Crestor generic name
Pink, oval, biconvex, coated tablets. How Supplied/Storage and name Handling Crestor generic (rosuvastatin calcium) Tablets are supplied as: NDC : 5 mg. Caution should be exercised when generic rosuvastatin crestor is crestor coadministered name with protease inhibitors see Dosage and crestor Administration (2.4), Warnings and Precautions (5.1) and Clinical Pharmacology (12.3). Results are shown in generic Table 12 below. Your doctor generic should do blood tests to check your liver before you start taking Crestor and if you have symptoms of generic liver problems while name you take Crestor. The combinations of generic fosamprenavir/ritonavir or tipranavir/ritonavir, which are HIV-1 protease inhibitors, produce little or no change in rosuvastatin exposure. Rosuvastatin is name a substrate for generic certain transporter proteins including the crestor hepatic uptake transporter organic anion-transporting polyprotein 1B1 (oatp1B1) and efflux transporter breast cancer resistance protein (bcrp). In most cases, the elevations were name transient and resolved or improved on continued therapy or after a brief interruption in therapy. Debossed Crestor and 5 on one side of name the tablet. Patients ranged in age from 7 to 15 years of age (median 11 years 50 were crestor male, 71 were Caucasian, 21 were Asian, 7 were Black, and no patients generic were of Hispanic ethnicity. Edema, hemorrhage, and partial necrosis in the interstitium of the choroid plexus was crestor observed in a female dog sacrificed moribund at crestor day 24 at 90 mg/kg/day by oral gavage (systemic exposures 100 times the human crestor exposure at 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). Crestor Tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet generic contains: microcrystalline name cellulose NF, crestor lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin. In rare cases, Crestor can generic cause a condition that crestor results in the breakdown of skeletal muscle tissue, leading to kidney failure. Pediatric Patients with Familial Hypercholesterolemia, crestor is indicated as an adjunct to diet to: reduce Total-C, LDL-C and ApoB levels in children crestor and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial. There have been rare postmarketing reports name of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. Adverse reactions reported in 2 of patients and at a rate greater than placebo are shown in Table. If concomitant use cannot be avoided, initiate Crestor at 5 mg once daily. The dose was increased by 6-week intervals. Approximately 89 crestor were Caucasian, 7 were Asian, 1 were Black, and fewer than 1 were Hispanic. Do not use Crestor for a condition for which it was not prescribed. You may need to take Crestor on a long-term basis. If you have any questions crestor about Crestor, ask your doctor. The following laboratory generic abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria see Warnings and Precautions (5.4) ; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, crestor alkaline phosphatase, and bilirubin; and thyroid function abnormalities. In 89 of the prospectively followed pregnancies, drug treatment name was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Due to an observed increased risk crestor of myopathy/rhabdomyolysis, combination therapy with Crestor and gemfibrozil should be avoided. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Spermatidic giant cells were observed in monkeys after 6month treatment at 30 name mg/kg/day in addition to vacuolation of seminiferous tubular epithelium. Crestor is a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin calcium. Total crestor 5 mg D40. Patients taking atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir Initiate Crestor therapy with 5 mg once daily. A higher percentage of rosuvastatin-treated patients versus placebo-treated patients,.6 and.2, respectively, discontinued study medication due to an adverse event, generic irrespective of treatment causality. This binding is reversible and independent of plasma concentrations. Make sure your doctor knows if you are Asian. In animal reproduction studies, there were no adverse developmental effects with oral administration of rosuvastatin during organogenesis at systemic exposures equivalent to a maximum recommended human dose (mrhd) of 40 mg/day in rats or rabbits (based on AUC and body surface area, respectively). Lactation Advise women not to breastfeed during treatment with Crestor see Contraindications (4) and Use in Specific Populations (8.2). Doses should be individualized according to the recommended goal of therapy. It can raise triglyceride levels and may increase your risk of liver damage. Use effective birth control to prevent pregnancy while you are taking this medicine. Adverse Reactions Reported name in 2 of Patients Treated with Crestor and Placebo generic in the meteor Trial ( of Patients) Adverse Reactions Crestor 40 mg N700 Placebo N281 Myalgia.7.1 Arthralgia.1.1 name Headache.4.3 Dizziness.0.8. Crestor may harm your unborn baby. Debossed Crestor and 20on one side; unit dose packages of : 40 mg. Crestor should be discontinued as soon as pregnancy is recognized see Contraindications (4). Mean LDL-C at baseline was 233 mg/dL (range of 129 to 399). Both Cmax and AUC increased in approximate proportion to Crestor dose. Although the clinical significance of this finding is unknown, a dose reduction should be considered for patients on Crestor therapy with unexplained persistent proteinuria and/or hematuria during routine urinalysis testing. There is no generic form of Crestor currently available to consumers. They are quite similar in many aspects; however, there are a few important differences between the two medications. General Information about the safe and effective use of Crestor Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Percent Change in LDL-C From Baseline to Week 6 (LS Mean) by Treatment Group (Sample Sizes Ranging from 156-167 Patients Per crestor Group) Treatment Daily Dose Treatment 10 mg 20 mg 40 mg 80 mg Crestor Atorvastatin Simvastatin Pravastatin Heterozygous Familial Hypercholesterolemia. Renal Impairment Mild to moderate renal impairment (CLcr 30 mL/min/1.73 m2) had generic no influence on plasma concentrations of rosuvastatin. In patients with ChildPugh B disease, crestor coupons Cmax and AUC were increased 100 and 21, respectively, compared with patients with normal liver function. High cholesterol usually has no symptoms. Crestor has not been studied in controlled clinical trials involving prepubertal patients or patients younger than 10 years of age with heterozygous familial hypercholesterolemia. Adverse Reactions Reported in 2 of Patients Treated with Crestor and Placebo in Placebo-Controlled Trials ( of Patients) Adverse Reactions Crestor 5 mg N291 Crestor 10 mg N283 Crestor 20 mg N64 Crestor 40 mg N106 Total Crestor 5 mg40 mg N744 Placebo. A chemically similar drug in this class produced dose-dependent optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in dogs, at a dose that produced plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose. Drug-Drug Interactions Rosuvastatin clearance is not dependent on metabolism by cytochrome P450 side effects of crestor 3A4 to a clinically significant extent. Postmarketing Experience The following adverse reactions have been identified during postapproval use of Crestor: arthralgia, fatal and non-fatal hepatic failure, hepatitis, jaundice, thrombocytopenia, depression, name sleep disorders (including insomnia and nightmares peripheral neuropathy, interstitial lung disease and gynecomastia. Imnm is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. Active Ingredient: rosuvastatin as rosuvastatin calcium Inactive Ingredients: microcrystalline cellulose NF, lactose monohydrate NF, tribasic calcium phosphate NF, crospovidone NF, magnesium stearate NF, hypromellose NF, triacetin NF, titanium dioxide USP, yellow ferric oxide, and red ferric oxide. Table 2: Adverse Reactions Reported in 2 of Patients Treated with crestor and Placebo in the meteor Trial ( of Patients ) generic Adverse Reactions crestor 40 mg N700 Placebo N281 Myalgia.7.1 Arthralgia.1.1 Headache.4. The most common adverse reactions that led to treatment discontinuation were: The most commonly reported adverse reactions (incidence 2) in the crestor controlled clinical trial database of 5394 patients were: headache myalgia abdominal pain asthenia nausea, adverse reactions reported. Pediatric In a population pharmacokinetic analysis of two pediatric trials involving patients with heterozygous familial hypercholesterolemia 10 to 17 years of age and 8 to 17 years of age, respectively, rosuvastatin exposure appeared comparable to or lower than rosuvastatin exposure in adult patients. Asian Patients Pharmacokinetic studies have demonstrated an approximate 2fold increase in median exposure to rosuvastatin in Asian subjects when compared with Caucasian controls. Not all possible interactions are listed in this medication guide. Effect of Rosuvastatin Coadministration on Systemic Exposure to Other Drugs Rosuvastatin Dosage Regimen Coadministered Drug name Mean Ratio (ratio with/without coadministered drug) No Effect.0 Name and Dose Change in AUC Change in Cmax 40 mg QD for 10 days Warfarin. Comparing Lipitor and Crestor: An Overview. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week carcinogenicity study in rats at dose levels of 2, 20, 60, generic or 80 mg/kg/day by oral gavage, the incidence of uterine stromal polyps was significantly crestor increased in females at 80 mg/kg/day. Overdosage There is no specific treatment in the event of overdose. This medication may rarely cause liver problems. This is not a complete list of possible side effects. Concomitant Use of Antacids When taking Crestor with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after Crestor administration. Excretion Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90). Other adverse reactions reported in clinical studies were abdominal pain, generic dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema ) and pancreatitis. For more information, ask your doctor or pharmacist. Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were modestly increased. Before taking Crestor, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily. You may need to stop using Crestor for a short time if you have: uncontrolled seizures; an electrolyte imbalance (such as high or low potassium levels in your blood severely low blood pressure; a severe infection or illness; dehydration; or surgery or a medical emergency. Tell your doctor right away if: o you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take Crestor. Who should not take Crestor? Primary Prevention of Cardiovascular Disease In the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (jupiter) study, the effect of Crestor (rosuvastatin calcium) on the occurrence of major cardiovascular (CV) disease events was. Mean HbA1c was significantly increased.1 in rosuvastatin-treated patients compared to placebo-treated patients. The 12-week double blind phase was followed by a 40-week open label dose-titration phase, where all patients (n173) received 5 mg, 10 mg or 20 mg rosuvastatin daily. You should not take rosuvastatin if you have liver disease, or if you breast-feeding a baby. Your doctor may occasionally change your dose to make sure you get the best results. Keep a list of them to show your doctor and pharmacist when you get new medicine. Adverse Reactions The following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) see Warnings and Precautions (5.1) Liver enzyme abnormalities see Warnings and Precautions. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual crestor tiredness, and dark colored urine. AstraZeneca 2015, 2016 Licensed from shionogi., LTD., Osaka, Japan Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 astrazeneca Rev. The jupiter study was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy in rosuvastatin-treated subjects. Effect of Coadministered Drugs on Rosuvastatin Systemic Exposure Coadministered drug and dosing regimen Rosuvastatin Mean Ratio (ratio with/without coadministered drug) No Effect.0 Dose (mg) Change in AUC Change in Cmax Cyclosporine stable dose required (75 mg 200 mg BID) 10 mg QD for 10 days.1 11 Atazanavir/ritonavir. If you notice other effects not listed above, contact your doctor or pharmacist. These studies had a treatment duration of up to 12 weeks. In the US - Call your doctor for medical advice about side effects. Dose-Response in Patients with Primary Hypertriglyceridemia over 6 Weeks Dosing Median (Min, Max) Percent Change from Baseline Dose Placebo (n26) Crestor 5 mg (n25) Crestor 10 mg (n23) name Crestor 20 mg (n27) Crestor 40 mg (n25) Triglycerides 1 (-40, 72). Adult Patients with Homozygous Familial Hypercholesterolemia. There was no detectable effect of Crestor on growth, weight, generic BMI (body mass index or sexual maturation see Clinical Studies (14.7) in children and adolescents (10 to 17 years of age). Both are also approved to prevent heart attacks, strokes, and certain heart procedures (such as bypass surgery ) in people who do not yet have heart disease but who have certain risk factors for heart disease. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day see. Crestor Dosage and Administration, general Dosing Information. Important information, crestor can harm an unborn baby or cause birth defects. Do not take extra medicine to make up the missed dose. Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Lactation Risk Summary Rosuvastatin use is contraindicated name during breastfeeding see Contraindications (4). Lipitor is known to interact with grapefruit juice, but there are no dietary restrictions for Crestor. Crestor dosage should be adjusted in Asian patients see Dosage and Administration (2.3) and Clinical Pharmacology (12.3). It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment with Crestor, especially: colchicine; cyclosporine; another "statin" medicine - atorvastatin, lovastatin, simvastatin, Lipitor, Pravachol, Zocor, Vytorin, and others; antifungal. Swallow the tablet generic whole. Mean LDL-C at baseline was 236 mg/dL. Lipitor Precautions and Warnings ). However, plasma concentrations of rosuvastatin increased to a clinically significant extent (about 3fold) in patients with severe renal impairment (CLcr 30 mL/min/1.73 m2) not receiving hemodialysis compared with healthy subjects (CLcr 80 mL/min/1.73 m2). Four of 130 (3) children treated crestor generic name with rosuvastatin (2 treated with 10 mg and 2 treated with 20 mg) had increased CK 10 x ULN, compared to 0 of 46 children on placebo. Adverse Reactions Reported in 2 of Patients Treated with Crestor and Placebo in the jupiter Trial ( of Patients) Adverse Reactions Crestor 20 mg N8901 Placebo N8901 Myalgia.6.6 Arthralgia.8.2 Constipation.3.0 Diabetes mellitus.8.3 crestor side effects Nausea. 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. Dose-Ranging Study: In a multicenter, double-blind, placebo-controlled, dose-ranging study in patients with hyperlipidemia Crestor given as a single daily dose for 6 weeks significantly reduced TotalC, ldlc, nonhdlc, and ApoB, across the dose range (Table 6). Hypertriglyceridemia, crestor is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Protease Inhibitors Coadministration of rosuvastatin with certain protease inhibitors has differing effects on rosuvastatin exposure. Both medications are currently available only in brand-name form, although it is very likely that Lipitor will "go generic" before Crestor, since Lipitor is an older medication. In the crestor controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks,.4 of patients discontinued due to adverse reactions. Adjustments should be made at intervals of 4 weeks or more. Take the missed dose as soon as you remember. This causes the liver to make less cholesterol. Crestor can be administered as a single dose at any time of day, with or without food.
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