Stromix-75mg
Manufactured By
Nicholas Piramal India Limited
Class: Antiplatelet Aggregation Inhibitor
Actions Clopidogrel is a thienopyridine derivative, chemically related to ticlopidine, that inhibits platelet aggregation. It acts by irreversibly modifying the platelet ADP receptor. Therefore, platelet aggregation is inhibited for both ADP-mediated and ADP-amplified (by other agonists) platelet activation. Consequently, platelets exposed to clopidogrel are affected for the remainder of their lifespan.
Indications Reduction of atherosclerotic events (eg, MI, stroke, vascular death) in patients with atherosclerosis documented by recent stroke, recent MI, or established peripheral arterial disease. Treatment of acute coronary syndrome (unstable angina/non-Q-wave MI) including patients managed medically and those managed with percutaneous coronary intervention (with or without stent) or coronary artery bypass graft.
Contraindications Hypersensitivity to the drug; active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
Route/Dosage
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: PO 75 mg once daily with or without food. Acute Coronary Syndrome (Unstable Angina/Non-Q-Wave MI): ADULTS: PO Start with a 300 mg loading dose, then continue at 75 mg once daily, initiating and continuing aspirin (75 to 325 mg/day) in combination with clopidogrel.
Interactions
Clopidogrel inhibits P450 2C9. Accordingly, clopidogrel may interfere with the metabolism of phenytoin, tamoxifen, tolbutamide, warfarin (prolongs bleeding time), torsemide, fluvastatin, and many NSAIDs, but there are no data with which to predict the magnitude of these interactions. Use with caution when administering clopidogrel with any of these drugs.
Lab Test Interferences None well documented.
Adverse Reactions
CARDIOVASCULAR: Edema; hypertension. CNS: Headache; dizziness. DERMATOLOGIC: Skin/appendage disorders; rash; pruritus. GI: Abdominal pain; dyspepsia; diarrhea; nausea; hemorrhage. HEMATOLOGIC:-LYMPHATIC Purpura; epistaxis. RESPIRATORY: Upper respiratory tract infection; dyspnea; rhinitis; coughing; bronchitis. OTHER: Arthralgia; back pain; chest pain; pain; accidental injury; influenza-like symptoms, UTI, hypercholesterolemia; depression; fatigue.
Precautions
Pregnancy: Category B. Lactation: Undetermined. CHILDREN: Safety and efficacy not established. Bleeding risk: Caution in patients with increased bleeding from trauma, surgery, or other pathological conditions. If undergoing surgery and antiplatelet effect is not desired, discontinue clopidogrel 7 days prior. GI bleeding: Clopidogrel prolongs bleeding time. Use with caution in patients who have lesions with a propensity to bleed (eg, ulcers). Cautiously use drugs that might increase such lesions (eg, aspirin, NSAIDs). Hepatically impaired: Use with caution in patients with severe hepatic disease who may have bleeding diatheses.
PATIENT CARE CONSIDERATIONS
Administration/Storage
Usual dose is 1 tablet once daily without regard to meals.
Store at controlled room temperature.
Assessment/Interventions
Obtain patient history, including drug history and any known allergies. Note history of peptic ulcer disease and bleeding disorders.
Monitor patient for unusual bleeding or bruising and report to health care provider if noted.
Monitor patient for GI, CNS, CV, and musculoskeletal side effects. Report to health care provider if noted and significant.
Patient/Family Education
Explain name, dose, action, and potential side effects of drug.
Advise patient that each dose may be taken without regard to meals.
Inform patient that it may take longer than usual to stop bleeding while taking this drug; advise the patient to report unusual bleeding or bruising to health care provider without delay.
Advise patient to inform health care provider about the use of this drug before undergoing surgical or dental procedures and before any new drug is taken.
Advise patient to not take any prescription or OTC medication or dietary supplements unless advised by health care provider.
Advise patient that follow-up visits and laboratory tests may be required to monitor therapy and to keep appointments.
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