Rosugrel

Per 75 mg/10 mg Clopidogrel bisulfate 75 mg, rosuvastatin Ca 10 mg. Per 75 mg/20 mg Clopidogrel bisulfate 75 mg, rosuvastatin Ca 20 mg

Reduction of atherosclerotic events (MI, stroke & vascular death) in patients w/ atherosclerosis documented by recent stroke, MI or established peripheral arterial disease.

Adult & elderly 1 tab once daily.

May be taken with or without food.

Hypersensitivity to clopidogrel or rosuvastatin. Patients w/ active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation exceeding 3 x the ULN. Myopathy; active pathological bleeding eg, peptic ulcer or intracranial hemorrhage. Concomitant w/ ciclosporin. Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation. Women of childbearing potential.

Clopidogrel: Caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions & in patients receiving ASA, heparin, glycoprotein IIb/IIIa inhibitors or NSAIDs including COX-2 inhibitors. Thrombotic thrombocytopenic purpura. Recent ischemic stroke. Concomitant use w/ CYP2C19 inhibitors. Renal & hepatic impairment. Rosuvastatin: Proteinuria. Myalgia. Patients w/ predisposing factors for myopathy/rhabdomyolysis eg, renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels may occur, concomitant use of fibrates. Discontinue if CK levels are markedly elevated or if muscular symptoms are severe & cause daily discomfort. Concomitant use w/ gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, PIs & macrolides. Asians. Interstitial lung disease. DM. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Elderly >70 yr.

Abdominal pain. Clopidogrel: Hematoma; epistaxis; GI hemorrhage, diarrhea, dyspepsia; bruising; bleeding at puncture site. Rosuvastatin: DM; headache, dizziness; constipation, nausea; myalgia; asthenia.

Increased intensity of bleedings w/ oral anticoagulants. Increased risk of bleeding w/ glycoprotein IIb/IIIa inhibitors, acetylsalicylic acid, heparin, NSAIDs. Increased INR w/ vit K antagonists. May increase in AUC of ethinyl estradiol & norgestrel of OC/hormone replacement therapy (HRT). Clopidogrel: May reduce the drug levels of the active metabolite w/ drugs inhibiting CYP2C19. Rosuvastatin: Increased AUC values w/ ciclosporin. Increased C_max & AUC w/ gemfibrozil & other lipid-lowering products. May strongly increase exposure w/ PIs. May decrease plasma conc w/ antacid susp containing Al & Mg hydroxide. May decrease AUC_(0-t) & C_max w/ erythromycin.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics) / Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
B01AC04 - clopidogrel ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.

Rx