GEMFIBROZIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Health, LLC

INN (International Name):

GEMFIBROZIL

Composition:

GEMFIBROZIL 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Gemfibrozil tablets, USP 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 tablets, USP 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 eleva

Product summary:

Gemfibrozil Tablets USP, 600 mg are white to off-white, elliptical, biconvex, film-coated tablets, debossed with ‘E’ on one side and ‘82’ on the other side.             Bottles of 60                  NDC 57237-163-60             Bottles of 500                NDC 57237-163-05 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and humidity. Distributed by: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/22/2009 Revised: 12/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GEMFIBROZIL - GEMFIBROZIL TABLET, FILM COATED
RISING HEALTH, LLC
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GEMFIBROZIL TABLETS, USP
RX ONLY
DESCRIPTION
Gemfibrozil is a lipid regulating agent. It is available as tablets
for oral administration. Each tablet
contains 600 mg gemfibrozil. Each tablet also contains calcium
stearate, colloidal silicon dioxide,
hypromellose, low substituted hydroxypropyl cellulose, low viscosity
hydroxypropyl cellulose,
microcrystalline cellulose, polyethylene glycol, polysorbate,
pregelatinized starch (maize), and titanium
dioxide. The chemical name is
5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following
structural formula:
The molecular formula is C
H O and the molecular weight is 250.35; practically insoluble in
water,
soluble in alcohol, in methanol and in chloroform. The melting point
is 58° to 61°C. Gemfibrozil USP
is a white or almost white, waxy crystalline solid.
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-