GEMFIBROZIL tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

GEMFIBROZIL (UNII: Q8X02027X3) (GEMFIBROZIL - UNII:Q8X02027X3)

Dostupno od:

West-ward Pharmaceutical Corp

INN (International ime):

GEMFIBROZIL

Sastav:

GEMFIBROZIL 600 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for: 1.  Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil tablets, USP therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride ele

Proizvod sažetak:

Gemfibrozil Tablets, USP are supplied as White film-coated tablets, capsule-shaped, biconvex tablets; Debossed with "I" on the left side of the bisect and "G" on the right side of the bisect on one side and "225" on the other, and available as follows: Bottles of 60 Bottles of 500 Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP]. Protect from light and humidity. Manufactured by: InvaGen Phamaceuticals, Inc Hauppauge, NY 11788 Distributed by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Rev. 12/10

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED
WEST-WARD PHARMACEUTICAL CORP
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GEMFIBROZIL TABLETS, USP
REV. 12/10
DESCRIPTION
Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP, for
oral administration, contain 600
mg gemfibrozil. Each tablet also contains the following inactive
ingredients: colloidal silicon dioxide,
NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline
cellulose, NF; methylcellulose,
USP and opadry white.
The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic
acid, with the following
structural formula:
The empirical formula is C
H O and the molecular weight is 250.35; the solubility in water and
acid
is 0.0019% and in dilute base it is greater than 1%. The melting point
is 58°-61°C. Gemfibrozil is a
white solid which is stable under ordinary conditions.
CLINICAL PHARMACOLOGY
Gemfibrozil is a lipid regulating agent which decreases serum
triglycerides and very low density
lipoprotein (VLDL) cholesterol, and increases high density lipoprotein
(HDL) cholesterol. While
modest decreases in total and low density lipoprotein (LDL)
cholesterol may be observed with
gemfibrozil therapy, treatment of patients with elevated triglycerides
due to Type IV
hyperlipoproteinemia often results in a rise in LDL-cholesterol.
LDL-cholesterol levels in Type IIb
patients with elevations of both serum LDL-cholesterol and
triglycerides are, in general, minimally
affected by gemfibrozil treatment; however, gemfibrozil usually raises
HDL-cholesterol significantly
in this group. Gemfibrozil increases levels of high density
lipoprotein (HDL) subfractions HDL2 and
HDL3, as well as apolipoproteins AI and AII. Epidemiological studies
have shown that both low HDL-
cholesterol and high LDL-cholesterol are independent risk factors for
coronary heart disease.
In the primary prevention component of the Helsinki Heart Study, in
which 4081 male patients between
the ages of 40 and 55 were studied in a randomized, double-blind,
placebo-controlled fashion,
gemfibrozil therapy was asso