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Cautions

Contraindications

• Extended-release capsules (Pentasa^®), delayed-release tablets (1.2-g; Lialda^®), rectal suppositories (Canasa^®): Known hypersensitivity to salicylates (including aspirin, mesalamine) or any ingredient in the respective formulation.

Warnings/Precautions

Sensitivity Reactions

Possible acute intolerance (sensitivity reaction) syndrome (e.g., cramping, abdominal pain, bloody diarrhea, fever, headache, malaise, conjunctivitis, pruritus, rash); may require prompt discontinuance. A history of sulfasalazine intolerance, if any, should be reevaluated.

Use with caution in patients with a history of hypersensitivity to sulfasalazine.

Sulfite Sensitivity

Rectal suspension contains a sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.

General Precautions

Renal Impairment

Renal impairment (e.g., minimal change nephropathy, acute and chronic interstitial nephritis, renal failure) and increases in BUN and S_cr reported.

Use with caution and only if the benefits outweigh the risks in patients with renal impairment.

Renal function should be evaluated prior to initiation of therapy and periodically thereafter.

GI Effects

Pancolitis reported rarely in patients receiving rectal mesalamine.

Possible worsening colitis or symptoms of inflammatory bowel disease (e.g., melena, hematochezia) in patients receiving rectal mesalamine.

Potential for prolonged gastric retention of oral delayed-release tablets in patients with pyloric stenosis.

The possibility of acute pancreatitis should be considered in any patient who develops new abdominal complaints while receiving mesalamine therapy.

Cardiac Effects

Use with caution in patients with conditions predisposing them to the development of myocarditis or pericarditis. The possibility of pericarditis should be considered in any patient who develops chest pain or dyspnea during mesalamine therapy. Discontinuance may be needed.

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk following oral administration. Use with caution.

Not known whether the rectal drug is distributed into milk. Use of rectal mesalamine usually not recommended, although one manufacturer of rectal suppositories states the preparation may be used with caution.

Pediatric Use

Safety and efficacy not established in children.

Has been used (as oral delayed-release tablets) for the management of inflammatory bowel disease (i.e., mild ileal, ileocecal, ileocolonic, or colonic disease) and (as rectal mesalamine suspension) in those with left-sided colitis in a limited number of pediatric patients†. (See Pediatric Patients under Dosage.)

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients. Response does not appear to differ from that in younger adults; however, drug dosage should be selected cautiously.

Possibility of increased incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, pancytopenia); CBCs should be monitored closely.

Because mesalamine is substantially eliminated by kidneys, assess renal function prior to initiation of therapy and periodically thereafter since geriatric patients more likely to have decreased renal function.

Hepatic Impairment

Use with caution in patients with hepatic impairment.

Renal Impairment

Use with caution in patients with renal impairment.

Common Adverse Effects

Oral therapy: Headache, rash, vomiting, diarrhea, flatulence, constipation, nausea, dyspepsia, abdominal pain, fever, arthralgia, flu syndrome.

Rectal therapy: Headache, abdominal pain, nausea, diarrhea, gas/flatulence, fever, dizziness, rectal pain, rash, leg/joint pain, flu syndrome.

Interactions

No known drug interactions.

Specific Drugs