GEMFIBROZIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

GEMFIBROZIL

Composition:

GEMFIBROZIL 600 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GEMFIBROZIL- GEMFIBROZIL TABLET
ST MARYS MEDICAL PARK PHARMACY
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GEMFIBROZIL TABLETS, USP 600 MG
RX ONLY
DESCRIPTION
Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets USP for
oral administration, contain 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 C15H2203 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 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 therapy was associated