Mesalamine (Oral route)

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

Classifications:

Therapeutic—

Anti-Inflammatory

Chemical—

Salicylate, Non-Aspirin

Uses of This Medicine:

Mesalamine is used to treat and prevent 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 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 have not been performed on the relationship of age to the effects of Apriso®, Asacol® HD, Lialda®, 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 and age-related kidney 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
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Magnesium Salicylate
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mercaptopurine
  • 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 sulfasalazine (Apriso®, 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.
  • Liver disease—Use with caution. May make this condition 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.

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):
      • Adults—
        • For Asacol® HD: 1600 milligrams (mg) 3 times a day for 6 weeks.
        • For Lialda®: 2.4 to 4.8 grams (g) once a day.
      • Children—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 (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.

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.

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.

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.

Pentasa® extended-release capsules 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 Pentasa® extended-release capsules. 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 (severe)
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 (severe)
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 (severe)
stomach pain sweating
swelling of the abdominal or stomach area
trouble sleeping
unpleasant breath odor
unusual tiredness or weakness
vomiting
vomiting of blood
yellow eyes or skin
Rare
Anxiety
back pain (severe)
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 pain or discomfort
constipation
continuing stomach pain
decreased frequency or amount of urine
dry cough
greatly increased frequency of urination or amount of urine
headache
hives or welts
hoarseness
inability to move the arms and legs
increased blood pressure
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
pains in the stomach, side, or abdomen, possibly radiating to the back
rapid breathing
red skin lesions, often with a purple center
red, irritated eyes
severe nausea or vomiting
sore throat
sores, ulcers, or white spots in the mouth or on the lips
stomach pain or 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
vomiting of blood or material that looks like coffee grounds
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
Diarrhea (mild)
sneezing
Less common
Acne
back pain
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.


Last Updated: 12/6/2019

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.

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