Generic Name: mesalamine (Oral route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

  • Apriso
  • Asacol
  • Asacol HD
  • Delzicol
  • Lialda
  • Pentasa

In Canada

  • Asacol 800

Available Dosage Forms:

  • Capsule, Delayed Release
  • Tablet, Delayed Release
  • Tablet, Enteric Coated
  • Capsule, Extended Release
  • Tablet

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For Apriso

Mesalamine is used to treat and prevent an inflammatory bowel disease called ulcerative colitis. It works inside the intestines (bowel) to reduce the inflammation and other symptoms of the disease.

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

This medicine is available only with your doctor's prescription.

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 is used in certain patients with the following medical conditions:

  • Mild or moderate Crohn's disease—for treatment and to prevent it from occurring again.

Before Using Apriso

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Asacol® delayed-release tablets to treat mild to moderately active ulcerative colitis in children 5 years of age and older. However, safety and efficacy have not been established in children younger than 5 years of age, and for prevention of ulcerative colitis in children.

Appropriate studies have not been performed on the relationship of age to the effects of mesalamine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mesalamine in the elderly. However, elderly patients are more likely to have blood problems (eg, agranulocytosis, neutropenia, pancytopenia) and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving mesalamine.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Varicella Virus Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Tamarind
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

  • Allergy to aminosalicylates or salicylates (eg, aspirin)—Should not be used in patients with this condition.
  • Kidney disease, or history of—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease or
  • Myocarditis (heart disease), history of or
  • Pericarditis (heart disease), history of—Use with caution. May make these conditions worse.
  • Phenylketonuria (PKU)—The Apriso™ capsules contain aspartame, which may require caution in patients with PKU.
  • Pyloric stenosis (tube where food passes out of the stomach is too narrow) or
  • Stomach or bowel blockage—May delay the release of mesalamine into the body.

Proper Use of mesalamine

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Apriso. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without first checking with 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.

You should take the Lialda® delayed-release tablets with food. The delayed-release capsules should be taken at least 1 hour before or 2 hours after a meal. All other brands of capsules and tablets can be taken with or without food.

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

If you are taking the delayed-release capsule, extended-release capsule or the delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For the treatment of ulcerative colitis:
    • For long-acting oral dosage form (delayed-release capsules):
      • Adults—800 milligrams (mg) (two 400 mg capsules) three times a day.
      • 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) (two 400 mg tablets) three times a day.
        • For Asacol® HD: 1600 milligrams (mg) (two 800 mg tablets) three times a day for 6 weeks.
        • For Lialda®: 2.4 to 4.8 grams (two to four tablets) once a day as a single dose with food.
      • Children—
        • For Asacol®:
          • Children 5 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually not more than 1200 to 2400 mg per day, divided into two doses.
          • Children younger than 5 years of age—Use and dose must be determined by your doctor.
        • For Asacol® HD or Lialda®: Use and dose must be determined by your doctor.
    • For long-acting oral dosage form (extended-release capsules):
      • Adults—
        • For Apriso™: 1.5 grams (four capsules) once a day as a single dose in the morning.
        • For Pentasa®: 1 gram (two or four capsules) four times a day.
      • Children—Use and dose must be determined by your doctor.
  • For prevention of ulcerative colitis:
    • For long-acting oral dosage form (delayed-release capsules):
      • Adults—1600 milligrams (mg) (four 400 mg capsules) per day, taken in divided doses.
      • Children—Use and dose must be determined by your doctor.
    • For long-acting oral dosage form (delayed-release tablets):
      • Adults—
        • Asacol®: 1600 milligrams (mg) (four 400 mg tablets) per day, taken in divided doses.
        • Lialda®: 2.4 grams (two tablets) once a day as a single dose with food.
      • 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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the delayed-release capsules or delayed-release tablets in a tightly-closed container to protect them from moisture.

Precautions While Using Apriso

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Urine or blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Do not take antacids (eg, Amphojel®, Maalox®, Mylanta®, Tums®) while you are taking the Apriso™ extended-release capsules. Using these medicines together may change the amount of medicine that is released in the body.

Tell your doctor if you have had an allergic reaction to sulfasalazine (Azulfidine®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Apriso Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Abdominal or stomach pain (severe)
  • bloody diarrhea
  • rectal bleeding
Less common
  • Abdominal or stomach cramps (severe)
  • blurred vision
  • dizziness
  • fever
  • full or bloated feeling
  • headache (severe)
  • nervousness
  • pounding in the ears
  • pressure in the stomach
  • skin rash and itching
  • slow or fast heartbeat
  • swelling of the abdominal or stomach area
  • unusual tiredness or weakness
Rare
  • Anxiety
  • back pain (severe)
  • blue or pale skin
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • nausea or vomiting
  • shortness of breath
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Confusion
  • deep or fast breathing with dizziness
  • diarrhea (severe or continuing)
  • difficult or labored breathing
  • dizziness or lightheadedness
  • drowsiness (severe)
  • feeling of constant movement of self or surroundings
  • headache (severe or continuing)
  • hearing loss or ringing or buzzing in the ears (continuing)
  • nausea or vomiting (continuing)
  • numbness of the feet, hands, and around the mouth
  • seizures
  • sensation of spinning
  • sweating
  • tightness in the chest

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach cramps or pain (mild)
  • diarrhea (mild)
  • headache (mild)
  • runny or stuffy nose
  • sneezing
Less common
  • Acid or sour stomach
  • acne
  • back or joint pain
  • belching
  • difficulty with moving
  • excess air or gas in the stomach or intestines
  • hair loss or thinning of the hair
  • heartburn
  • indigestion
  • loss of appetite
  • muscle pain or stiffness
  • passing gas
  • stomach discomfort or upset

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

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

See also: Side effects (in more detail)

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