GEMFIBROZIL tablet film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

McKesson Contract Packaging

INN (International Name):

GEMFIBROZIL

Sammensetning:

GEMFIBROZIL 600 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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GEMFIBROZIL TABLETS USP, 600 MG
RX ONLY
DESCRIPTION
Gemfibrozil is a lipid regulating agent. It is available as tablets
for oral administration. Each tablet
contains 600 mg gemfibrozil. 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 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,
placebo-controll