Fluvastatin 40 mg/1
Fluvastatin · CAPSULE · Bryant Ranch Prepack
Fluvastatin is a capsule containing fluvastatin at 40 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Fluvastatin
- Generic Name
- Fluvastatin
- NDC Code (Product)
72162-1034- Manufacturer
- Bryant Ranch Prepack
- Strength
- 40 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078407
- Marketing Start
- 07/05/2012
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 ( 1.1 ) 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 ( 1.1 ) Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD ( 1.2 ) Slow the progression of atherosclerosis in patients with CHD ( 1.2 ) Limitations of Use: Fluvastatin capsules have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLD…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dose range: 20 mg to 80 mg/day ( 2.1 ) Fluvastatin capsules can be taken with or without food. ( 2.1 ) Do not open fluvastatin capsules prior to administration ( 2.1 ) Adults: the recommended starting dose is 40 mg to 80 mg (administered as one fluvastatin capsule, 40 mg twice daily) ( 2.2 ) 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 ( 2.3 ) 2.1 General Dosing Information Dose range: 20 mg to 80 mg/day. Fluvastatin capsules can be administered orally as a single dose, with or without food. Do not open fluvastatin capsules prior to administration. Do not take two fluvastatin capsules, 40 mg at one time. Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines. For patients requiring LDL-C reduction to a goal of ≥ 25%, the recommended starting dose is 40 mg as one capsule in the evening, or 80 mg in divided doses of th…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to any component of this medication ( 4 ) Active liver disease or unexplained, persistent elevations in serum transaminases ( 4 , 5.3 ) Women who are pregnant or may become pregnant ( 4 , 8.1 ) Nursing mothers ( 4 , 8.3 ) 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 transaminases [see Warnings and Precautions ( 5.3 )] . 4.3 Pregnancy Fluvastatin capsules are contraindicated in women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Fluvastatin capsules may cause fetal harm when administered to pregnant women. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Fluvastatin capsules should be admi…
Drug Interactions
7 DRUG INTERACTIONS Cyclosporine: Combination increases fluvastatin exposure. Limit fluvastatin dose to 20 mg ( 2.4 , 7.1 ) Fluconazole: Combination increases fluvastatin exposure. Limit fluvastatin dose to 20 mg ( 2.5 , 7.2 ) 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 ( 5.1 , 7.3 , 7.4 ) Glyburide: Monitor blood glucose levels when fluvastatin dose is changed ( 7 ) Phenytoin: Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed ( 7 ) Warfarin and coumarin derivates: Monitor prothrombin times when fluvastatin coadministration is initiated, discontinued, or the dosage changed ( 7 ) 7.1 Cyclosporine Cyclosporine coadministration increases fluvastatin exposure. Therefore, in patients taking cyclosporine, therapy should be limited to fluvastatin 20 mg twice daily [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )]. 7.2 Fluconazole Administration of fluvastatin 40 mg single dose to healthy volunteers pre-treated with fluconazole for 4 days results …
Adverse Reactions
6 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 ( 5.3 ) ]. Most frequent adverse reactions (rate ≥ 2% and > placebo) are: headache, dyspepsia, myalgia, abdominal pain and nausea ( 6.1 ) 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 Because clinical studies on fluvastatin capsules are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of fluvastatin capsules cannot be directly compared with that in the clinical studies of other statins and may not reflect the frequency of adverse reactions observed in clinical practice. In the fluvastatin capsules placebo-controlled clinical trials database of 2326 patients treated with fluvastatin capsules 1 (age range 18 to 75 years, 44% women, 94% Caucasians, 4% Blacks, 2% other ethniciti…
Frequently Asked Questions
What is Fluvastatin used for?
Fluvastatin contains Fluvastatin. It is a capsule taken oral. Consult your doctor for specific uses.
Is Fluvastatin a controlled substance?
Fluvastatin is not classified as a controlled substance by the DEA.
What is the generic name for Fluvastatin?
The generic name for Fluvastatin is Fluvastatin. There are 5 other brand versions of Fluvastatin.
What is the NDC code for Fluvastatin 40 mg/1?
The NDC (National Drug Code) for Fluvastatin 40 mg/1 is 72162-1034, listed by Bryant Ranch Prepack.