GEMFIBROZIL tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

State of Florida DOH Central Pharmacy

INN (International Name):

GEMFIBROZIL

Sammensetning:

GEMFIBROZIL 600 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 ele

Produkt oppsummering:

Gemfibrozil Tablets USP, 600 mg, white, capsule-shaped tablets with the logo "B260" debossed on one side and bisected on the other side of the tablet, each containing 600 mg gemfibrozil. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP]. Protect from light and humidity. Manufactured by: Blu Caribe, Dorado, PR 00646 USA Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134, 1-877-264-0258 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

GEMFIBROZIL - GEMFIBROZIL TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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GEMFIBROZIL TABLETS USP, 600 MG TABLET, FILM COATED 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: calcium
stearate NF, carnauba wax NF, colloidal silicon dioxide
NF,croscarmellose sodium NF, hydroxypropyl
cellulose NF, microcrystalline cellulose NF, polyethylene glycol 3350
NF, polyvinyl alcohol USP,
pregelatinized starch NF, sodium lauryl sulfate NF, talc USP and
titanium dioxide USP. The chemical
name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the
following structural formula:
PICTURE OF GEMFIBROZIL STRUCTURE
The molecularformula is C15H22O3 and the molecular weight is 250.33;
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. 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.
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