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 meal (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

Gemfibrozil Tablets USP are supplied as follows:

600 mg: Light orange, oval-shaped, film-coated, partial bisected tablets, debossed WATSON and 454 , in bottles of 60 and 500.

Store at controlled room temperature 20°-25°C (68°-77°F). [See USP.]

Dispense in a tight container as defined in USP/NF.

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, Connor 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.

Manufactured for:
Watson Laboratories, Inc.
Corona, CA 92880 USA

Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45215 USA

Rev: July 2004

GEMFIBROZIL
gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0454
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
colloidal silicon dioxide
croscarmellose sodium
FD & C red #40 aluminum lake
FD & C red #6 aluminum lake
hydroxypropyl cellulose
microcrystalline cellulose
polyethylene glycol
polysorbate 80
pregelatinized starch
titanium dioxide
Product Characteristics
Color ORANGE (Light orange) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code WATSON;454
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0454-60 60 TABLET (60 TABLET) in 1 BOTTLE None
2 NDC:0591-0454-05 500 TABLET (500 TABLET) in 1 BOTTLE None
Labeler — Watson Laboratories, Inc.

Revised: 01/2007 Watson Laboratories, Inc.

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