GEMFIBROZIL tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Northstar RxLLC

INN (Международно Name):

GEMFIBROZIL

Композиция:

GEMFIBROZIL 600 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични 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 accompanying

Каталог на резюме:

Gemfibrozil Tablets USP are supplied as: 600 mg: White to off-white, elliptical, biconvex, film-coated tablets with 'N111' debossed and scored on one face and scored on the other face. Bottles of 60                  NDC 16714-101-02 Bottles of 500                NDC 16714-101-05 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light and humidity.   KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. Manufactured for:    Northstar Rx LLC                                  Memphis, TN38141                                 Toll Free Number:     1-800-206-7821 Manufactured by :   Piramal Pharma Limited                                                  Plot No. 67-70, Sector -2, Pithampur 454775, Dist. Dhar,                                    Madhya Pradesh, INDIA.                                                                                      December 2020

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

GEMFIBROZIL - GEMFIBROZIL TABLET
NORTHSTAR RXLLC
----------
RX ONLY
BOXED WARNING
DESCRIPTION
Gemfibrozil is a lipid regulating agent. It is available as tablets
for oral administration. Each tablet
contains 600 mg gemfibrozil USP. Each tablet also contains colloidal
silicon dioxide, hydroxypropyl
cellulose, hypromellose, low substituted hydroxypropyl cellulose,
magnesium stearate,
microcrystalline cellulose, polysorbate 80, pregelatinized starch
(botanical source: maize), sodium
starch glycolate and titanium dioxide. 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; practically insoluble in
water,
soluble in alcohol, in methanol, and in chloroform. 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