Gemfibrozil (Page 4 of 5)

ADVERSE REACTIONS

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 (histologically confirmed in most cases where data were available) 1.2 0.6
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

Gallbladder surgery 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 group compared to the placebo group of the WHO study. Gallbladder surgery was also performed more frequently in the gemfibrozil group compared to the placebo group (1.9% versus 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 versus 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 WARNINGS), and to ABNORMAL LIVER FUNCTION TESTS and HEMATOLOGIC CHANGES (see PRECAUTIONS).

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 tablets are listed below by system. These are categorized according to whether a causal relationship to treatment with gemfibrozil tablets is probable or not established:

CAUSAL RELATIONSHIP PROBABLE CAUSAL RELATIONSHIP NOT ESTABLISHED
General: weight loss
Cardiac: extrasystoles
Gastrointestinal: cholestatic jaundice pancreatitishepatomacolitis
Central Nervous System: dizzinesssomnolenceparesthesiaperipheral neuritisdecreased libidodepressiondepressionheadache confusionconvulsionssyncope
Eye: blurred vision retinal edema
Genitourinary: impotence decreased male fertilityrenal dysfunction
Musculoskeletal: myopathy myasthenia myalgia painful extremities arthralgia synovitis rhabdomyolysis (see WARNINGS and Drug Interactions under PRECAUTIONS)
Clinical Laboratory: increased creatinephosphokinaseincreased bilirubinincreased liver transaminases(AST, ALT)increased alkaline phosphatase positive antinuclearantibody
Hematopoietic: anemialeukopeniabone marrow hypoplasiaeosinophilia thrombocytopenia
Immunologic: angioedemalaryngeal edemaurticaria anaphylaxisLupus-like syndromevasculitis
Integumentary: exfoliative dermatitisrashdermatitispruritus 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 meals (see CLINICAL PHARMACOLOGY).

OVERDOSAGE

There have been reported cases of overdosage with gemfibrozil tablets. In one case, a 7-year-old child recovered after ingesting up to 9 grams of gemfibrozil tablets. 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, 600 mg are white to off white colored, oval shaped, film coated tablets, debossed with “553” on one side and separating “5” & “53” with break line and plain on other side and are supplied as follows:

NDC 68382-553-06 in bottles of 30 tablets

NDC 68382-553-14 in bottles of 60 tablets

NDC 68382-553-16 in bottles of 90 tablets

NDC 68382-553-01 in bottles of 100 tablets

NDC 68382-553-05 in bottles of 500 tablets

NDC 68382-553-10 in bottles of 1,000 tablets

NDC 68382-553-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and humidity.

Dispense in a tight, light-resistant container (USP).

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 05/18

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