Rowasa

DRUG DESCRIPTION

The active ingredient in ROWASAź (mesalamine) Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid.

The empirical formula is C7H7N03, representing a molecular weight of 153.14. The structural formula is:

ROWASA (mesalamine) structural formula illustration

Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.

What are the possible side effects of mesalamine rectal (Canasa, Canasa Pac, Rowasa)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using mesalamine rectal and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • rectal pain, constipation;
  • ...

Read All Potential Side Effects and See Pictures of Rowasa »

What are the precautions when taking mesalamine rectal suspension enema (Rowasa)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications that are broken down into mesalamine (such as sulfasalazine, olsalazine); or to other salicylates (such as aspirin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, kidney problems, pancreas problems (pancreatitis), inflammation of the sac around the heart (pericarditis).

This medication may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for...

Read All Potential Precautions of Rowasa »


Rowasa Consumer (continued)

SIDE EFFECTS: Rectal pain, pain while inserting the bottle tip, gas, and joint/leg pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor immediately if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, severe/prolonged headache.

Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain, trouble breathing, severe stomach/abdominal pain (especially if spreading to the back), change in the amount of urine, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other medications that are broken down into mesalamine (such as sulfasalazine, olsalazine); or to other salicylates (such as aspirin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, kidney problems, pancreas problems (pancreatitis), inflammation of the sac around the heart (pericarditis).

This medication may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this drug, especially the effects on the kidneys and decreased blood cell counts.

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (such as varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.


Rowasa Patient Information Including Side Effects

Brand Names: Canasa, Canasa Pac, Rowasa

Generic Name: mesalamine (rectal) (Pronunciation: me SAL a meen)

  • What is mesalamine rectal (Rowasa)?
  • What are the possible side effects of mesalamine rectal (Rowasa)?
  • What is the most important information I should know about mesalamine rectal (Rowasa)?
  • What should I discuss with my health care provider before taking mesalamine rectal (Rowasa)?
  • How should I use mesalamine rectal (Rowasa)?
  • What happens if I miss a dose (Rowasa)?
  • What happens if I overdose (Rowasa)?
  • What should I avoid while taking mesalamine rectal (Rowasa)?
  • What other drugs will affect mesalamine rectal (Rowasa)?
  • Where can I get more information?

What is mesalamine rectal (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.

What are the possible side effects of mesalamine rectal (Rowasa)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using mesalamine rectal and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • rectal pain, constipation;
  • headache or dizziness;
  • tired feeling; or
  • skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mesalamine rectal (Rowasa)?

Do not take mesalamine rectal by mouth. It is for use only in your rectum.

Tell your doctor if you have any type of kidney or liver disease, or if you are allergic to aspirin. You may not be able to use mesalamine, or you may need a dosage adjustment or special tests during treatment.

This medication comes with patient instructions for using either the rectal suppository or the rectal enema. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Try to empty your bowel and bladder just before using the mesalamine suppository or enema. Try to use the medicine at a time when you can lie down afterward and hold the medicine in. Avoid using the bathroom during this time. It may be best to use this medicine at bedtime.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Shake the rectal enema liquid well just before each use.

The rectal enema liquid may darken in color after it has been removed from the foil pouch. This should not affect the medicine. However, throw away any enema liquid that has turned dark brown.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Avoid getting the rectal suppositories or enema liquid on clothing, flooring, painted surfaces, vinyl, marble, granite, and other surfaces. Mesalamine rectal products may stain surfaces.

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