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Medication Written by Pharmacists Reviewed by Doctors

GENERIC NAME: mesalamine

BRAND NAMES: Pentasa; Rowasa; Asacol

DRUG CLASS AND MECHANISM: Mesalamine is a derivative of salicylic acid and is thought to be the active component of sulfasalazine (Azulfidine), a combination of a sulfa drug and salicylic acid. Mesalamine works as an antiinflammatory agent in treating ulcerative colitis and Crohn's disease. Its benefit is believed to be due to a topical effect on the inflamed bowel. Following rectal administration of mesalamine (by enema or suppository), only 15% of a dose is absorbed. Following oral administration, 28% of a dose is absorbed. Mesalamine was approved by the FDA in December 1987.

PRESCRIPTION: yes

GENERIC AVAILABLE: no

PREPARATIONS: sustained-action gelatin capsules (Pentasa) containing 250mg; enteric coated tablets containing 400mg; rectal enema (Rowasa) containing 4 grams per 60 mL enema; rectal suppositories (Rowasa) containing 500mg.

STORAGE: The tablets, capsules, and enemas should be kept at room temperature, 15-30°C (59-86°F). The suppositories should be stored between 19-26°C (66-79°F).

PRESCRIBED FOR: Mesalamine is used for the treatment of mild to moderately severe colitis. The suppositories are limited to use in proctitis, the enemas to distal colitis (colitis involving only the part of the colon close to the rectum) or proctitis.

DOSING: The enema is inserted rectally, generally once daily at bedtime. It should be retained for at least 8 hours. The bottle should be shaken well prior to use. The protective sheath must be removed. Many physicians recommend that the patient lie on his/her left side with the lower leg extended and the upper (right) leg flexed forward for balance for ease of administration.

The suppositories are often given twice daily; each should be retained for 1 to 3 hours or longer.

The 400mg delayed release (enteric-coated) tablets (Asacol) are generally taken 3 times a day. The sustained-action capsules (Pentasa) are generally taken 4 times a day during the acute phase, in order to induce remission.

While the benefits of mesalamine can be seen within 3 to 21 days of starting therapy, it may take up to 3 to 6 weeks for the enemas and suppositories, 6 weeks for the tablets, and 8 weeks for the capsules to have maximum effect.

DRUG INTERACTIONS: There are no known drug interactions with any of the mesalamine products.

PREGNANCY: There are no adequate studies of mesalamine in pregnant women; however, studies in animals suggest no important effects on the fetus. Therefore, mesalamine may be used in pregnancy if the physician feels that it is necessary. It also should be noted that there is no effect of mesalamine on sperm count as there is with sulfasalazine (Azulfidine).

NURSING MOTHERS: Mesalamine is excreted in small amounts in breast milk. No side effects have been reported in nursing infants whose mothers have taken mesalamine. Since the possibility of side effects always exists, physicians must weigh the potential risks of mesalamine on the infant against the benefits for the mother.

SIDE EFFECTS: Mesalamine is usually well-tolerated. Adverse effects that have been reported in large studies include: headache, abdominal pain, diarrhea, nausea, and dizziness. None of these effects, however, were reported more frequently with mesalamine than with placebo. Infrequently, patients may be intolerant of mesalamine, experiencing cramping, abdominal pain, bloody diarrhea, and sometimes fever or rash. In such cases, the medication is stopped. Mesalamine enemas contain sulfites and should be avoided in persons who are sensitive to sulfites.


Last Editorial Review: 12/31/1997





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