Gemfibrozil
FULL PRESCRIBING INFORMATION: CONTENTS*
- GEMFIBROZIL DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- GEMFIBROZIL CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GEMFIBROZIL ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
- OVERDOSAGE
- HOW SUPPLIED
- STORAGE AND HANDLING
- REFERENCES
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
GEMFIBROZIL DESCRIPTION
CLINICAL PHARMACOLOGY
All Patients
Group:PDropPNPGGDropGNGGN=215N=494N=1283N=221N=574N=1207
EventGemfibrozilPlacebo atGemfibrozil:Placeboat StudyStudy StartHazardCl HazardStartRatioRatio
INDICATIONS & USAGE
GEMFIBROZIL CONTRAINDICATIONS
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● Hepatic or severe renal dysfunction, including primary biliary cirrhosis.
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● Preexisting gallbladder disease (see WARNINGS).
-
● Hypersensitivity to gemfibrozil.
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● Combination therapy of gemfibrozil with repaglinide (see PRECAUTIONS).
WARNINGS
PRECAUTIONS
GeneralDRUG INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
NURSING MOTHERS
PEDIATRIC USE
GEMFIBROZIL ADVERSE REACTIONS
GEMFIBROZIL (N = 2046)PLACEBO (N = 2035)Frequency in percent of subjects
CAUSAL RELATIONSHIP PROBABLECAUSAL RELATIONSHIP NOT ESTABLISHED
DOSAGE & ADMINISTRATION
OVERDOSAGE
HOW SUPPLIED
STORAGE AND HANDLING
REFERENCES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
GemfibrozilGemfibrozil TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
