GEMFIBROZIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the nee

Product summary:

Gemfibrozil Tablets, USP are supplied as: White to off white, film coated, oval tablets, debossed with “1” with two partial bisects on one side and two partial bisects on other side, each containing 600 mg gemfibrozil, USP are available as follows: Store at controlled room temperature 20° – 25°C (68° – 77°F) [see USP]. Protect from light and humidity. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 08/21 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GEMFIBROZIL- GEMFIBROZIL TABLET
PREFERRED PHARMACEUTICALS, INC.
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GEMFIBROZIL TABLETS, USP
DESCRIPTION
Gemfibrozil, USP is a lipid regulating agent. It is available as
tablets for oral
administration. Each tablet contains 600 mg gemfibrozil. Each tablet
also contains the
following inactive ingredients: pregelatinized starch,
microcrystalline cellulose, povidone,
colloidal silicon dioxide, polysorbate, croscarmellose sodium, calcium
stearate,
hydroxypropyl cellulose, and talc. 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 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-controlled fashion, g