Pregnancy Risk Category B
How supplied
Tablets (delayed-release): 400 mg
Capsules (controlled-release): 250 mg
Rectal suspension: 4 g/60 ml
Suppositories: 500 mg
Action
Unknown. An active metabolite of sulfasalazine; probably acts topically by inhibiting prostaglandin production in the colon.
Indications & dosage
Active mild to moderate distal ulcerative colitis, proctitis, or proctosigmoiditis--
Adults: 800 mg P.O. (tablets) t.i.d. for total dose of 2.4 g/day for 6 weeks; or 1 g P.O. (capsules) q.i.d. for total dose of 4 g up to 8 weeks; or 500 mg P.R. (suppository) b.i.d.; or 4 g as retention enema once daily (preferably h.s.). Rectal dosage form should be retained overnight (for about 8 hours). Usual course of therapy for rectal form is 3 to 6 weeks.
Adverse reactions
CNS: headache, dizziness, fatigue, malaise, asthenia, chills.
CV: chest pain.
GI: abdominal pain, cramps, discomfort, flatulence, diarrhea, rectal pain, bloating, nausea, pancolitis, vomiting, constipation, eructation.
Musculoskeletal: arthralgia, myalgia, back pain, hypertonia.
Respiratory: wheezing.
Skin: itching, rash, urticaria, hair loss.
Other: fever.
Interactions
Drug-drug. Lactulose: may impair release of delayed or extended-release products. Monitor closely.
Omeprazole: increased absorption of mesalamine. Monitor closely.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients with hypersensitivity to drug, its components, or salicylates.
Nursing considerations
Patient teaching
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING