Pronunciation:

me-SAL-a-meen

Brand Names:

• Apriso
• Asacol HD
• Delzicol
• Lialda
• Pentasa
• Asacol 800

Dosage Forms:

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

Classifications:

Therapeutic—

Anti-Inflammatory

Chemical—

Salicylate, Non-Aspirin

Uses of This Medicine:

Mesalamine is used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease). It works inside the bowels to reduce inflammation and other symptoms of the disease.

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

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 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Asacol® and Delzicol® for the treatment of ulcerative colitis in children 5 years of age and older. Safety and efficacy have not been established in children younger than 5 years of age and for the prevention of ulcerative colitis in children.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Lialda® for the treatment of ulcerative colitis in children 5 years of age and older weighing 24 kilograms (kg) or more. Safety and efficacy have not been established in children younger than 5 years of age, weighing less than 24 kg, or for the prevention of ulcerative colitis in children.

Appropriate studies have not been performed on the relationship of age to the effects of Apriso®, Asacol® HD, or Pentasa® in the pediatric population. Safety and efficacy have not been established.

Older adults—

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, liver, or heart disease, which may require caution and an adjustment in the dose for patients receiving mesalamine.

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.

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. 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.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Balsalazide
• Bismuth Subsalicylate
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Furosemide
• Ibuprofen
• Indomethacin
• Ketoprofen
• Levoketoconazole
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mercaptopurine
• Methotrexate
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olsalazine
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulfasalazine
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Trolamine Salicylate
• Valdecoxib
• Varicella Virus Vaccine, Live

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

Other interactions—

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.

• Allergy to sulfasalazine (Azulfidine®) or
• Skin problems (eg, atopic dermatitis, atopic eczema)—Use with caution. May cause side effects to become worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Heart disease or
• Liver disease—Use with caution. May make these conditions worse.

• Phenylketonuria (PKU)—The Apriso® capsules contain aspartame, which can make this condition worse and require caution in patients with PKU.

Proper Use of This Medicine:

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

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.

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

If you are taking the Asacol® delayed-release tablet:

• You may take this medicine with or without food.
• Drink extra fluids so you will urinate more often and help prevent kidney problems (eg, kidney stones).

Take the Asacol® HD tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

You should take the Lialda® tablets with food. All other brands of capsules and tablets can be taken with or without food.

If you have trouble swallowing the Delzicol® capsule, carefully open the capsule and take out the 4 tablets. Swallow the tablets whole and make sure all 4 are taken at the same time as one dose. Do not cut, break, crush, or chew them.

The contents of the Pentasa® capsule may be sprinkled onto soft foods (eg, applesauce or yogurt) if you have trouble swallowing the capsule. The mixture must be swallowed right away without chewing.

If you are taking the delayed-release capsule, extended-release capsule, or delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. Contact your doctor if this happens more often than 1 or 2 times.

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) 3 times a day.
    • 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 2400 mg per day, divided in 2 doses.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (delayed-release tablets):
    • Asacol®:
      • Adults—800 milligrams (mg) (two 400 mg tablets) 3 times a day for 6 weeks.
      • Children 5 years of age and older—Dose is based on body weight and must be determined by your doctor:
        • Weighing 54 to 90 kilograms (kg)—1200 mg (three 400 mg tablets) in the morning, then 1200 mg (three 400 mg tablets) in the afternoon for 6 weeks.
        • Weighing 33 to less than 54 kg—1200 mg (three 400 mg tablets) in the morning, then 800 mg (two 400 mg tablets) in the afternoon for 6 weeks.
        • Weighing 17 to less than 33 kg—800 mg (two 400 mg tablets) in the morning, then 400 mg (1 tablet) in the afternoon for 6 weeks.
      • Children younger than 5 years of age or weighing less than 17 kg—Use and dose must be determined by your doctor.
    • Asacol® HD:
      • Adults—1600 milligrams (mg) 3 times a day for 6 weeks.
      • Children—Use and dose must be determined by your doctor.
    • Lialda®:
      • Adults—2.4 to 4.8 grams (g) once a day.
      • Children 5 years of age and older—Dose is based on body weight and must be determined by your doctor:
        • Weighing more than 50 kilograms (kg)—4.8 grams (g) once a day for 8 weeks. Then 2.4 g once a day.
        • Weighing more than 35 to 50 kg—3.6 g once a day for 8 weeks. Then 2.4 g once a day.
        • Weighing 24 to 35 kg—2.4 g once a day for 8 weeks. Then 1.2 g once a day.
      • Children younger than 5 years of age or weighing less than 24 kg—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (extended-release capsules):
    • Adults—
      • For Apriso®: 1.5 grams (g) (four capsules) once a day as a single dose in the morning.
      • For Pentasa®: 1 g (four 250 milligrams [mg] capsules or two 500 mg capsules) 4 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) per day, taken in divided doses.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (Asacol® delayed-release tablets):
    • Adults—1600 milligrams (mg) (four 400 mg tablets) per day, taken in 2 to 4 divided doses.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (Lialda® delayed-release tablets):
    • Adults—2.4 grams (g) once 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—

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 and delayed-release tablets in a tightly-closed container to protect them from moisture.

Precautions While Using This Medicine:

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. Blood and urine tests may be needed to check for unwanted effects.

Asacol® delayed-release tablet and Pentasa® extended-release capsule may cause serious kidney problems, including kidney stones. Check with your doctor right away if you have lower back or side pain, decreased frequency or amount of urine, bloody urine, increased thirst, loss of appetite, nausea, vomiting, unusual tiredness or weakness, swelling of the face, fingers, or lower legs, weight gain, or trouble breathing.

Check with your doctor right away if you have 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.

Call your doctor right away if you have difficulty breathing or swallowing, a fast heartbeat, itching, rash, or skin redness, or swelling of the face, throat, or tongue. These may be symptoms of an allergic reaction to this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make you more sensitive to light and cause serious unwanted skin reaction. This is more likely if you have an existing skin problem (eg, atopic dermatitis, atopic eczema). Check with your doctor right away if you have increased sensitivity of the skin to sunlight, itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

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

Make sure any doctor or dentist who treats you knows that you are using mesalamine. This medicine may affect the results of certain medical tests.

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.

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.

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

More common

Bloody diarrhea

rectal bleeding

stomach pain

Less common

Bloody stools

bloody urine

blurred vision

chest tightness

chills

clay-colored stools

cough

dark urine

diarrhea

difficulty with breathing

dizziness

fever

full or bloated feeling

general feeling of discomfort or illness

headache

itching, skin rash

joint pain

loss of appetite

muscle aches and pains

nausea

nervousness

pain or tenderness around the eyes and cheekbones

pounding in the ears

pressure in the stomach

runny or stuffy nose

shivering

slow or fast heartbeat

sore throat

stomach cramps

sweating

swelling of the stomach area

trouble sleeping

unpleasant breath odor

unusual tiredness or weakness

vomiting

vomiting of blood

yellow eyes or skin

Rare

Anxiety

back pain

blue or pale skin

chest pain, possibly moving to the left arm, neck, or shoulder

Incidence not known

Black, tarry stools

blistering, peeling, or loosening of the skin

bloating

change in the ability to see colors, especially blue or yellow

chest discomfort

constipation

decreased frequency or amount of urine

dry cough

greatly increased frequency of urination or amount of urine

hives or welts

hoarseness

inability to move the arms and legs

increased thirst

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

lower back or side pain

muscle weakness, sudden and progressing

pain in the ankles or knees

painful or difficult urination

painful, red lumps under the skin, mostly on the legs

rapid breathing

red, irritated eyes

red skin lesions, often with a purple center

severe nausea or vomiting

sores, ulcers, or white spots in the mouth or on the lips

stomach tenderness

sudden numbness and weakness in the arms and legs

swelling of the feet or lower legs

swollen or painful glands

thickening of bronchial secretions

unusual bleeding or bruising

weight gain

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

Sneezing

Less common

Acne

belching

continuing ringing or buzzing or other unexplained noise in the ears

difficulty with moving

dizziness or lightheadedness

excess air or gas in the stomach or bowels

feeling of constant movement of self or surroundings

hair loss or thinning of the hair

hearing loss

heartburn

muscle stiffness

passing gas

sensation of spinning

stomach discomfort or upset

Incidence not known

Burning, numbness, tingling, or painful sensations

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

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.