Mesalamine

Mesalamine is a prescription medication used to treat ulcerative colitis, or inflammation of the lining of the colon. It helps relieve the symptoms of ulcerative colitis including diarrhea, rectal bleeding, and stomach pain. Mesalamine belongs to a group of drugs called aminosalicylates. These work by stopping the body from producing a certain substance that may cause pain or inflammation in the colon.

• Regular-release capsules: these are taken up to 4 times a day, with or without food
• Delayed-release capsules: these are taken up to 3 times a day, 1 hour before or 2 hours after a meal. These should be swallowed whole, not chewed, crushed, or split.
• Extended-release capsules: these are usually taken once a day in the morning, with or without food.
• Delayed-release tablets
  • The Lialda brand is to be taken once daily with food. Swallowed tablets whole (do not chew, crush, or split).
  • The Asacol and Asacol HD brands are taken 3 times a day, with or without food. Swallowed tablets whole (do not chew, crush, or split).

• Mesalamine rectal suspension enema is instilled once a day, preferably at bedtime, and retained for approximately 8 hours.
• Mesalamine rectal suppositories is instilled once a day at bedtime.

Common side effects of mesalamine include headache, gas, and stomach pain.

Oral:

Mesalamine is a prescription medication used to treat ulcerative colitis (UC). UC is a condition in which part or all of the lining of the colon (also known as the large intestine) is swollen or worn away. It is used to cause the disease to temporarily go away ("induce remission") and to keep it from coming back ("maintain remission").

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Topical:

Mesalamine is a prescription medication used to treat ulcerative colitis (UC). UC is a condition in which part or all of the lining of the colon is swollen or worn away. It also works inside your rectum (lower intestine) to help reduce bleeding, mucous and bloody diarrhea caused by inflammation (swelling and soreness) of the rectal area.

Mesalamine may be found in some form under the following brand names:

• Apriso

• Asacol

• Canasa

• Delzicol

• Fiv-asa

• Lialda

• Pentasa

• Rowasa

Oral/Topical:

Serious side effects have been reported with mesalamine. See “Mesalamine Precautions” section.

Common side effects of mesalamine include:

• headache
• flatulence
• abdominal pain
• diarrhea

Other less common side effects include:

• abnormal liver function tests
• hair loss
• itching
• upset stomach
• back pain
• rash
• joint pain
• fatigue
• hypertension

This is not a complete list of mesalamine side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines that can damage the kidneys, including non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and aspirin (Ecotrin)
• azathioprine (Imuran)
• 6-mercaptopurine (Purinethol)
• antacids such as Maalox, Mylanta, Mag-Ox, Caltrate, Tums, or Rolaids

This is not a complete list of mesalamine drug interactions.  Ask your doctor or pharmacist for more information.

Oral/Topical:

Serious side effects have been reported with mesalamine including:

• Kidney problems. Tell your doctor if you take non-steroidal anti-inflammatory drugs or have kidney disease. Your doctor will check your kidney function with a simple blood test before you start taking mesalamine.
• Mesalamine may worsen ulcerative colitis. Tell your doctor if you experience the following symptoms:
  • cramping
  • acute abdominal pain
  • bloody diarrhea
  • fever
  • headache
  • rash
• Hypersensitivity reaction. An allergic reaction is possible with mesalamine. Tell your doctor if you are allergic to sulfasalazine (Azulfidine) or mesalamine. Serious reactions can lead to heart problems, like myocarditis or pericarditis.
• Liver failure is possible with mesalamine. Tell your doctor if you have liver disease.
• Upper GI tract obstruction. Pyloric stenosis or an obstruction in the digestive tract could prevent mesalamine from reaching the colon and treating ulcerative colitis.
• Pericarditis (inflammation of the lining around the heart). Tell your doctor if you experience symtoms of pericarditis including chest pain, rapid heartbeat, difficulty breathing, and fever. Your doctor may want to temporarily stop use of mesalamine.

Do not take mesalamine if you:

• have kidney disease
• are allergic to mesalamine or any ingredients in mesalamine
• are allergic to salicylates (including aspirin)

Oral:

• Intact, partially intact, and/or capsule shells have been reported in the stool. Contact your doctor if this occurs repeatedly.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of mesalamine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking mesalamine, tell your doctor about all your medical conditions. Especially tell your doctor if you:

• have had an allergic reaction to sulfasalazine (Azulfidine), salicylates (such as aspirin), or mesalamine
• are taking nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil) and aspirin (Ecotrin) or other drugs that affect the kidneys
• are taking azathioprine (Imuran) or 6-mercaptopurine (Purinethol)
• have cramping, abdominal pain, bloody diarrhea, fevers, headaches, or rashes
• have a history of myocarditis or pericarditis
• have had inflamed pancreas (pancreatitis)
• are allergic to other things, such as foods, preservatives, or dyes
• have kidney, liver, or heart disease
• have a history of stomach blockage
• repeatedly see intact, partially intact, and/or capsule shells in the stool
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescriptions medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.  

The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Mesalamine falls into category B. Studies in animals have failed to demonstrate a risk to the unborn baby and there are no well-controlled studies in pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in mesalamine is excreted in human breast milk. The effect of mesalamine on the nursing infant is not known.

Take mesalamine exactly as prescribed. Do not change the dose or stop taking mesalamine without talking to your doctor.

Oral:

• Immediate-release capsules: these are usually take 4 times a day.
• Delayed-release capsules: these are taken up to 3 times a day, 1 hour before or 2 hours after a meal. These should be swallowed whole, not chewed, crushed, or split.
  • Two delayed-release capsules (800 mg for 2 capsules) are not equal in dose to one delayed-release tablet (800 mg per tablet)
• Extended-release capsules: these are usually taken once a day in the morning, with or without food.
  • If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of mesalamine at the same time.
• Delayed-release tablets
  • The Lialda brand is to be taken once daily with food. Swallowed tablets whole (do not chew, crush, or split).
  • The Asacol brand is taken 3 times a day, with or without food. Swallowed tablets whole (do not chew, crush, or split).

Topical:

• Mesalamine rectal suspension enema is instilled once a day, preferably at bedtime, and retained for approximately 8 hours.
  • For best results, empty your rectum (have a bowel movement) just before using the enema suspension.
  • Shake the bottle well to make sure the suspension is well mixed. Remove the protective sheath from the applicator tip. The position most often used is obtained by lying on the left side; with the lower leg extended and the upper right leg flexed forward for balance. An alternative is the knee-chest position. The tip should be gently inserted in the rectum. A steady squeezing of the bottle will discharge most of the suspension. The preparation should be taken at bedtime with the objective of retaining it all night (or at least 8 hours).
• Mesalamine rectal suppositories is instilled once a day at bedtime.
  • For best results, empty your rectum (have a bowel movement) just before using the suppository.
  • Detach one suppository from the strip of suppositories.
  • Hold the suppository upright and carefully peel open the plastic at the pre-cut line to take out the suppository.
  • Insert the suppository with the pointed end first completely into your rectum, using gentle pressure.
  • For best results, keep the suppository in your rectum for 3 hours or longer, if possible.
  • If you have trouble inserting the suppository, you may put a little bit of lubricating gel on the suppository.
  • Do not handle the suppository too much, since it may begin to melt from the heat from your hands and body.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Oral:

• Lialda (mesalamine delayed release tablets)
  • For induction of remission of active, mild to moderate ulcerative colitis, two to four 1.2 gram tablets taken once daily with food.
  • For maintenance of remission of ulcerative colitis, two 1.2 gram tablets taken once daily with food.
• Asacol (mesalamine delayed release tablets)
  • For the treatment of mildly to moderately active ulcerative colitis, the usual dosage in adults is two 400 mg tablets to be taken 3 times a day for a total daily dose of 2.4 grams.
• Asacol HD (mesalamine delayed release tablets)
  • The recommended dosage is two 800 mg tablets three times daily (4.8 grams/day) with or without food.
  • NOTE: one Asacol HD 800 mg tablet cannot be substituted for two Asacol delayed-release 400 mg tablets. 
• Delzicol (mesalamine delayed release capsules)
  • For the treatment of mildly to moderately active ulcerative colitis - 800 mg three times daily
  • For the maintenance of remission of ulcerative colitis - 1.6 g daily, in divided doses
• Apriso (mesalamine extended release capsules)
  •  4 capsules once daily (1.5 grams/day) in the morning with or without food
• Pentasa (mesalamine capsules)
  • The recommended dose for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis is 1 gram (4 Pentasa 250 mg capsules or 2 Pentasa 500 mg capsules) 4 times a day for a total daily dosage of 4 grams.

Topical:

• Rowasa and SF Rowasa (mesalamine rectal suspension enema)
  • The usual dosage is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours.
• Canasa (mesalamine suppository)
  • The dosage is one 1000 mg rectal suppository once daily at bedtime.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store mesalamine at room temperature.
• Protect delayed-release capsules from moisture.
  • Close the container tightly and to leave any desiccant pouches present in the bottle along with the capsules.
• Enema suspension: slight darkening of suspension will not affect quality of the medication. However, suspensions with dark brown solid contents should be discarded.
  • Enema suspension can cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.
• Rectal suppositories: these can cause stains on things it touches. Therefore keep it away from clothing and other fabrics, flooring, painted surfaces, marble, granite, plastics, andenamel. Be careful since the suppository may stain clothing.
• Keep this and all medicines out of the reach of children.