Pentasa
FULL PRESCRIBING INFORMATION: CONTENTS*
- PENTASA DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- PENTASA CONTRAINDICATIONS
- PRECAUTIONS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- PENTASA ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
PENTASA DESCRIPTION
CLINICAL PHARMACOLOGY
Human Pharmacokinetics and Metabolism
Absorption.
Elimination.
CLINICAL TRIALS
INDICATIONS & USAGE
PENTASA CONTRAINDICATIONS
PRECAUTIONS
GeneralRenal
DRUG INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
NURSING MOTHERS
PEDIATRIC USE
PENTASA ADVERSE REACTIONS
Table 1. Adverse Events Occurring in More than 1% of Either Placebo or PENTASA Patients in Domestic Placebo-controlled Ulcerative Colitis Trials. (PENTASA Comparison to Placebo)
Gastrointestinal:
Dermatological:
Nervous System:
Cardiovascular:
Other:
Postmarketing Reports
Gastrointestinal:
Other:
OVERDOSAGE
Treatment of Overdosage.
DOSAGE & ADMINISTRATION
HOW SUPPLIED
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
PentasaMesalamine CAPSULE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!