gemfibrozil- Gemfibrozil tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Gemfibrozil (UNII: Q8X02027X3) (Gemfibrozil - UNII:Q8X02027X3)

Доступна с:

Watson Laboratories, Inc.

ИНН (Международная Имя):

Gemfibrozil

Фармацевтическая форма:

TABLET

состав:

600 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Gemfibrozil tablets 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 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 accompanyi

Обзор продуктов:

Gemfibrozil Tablets USP are supplied as follows: 600 mg: Light orange, oval-shaped, film-coated, partial bisected tablets, debossed WATSON and 454 , in bottles of 60 and 500. Store at controlled room temperature 20°-25°C (68°-77°F). [See USP.] Dispense in a tight container as defined in USP/NF.

Характеристики продукта

GEMFIBROZIL- GEMFIBROZIL TABLET
WATSON LABORATORIES, INC.
----------
70011405
FPO
GEMFIBROZIL
TABLETS USP
REVISED: JULY 2004
RX ONLY
DESCRIPTION
Gemfibrozil is a lipid regulating agent. The chemical name is
5-(2,5-dimethylphenoxy)-2,2-
dimethylpentanoic acid, with the following structural formula:
C H O
M.W. 250.33
Gemfibrozil is a white solid which is stable under ordinary
conditions. 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.
Each tablet for oral administration contains 600 mg of gemfibrozil. In
addition, each tablet also contains
the following inactive ingredients: calcium stearate, colloidal
silicon dioxide, croscarmellose sodium,
FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake,
hydroxypropyl cellulose,
hypromellose, microcrystalline cellulose, polyethylene glycol,
polysorbate 80, pregelatinized starch,
and titanium dioxide.
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 (refs.
1,2), in which 4081 male patients
between the ages of 40 and 55