Rosuvastatin

May be taken with or without food.

Active liver disease, including unexplained, persistent elevations of serum transaminases; myopathy. Severe renal impairment (CrCl <30 mL/min). Pregnancy and lactation.

Patient with hypothyroidism; history of hereditary muscular disorders or muscular toxicity with another HMG-CoA reductase inhibitor or fibrates; excessive alcohol consumption, history of liver disease, severe respiratory failure. Patients of Asian ancestry, those with predisposing factors to myopathy or those taking concomitant ciclosporin, gemfibrozil, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. Patient with SLCO1B1 and ABCG2 polymorphism. Moderate renal impairment (CrCl 30-60 mL/min). Children and elderly. Monitoring Parameters Obtain lipid panel (HDL, LDL, total cholesterol, triglycerides) prior to therapy, then every 4-12 weeks after initial therapy and every 3-12 months thereafter; LFT prior to therapy and as needed thereafter; creatine phosphokinase when myopathy is considered or in high-risk patients.

Significant: Myopathy, myalgia, diabetes mellitus, haematuria, proteinuria, interstitial lung disease, liver enzyme abnormalities, increased creatine phosphokinase levels. Blood and lymphatic system disorders: Rarely, thrombocytopenia. Gastrointestinal disorders: Abdominal pain, constipation, nausea. General disorders and administration site conditions: Asthenia. Hepatobiliary disorders: Rarely, pancreatitis, hepatitis, jaundice. Immune system disorders: Hypersensitivity (e.g. angioedema). Musculoskeletal and connective tissue disorders: Rarely, arthralgia, muscle rupture, Lupus-like syndrome. Nervous system disorders: Dizziness, headache, peripheral neuropathy. Psychiatric disorders: Depression, sleep disorders (e.g. insomnia, nightmares). Reproductive system and breast disorders: Rarely, gynaecomastia. Skin and subcutaneous tissue disorders: Pruritus, rash, urticaria.
Potentially Fatal: Rarely, rhabdomyolysis with acute renal failure secondary to myoglobinuria, hepatic failure.

Increased exposure with certain protease inhibitors (e.g. ritonavir-boosted regimens, simeprevir), gemfibrozil, ezetimibe, ciclosporin, colchicine. Decreased plasma concentration with Al- and Mg-containing antacids, erythromycin. May increase INR when given with vit K antagonists (e.g. warfarin). May increase the plasma concentration of oral contraceptives. May increase risk of myopathy with concurrent use of strong CYP3A4 inhibitors (e.g. clarithromycin, itraconazole), fenofibrate, nicotinic acid.

Dyslipidaemic Agents

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.