Mesalamine (Oral)

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

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

It is important for your doctor to check your progress during regular visits. This helps your doctor see if the medicine is working well and decide if you should keep taking it. Blood and urine tests may be needed to check for unwanted effects.

Asacol® delayed-release tablet and Pentasa® extended-release capsule can cause serious kidney problems, including kidney stones. Contact your doctor immediately if you have lower back or side pain, decreased urination, 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.

Contact your doctor immediately if you experience stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while using this medicine. These may be signs of a condition called mesalamine-induced acute intolerance syndrome.

Call your doctor right away if you have trouble breathing or swallowing, a fast heartbeat, itching, rash, or skin redness, or swelling of the face, throat, or tongue. These may be signs 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). Contact your doctor immediately 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.

Contact 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 signs of a serious liver problem.

This medicine may make you more sensitive to light and cause serious unwanted skin reactions. This is more likely if you have an existing skin problem (for example, atopic dermatitis, atopic eczema). Contact your doctor immediately if you have increased sensitivity of the skin to sunlight, itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Use sunscreen when you are outside. Avoid sunlamps and tanning beds.

Do not take antacids (for example, Amphojel®, Maalox®, Mylanta®, Tums®) while using the Apriso® capsules. Using these medicines together may change how much medicine is released in the body.

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

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

In deciding to use a medicine, you and your doctor must weigh the risks of taking it against the benefits it provides. Consider the following for this medicine:

Allergies

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

Pediatric

Studies to date have not shown any specific problems in children 5 years of age and older that would limit the usefulness of Asacol® and Delzicol® for treating ulcerative colitis. Safety and effectiveness have not been established in children younger than 5 years of age or for preventing ulcerative colitis in children.

Studies have not shown any specific problems in children 5 years of age and older weighing 24 kilograms (kg) or more that would limit the usefulness of Lialda® for treating ulcerative colitis. Safety and effectiveness have not been established in children younger than 5 years of age, weighing less than 24 kg, or for preventing ulcerative colitis in children.

There have been no studies on how age affects the effects of Apriso®, Asacol® HD, or Pentasa® in children. Safety and effectiveness have not been established.

Geriatric

Studies performed so far have not shown any specific problems in elderly patients that would limit the usefulness of mesalamine. However, older adults are more likely to have blood issues (like agranulocytosis, neutropenia, pancytopenia) and age-related kidney, liver, or heart diseases, which may require caution and adjustments in the dose for patients taking mesalamine.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of an interaction. In these cases, your doctor may want to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take 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 increase the risk of certain side effects, but using both medicines may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Tamarind
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Allergy to aminosalicylates or salicylates (like aspirin)—Should not be used in patients with this condition.

• Allergy to sulfasalazine (Azulfidine®) or
• Skin problems (like atopic dermatitis, atopic eczema)—Use with caution. May worsen side effects.

• Kidney disease—Use with caution. Effects may be stronger due to slower removal of the medicine from the body.

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

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

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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.

In the U.S.

• Apriso
• Asacol HD
• Delzicol
• Lialda
• Pentasa

In Canada

• Asacol 800

Available Dosage Forms:

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

Therapeutic Class: Anti-Inflammatory

Chemical Class: Salicylate, Non-Aspirin

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.