Rowasa

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.

Rowasa is a prescription medication used to treat ulcerative colitis (UC), proctitis (swelling in the rectum), and proctosigmoiditis (swelling in the rectum and sigmoid colon (last section of the colon).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Alaven Pharmaceutical LLC

• Meda Pharmaceuticals, Inc.

• Solvay Pharmaceuticals, Inc.

Serious side effects have been reported with Rowasa. See “Rowasa Precautions” section.

Common side effects of Rowasa include:

• stomach pain
• Stomach cramps
• stomach discomfort
• headache
• gas
• nausea
• flu 

This is not a complete list of Rowasa side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines that can damage the kidneys, including non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and aspirin (Ecotrin)
• azathioprine (Imuran)
• 6-mercaptopurine (Purinethol)
• antacids such as Maalox, Mylanta, Mag-Ox, Caltrate, Tums, or Rolaids

Ask your doctor or pharmacist for more information.

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)

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Rowasa, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Rowasa, tell your doctor about all your medical conditions. Especially tell your doctor if you:

• have had an allergic reaction to sulfasalazine (Azulfidine), salicylates (such as aspirin), or Rowasa
• are taking nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil) and aspirin (Ecotrin) or other drugs that affect the kidneys
• are taking azathioprine (Imuran) or 6-mercaptopurine (Purinethol)
• have cramping, abdominal pain, bloody diarrhea, fevers, headaches, or rashes
• have a history of myocarditis or pericarditis
• have had inflamed pancreas (pancreatitis)
• are allergic to other things, such as foods, preservatives, or dyes
• have kidney, liver, or heart disease
• have a history of stomach blockage
• repeatedly see intact, partially intact, and/or capsule shells in the stool
• are pregnant or breastfeeding

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

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.

Use Rowasa exactly as prescribed. Do not change the dose or stop using Rowasa without talking to your doctor.

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). 

Rowasa is instilled once a day, preferably at bedtime, and retained for approximately 8 hours.

• For best results, empty your rectum (have a bowel movement) just before using the enema suspension.
• Shake the bottle well to make sure the suspension is well mixed. Remove the protective sheath from the applicator tip. The position most often used is obtained by lying on the left side; with the lower leg extended and the upper right leg flexed forward for balance. An alternative is the knee-chest position. The tip should be gently inserted in the rectum. A steady squeezing of the bottle will discharge most of the suspension. The preparation should be taken at bedtime with the objective of retaining it all night (or at least 8 hours).

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The usual dosage of Rowasa is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Rowasa at room temperature.
• Enema suspension: slight darkening of suspension will not affect quality of the medication. However, suspensions with dark brown solid contents should be discarded.
• Enema suspension can cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.
• Keep this and all medicines out of the reach of children.