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NDC 31722-0128-60

Gemfibrozil 600 mg/1 TABLET

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NDC
31722-0128-60
Generic Name
Gemfibrozil
Brand Name
GEMFIBROZIL
Strength
600 mg/1
Dosage Form
TABLET
Route
ORAL
Package Size
Labeler
Camber Pharmaceuticals, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE 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)…

Important Warnings

WARNINGS 1. Because of chemical, pharmacological, and clinical similarities between gemfibrozil and clofibrate, the adverse findings with clofibrate in two large clinical studies may also apply to gemfibrozil. In the first of those studies, the Coronary Drug Project, 1000 subjects with previous myocardial infarction were treated for five years with clofibrate. There was no difference in mortality…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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