Also found in: Dictionary, Wikipedia.
Related to Asacol: Asacol HD

mesalamine (5-aminosalicylic acid, 5-ASA, mesalazine, mesalazine (UK))

Apriso, Asacol, Asacol HD, Canasa, Ipocol (UK), Lialda, Mesasal (CA), Mesren (UK), Mezavant (CA), Novo-5-ASA-Ect (CA), Pentasa, Rowasa, Salofalk (CA) (UK)

Pharmacologic class: 5-amino-2-hydroxybenzoic acid

Therapeutic class: GI anti-inflammatory drug

Pregnancy risk category B


Unknown. Thought to act in colon, where it blocks cyclooxygenase and inhibits prostaglandin synthesis.


Capsules (extended-release): 250 mg, 500 mg, 0.375 g (Apriso)

Rectal suspension: 4 g/60 ml

Suppositories: 1,000 mg

Tablets (delayed-release): 400 mg (Pentasa), 800 mg (Asacol HD), 1.2 g (Lialda)

Indications and dosages

Active ulcerative colitis

Adults: 800 mg P.O. (Asacol delayed-release tablets) t.i.d. for 6 weeks

To induce remission in mildly to moderately active ulcerative colitis

Adults: 1 g P.O. (Pentasa extended-release capsules) q.i.d. for a total dosage of 4 g daily for up to 8 weeks. Or, two to four 1.2 g (Lialda) extended-release tablets P.O. once daily for total daily dose of 2.4 or 4.8 g for up to 8 weeks.

Active distal ulcerative colitis, proctosigmoiditis, or proctitis

Adults: 4-g enema (Rowasa 60 ml) P.R. daily at bedtime, retained for 8 hours. Continue for 3 to 6 weeks.

Active ulcerative proctitis

Adults: 500 mg (Canasa suppository) P.R. b.i.d., increased to t.i.d. if response inadequate after 2 weeks. Or 1,000 mg (suppository) P.R. at bedtime, continued for 3 to 6 weeks.

To maintain remission of ulcerative colitis

Adults: 1.6 g (Asacol) P.O. daily in divided doses. Or, 1.5 g (Apriso) P.O. daily in the morning.


• Hypersensitivity to drug, its components, or salicylates


Use cautiously in:
• severe hepatic or renal impairment
• allergy to sulfasalazine
• pyloric stenosis (delayed-release tablets)
• conditions predisposing to development of myocarditis or pericarditis
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).


• Give Apriso capsules with or without food. Don't give concurrently with antacids.
• Give Lialda tablets with meal.
• Make sure patient swallows tablets whole without crushing or chewing.
• For best effect, have patient retain suppository for 1 to 3 hours.

Adverse reactions

CNS: headache, dizziness, malaise, weakness

CV: chest pain, mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis)

EENT: rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, eructation, flatulence, anal irritation (with rectal use), pancreatitis

GU: interstitial nephritis, renal failure

Musculoskeletal: back pain

Skin: alopecia, rash

Other: fever, acute intolerance syndrome, anaphylaxis, acute intolerance syndrome


Drug-drug.Antacids: increased risk of dissolution of coating of Apriso granules

Azathioprine, 6-mercaptopurine: increased potential for blood disorders

Nephrotoxic drugs (including nonsteroidal anti-inflammatory agents): increased risk of renal adverse reactions

Patient monitoring

Monitor carefully for mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis).

Closely monitor patients with history of allergic reactions to sulfasalazine or sulfite sensitivity (if using enema).
• Assess kidney and liver function before and periodically during therapy.
• Monitor for suppository efficacy, which should appear in 3 to 21 days. However, know that treatment usually continues for 3 to 6 weeks.

Watch for signs and symptoms of intolerance syndrome, such as cramping, acute abdominal pain, bloody diarrhea, fever, headache, and rash. If these occur, discontinue drug and notify prescriber.

Watch for signs and symptoms of intolerance syndrome, such as cramping, acute abdominal pain, bloody diarrhea, fever, headache, and rash. If these occur, discontinue drug. Drug may be restarted later only if clearly needed, under close medical supervision and at reduced dosage.

Patient teaching

• Instruct patient to swallow tablets or capsules whole.
• Tell patient to contact prescriber if partially intact tablets repeatedly appear in stools.
• Advise patient using suppository to avoid excessive handling and to retain suppository for 1 to 3 hours or longer for maximum benefit.
• Teach patient about proper enema administration. Tell him to stay in position for at least 30 minutes and, if possible, retain medication overnight.

Advise patient to immediately report breathing difficulties, allergic symptoms, cramping, acute abdominal pain, bloody diarrhea, fever, headache, or rash.
• As appropriate, review all other significant and life-threatening adverse reactions, especially those related to the drugs mentioned above.


A trademark for the drug mesalamine.


A delayed-release anti-inflammatory salicylate developed for delivery to synovial tissue in arthritics; it is used to maintain remission in Crohn’s disease, and to treat ulcerative colitis. Mesalamine’s anti-inflammatory activity in the intestine is similar to (and better tolerated than) sulfasalazine, but it is more expensive.


Mesalamine, see there.


A brand name for MESALAZINE.
References in periodicals archive ?
Asacol was exclusively licensed in 2004 from Tillotts Pharma AG in Switzerland to Zeria, and the clinical Phase III trials are underway.
If Zydus does not gain FDA approval of its generic Asacol HD by 1 July 2016, Zydus will be permitted to launch an authorised generic version of Actavis product starting on 1 July 2016.
In contrast, Asacol showed only a nonsignificant trend to be better than placebo.
In this article we report on medications as a potential source of exposure to DBP in a man who took Asacol [active ingredient mesalamine (mesalazine)] for the treatment of ulcerative colitis.
In September 1997 I found an herbal combination for my problem and began taking it along with Asacol.
The reference arms using Entocort EC in the European study and Asacol in the U.
Our study forecasts individual revenues of 17 prominent agents for those colonic disorders, including these agents: -- Humira (adalimumab) -- Remicade (infliximab) -- Asacol (mesalazine) -- Lialda (mesalamine) -- Tysabri (natalizumab) -- Cimzia (certolizumab pegol).
If approved, the new 800-mg mesalamine tablet (marketed as Asacol by Procter & Gamble Pharmaceuticals, which sponsored this study), will offer patients a more convenient option and could reduce the need for steroid treatment, Dr.
Safety data from the open-label UCERIS 9 mg clinical study indicated that overall frequencies of treatment emergent adverse events occurred to a similar extent regardless of which prior treatment group (UCERIS 9 mg, UCERIS 6 mg, Asacol 2400 mg, or placebo) the patient was in during the previous eight week pivotal Phase III clinical study.
8g of Asacol per day was well tolerated and demonstrated an encouraging response.
Three randomized controlled trials confirm that high-dose mesalamine--Pentasa at 4 g/day or Asacol at 3.