Gemfibrozil: Package Insert and Label Information (Page 3 of 3)

Adverse Reactions to Gemfibrozil

In the double-blind controlled phase of the primary prevention component of the Helsinki Heart Study, 2046 patients received gemfibrozil for up to five years. In that study, the following adverse reactions were statistically more frequent in subjects in the gemfibrozil group:

GEMFIBROZIL (N = 2046) PLACEBO (N = 2035)
Frequency in percent of subjects
Gastrointestinal reactions 34.2 23.8
Dyspepsia 19.6 11.9
Abdominal pain 9.8 5.6
Acute appendicitis 1.2 0.6
(histologically confirmed in most cases where data were available)
Atrial fibrillation 0.7 0.1
Adverse events reported by more than 1% of subjects, but without a significant difference between groups:
Diarrhea 7.2 6.5
Fatigue 3.8 3.5
Nausea/Vomiting 2.5 2.1
Eczema 1.9 1.2
Rash 1.7 1.3
Vertigo 1.5 1.3
Constipation 1.4 1.3
Headache 1.2 1.1

was performed in 0.9% of gemfibrozil and 0.5% of placebo subjects in the primary prevention component, a 64% excess, which is not statistically different from the excess of gallbladder surgery observed in the clofibrate compared to the placebo group of the WHO study. Gallbladder surgery

Gallbladder surgery was also performed more frequently in the gemfibrozil group compared to placebo (1.9% vs 0.3%, p=0.07) in the secondary prevention component. A statistically significant increase in appendectomy in the gemfibrozil group was seen also in the secondary prevention component (6 on gemfibrozil vs 0 on placebo, p=0.014).

Nervous system and special senses adverse reactions were more common in the gemfibrozil group. These included hypesthesia, paresthesias, and taste perversion. Other adverse reactions that were more common among gemfibrozil treatment group subjects but where a causal relationship was not established include cataracts, peripheral vascular disease, and intracerebral hemorrhage.

From other studies it seems probable that gemfibrozil is causally related to the occurrence of MUSCULOSKELETAL SYMPTOMS (see ), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see ). WARNINGSPRECAUTIONS

Reports of viral and bacterial infections (common cold, cough, urinary tract infections) were more common in gemfibrozil treated patients in other controlled clinical trials of 805 patients. Additional adverse reactions that have been reported for gemfibrozil are listed below by system. These are categorized according to whether a causal relationship to treatment with gemfibrozil is probable or not established:

CAUSAL RELATIONSHIP PROBALE CAUSAL RELATIONSHIP NOT ESTABLISHED
General: Weight loss
Cardiac: extrasystoles
Gastrointestinal: cholestatic jaundice pancreatitis hepatoma colitis
Central Nervous System: dizziness Somnolence Paresthesiaperipheral neuritisdecreased libidodepression headache confusion convulsions syncope
Eye: blurred vision Retinal edema
Genitourinary: impotence decreased male fertility renal dysfunction
Musculoskeletal: myopathy myasthenia myalgia painful extremities arthralgia synovitis rhabdomyolysis (see and under ) WARINGSDrug InteractionsPRECUATIONS
Clinical Laboratory: increased creatine phosphokinase increased bilirubin increased liver transaminases (AST [SGOT],ALT [SGPT]) increased alkaline phosphatase positive antinuclear antibody
Hematopoietic: anemia leukopenia bone marrow hypoplasiaeosinophilia thrombocytopenia
Immunologic: angicedema laryngeal edema urticaria anaphylaxis lupus like syndrome vasculitis
Integumentary: exfoliative dermatitisrash dermatitis pruritus alopeciaphotosensitivity

Additional adverse reactions that have been reported include cholecystitis and cholelithiasis (see WARNINGS ).

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

NDC:68151-2893-8 in a CUP of 1 TABLETS

GEMFIBROZIL TABLET

Label Imagefbfdad8d-figure-01Label Image
GEMFIBROZIL gemfibrozil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-2893(NDC:31722-225)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CALCIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
METHYLCELLULOSE (15 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code 225;IG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-2893-8 1 TABLET in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 01/01/2011
Labeler — Carilion Materials Management (079239644)
Registrant — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-2893)

Revised: 03/2015 Carilion Materials Management

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