Mesalamine Rectal Suspension

Mesalamine Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

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.

The usual dosage of Mesalamine Rectal Suspension Enema in 60 mL units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. While the effect of Mesalamine Rectal Suspension Enema may be seen within 3 to 21 days, the usual course of therapy would be from 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Studies available to date have not assessed if Mesalamine Rectal Suspension Enema will modify relapse rates after the 6-week, short-term treatment. Mesalamine Rectal Suspension Enema is for rectal use only.

Patients should be instructed to shake the bottle well to make sure the suspension is homogeneous. The patient should remove the protective sheath from the applicator tip. Holding the bottle at the neck will not cause any of the medication to be discharged. The position most often used is obtained by lying on the left side (to facilitate migration into the sigmoid colon); with the lower leg extended and the upper right leg flexed forward for balance. An alternative is the knee-chest position. The applicator tip should be gently inserted in the rectum pointing toward the umbilicus. A steady squeezing of the bottle will discharge most of the preparation. The preparation should be taken at bedtime with the objective of retaining it all night. Patient instructions are included with every seven units.

How to Use this Medication.

Best results are achieved if the bowel is emptied immediately before the medication is given.

NOTE: 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.

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. 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.

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.

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 sown here.

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 slighty 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.

Rx only
Ref CL5-066-00-0110         Rev. 01/10
5-066-00-0110

Franklin Pharmaceutical LLC
200 North Cobb Parkway, Bldg., 400, Suite 428
Marietta, GA 30062
For Medical Inquiries, Call Toll-Free:
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www.FranklinPharm.com

Mesalamine is available in these forms: extended-release oral tablet, extended-release oral capsule, rectal suppository, and enema.

Mesalamine is used treat ulcerative colitis (inflammation and sores that develop in your colon). It’s also used to manage or prevent symptoms of ulcerative colitis symptoms.

Mesalamine is available as the following brand-name drugs: Asacol, Asacol HD, Lialda, Apriso, Delzicol, Pentasa, Canasa, and Rowasa. It’s also available in its generic form for some formulations.

More common side effects of taking this drug include headache, nausea, stomach pain, diarrhea, and gas.

In some cases, mesalamine can cause serious side effects. These can include a reaction that worsens the symptoms of ulcerative colitis. Symptoms of this reaction can include cramping, stomach pain, and bloody diarrhea.

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What is mesalamine?

Mesalamine is a prescription drug. The enema form of this drug is available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.  

Mesalamine may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

Mesalamine is used treat ulcerative colitis (inflammation and sores that develop in your colon). It’s also used to manage or prevent symptoms of ulcerative colitis symptoms.

How it works

Mesalamine belongs to a class of drugs called anti-inflammatory agents. A class of drugs is a group of medications that work in a similar way.

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