patients with acute coronary syndrome (unstable angina/non-Qwave MI), clopidogrel should be initiated with a single 300 mg loading dose and then continued at 75 mg once daily. Aspirin (75 mg - 325 mg once daily) should be initiated and continued in combination with clopidogrel. No dosage adjustment is necessary for elderly patients or patients with renal disease.
Or as prescribed by the physician.
Contraindications
Hypersensitivity to clopidogrel or other product components. Clopidogrel should not be administered to patients with an increased risk of bleeding such as peptic ulcer disease.
Special Precautions
General: Clopidogrel prolongs the bleeding time and therefore should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or other pathological conditions.
GI Bleeding: Clopidogrel should be used with caution in patients who have lesions with a susceptibility to bleed such as ulcers.
Drugs that might induce such lesions should be used with caution in patients taking clopidogrel.
Hepatically Impaired Patients: Clopidogrel should be used with caution in hepatically impaired patients, as there is no study to indicate the safety of clopidogrel in patients with severe hepatic disease who may have bleeding diatheses.
Renally Impaired Patients: Clopidogrel should used with caution in patients with severe renal impairment, as there is no information about its safety in these patients.
Use in Pregnancy: Category B: There are no adequate and well-controlled studies of clopidogrel in pregnant women; therefore clopidogrel should be used during pregnancy only if clearly needed.
Use in Lactation: It is not known whether clopidogrel is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the nursing mother.
Use in Children: Use Safety and effectiveness in the pediatric population have not been established.
Use In Pregnancy & Lactation
Use in Pregnancy: Category B: There are no adequate and well-controlled studies of clopidogrel in pregnant women; therefore clopidogrel should be used during pregnancy only if clearly needed.
Use in Lactation: It is not known whether clopidogrel is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the nursing mother.
Adverse Reactions
Clopidogrel has been evaluated for safety in more than 17,500 patients, including over 9,000 patients treated for 1 year or more. The overall tolerability of clopidogrel was similar to that of aspirin regardless of age, gender and race. The most common adverse effects were gastrointestinal hemorrhage, gastrointestinal events like abdominal pain, dyspepsia, gastritis, constipation and diarrhea. Other adverse effects occurring in 1% to 2.5% of patients receiving clopidogrel are rash and skin disorders, syncope, palpitation, asthenia, hernia, cramps in legs, hypoaesthesia, neuralgia, paraesthesia, vertigo, arthritis, arthrosis, anxiety, insomnia, anemia, hemorrhagic gastritis, hemorrhagic upper GI ulcer, bilirubinemia, infectious hepatitis, and fatty liver.
Drug Interactions
Concomitant administration of clopidogrel with NSAIDs is associated with increased occult gastrointestinal blood loss. Therefore, NSAIDs and clopidogrel should be coadministered with caution. Clopidogrel may interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, and therefore, should be, coadministered with caution.
Storage
Store at a temperatures not exceeding 30°C.
Protect from light.
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
FC tab 75 mg x 100's.
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