Gemfibrozil
FULL PRESCRIBING INFORMATION: CONTENTS*
- GEMFIBROZIL DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- GEMFIBROZIL CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- GEMFIBROZIL ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- OVERDOSAGE
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
GEMFIBROZIL DESCRIPTION
CLINICAL PHARMACOLOGY
All Patients
*
Group:PDropPNPLLDropLNLLN=215N=494N=1283N=221N=574N=1207*
*
EventLOPIDPlaceboLOPID:Placeboat Studyat StudyHazardCl HazardStartStartRatioRatio *
DOSAGE AND ADMINISTRATION
PRECAUTIONS
INDICATIONS & USAGE
WARNINGSPRECAUTIONSCLINICAL PHARMACOLOGY
GEMFIBROZIL CONTRAINDICATIONS
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● Hepatic or severe renal dysfunction, including primary biliary cirrhosis.
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● Preexisting gallbladder disease (seeWARNINGS).
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● Hypersensitivity to gemfibrozil.
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● Combination therapy of gemfibrozil with repaglinide (seePRECAUTIONS).
WARNINGS
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
PRECAUTIONSDrug Interactions
PRECAUTIONS
1. Initial Therapy2. Continued Therapy
3. Drug Interactions
(A) HMG-CoA Reductase Inhibitors
WARNINGS
(B) Anticoagulants
(C) Repaglinide
CONTRAINDICATIONS
(D) Bile Acid-Binding Resins
4. Carcinogenesis, Mutagenesis, Impairment of Fertility
5. Pregnancy Category C
6. Nursing Mothers
7. Hematologic Changes
8. Liver Function
9. Kidney Function
10. Pediatric Use
GEMFIBROZIL ADVERSE REACTIONS
GEMFIBROZIL (N = 2046)PLACEBO (N = 2035)Frequency in percent of subjects
WARNINGSABNORMAL LIVER FUNCTION TESTSHEMATOLOGIC CHANGESPRECAUTIONS
CAUSAL RELATIONSHIP PROBABLECAUSAL RELATIONSHIP NOT ESTABLISHEDWARNINGSDrug InteractionsPRECAUTIONSWARNINGS
DOSAGE & ADMINISTRATION
CLINICAL PHARMACOLOGYOVERDOSAGE
HOW SUPPLIED
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
GemfibrozilGemfibrozil TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
