GEMFIBROZIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Pharmaceuticals Limited

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: 1.  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 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 elevations accom

Product summary:

Gemfibrozil Tablets, USP 600 mg: White, elliptical, film-coated, scored tablets, imprinted 'C17' on one side,are available as follows: NDC 71209-008-03: Bottles of 60 NDC 71209-008-08: Bottles of 180 NDC 71209-008-10: Bottles of 500 Store at controlled room temperature 20° – 25°C (68° – 77°F) [see USP]. Protect from light and humidity. Rx only Manufactured by: Cadila Pharmaceuticals Limited, 1389 Trasad Road, Dholka, District - Ahmedabad, Gujarat, INDIA Revised: January 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GEMFIBROZIL - GEMFIBROZIL TABLET
CADILA PHARMACEUTICALS LIMITED
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GEMFIBROZIL TABLETS, USP, 600 MG - GEMFIBROZIL TABLETS
DESCRIPTION
Gemfibrozil tablets, USP 600 mg 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, NF; microcrystalline cellulose, NF; hydroxypropyl
cellulose, NF;
polysorbate 80, NF; colloidal silicon dioxide, NF; pregelatinized
starch (maize starch), NF;
croscarmellose sodium, NF; opadry white; opacode Blue. opadry white
contains
hypromellose, titanium dioxide, polyethylene glycol 400 and opacode
blue contains
shellac, FD&C Blue #1, N-butyl alcohol, titanium dioxide, propylene
glycol, isopropyl
alcohol. 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, USP 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-