MESALAMINE (Rectal)
Some commonly used brand names are:
In the U.S.?
In Canada?
Other commonly used names are 5-aminosalicylicacid, 5-ASA, and mesalamine.
Category
- Bowel disease (inflammatory) suppressant
Description
Mesalamine (me-SAL-a-meen) isused to treat inflammatory bowel disease, such as ulcerative colitis. Thismedicine works inside the bowel by helping to reduce inflammation and othersymptoms.
Mesalamine is available only with your doctor's prescription in the followingdosage forms:
Rectal- Enema (U.S. and Canada)
- Suppositories (U.S. and Canada)
Before Using This Medicine
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 followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to mesalamine, olsalazine, sulfasalazine, or salicylates(e.g., aspirin) or to any component of the suppository. Also tell your healthcare 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 problemsin animal studies. Before taking this medicine, make sure your doctor knowsif you are pregnant or if you may become pregnant.
Breast-feeding?It is not known whether mesalamine passes intothe 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 takingthis medicine and who wish to breast-feed should discuss this with their doctor.
Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of mesalaminein children with use in other age groups.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof mesalamine in the elderly with use in other age groups.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other medicines.
Other medical problems?The presence of other medicalproblems may affect the use of mesalamine. Make sure you tell your doctorif you have any other medical problems, especially:
- Kidney disease?The use of mesalamine may make this conditionworse
Proper Use of This Medicine
For bestresults, 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 carefullybefore using this medicine.
- Remove the bottles from the protective foil pouch, being carefulnot to squeeze or puncture them. The enema is an off-white to tan color. Contentsof the enemas removed from the foil pouch may darken with time. Slight darkeningwill not affect the potency of the contents. However, enemas with dark browncontents should be discarded.
- Shake the bottle well to make sure that the medication is thoroughlymixed. Remove the protective cover from the applicator tip. Hold bottle atthe neck so that no medicine spills out.
- Lie on your left side with your left leg straight and your rightknee bent in front of you for balance. You can also lie in the knee-chestposition, on your knees with your chest touching the bed.
- Gently insert the rectal tip of the enema applicator pointed slightlytoward your naval to prevent damage to the rectal wall. Tilt the nozzle slightlytoward 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 medicineto distribute thoroughly. Retain the medicine all night if possible.
For patients using the suppository form ofthis medicine:
- This medicine usually comes with patient directions. Read them carefullybefore using this medicine.
- Detach one suppository from strip of suppositories. Hold suppositoryupright and carefully remove the foil wrapper.
- Avoid excessive handling of the suppository, which is designed tomelt at body temperature.
- Insert suppository (pointed end first) completely into rectum withgentle pressure. Retain the suppository for 3 hours or longer, if possible,to achieve the best result.
Dosing?The dose of mesalamine may be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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, everynight 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 yourrectum, two or three times a day for three to six weeks or 1000 mg, insertedinto your rectum, one time a day at bedtime 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 itas soon as possible if you remember it that same night. However, if you donot remember it until the next morning, skip the missed dose and go back toyour 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. Donot 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 surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
It isimportant that your doctor check your progress at regular visits.
Contact your doctor if you develop cramping, acute abdominal pain, bloodydiarrhea, fever, headache or rash. These may be symptoms of a serious condition.
Tell your doctor right away if you experience chest pain or shortness ofbreath.
Check with your doctor if you notice rectal bleeding, blistering, pain,burning, itching, or other sign of irritation not present before you startedusing this medicine.
Mesalamine rectal enema may stain clothing, fabrics, painted surfaces,marble, granite, vinyl, or other surfaces it touches.
Side Effects of This Medicine
Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.
Stop using this medicineand check with your doctor immediately if any of the following sideeffects occur:
Less common or rare
Abdominal or stomach cramps or pain (severe); anxiety; back pain (severe); bloody, black, or tarry stools ; blue or pale skin; bright red blood in the stool; chest pain, possibly moving to the left arm, neck, or shoulder; chills; diarrhea (severe); fast heartbeat; fever; headache (severe); nausea or vomiting; shortness of breath; skin rash; stomach cramps, tenderness, pain; swelling of the stomach; unusual tirednessor weakness; watery or bloody diarrhea; yellow eyes or skin
Incidence not known
Blood in urine; change in frequencyof urination or amount of urine; cough; difficulty in breathing; drowsiness; high fever; increasedthirst; loss of appetite; lower back or side pain; painful or difficult urination; pale skin; sore throat; sores, ulcers, or white spots on lips or in mouth; swelling of feet or lower legs; swollen glands; troubled breathing; unexplained or unusual bleeding or bruising; weakness
Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if the following side effectscontinue or are bothersome:
Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.
Additional Information
Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,mesalamine may be used in patients who have had ulcerative colitis to preventthe condition from occurring again.
Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.
Revised: 04/20/2006
