In the U.S.—

In Canada—

Other commonly used names are 5-aminosalicylic acid; 5-ASA; mesalamine.

• Bowel disease (inflammatory) suppressant

Mesalamine (me-SAL-a-meen) is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine is available only with your doctor's prescription in the following dosage forms:

Rectal
• Enema (U.S. and Canada)
• Suppositories (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mesalamine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to mesalamine, olsalazine, sulfasalazine, or salicylates (e.g., aspirin). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Mesalamine has not been studied in pregnant women. However, mesalamine has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether mesalamine passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesalamine in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other medicines.

• Kidney disease—The use of mesalamine may make this condition worse

For best results, empty your bowel just before using the rectal enema or suppository.

Keep using this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.
• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.
• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.
• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.
• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.
• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.
• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.
• Avoid excessive handling of the suppository, which is designed to melt at body temperature.
• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

Dosing—

The dose of mesalamine may be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of mesalamine. If your dose is different, do not change it unless your doctor tells you to do so.

• For inflammatory bowel disease:
  • For enema dosage form:
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    • Children—Use and dose must be determined by your doctor.
  • For suppository dosage form:
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of mesalamine enema, use it as soon as possible if you remember it that same night. However, if you do not remember it until the next morning, skip the missed dose and go back to your regular dosing schedule. If you miss a dose of mesalamine suppository, use it as soon as possible unless it is almost time for your next dose. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat, humidity, and direct light.
• Keep the enema from freezing.
• Keep the suppositories at room temperature. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is important that your doctor check your progress at regular visits.

Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

Mesalamine rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop using this medicine and check with your doctor immediately if any of the following side effects occur:

• Rare
  • Abdominal or stomach cramps or pain (severe);  anxiety;  back pain (severe);  bloody diarrhea;  blue or pale skin;  chest pain, possibly moving to the left arm, neck, or shoulder ;  chills;  fast heartbeat ;  fever;  headache (severe) ;  nausea or vomiting;  shortness of breath;  skin rash;  swelling of the stomach;  unusual tiredness or weakness;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if the following side effects continue or are bothersome:

• More common
  • Abdominal or stomach cramps or pain (mild);  gas or flatulence;  headache (mild);  nausea 
  
  

• Less common or rare
  • Acne;  leg or joint pain;  loss of hair;  rectal pain or irritation  
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, mesalamine may be used in patients who have had ulcerative colitis to prevent the condition from occurring again.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.