GEMFIBROZIL tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NuCare Pharmaceuticals, Inc.

INN (Alþjóðlegt nafn):

GEMFIBROZIL

Samsetning:

GEMFIBROZIL 600 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 accomp

Vörulýsing:

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 66267-436-30: Bottles of 30 NDC 66267-436-60: Bottles of 60 NDC 66267-436-92: Bottles of 180 Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP]. Protect from light and humidity. Manufactured for: Cipla USA Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156 Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Revised: 7/2016

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

GEMFIBROZIL- GEMFIBROZIL TABLET
NUCARE PHARMACEUTICALS, INC.
----------
GEMFIBROZIL TABLETS, 600 MG
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 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
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,
gemfibrozil therapy was a