Indications and Usage:
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.
2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides.
THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL TABLETS, USP ARE ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.
For more information please see the prescribing information.
|Product Name||Gemfibrozil Tablets|
|Pack Size||60 count and 500 count|
|NDC||60 count: 57237-163-60
500 count: 57237-163-05
|UPC||60 count: 357237163603
500 count: 357237163054
|Color||White to off-white|
|Gluten||Free from Gluten|
|Sweeteners||Free from Sweeteners|
|Soy||Free from Soy|
|Gelatin||Free from Gelatin|
|Allergen Info||Contains Corn Starch|
|Other Product Info||Not Applicable|
|Manufacturing and Packing Information|
|Case Weight||60 count: 9.671 lbs
500 count: 4.14 lbs
|Case Dimensions (L x W x H)||60 count: 7.953" x 6.063" x 3.858"
500 count: 16.54" x 12.6" x 7.68"
|Bottle Size||60 count: 100 cc
500 count: 850 cc
|Bottle Weight||60 count: 0.174 lbs
500 count: 0.179 lbs
|Master Shipper||60 count: 48
500 count: 12
|Inner case pack (min. order qty)||60 count: 12
500 count: N/A
|Inactive Ingredients||Calcium stearate, colloidal silicon dioxide, hypromellose, low substituted hydroxypropyl cellulose, low viscosity hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, polysorbate, pregelatinized starch (maize), and titanium dioxide.|
|Imprint / Markings||E; 82|
|Special Instructions||Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and humidity.|
|Product Shelf Life||24 Months|
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