Salofalk

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MESALAMINE (Oral)

Some commonly used brand names are:

In the U.S.—

  • Asacol
  • Pentasa

In Canada—

  • Asacol
  • Mesasal
  • Pentasa
  • Salofalk

Other commonly used names are: 5-aminosalicylic acid , 5-ASA , and mesalazine .

Category

  • Bowel disease (inflammatory) suppressant

Description

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

Mesalamine is available only with your doctor"s prescription. It is available in the following dosage forms:

  • Oral
  • Extended-release capsules (U.S. and Canada)
  • Delayed-release tablets (U.S. and Canada)
  • Extended-release tablets (Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking 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 any salicylates (for example, 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—Mesalamine may pass into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

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 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 using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of mesalamine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease—The use of mesalamine may cause further damage to the kidneys
  • Narrowing of the tube where food passes out of the stomach—May delay release of mesalamine into the body

Proper Use of This Medicine

Swallow the capsule or tablet whole. Do not break, crush, or chew it before swallowing.

Take this medicine before meals and at bedtime with a full glass (8 ounces) of water, unless otherwise directed by your doctor.

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

Do not change to another brand without checking with your doctor . The doses are different for different brands. If you refill your medicine and it looks different, check with your pharmacist.

Dosing—The dose of mesalamine will 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.

The number of capsules or tablets that you take depends on the brand and strength of the medicine.

  • For inflammatory bowel disease:
    • For long-acting oral dosage form (extended-release capsules or tablets):
      • Adults—1 gram four times a day for up to eight weeks.
      • Children—Use and dose must be determined by your doctor.
    • For long-acting oral dosage form (delayed-release tablets):
      • Adults—
        • For Asacol : 800 milligrams (mg) three times a day for six weeks. For maintenance treatment of ulcerative colitis, 1600 mg a day, divided into smaller doses that are taken at separate times.
        • For Mesasal : A total of 1.5 to 3 grams a day, divided into smaller doses that are taken at separate times.
        • For Salofalk : 1 gram three or four times a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Keep the medicine from freezing. 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.

Precautions While Using This Medicine

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

For patients taking the capsule form of this medicine:

  • You may sometimes notice what looks like small beads in your stool. These are just the empty shells that are left after the medicine has been absorbed into your body.

For patients taking the tablet form of this medicine:

  • You may sometimes notice what looks like a tablet in your stool. This is just the empty shell that is left after the medicine has been absorbed into your body.

Side Effects of This Medicine

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

Less common

Abdominal or stomach cramps or pain (severe); bloody diarrhea; fever; headache (severe); skin rash and itching

Rare

Anxiety; back or stomach pain (severe); blue or pale skin; chest pain, possibly moving to the left arm, neck, or shoulder; chills; fast heartbeat; nausea or vomiting; shortness of breath; swelling of the stomach; unusual tiredness or weakness; yellow eyes or skin

Symptoms of overdose

Confusion; diarrhea (severe or continuing); dizziness or lightheadedness; drowsiness (severe); fast or deep breathing; headache (severe or continuing); hearing loss or ringing or buzzing in ears (continuing); nausea or vomiting (continuing)

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 any of the following side effects continue or are bothersome:

More common

Abdominal or stomach cramps or pain (mild); diarrhea (mild); dizziness; headache (mild); runny or stuffy nose or sneezing

Less common

Acne; back or joint pain; gas or flatulence; indigestion; loss of appetite; loss of hair

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

Additional Information

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 to treat mild or moderate Crohn"s disease and help prevent it from occurring again.

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

Developed: 03/17/1995
Revised: 08/14/1998

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