Rowasa (Mesalamine Rectal Suspension Enema) Drug Information: Medication Guide and Patient Information

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May 27, 2012

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Ulcerative Colitis »

What is Ulcerative Colitis?

Ulcerative colitis is a chronic inflammation of the large intestine (colon). The colon is the part of the digestive system where waste material is stored. The rectum is the end of the colon adjacent to the anus. In patients with ulcerative colitis, ulcers and inflammation of the inner lining of the colon lead to symptoms of abdominal pain, diarrhea, and rectal bleeding.

Ulcerative colitis is closely related to another condition of inflammation of the intestines called Crohn's disease. Together, they are frequently referred to as inflammatory bowel disease (IBD). Ulcerative colitis and Crohn's diseases are chronic conditions that can last years to decades. They affect approximately 500,000 to 2 million people In the United States. Men and women are affected equally. They most commonly begin during adolescence and early adulthood, but they also can begin during childhood and later in life.

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PATIENT INFORMATION

How to Use this Medication.

Best results are achieved if the bowel is emptied immediately before the medication is given. NOTE: ROWASA® (mesalamine) Rectal Suspension Enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product.

Remove the Bottles
1. Remove the bottles from the protective foil pouch by tearing or by using scissors as shown, being careful not to squeeze or puncture bottles. ROWASA® (mesalamine) Rectal Suspension Enema is an off-white to tan colored suspension. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded.

How to Use this Medication - illustration 1

Prepare the Medication for Administration
1. Shake the bottle well to make sure that the medication is thoroughly mixed.
2. Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the medication to be discharged.

How to Use this Medication - illustration 2

Assume the Correct Body Position
1. Best results are obtained by lying on the left side with the left leg extended and the right leg flexed forward for balance.
2. An alternative to lying on the left side is the "knee-chest" position as shown here.
Administer theMedication
1. Gently insert the lubricated applicator tip into the rectum to prevent damage to the rectal wall, pointed slightly toward the navel.
2. Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back, squeeze slowly to instill the medication. Steady hand pressure will discharge most of the medication. After administering, withdraw and discard the bottle.
3. Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the medication all night, if possible.