Asacol
FULL PRESCRIBING INFORMATION: CONTENTS*
- ASACOL DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- CLINICAL STUDIES
- 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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FULL PRESCRIBING INFORMATION
ASACOL DESCRIPTION
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
CLINICAL STUDIES
Mildly to moderately active ulcerative colitis:AsacolAsacolAsacolAsacolAsacolAsacol
Maintenance of remission of ulcerative colitis:AsacolAsacolAsacol
AsacolAsacol
Study to assess the effect on male fertility:AsacolAsacol
INDICATIONS & USAGE
AsacolASACOL CONTRAINDICATIONS
AsacolAsacolPRECAUTIONS
General:AsacolAsacolAsacolAsacol
Asacol
Renal:AsacolAsacolAsacolAsacol
Asacol
INFORMATION FOR PATIENTS
AsacolAsacol
DRUG INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
AsacolPREGNANCY
Teratogenic Effects:NURSING MOTHERS
PEDIATRIC USE
AsacolGERIATRIC USE
AsacolAsacol.AsacolPRECAUTIONSAsacolAsacol
ASACOL ADVERSE REACTIONS
AsacolAsacolAsacolAsacolAsacol
AsacolTable 1Asacol
Table 1 Frequency (%) of Common Adverse Events Reported in Ulcerative Colitis Patients Treated with Asacol Tablets or Placebo in Short-Term (6-Week) Double-Blind Controlled Studies
Asacol
AsacolAsacol
AsacolTable 1Asacol-
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
OVERDOSAGE
AsacolAsacolAsacolDOSAGE & 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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
AsacolMESALAMINE TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
