Asacol
FULL PRESCRIBING INFORMATION: CONTENTS*
- ASACOL DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- ASACOL CONTRAINDICATIONS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- ASACOL ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
ASACOL DESCRIPTION
Inactive Ingredients:
CLINICAL PHARMACOLOGY
Pharmacokinetics:
Clinical Studies:
Mildly to moderately active ulcerative colitis:
Maintenance of remission of ulcerative colitis:
Study to assess the effect on male fertility:
INDICATIONS & USAGE
ASACOL CONTRAINDICATIONS
PRECAUTIONS
General:
Renal:
Therefore, caution should be exercised when using Asacol (or other compounds which contain or are converted to mesalamine or its metabolites) in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy.
Use in Hepatic Impairment:
INFORMATION FOR PATIENTS
DRUG INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
NURSING MOTHERS
PRECAUTIONS, Pregnancy
PEDIATRIC USE
GERIATRIC USE
ASACOL ADVERSE REACTIONS
Table 1
Table 1
Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hematologic:
Musculoskeletal:
Nervous:
Respiratory/Pulmonary:
Skin:
Special Senses:
Urogenital:Renal subsection in PRECAUTIONS
Laboratory Abnormalities:
DRUG ABUSE AND DEPENDENCE
Abuse:Dependency:
OVERDOSAGE
DOSAGE & ADMINISTRATION
For the treatment of mildly to moderately active ulcerative colitis:For the maintenance of remission of ulcerative colitis:
HOW SUPPLIED
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
AsacolAsacol TABLET, DELAYED RELEASE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
