The creatinine clearance is a test that allows your doctor to assess your kidney function. Chronic alcohol liver disease is known to increase rosuvastatin exposure; CRESTOR should be used with caution in these patients
Rare reports of congenital anomalies have been received following intrauterine exposure to other statins. There have been rare reports of immune-mediated necrotizing myopathy associated with statin use A total of 13 patients completed both treatment periods of the randomized cross-over phase; one patient withdrew consent due to inability to have blood drawn during the cross-over phase.CRESTOR 20 mg significantly reduced LDL-C, total cholesterol, ApoB, and non-HDL-C compared to placebo (Table 11).% Difference estimates are based on transformations of the estimated mean difference in log LDL measurements between CRESTOR and placebo using a mixed model adjusted for study periodIn a double-blind, randomized, multicenter, placebo-controlled, 12-week study, 176 (97 male and 79 female) children and adolescents with heterozygous familial hypercholesterolemia were randomized to rosuvastatin 5, 10 or 20 mg or placebo daily. Gemfibrozil significantly increased rosuvastatin exposure. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy. Avoid concomitant use of CRESTOR with gemfibrozil. Additional side effects that have been reported with CRESTOR include memory loss and confusion. In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD dose of 40 mg/day based on AUC).In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area).In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area).Rosuvastatin use is contraindicated during breastfeeding Both C Elderly patients are at higher risk of myopathy and CRESTOR should be prescribed with caution in the elderly Caution should be exercised when anticoagulants are given in conjunction with CRESTOR because of its potentiation of the effect of coumarin-type anticoagulants in prolonging the prothrombin time/INR. CRESTOR should be discontinued as soon as pregnancy is recognized The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria Creatinine leaves the body through urine.
Rosuvastatin also boosts the breakdown of lipids. Pediatric Patients with Heterozygous Familial HypercholesterolemiaTable 4.
It is recommended that liver enzyme tests be performed before the initiation of CRESTOR and if signs or symptoms of liver injury occur. Coadministration of rosuvastatin with certain protease inhibitors has differing effects on rosuvastatin exposure and may increase risk of myopathy. This Patient Information has been approved by the U.S. Food and Drug Administration Revised 11/2018 Select one or more newsletters to continue.
Percent Change in LDL-C From Baseline to Week 6 (LS Mean Common medications that may interact with Crestor include:Note that this list is not all-inclusive and includes only common medications that may interact with Crestor. Cataracts were seen in dogs treated for 12 weeks by oral gavage at 30 mg/kg/day (systemic exposures 60 times the human exposure at 40 mg/day based on AUC). General Information about the safe and effective use of CRESTOR Although clinical studies have shown that CRESTOR alone does not reduce basal plasma cortisol concentration or impair adrenal reserve, caution should be exercised if CRESTOR is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones such as ketoconazole, spironolactone, and cimetidine.The following serious adverse reactions are discussed in greater detail in other sections of the label: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.Limited published data on rosuvastatin have not shown an increased risk of major congenital malformations or miscarriage. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily.