RiteMED Clopidogrel

RiteMED Clopidogrel

clopidogrel

Manufacturer:

RiteMED

Distributor:

United Lab
Concise Prescribing Info
Contents
Clopidogrel bisulfate
Indications/Uses
Prevention of atherosclerotic events in patients w/ history of recent MI (w/in a few days until <35 days from occurrence), recent ischemic stroke (from 7 days until <6 mth) or established peripheral arterial disease; non-ST segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) including patients who are managed medically w/ percutaneous coronary intervention (w/ or w/o stent) or CABG. Given prophylactically as an alternative to aspirin in patients at risk of thromboembolic disorders eg, MI, peripheral arterial disease & stroke.
Dosage/Direction for Use
Recent MI or stroke, or established peripheral arterial disease, prophylaxis of thromboembolic events 75 mg once daily. Non-ST segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) Initially 300 mg as a single loading dose followed by 75 mg once daily in combination w/ aspirin.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active pathological bleeding (eg, peptic ulcer or intracranial hemorrhage) or coagulation disorders.
Special Precautions
Thrombocytopenic purpura. Patients w/ platelet disorders &/or increased risk of bleeding (eg, PUD, trauma or surgery), severe hepatic & renal impairment. Discontinue use 5 days prior to elective surgery except in patients w/ cardiac stents that have not completed their full course of dual antiplatelet therapy. Pregnancy & lactation. Patient <21 yr.
Adverse Reactions
Abdominal pain, vomiting, nausea, dyspepsia, gastritis, diarrhea, constipation, GI hemorrhage, pancreatitis, stomatitis; chest pain, edema, HTN, atrial fibrillation, cardiac failure, palpitation, syncope, angioedema, vasculitis; headache, dizziness, depression, fatigue, general pain, fever, insomnia, vertigo, anxiety, hemorrhagic stroke, intracranial hemorrhage, confusion, hallucination; rash (severe, maculopapular), pruritus, eczema, allergic reaction, anaphylactoid reaction, bullous eruption, urticaria, erythema multiforme, lichen planus, SJS, TEN; hypercholesterolemia, gout, hyperuricemia, pancreatitis; serum sickness; UTI, cystitis, hematuria; bleeding, TTP, epistaxis, hematoma, anemia, agranulocytosis, bilirubinemia, granulocytopenia, hypochromic anemia, neutropenia, leukopenia, thrombocytopenia, aplastic anemia, retroperitoneal bleeding, pancytopenia; LFT abnormalities, fatty liver, acute liver failure, hepatitis; arthralgia, back pain, arthritis, leg cramps, neuralgia, paresthesia, weakness; dyspnea, rhinitis, bronchitis, cough, upper resp infection, bronchospasm, hemoptysis, hemothorax, pulmonary hemorrhage, interstitial pneumonitis; cataract, conjunctivitis, ocular hemorrhage; flu-like syndrome, ischemic necrosis, menorrhagia; hypersensitivity, taste disorder.
Drug Interactions
Increased risk of bleeding w/ aspirin. Increased occult of GI blood loss w/ NSAIDs. Increased risk of bleeding w/ warfarin, argatroban, enoxaparin, bivalirudin, heparin. May inhibit cytochrome P450 isoenzyme CYP2C9 & interactions w/ drugs metabolized by this isoenzyme (eg, phenytoin, tamoxifen, tolbutamide, warfarin, torsemide, fluvastatin, & NSAIDs). Reduced conversion of bupropion to its active metabolite. May develop rhabdomyolysis w/ cyclosporin & statins (eg, atorvastatin, lovastatin or simvastatin). May attenuate the effects w/ macrolides eg, clarithromycin, erythromycin & troleandomycin.
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
RiteMED Clopidogrel FC tab 75 mg
Packing/Price
50's (P20.5/film-coated tab, P1,025/box)
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