GEMFIBROZIL tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Carilion Materials Management

INN (Isem Internazzjonali):

GEMFIBROZIL

Kompożizzjoni:

GEMFIBROZIL 600 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

NDC:68151-2893-8 in a CUP of 1 TABLETS

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

GEMFIBROZIL- GEMFIBROZIL TABLET
CARILION MATERIALS MANAGEMENT
----------
GEMFIBROZIL TABLETS, USP 600 MG
RX ONLY
DESCRIPTION
Gemfibrozil is a lipid regulating agent. It is available as tablet 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 0 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 HDL2 and
HDL3, 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 w