GEMFIBROZIL tablet film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

American Health Packaging

INN (שם בינלאומי):

GEMFIBROZIL

הרכב:

GEMFIBROZIL 600 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
GEMFIBROZIL TABLETS, USP
8247301/1015
RX ONLY
DESCRIPTION
Gemfibrozil is a lipid regulating agent. It is available as tablet for
oral administration. Each tablet
contains 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
0
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° 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 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,
gemfib