LESCOL- fluvastatin sodium capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Physicians Total Care, Inc.

INN (Nome Internazionale):

FLUVASTATIN SODIUM

Composizione:

FLUVASTATIN SODIUM 20 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Therapy with lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Lescol® (fluvastatin sodium) and Lescol® XL (fluvastatin sodium) are indicated to reduce elevated total cholesterol (Total-C), LDL-C, TG and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate. Lescol and Lescol XL are indicated as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia whose response to dietary restriction has not been adequate and the following findings are present: - LDL-C remains > 190 mg/dL or - LDL-C remains > 160 mg/dL and:

Dettagli prodotto:

Brown and light brown imprinted twice with "     " and “20” on one half and “LESCOL” and the Lescol® (fluvastatin sodium) logo twice on the other half of the capsule. Brown and gold imprinted twice with "     " and “40” on one half and “LESCOL” and the Lescol® (fluvastatin sodium) logo twice on the other half of the capsule. Store at 25ºC (77ºF); excursions permitted to 15 -30ºC (59 -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

LESCOL - FLUVASTATIN SODIUM CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
LES COL
(fluvastatin sodium)
CAPS ULES
LES COL
XL
(fluvastatin sodium)
EXTENDED-RELEASE TABLETS
RX ONLY
DESCRIPTION
Lescol
(fluvastatin sodium), is a water-soluble cholesterol lowering agent
which acts through the
inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase.
Fluvastatin sodium is
[_R_*,_S_*-(_E_)]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1_H_-indol-2-yl]-3,5-
dihydroxy-6-heptenoic acid, monosodium salt. The empirical formula of
fluvastatin sodium is
C
H FNO •Na, its molecular weight is 433.46 and its structural formula
is:
This molecular entity is the first entirely synthetic HMG-CoA
reductase inhibitor, and is in part
structurally distinct from the fungal derivatives of this therapeutic
class.
Fluvastatin sodium is a white to pale yellow, hygroscopic powder
soluble in water, ethanol and
methanol. Lescol is supplied as capsules containing fluvastatin
sodium, equivalent to 20 mg or 40 mg of
fluvastatin, for oral administration. Lescol
XL (fluvastatin sodium) is supplied as extended-release
tablets containing fluvastatin sodium, equivalent to 80 mg of
fluvastatin, for oral administration.
Active Ingredient: fluvastatin sodium
Inactive Ingredients in capsules: gelatin, magnesium stearate,
microcrystalline cellulose, pregelatinized
starch (corn), red iron oxide, sodium lauryl sulfate, talc, titanium
dioxide, yellow iron oxide, and other
ingredients.
Capsules may also include: benzyl alcohol, black iron oxide,
butylparaben, carboxymethylcellulose
sodium, edetate calcium disodium, methylparaben, propylparaben,
silicon dioxide and sodium
propionate.
Inactive Ingredients in extended-release tablets: microcrystalline
cellulose, hydroxypropyl cellulose,
hydroxypropyl methyl cellulose, potassium bicarbonate, povidone,
magnesium stearate, yellow iron
oxide, titanium dioxide and polyethylene glycol 8000.
CLINICAL PHARMACOLOGY
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PRESCRIBING INFORMATION
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A variety of clinical studies have demonstrated th