mesalamine

Pronunciation

Generic Name: mesalamine (oral) (me SAL a meen)
Brand Name: Apriso, Asacol, Asacol HD, Delzicol, Lialda, Pentasa

What is mesalamine oral?

Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Mesalamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about mesalamine oral?

Mesalamine is used to treat ulcerative colitis, proctitis, and proctosigmoiditis.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

What should I discuss with my healthcare provider before taking mesalamine oral?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure mesalamine is safe for you, tell your doctor if you have:

  • a stomach condition called pyloric stenosis;

  • a history of allergy to sulfasalazine (Azulfidine);

  • heart disease;

  • kidney disease; or

  • liver disease.

FDA pregnancy category C. It is not known whether mesalamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Mesalamine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take mesalamine oral?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take mesalamine with a full glass of water.

Lialda should be taken with a meal.

Delzicol on an empty stomach, at least 1 hour before or 2 hours after a meal.

Other brands of mesalamine can be taken with or without food. Follow your doctor's instructions or the directions on your medicine label.

Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole.

The extended-release capsule is specially formulated to release the medicine after it has passed through your stomach into your intestines. Breaking the pill may cause the drug to be released too early in the digestive tract.

The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.

Call your doctor if you find undissolved tablets in your stool.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are taking mesalamine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking mesalamine oral?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Mesalamine oral side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using mesalamine and call your doctor at once if you have:

  • severe stomach pain, cramping, bloody diarrhea;

  • fever, headache, skin rash;

  • chest pain, shortness of breath;

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • little or no urinating;

  • swelling, rapid weight gain; or

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

  • mild stomach discomfort, gas, vomiting;

  • diarrhea, constipation;

  • flu symptoms, runny nose;

  • dizziness, weakness; or

  • back pain, joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Mesalamine dosing information

Usual Adult Dose for Ulcerative Colitis -- Active:

ORAL:
Asacol(R), Delzicol(TM): 800 mg orally 3 times a day
Asacol(R) HD: 1600 mg orally 3 times a day
Lialda(R): 2.4 to 4.8 g orally once a day
Pentasa(R): 1 g orally 4 times a day

Duration of therapy:
-Asacol(R), Asacol(R) HD, Delzicol(TM): 6 weeks
-Lialda(R), Pentasa(R): Up to 8 weeks in controlled trials

Comments:
-Asacol(R) HD: Safety and efficacy have not been established beyond 6 weeks.

Approved indications:
-Asacol(R), Delzicol(TM): For the treatment of mildly to moderately active ulcerative colitis
-Asacol(R) HD: For the treatment of moderately active ulcerative colitis
-Lialda(R): For the induction of remission of active mild to moderate ulcerative colitis
-Pentasa(R): For the induction of remission and for the treatment of mildly to moderately active ulcerative colitis

RECTAL:
Rectal suspension enema: 4 g rectally once a day at bedtime
Duration of therapy: Generally from 3 to 6 weeks, depending on symptoms and sigmoidoscopic findings; effect may be seen within 3 to 21 days

Comments:
-Best results are achieved if used soon after the bowel is emptied.
-Rectal suspension enemas should be retained for approximately 8 hours.

Approved indications: For the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis

Usual Adult Dose for Ulcerative Colitis -- Maintenance:

Apriso(R): 1.5 g orally once a day in the morning
Asacol(R), Delzicol(TM): 1.6 g orally per day in divided doses
Lialda(R): 2.4 g orally once a day
Pentasa(R): 1 g orally 4 times a day

Approved indication: For the maintenance of remission of ulcerative colitis; Pentasa(R) has not been explicitly approved for this indication.

Usual Adult Dose for Ulcerative Proctitis:

Rectal suppository: 1 g rectally once a day at bedtime
Duration of therapy: Generally from 3 to 6 weeks, depending on symptoms and sigmoidoscopic findings

Comments:
-Rectal suppositories should be retained for 1 to 3 hours or longer, if possible.
-Safety and efficacy have not been established beyond 6 weeks.

Approved indication: For the treatment of mild to moderately active ulcerative proctitis

Usual Pediatric Dose for Ulcerative Colitis -- Active:

Asacol(R):
5 years or older:
17 to less than 33 kg: 36 to 71 mg/kg/day orally in 2 divided doses
Maximum dose: 1.2 g/day

33 to less than 54 kg: 37 to 61 mg/kg/day orally in 2 divided doses
Maximum dose: 2 g/day

54 to 90 kg: 27 to 44 mg/kg/day orally in 2 divided doses
Maximum dose: 2.4 g/day

Duration of therapy: 6 weeks

Comments:
-Tablets should be swallowed whole without cutting, breaking, or chewing.

Approved indication: For the treatment of mildly to moderately active ulcerative colitis

What other drugs will affect mesalamine oral?

Other drugs may interact with mesalamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about mesalamine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.04. Revision Date: 2013-08-23, 1:05:43 PM.

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