GEMFIBROZIL tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

NCS HealthCare of KY, LLC dba Vangard Labs

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

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.             Blistercards of 30                  NDC 0615-8354-39          Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and humidity. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Revised: 07/2018

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

GEMFIBROZIL- GEMFIBROZIL TABLET, FILM COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
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