GEMFIBROZIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Gemfibrozil Tablets USP, 600 mg are 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, are available as follows: NDC 68788-7011-3: bottles of 30 NDC 68788-7011-6: bottles of 60 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from light and humidity. Dispense in a tight container as defined in the USP. Manufactured by: PuraCap Caribe Dorado, PR 00646 USA Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Product of USA Rev. 06-2017-00 OE1644 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
[Enter Medication Guide here]
Revised: 8/2017
Document Id: 991b0066-ffdc-4ca5-8aa1-15674bcdedd1
34391-3
Set id: 991b0066-ffdc-4ca5-8aa1-15674bcdedd1
Version: 1
Effective Time: 20170828
Preferred Pharmaceuticals Inc.

Summary of Product characteristics

GEMFIBROZIL- GEMFIBROZIL TABLET
PREFERRED PHARMACEUTICALS INC.
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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 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:
The empirical formula is C
H O 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 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 ma