Mesalamine Dosage

Usual Adult Dose for Ulcerative Colitis - Active

Oral:
Asacol (R): 800 mg orally 3 times a day for the treatment of mildly to moderately active ulcerative colitis
Asacol HD (R): 1600 mg orally 3 times a day for the treatment of moderately active ulcerative colitis
Lialda (R): 2.4 to 4.8 g orally once a day for the induction of remission of mildly to moderately active ulcerative colitis
Pentasa (R): 1 g orally 4 times a day for the treatment and induction of remission of mildly to moderately active ulcerative colitis

Rectal:
Suspension enema: 4 g rectally once a day at bedtime for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis

Usual Adult Dose for Ulcerative Colitis - Maintenance

Maintenance of remission of ulcerative colitis:
Apriso (TM): 1.5 g orally once a day in the morning
Asacol (R): 1.6 g/day orally in divided doses
Lialda (R): 2.4 g orally once a day
Pentasa (R): 1 g orally 4 times a day

Usual Adult Dose for Ulcerative Proctitis

Suppository: 1 g rectally once a day at bedtime for the treatment of active ulcerative proctitis

Usual Adult Dose for Crohn's Disease - Maintenance

Mildly to moderately active Crohn's disease: 500 mg to 1 g orally 4 times a day as Pentasa (R)

Renal Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with known renal dysfunction or a history of renal disease.

Liver Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with liver dysfunction.

Dose Adjustments

Maintenance ulcerative colitis: Lower doses of Asacol (R) have shown to be effective (800 to 1600 mg/day) or extending the dosage frequency of the rectal suspension to every other or every third night.

Precautions

Colitis symptoms have been exacerbated after starting mesalamine or sulfasalazine in 3% of patients in controlled clinical trials. This acute intolerance syndrome may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain, and bloody diarrhea, and occasionally fever, headache, malaise, pruritus, rash, and conjunctivitis. Patients should be observed closely for worsening of these symptoms during treatment. Mesalamine should be discontinued promptly if acute intolerance syndrome is suspected.

Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure (rare), associated with products containing or converted to mesalamine has been reported. Patients with known renal dysfunction or a history of renal disease should be administered mesalamine with caution. An evaluation of renal function prior to initiation of and periodically during mesalamine therapy is recommended for all patients. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during therapy.

A higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, pancytopenia) has been reported during uncontrolled clinical trials and postmarketing experience in patients 65 years or older receiving mesalamine. Blood cell counts should be monitored closely during mesalamine therapy.

The use of Asacol HD (R) beyond 6 weeks has not been evaluated.

Safety and efficacy have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Active therapy for ulcerative colitis and Crohn's disease should be continued until remission, usually 2 to 4 months. Apriso (TM), Asacol (R), and Lialda (R) have been approved by the FDA for maintenance of remission of ulcerative colitis. Pentasa (R) has not been explicitly approved for this indication.

Rectal suspensions should be retained for approximately 8 hours. Suppositories should be retained for 1 to 3 hours or longer.

Lialda (R) tablets should be taken with a meal. The tablets should be swallowed whole, keeping the outer coating intact.

The release of mesalamine in the colon may be delayed in patients with pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract due to prolonged gastric retention of mesalamine tablets.

The coating of the granules in Apriso (TM) capsules depends on pH for dissolution; therefore, this product should not be coadministered with antacids.

Asacol (R) and Asacol HD (R) should be swallowed whole without cutting, breaking, or chewing. Asacol HD (R) may be taken without regard to meals. One Asacol HD (R) 800 mg tablet is not bioequivalent to two Asacol (R) 400 mg tablets.

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