Gemfibrozil (Page 4 of 4)

DOSAGE AND ADMINISTRATION

The recommended dose for adults is 1200 mg administered in two divided doses 30 minutes before the morning and evening meals (see CLINICAL PHARMACOLOGY).

OVERDOSAGE

There have been reported cases of overdosage with Gemfibrozil. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil. Symptoms reported with overdosage were abdominal cramps, abnormal liver function tests, diarrhea, increased CPK, joint and muscle pain, nausea and vomiting. Symptomatic supportive measures should be taken, should an overdose occur.

HOW SUPPLIED

Repackaged by Aphena Pharma Solutions — TN.See Repackaging Information for available configurations.

Aphena Pharma Solutions -- TN

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, are available as follows:

NDC 24658-260-30: Bottles of 30
NDC 24658-260-60: Bottles of 60NDC 24658-260-90: Bottles of 90

NDC 24658-260-18: Bottles of 180

NDC 24658-260-05: Bottles of 500

Store at controlled room temperature 20° — 25°C (68° — 77°F) [see USP]. Protect from light and humidity.

Dispense in a tight container as defined in the USP.

Manufactured by: Blu Caribe, Dorado, PR 00646 USA

Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134, 1-877-264-0258

November 2010

BP0032-00

REFERENCES

1. Frick MH, Elo O, Haapa K, et al: Helsinki Heart Study: Primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia. N Engl J Med 1987; 317:1237-1245.

2. Manninen V, Elo O, Frick MH, et al: Lipid alterations and decline in the incidence of coronary heart disease in the Helsinki Heart Study. JAMA 1988; 260:641-651.

3. Frick MH, Heinonen OP, et al: Efficacy of gemfibrozil in dyslipidemic subjects with suspected heart disease. An ancillary study in the Helsinki Heart Study frame population. Annals of Medicine 1993; 25:41-45.

4. Data on file. Parke-Davis; Morris Plains, NJ.

5. Nikkila EA: Familial lipoprotein lipase deficiency and related disorders of chylomicron metabolism. In Stanbury JB et al. (eds.): The Metabolic Basis of Inherited Disease, 5th ed., McGraw-Hill, 1983, Chap. 30, pp. 622-642.

6. Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol. Arch Int Med 1988;148:36-69.

7. Data on file. Pfizer; NY, NY.

8. Pierce LR, Wysowski DK, Gross TP. Myopathy and rhabdomyolysis associated with lovastatin/gemfibrozil combination therapy. JAMA 1990; 264:71-75.

9. Bermingham RP, Whitsitt TB, Smart ML et al. Rhabdomyolysis in a patient receiving the combination of cerivastatin and gemfibrozil. Am J Health-Syst Pharm 2000; 57:461-464.

10. Duell PB, Conner WE, Illingworth DR. Rhabdomyolysis after taking atorvastatin with gemfibrozil. Am J Cardiol 1998; 81:368-369.

11. Tal A, Rajeshawari M, Isley W. Rhabdomyolysis associated with simvastatin/gemfibrozil therapy. South Med J 1997; 90:546-547.

12. Data on file. Pfizer; NY, NY.

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

CountB260
9043353-772-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20120329AW

PRINCIPAL DISPLAY PANEL — B260

NDC 43353-772 — Gemfibrozil 600mg — Rx Only

Bottle Label 600mg
(click image for full-size original)

GEMFIBROZIL gemfibrozil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-772(NDC:24658-260)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMFIBROZIL (GEMFIBROZIL) GEMFIBROZIL 600 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
CARNAUBA WAX
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL
STARCH, PREGELATINIZED CORN
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (B260) Score 2 pieces
Shape OVAL Size 20mm
Flavor Imprint Code B260
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-772-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078012 04/01/2011
Labeler — Aphena Pharma Solutions — Tennessee, Inc. (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, Inc. 128385585 Repack

Revised: 03/2012 Aphena Pharma Solutions — Tennessee, Inc.

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