Cholestor Special Precautions

Fetal/Neonatal Morbidity and Mortality: Suppression of cholesterol biosynthesis could cause fetal harm. Administer to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. 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]). Therefore, the 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. Patients who develop increased serum transaminase concentrations or manifestations of liver disease should have frequent liver function tests performed thereafter until the abnormalities return to normal. If increases in AST or ALT concentrations of 3 times the upper limit of normal or higher persist, the dosage of rosuvastatin should be reduced or the drug discontinued. Jaundice has been reported rarely with rosuvastatin therapy.
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. Rhabdomyolysis (characterized by musce pain or weakness with marked increases [exceeding 10 times the upper limit of normal] in serum CK concentrations and increases in serum creatinine concentrations [usually accompanied by brown urine and urinary myoglobinuria]) with or without acute renal failure secondary to myoglobinuria has been reported rarely with statin therapy, including with rosuvastatin. Rhabdomyolysis occurs more frequently in patients receiving rosuvastatin 40 mg daily compared with lower dosages. However, it does not appear that the risk of rhabdomyolysis is greater with rosuvastatin than with other statins. In clinical studies, the incidence of myopathy and rhabdomyolysis increased in patients receiving rosuvastatin dosages exceeding the recommended dosage range of 5-40 mg daily. Risk of myopathy may be increased in patients with predisposing factors for myopathy (e.g., advanced age [65 years or older, particularly women], hypothyroidism), patients receiving rosuvastatin dosages exceeding the recommended dosage range of 5-40 mg daily, and patients at risk of increased exposure to rosuvastatin (e.g., Asian patients, patients with renal impairment). Risk also may be increased by concomitant use of certain drugs, including cyclosporine, niacin, fibric-acid derivatives, macrolide antibiotics (e.g. erythromycin), certain azole antifungals, and alcohol. Use of rosuvastatin with fibric acid derivatives or niacin should be carefully weighed against the potential risks of this combination; combination therapy with gemfibrozil generally should be avoided. Discontinue rosuvastatin if serum CK concentrations become markedly elevated or if myopathy is diagnosed or suspected. Temporarily withhold therapy in any patient experiencing an acute, serious condition suggestive of myopathy or predisposing to the development of acute renal failure secondary to rhabdomyolysis (e.g., sepsis; hypotension; dehydration; major surgery;trauma; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures).
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 Population Pharmacokinetic studies, including a large study conducted in the US, show an approximate two-fold elevation in median exposure to rosuvastatin (peak plasma concentration and AUC) in Asian patients (of Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian ancestry) compared with Caucasian patients. This increase should be considered when deciding upon rosuvastatin dosage in Asian patients.
Renal Effects: Transient dipstick-positive proteinuria and microscopic hematuria (not associated with worsening renal function) have been reported in patients receiving rosuvastatin. These findings occurred predominantly in patients receiving higher than recommended dosages (i.e., 80 mg), but were more frequent in patients receiving rosuvastatin 40 mg compared with lower doses of rosuvastatin or comparator statins in clinical trials. Although the clinical importance of this finding is not known, dosage reduction should be considered for patients receiving 40 mg of rosuvastatin daily who have unexplained persistent proteinuria during routine urinalysis testing.
Endocrine Effects: Although clinical studies have shown that rosuvastatin alone does not reduce basal plasma cortisol concentration or impair adrenal reserve, statins interfere with cholesterol synthesis and theoretically may blunt adrenal or gonadal steroid hormone production. Caution should be exercised if any statin, including rosuvastatin, or other agent used to lower cholesterol levels is used concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones (e.g., ketoconazole, spironolactone, cimetidine).