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:

Teva Pharmaceuticals USA, Inc.

INN (International ime):

GEMFIBROZIL

Sastav:

GEMFIBROZIL 600 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Gemfibrozil tablets 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 accompanying

Proizvod sažetak:

Gemfibrozil tablets USP, 600 mg are available as white to off-white, film-coated, oval-shaped tablets, scored on one side and debossed with “93” on one side of the breakline and debossed with “670” on the other side of the breakline. Other side of tablet is plain. Packaged in bottles of 60 and 500. NDC 0093-0670-06: Bottles of 60 NDC 0093-0670-05: Bottles of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and humidity. Dispense contents in a tight container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. T 4/2017

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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GEMFIBROZIL TABLETS USP, 600 MG
RX ONLY
DESCRIPTION
Gemfibrozil, USP is a lipid regulating agent. It is available as
tablets for oral administration. Each tablet
contains 600 mg gemfibrozil, USP. In addition, each tablet contains
the following inactive ingredients:
calcium stearate, colloidal silicon dioxide, hydroxypropyl cellulose,
hypromellose, microcrystalline
cellulose, polydextrose K, polyethylene glycol 4000, polysorbate 80,
pregelatinized starch and
titanium dioxide. The chemical name is
5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the
following structural formula:
C
H O M.W. 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° to 61°C. Gemfibrozil, USP 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 HDL and
HDL , 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