Pronunciation:

me-SAL-a-meen

Brand Names:

• Canasa
• Rowasa
• sfRowasa
• Mesasal
• Pentasa
• Salofalk

Dosage Forms:

• Suppository
• Enema

Classifications:

Therapeutic—

Gastrointestinal Agent

Chemical—

Salicylate, Non-Aspirin

Uses of This Medicine:

Mesalamine is used to treat an inflammatory bowel disease, including ulcerative colitis. Mesalamine suppositories are used to treat mild to moderate active ulcerative proctitis (inflammation of the rectum). Mesalamineenema is used to treat active mild to moderate ulcerative colitis, proctitis or proctosigmoiditis (inflammation of the rectum and bowel). It works inside the intestines (bowels) to reduce the 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 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.

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) or
• Allergy to saturated vegetable fat—Should not be used in patients with these conditions.

• Allergy to sulfasalazine (Azulfidine®) or
• Heart disease or
• Liver disease or
• Skin problems (eg, atopic dermatitis, atopic eczema) or
• Stomach blockage—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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.

For best results, empty your bowel just before using the rectal enema or suppository.

If you are using the enema:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.
• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.
• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.
• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.
• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.
• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

If you are using the suppository:

• Never take rectal suppositories by mouth.
• Do not cut or break the suppository.
• Remove one suppository from the strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.
• Before inserting a suppository, go to the bathroom and empty your bladder and, if possible, have a bowel movement.
• This medicine will stain any surface it touches (eg, clothing, bedsheets, floors, countertops, etc.). To protect your clothing, consider wearing a sanitary napkin or adult undergarment such as Depend®. Protect your sheets by placing a waterproof pad on your bed. These pads, often called Chux® pads or underpads, are available from a medical supply store.
• Wash your hands with soap and water before and after using this medicine. Remove the foil or wrapper from the suppository before inserting it.
• Do not keep the suppository in your hand too long or it may begin to melt.
• To make the suppository easier to insert, you may use a lubricating gel such as K-Y® Jelly, but do not use petroleum jelly (Vaseline®).
• Insert suppository (pointed end first) completely into rectum with gentle pressure.
• The medicine needs to remain in your body for 1 to 3 hours or longer, depending on your doctor's advice. Try not to use the bathroom for at least that length of time after inserting the suppository.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.

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 ulcerative colitis, proctitis, or proctosigmoiditis:
  • For rectal dosage form (enema):
    • Adults—4 grams (1 unit) every night for 3 to 6 weeks.
    • Children—Use and dose must be determined by your doctor.
  • For rectal dosage form (suppository):
    • Adults—1000 milligrams (mg) inserted into your rectum once a day at bedtime for 3 to 6 weeks.
    • 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.

You may store the suppositories in the refrigerator, but do not freeze them.

Store the enema at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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 use it. Urine or blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have bloody urine, decreased amount of urine, lower back or side pain, nausea and vomiting, pain in the groin or genitals, sharp back pain just below the ribs, swelling of the face, fingers, or lower legs, or unusual tiredness or weakness. These could be symptoms of serious kidney problems, including kidney stones.

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 chest pain, 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 a serious 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, including liver failure.

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 if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

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.

Mesalamine may stain clothing, fabrics, flooring, painted surfaces, marble, granite, vinyl, enamel, or other surfaces it touches. Keep this medicine away from these surfaces to prevent staining.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

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

Back pain, severe

bladder pain

bloody, black, or tarry stools

bloody or cloudy urine

bright red blood in the stool

change in the frequency of urination or amount of urine

chills

cough

diarrhea, severe

difficult, burning, or painful urination

dizziness

fast heartbeat

fever

general feeling of discomfort or illness

headache, severe

increased sensitivity of the skin to sunlight

itching, skin rash

joint pain

loss of appetite

lower back or side pain

muscle aches and pains

nausea or vomiting

pain in the groin or genitals

redness or other discoloration of the skin

runny nose

severe sunburn

sharp back pain just below the ribs

shivering

sore throat

stomach cramps, tenderness, pain, or swelling

sweating

trouble sleeping

unusual tiredness or weakness

watery or bloody diarrhea

yellow eyes or skin

Less common

Anxiety

blue or pale skin

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

Incidence not known

Agitation

blistering, peeling, or loosening of the skin

chest discomfort

coma

confusion

dark-colored urine

decreased urine output

depression

difficulty with breathing

drowsiness

high fever

hostility

inability to move the arms and legs

increased thirst

irritability

lethargy

light-colored stools

muscle twitching

painful or difficult urination

pale skin

rapid weight gain

red, irritated eyes

red skin lesions often with a purple center

seizures

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

sudden numbness and weakness in the arms and legs

swelling of the face, hands, ankles, feet, or lower legs

swollen glands

trouble breathing

unexplained or unusual bleeding or bruising

weakness

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

Bloated or full feeling

constipation

excess air or gas in the stomach or bowels

gas or flatulence

headache, mild

passing gas

stomach cramps or pain, mild

Less common

Blemishes on the skin

diarrhea

dizziness

flushing, redness of the skin

hives or welts

leg pain

loss of hair

pimples

rectal pain or irritation

unusually warm skin

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.