Rowasa

Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine rectal is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Mesalamine rectal may also be used for other purposes not listed in this medication guide.

Rowasa is a prescription medication used to treat ulcerative colitis, proctitis (swelling in the rectum), and proctosigmoiditis (swelling in the rectum and sigmoid colon (last section of the colon). It helps relieve the symptoms of ulcerative colitis, proctitis, and proctosigmoiditis including diarrhea, rectal bleeding, and stomach pain. Rowasa belongs to a group of drugs called aminosalicylates. These work by stopping the body from producing a certain substance that may cause pain or inflammation in the colon.

Rowasa comes in a rectal suspension enema. It is usually instilled once a day, preferably at bedtime, and retained for approximately 8 hours.

This medication is also available in a sulfite free suspension for enema (SF Rowasa). 

Common side effects of Rowasa include stomach pain, headache, and gas.

Serious side effects have been reported with Rowasa including:

• Kidney problems. Tell your doctor if you take non-steroidal anti-inflammatory drugs or have kidney disease. Your doctor will check your kidney function with a simple blood test before you start using Rowasa.
• Rowasa may worsen ulcerative colitis. Tell your doctor if you experience the following symptoms:
  • cramping
  • acute abdominal pain
  • bloody diarrhea
  • fever
  • headache
  • rash
• Hypersensitivity reaction. An allergic reaction is possible with Rowasa. Tell your doctor if you are allergic to sulfasalazine (Azulfidine) or Rowasa. Serious reactions can lead to heart problems, like myocarditis or pericarditis.
• Liver failure is possible with Rowasa. Tell your doctor if you have liver disease.
• Upper GI tract obstruction. Pyloric stenosis or an obstruction in the digestive tract could prevent Rowasa from reaching the colon and treating ulcerative colitis.
• Pericarditis (inflammation of the lining around the heart). Tell your doctor if you experience symptoms of pericarditis including chest pain, rapid heartbeat, difficulty breathing, and fever. Your doctor may want to temporarily stop use of Rowasa.

Do not use Rowasa if you:

• have kidney disease
• are allergic to mesalamine or any ingredients in Rowasa
• are allergic to salicylates (including aspirin)

Tell your doctor if you are pregnant or plan to become pregnant.  

The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Rowasa falls into category B. Studies in animals have failed to demonstrate a risk to the unborn baby and there are no well-controlled studies in pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether the active ingredient of Rowasa or its metabolite(s) are excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

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

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.
• 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.

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 or proctitis:
  • 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.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Rowasa as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• You could be on both a tablet or capsule and a rectal product at the same time.
• Use enema rectally.
• Shake suspension well before use.
• Keep suspension in your rectum as long as you can.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain or heartburn.
• Headache.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Dizziness.
• Gas.
• Runny nose.
• Stuffy nose.
• Sore throat.
• Muscle or joint pain.
• Back pain.
• Upset stomach or throwing up.
• Feeling tired or weak.
• Rectal irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

There have been no documented reports of serious toxicity in man resulting from massive overdosing with mesalamine. Under ordinary circumstances, mesalamine absorption from the colon is limited.