MedCallyLooking up the FDA label…
Looking up the FDA label…
Also sold as Fluvastatin Sodium
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. Fluvastatin capsules are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD Slow the progression of atherosclerosis in patients with CHD Limitations of Use: Fluvastatin capsules have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, …
Patients taking fluvastatin capsules should be advised that high cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel to determine goal attainment. Patients should be advised about substances they should not take concomitantly with fluvastatin capsules. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking fluvastatin capsules. 17.1 Muscle Pain Patients starting therapy with fluvastatin capsules should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing fluvastatin. 17.2 Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of fluvastatin capsules and if signs or symptoms of liver injury occur. All patients treated with fluvastatin capsules should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. 17.3 Pregnancy Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using fluvastatin capsules. Discuss future pregnancy plans with your patients, and discuss when to stop taking fluvastatin capsules if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking fluvastatin capsules and call their healthcare professional. 17.4 Breastfeeding Women who are breastfeeding should not use fluvastatin capsules. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional. Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. …
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). Liver Enzyme Abnormalities. Most frequent adverse reactions (rate ≥ 2% and > placebo) are: headache, dyspepsia, myalgia, abdominal pain and nausea To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience in Adult Patients Becaus…
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Ask a doctor — $19.99Hypersensitivity to any component of this medication Active liver disease or unexplained, persistent elevations in serum transaminases Women who are pregnant or may become pregnant Nursing mothers 4.1 Hypersensitivity to any Component of This Medication Fluvastatin capsules are contraindicated in patients with hypersensitivity to any component of this medication. 4.2 Active Liver Disease Fluvastatin capsules are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum tra…
Dose range: 20 mg to 80 mg/day Fluvastatin capsules can be taken with or without food. Do not open fluvastatin capsules prior to administration Adults: the recommended starting dose is 40 mg to 80 mg (administered as one fluvastatin capsule, 40 mg twice daily) Do not take two fluvastatin capsules, 40 mg at one time Children with heterozygous familial hypercholesterolemia (ages 10 to 16, inclusive): the recommended starting dose is fluvastatin capsule, 20 mg once daily 2.1 General Dosing Information Dose range: 20 m…
Cyclosporine: Combination increases fluvastatin exposure. Limit fluvastatin dose to 20 mg Fluconazole: Combination increases fluvastatin exposure. Limit fluvastatin dose to 20 mg Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥ 1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with fluvastatin Glyburide: Monitor blood glucose levels when fluvastatin dose is changed Phenytoin: Monitor plasma phenytoin levels when fluva…
Taking something else alongside it?
Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationSame medicine, sold as
Works in a similar way — hmg coa reductase inhibitors
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.