Mesalazine

Pericarditis and myocarditis (mesalamine-induced cardiac hypersensitivity reactions) have been reported. Use with caution in patients predisposed to these conditions.

Mesalamine-induced hypersensitivity reactions have been reported and may include internal organ involvement, such as hepatitis, hematologic abnormalities, and/or pneumonitis. Discontinue treatment for mesalamine-induced hypersensitivity reactions.

May cause an acute intolerance syndrome (cramping, abdominal pain, bloody diarrhea; sometimes fever, headache, malaise, pruritus, rash, conjunctivitis); may be hard to discern from an exacerbation; discontinue immediately if syndrome occurs or is suspected. Symptoms usually abate if drug is discontinued. If rechallenge is performed to validate the hypersensitivity, use a reduced dose and only if clearly needed.

In males, oligospermia (rare, reversible) has been reported.

Renal impairment (including minimal change nephropathy, acute and chronic interstitial nephritis, nephrotic syndrome, and rarely renal failure) has been reported. A renal function evaluation is recommended prior to initiation of therapy and periodically during treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal impairment during treatment.

Patients with hypersensitivity to sulfasalazine may react to mesalamine. Disease-related concerns:

Use caution in patients with hepatic impairment; hepatic failure has been reported.

Use with caution in patients with renal impairment, a history of renal disease, or those on nephrotoxic medications. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Use with caution in the elderly; uncontrolled studies and postmarketing reports suggest an increased incidence of blood dyscrasias (ie, agranulocytosis, neutropenia, pancytopenia) in patients >65 years of age. Dosage form specific issues:

Contains phenylalanine.

Intact, partially intact, and/or tablet shells have been reported in the stool.

Contain saturated vegetable fatty acid esters (contraindicated in patients with allergy to these components). May stain surfaces including clothing, other fabrics, flooring, painted surfaces, enamel, granite, marble and vinyl. Avoid contact with these surfaces.

Contain metabisulfite salts that may cause severe hypersensitivity reactions (ie, anaphylaxis) in patients with sulfite allergies.

May stain direct contact surfaces including clothing, other fabrics, flooring, painted surfaces, enamel, granite, marble and vinyl. Choose a suitable location for product administration.

Patients with pyloric stenosis or other organic or functional upper gastrointestinal obstructive disorders may have prolonged gastric retention of tablets, delaying the release of mesalamine in the colon. Other warnings/precautions:

Asacol HD: Safety and effectiveness beyond 6 weeks have not been determined.

The Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Delzicol 400 mg capsules. Two Delzicol 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine 800 mg delayed-release tablet.