Rowasa (mesalamine, sfRowasa) is an enema used in the treatment of inflammatory bowel disease including ulcerative colitis, proctosigmoiditis and proctitis. It is a liquid suspension for topical use that you instill into your rectum using a small bottle with an applicator tip.

Rowasa contains the drug mesalamine, which is also known as mesalazine or 5-aminosalicylic acid (5-ASA). It belongs to a class of drugs called aminosalicylates.

Rowasa is thought to work by blocking the enzyme cyclooxygenase (COX) and inhibiting prostaglandin production in the colon, which helps to reduce inflammation. COX and prostaglandins (a group of lipids) are both involved in generating an inflammatory response. Rowasa is thought to work locally to reduce inflammation in the epithelial cells that line the colon.

Rowasa was the first mesalamine product to be approved by the US Food and Drug Administration (FDA) for ulcerative colitis when it was approved in 1987.

Rowasa contains a sulfite called potassium metabisulfite, which some people are sensitive too, particularly people who have asthma or other atopic conditions. A sulfite-free Rowasa enema called sfRowasa is also available.

What is Rowasa used for?

Rowasa is a prescription medication used to treat active mild-to-moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

Rowasa is for rectal use only. Do not take Rowasa by mouth.

• Use Rowasa exactly as prescribed by your doctor.
• It is important for you to stay well hydrated during treatment with Rowasa. Be sure to drink plenty of fluids while taking Rowasa.
• The recommended dose of Rowasa is one bottle (4 grams) instilled once daily at bedtime for 3 to 6 weeks. Your doctor will tell you what dose is right for you.
• Empty your bowels before instilling Rowasa if possible.
• Remove the Rowasa bottles from their protective foil pouch by tearing the pouch or using scissors. Take care not to squeeze or puncture the bottles.
  • Rowasa suspension is an off-white to tan color. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect how Rowasa works, however, enemas with dark brown contents should be discarded.
• To prepare Rowasa
  • Shake the bottle well to make sure the suspension is thoroughly mixed.
  • Remove the protective sheath from the applicator tip. Hold the bottle at the neck the suspension does not come out.
• Position yourself in the correct body position to administer Rowasa.
  • Lie down on your left side with your left leg extended and your right leg flexed forward for balance.
  • Alternatively you can put both knees on the ground and fold the top half of your body over so that your head is on the ground, your knees are close to your chest and your bottom is in the air.
• Administer Rowasa
  • Gently insert the lubricated applicator tip into your rectum to prevent damage to the rectal wall. Point the applicator tip slightly towards your navel.
  • Grasp the bottle firmly, then tilt it slightly so that the nozzle is aimed towards your back. Squeeze the bottle slowly to instill the medication. Apply steady hand pressure to squeeze the medication out of the bottle.
• After administering, withdraw the applicator tip and attached bottle and discard.
• Remain in position for at least 30 minutes to allow Rowasa to spread internally. Retain the medication all night, if possible.

The recommended adult dosage of Rowasa in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. The usual course of therapy is from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings.

See full prescribing information for further information about Rowasa dosing.

Do not use Rowasa, including sfRowasa, if you are, or suspect you are, hypersensitive to salicylates, aminosalicylates, sulfites or any other component of this medication.

What should I tell my doctor before using Rowasa?

Before using Rowasa, tell your doctor if you have any medical conditions, including if you:

• have kidney problems
• have liver problems
• have a history of allergic reaction to the medicine sulfasalazine (Azulfidine)

If you miss a dose of Rowasa, instill it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Instill the next dose at your regular time. Do not insert 2 doses at the same time.

Rowasa can stain surfaces including fabrics, flooring, painted surfaces, marble, granite, vinyl and enamel. Keep Rowasa away from these surfaces to prevent staining.

If you have atopic dermatitis or eczema you may become more sensitive to the sun while using Rowasa. Avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.

Most side effects of Rowasa are mild and transient.

Side effects of Rowasa include:

• Abdominal pain, cramps or discomfort
• Headache
• Gas or flatulence
• Nausea
• Flu
• Tiredness, weakness, malaise or fatigue
• Fever
• Rash or spots
• A cold or sore throat
• Diarrhea
• Leg or joint pain
• Dizziness
• Bloating
• Back pain
• Pain on insertion of enema tip
• Hemorrhoids
• Itching
• Rectal pain
• Constipation
• Hair loss
• Peripheral edema
• Urinary tract infection or urinary burning
• Rectal pain soreness or burning
• Asthenia
• Insomnia

Products containing the active ingredient mesalamine have been reported to cause:

• Kidney problems, including kidney stones
• Acute intolerance syndrome and other allergic reactions
• Liver problems
• Severe skin reactions
• Sun sensitivity

These are not all of the possible side effects of Rowasa.

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

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Using Rowasa with certain other medicines may affect each other. Using Rowasa with other medicines can cause serious side effects.

Especially tell your doctor if you take nonsteroidal anti-inflammatory drugs (NSAIDS), or medicines that contain azathioprine or 6-mercaptopurine. Taking Rowasa with NSAIDS may cause kidney problems. Taking Rowasa with azathioprine or 6-mercaptopurine may cause blood problems. Ask your doctor if you are not sure if you are taking one of these medicines.

Your doctor may do certain tests during treatment with Rowasa.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.