FLUVASTATIN SODIUM tablet, film coated, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

FLUVASTATIN SODIUM (UNII: PYF7O1FV7F) (FLUVASTATIN - UNII:4L066368AS)

Prieinama:

Lannett Company, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 sodium extended-release tablets are indicated - as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). - as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present: LDL-C remains ≥ 190 mg/dL or LDL-C remains ≥ 160 mg/dL and: there is a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present - LDL-C remains ≥ 190 mg/dL or - LDL-C remains ≥ 160 mg/dL and: there is a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present - there is a positive family history of premature cardiovascular disease or - two or more other cardiovascular disease risk factors are present The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below. Children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals. In patients with clinically evident CHD, fluvastatin sodium extended-release tablets are indicated to: - reduce the risk of undergoing coronary revascularization procedures - slow the progression of coronary atherosclerosis Fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V). Fluvastatin sodium extended-release tablets are contraindicated in patients with hypersensitivity to any component of this medication. Fluvastatin sodium extended-release tablets are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see Warnings and Precautions (5.2)] . Fluvastatin sodium extended-release tablets 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 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 sodium extended-release tablets should be administered 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 this drug, fluvastatin sodium extended-release tablets should be discontinued and the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)] . Fluvastatin is secreted into the breast milk of animals and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require treatment with fluvastatin sodium extended-release tablets should be advised not to breastfeed their infants [see Use in Specific Populations (8.3)] . Pregnancy Category X Fluvastatin is contraindicated in women who are or may become pregnant [see Contraindications (4)] . Lipid lowering drugs are contraindicated during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. Serum cholesterol and triglycerides increase during normal pregnancy. Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy. There are no adequate and well-controlled studies of use with fluvastatin during pregnancy. Rare reports of congenital anomalies have been received following intrauterine exposure to other statins. In a review 2 of about 100 prospectively followed pregnancies in women exposed to other statins, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed the rate expected in the general population. The number of cases is adequate only to exclude a 3- to 4-fold increase in congenital anomalies over background incidence. In 89% of prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.   Teratology studies with fluvastatin in rats and rabbits showed maternal toxicity at high dose levels, but there was no evidence of embryotoxic or teratogenic potential [see Non-Clinical Toxicology (13)] .  Fluvastatin should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If a woman becomes pregnant while taking fluvastatin sodium extended-release tablets, the drug should be discontinued and the patient advised again as to the potential hazards to the fetus. Based on animal data, fluvastatin is present in breast milk in a 2:1 ratio (milk:plasma). Because of the potential for serious adverse reactions in nursing infants, nursing women should not take fluvastatin [see Contraindications (4)] . The safety and efficacy of fluvastatin in children and adolescent patients 9-16 years of age with heterozygous familial hypercholesterolemia have been evaluated in open-label, uncontrolled clinical trials for a duration of two years. The most common adverse events observed were influenza and infections. In these limited uncontrolled studies, there was no detectable effect on growth or sexual maturation in the adolescent boys or on menstrual cycle length in girls [see Clinical Studies (14.2), Adverse Reactions (6.3) and Dosage and Administration (2.2)] . Adolescent females should be counseled on appropriate contraceptive methods while on fluvastatin therapy [see Contraindications (4)] . Fluvastatin exposures were not significantly different between the nonelderly and elderly populations (age ≥ 65 years) [see Clinical Pharmacology (12.3)] . Since advanced age ( > 65 years) is a predisposing factor for myopathy, fluvastatin should be prescribed with caution in the elderly. Fluvastatin is contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see Clinical Pharmacology (12.3)] . Dose adjustments for mild to moderate renal impairment are not necessary. Fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore caution should be exercised when treating such patients at higher doses [see Clinical Pharmacology (12.3)] .

Produkto santrauka:

Fluvastatin sodium extended-release tablets are available containing fluvastatin sodium, USP equivalent to 80 mg of fluvastatin. The 80 mg tablets are yellow, round, slightly biconvex film-coated tablets, imprinted with “BS08” and “80” on one side, plain on the other side. They are available as follows: Bottles of 30 tablets…………………………………………………………………………………...NDC 0527-2580-32 Bottles of 100 tablets…………………………………………………………………………………...NDC 0527-2580-37 Store and Dispense Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF - 86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FLUVASTATIN SODIUM- FLUVASTATIN SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
LANNETT COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVASTATIN SODIUM
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FLUVASTATIN SODIUM EXTENDED-RELEASE TABLETS.
FLUVASTATIN SODIUM EXTENDED-RELEASE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.2)
9/2020
INDICATIONS AND USAGE
Fluvastatin sodium extended-release tablets 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 sodium extended-release tablets have not been studied in
conditions where the major
abnormality is elevation of chylomicrons, VLDL, or IDL (i.e.,
hyperlipoproteinemia Types I, III, IV, or V) (
1.3)
DOSAGE AND ADMINISTRATION
Dose range: 20 mg to 80 mg/day ( 2.1)
Fluvastatin sodium extended-release tablets can be taken with or
without food and may be taken at
any time of the day ( 2.1)
Do not break, crush or chew fluvastatin sodium extended-release
tablets prior to administration ( 2.1)
Adults: the recommended starting dose is 80 mg (administered as one 80
mg fluvastatin sodium
extended-release tablet once daily) ( 2.2)
Children with heterozygous familial hypercholesterolemia (ages 10 to
16, inclusive): the recommended
starting dose is fluvastatin capsule 20 mg once daily ( 2.3)
DOSAGE FORMS AND STRENGTHS
Fluvastatin