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:

Aidarex Pharmaceuticals LLC

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: - 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 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 elevations accompa

Proizvod sažetak:

Gemfibrozil Tablets, USP, white to off-white, oval, scored, film-coated tablets, imprinted "APO" bisect "034" on one side and "600" on the other side, each containing 600 mg gemfibrozil, are available as follows: NDC 33261-0146-30: Bottles of 30 NDC 33261-0146-60: Bottles of 60 NDC 33261-0146-90: Bottles of 90 Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. GEMFIBROZIL TABLETS, USP 600 mg Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: January 2011

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED
AIDAREX PHARMACEUTICALS LLC
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GEMFIBROZIL TABLETS, USP 600 MG
DESCRIPTION
Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP for
oral administration, contains 600
mg gemfibrozil. Each tablet also contains the following inactive
ingredients: colloidal silicon dioxide,
croscarmellose sodium, hydroxypropyl cellulose, hypromellose,
magnesium stearate, methylcellulose,
polyethylene glycol and titanium dioxide. The chemical name is
5-(2,5-Dimethylphenoxy)-2,2-dimethyl
pentanoic acid, with the following structural formula:
The molecular formula is C
H O and the molecular weight is 250.34; 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 the