FLUVASTATIN capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Teva Pharmaceuticals USA, Inc.

SNN (starptautisko nepatentēto nosaukumu):

FLUVASTATIN SODIUM

Kompozīcija:

FLUVASTATIN 20 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 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 to 16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present

Produktu pārskats:

Fluvastatin Capsules, USP are available as follows: 20 mg - Hard gelatin capsules with ivory opaque body and pink opaque cap, filled with an off-white to yellowish powder with small agglomerates, cap imprinted with “TEVA” and body imprinted with “7442”, in bottles of 30 (NDC 0093-7442-56) and 100 (NDC 0093-7442-01). 40 mg - Hard gelatin capsules with yellow opaque body and pink opaque cap, filled with an off-white to yellowish powder with small agglomerates, cap imprinted with “TEVA” and body imprinted with “7443”, in bottles of 30 (NDC 0093-7443-56) and 100 (NDC 0093-7443-01). Store and Dispense Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

FLUVASTATIN- FLUVASTATIN CAPSULE
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVASTATIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUVASTATIN CAPSULES.
FLUVASTATIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
INDICATIONS AND USAGE
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, 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 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)
DOSAGE FORMS AND STRENGTHS
Capsules: 20 mg, 40 mg (3)
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)
WARNINGS AND