GEMFIBROZIL tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Exelan Pharmaceuticals, Inc.

INN (International Name):

GEMFIBROZIL

Sammensetning:

GEMFIBROZIL 600 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Gemfibrozil Tablets 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 2,000 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 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 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 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations acco

Produkt oppsummering:

Gemfibrozil Tablets, USP Supplied as White film-coated, capsule shaped, biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect on one side and 225 on the other. NDC 76282-225-60: Bottles of 60 NDC 76282-225-18: Bottles of 100 NDC 76282-225-05: Bottles of 500 Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP]. Protect from light and humidity. Preserve in tight containers. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Exelan Pharmaceuticals, Inc. Boca Raton, FL 33432 Revised: 01/2021 To report SUSPECTED ADVERSE REACTIONS, Exelan Pharmaceuticals, Inc. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED
EXELAN PHARMACEUTICALS, INC.
----------
GEMFIBROZIL TABLETS, USP 600 MG
RX ONLY
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: 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
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° 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 HDLcholesterol
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 4,081 male
patients between the ages of 40 and 55 were studied in a randomized,
double-blind,
placebo-controlled fashion, gemf