Starez Special Precautions

Fetal/Neonatal Morbidity and Mortality: If the patient becomes pregnant while taking the drug, discontinue therapy and apprise the patient of the potential hazard to the fetus.
Hepatic Effects: Therapy with rosuvastatin and other statins has been associated with increases in serum aminotransferase (transaminase) concentrations (i.e., AST [SGOT], ALT [SGPT]). Liver function tests be performed before and at 12 weeks after initiation of rosuvastatin therapy or any increase in dosage and periodically (e.g., semiannually) thereafter.
Musculoskeletal Effects: Myopathy (manifested as muscle pain, tenderness, or weakness and increases in serum creatinine kinase [CK] concentration exceeding 10 times the upper limit of normal) has been reported occasionally (up to 0.1 %) with rosuvastatin therapy.
Gemfibrozil increases the risk of myopathy when given concomitantly with some HMG-CoA reductase inhibitors. Therefore, the combination of rosuvastatin and gemfibrozil is not recommended. The benefit of further alteration in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of such combinations.
General Precautions: Prior to institution of antilipemic therapy, vigorously attempt to control serum cholesterol by appropriate dietary regimens, weight reduction, exercise, and treatment of any underlying disorder that might be the cause of lipid abnormality.
Asian Populations: Pharmacokinetic studies, including a large study conducted in the US, show an approximate twofold elevation in median exposure to rosuvastatin (peak plasma concentration and AUC) in Asian patients.
Immune-mediated necrotizing myopathy (IMNM): There have been very rare reports of an IMNM during or after treatment with some statins. IMNM is clinically characterized by: Persistent proximal muscle weakness and elevated serum creatinine kinase, which persist despite discontinuation of statin treatment;
Muscle biopsy showing necrotizing myopathy without significant inflammation;
Improvement with immunosuppressive agents.