Gastroenterology: Medications

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All About Pentasa ( mesalamine )

Many patients are not as well-informed about prescription medications as they ought to be. We believe that the more you know about your medications, the better. Therefore, we have written this to explain more about Pentasa and to explain the importance of taking it properly. If any of this information causes you concern or if you want additional information about your medicine and its use, please check with your doctor or pharmacist. Remember to keep all prescription drugs beyond the sight and reach of children when not in use. Store all drugs in their original labeled containers; the place of storage should be cool, dry, and away from light. Always read the label before each use.

What is Pentasa?
Doctors have been using the drug, Azulfidine, for over 50 years to treat inflammatory bowel disease. In some ways the Azulfidine molecule is half aspirin-like and half like the antibiotic sulfa. Some patients have an adverse reaction to Azulfidine, mostly due to its similarity to sulfa compounds. Scientists were able to remove the sulfa-like portion of Azulfidine, while maintaining the full beneficial effect. The result was meslamine, an aspirin-like antiinflammatory drug. Approved by the FDA in 1987, mesalamine comes in different formulations and delivery systems - one of which is named Pentasa.

Pentasa is a man-made compound that is taken by mouth to treat inflammatory disorders of the colon such as Crohn's disease, and other inflammatory conditions. It is sometimes given in conjunction with other medications such as the steroid, prednisone. Another common name for mesalamine is 5-aminosalicylic acid, or 5-ASA. Each capsule of Pentasa contains 400 mg of mesalamine. The shelf life is 3 years.

Targeted Delivery
One of the unique features of Pentasa is the fact that the pill does not release its medication until it reaches the diseased area. Each tablet has a special plastic coating which delays release of mesalamine until the tablets reach the end of the 20 feet of small intestine, or the ileum. This allows delivery of most of the medicine right where the problem lies - the ileum and right colon. How mesalamine works is unknown, but it appears to be topical rather than systemic. Once released in the colon, mesalamine is minimally absorbed. Most of it works directly on the lining of the ileum and colon - like putting a salve on a rash. Eventually most of it is excreted with the stool. Studies have shown that Pentasa can help bring a case of Crohn's under control and help maintain a remission over time. Realize that inflammatory bowel disease rarely goes into permanent remission, but the risk of flare-ups can be substantially reduced by continued use of Pentasa at the maintenance dose as directed by your doctor.

What Pentasa is not.
Pentasa is not a steroid like prednisone. It is not habit forming; it does not cause drowsiness. Since it lacks the sulfa-like properties of Azulfidine, most patients intolerant or allergic to Azulfidine and other sulfa drugs can be safely treated with Pentasa. In addition, Pentasa does not reduce a man's sperm count as does Azulfidine. There are no known interactions with other medications. As yet, there is no generic substitution available.

How does Pentasa differ from Asacol
Both Pentasa and Asacol are prescription forms of mesalamine. The difference between Asacol and Pentasa is in the outer chemical coating. Oral Pentasa has a unique formulation. The active ingredient is contained in coated microgranules, which enables a prolonged release of the active substance throughout the intestinal tract, from duodenum to the rectum. Therefore the Pentasa preparation is more useful for Crohn's patients who often have inflammation of the small intestine. The average small bowel transit time is approximately 3-4 hours in healthy volunteers.

Asacol is a delayed release enteric-coated tablets which generally releases the active ingredient only in the colon. While there are always clinical exceptions, Asacol is generally suitable for patients with colitis only (ulcerative colitis or Crohn's colitis), but not disease involving the small intestine.

Taking Pentasa properly
1. Swallow Pentasa tablets whole, taking care not to break the outer coating. It is important that you do not break or crush them. The outer coating is designed to remain intact, to protect the active ingredient until it reaches the end of the small intestine, where the tablet coating dissolves and the contents of the tablet are released directly into the ileum and colon. Pentasa is usually taken four times a day with food.

2. Take the dose as prescribed. There is no fixed rule for the correct dose of Pentasa. Each case is different, but the usual daily adult dose is 4 capsules taken all at once 4 times a day for a total of 16 capsules per day. Your doctor will determine what dose is best for you on the basis of your age, weight, the activity of your disease, and any other medical conditions that you may have. Do not alter the prescribed dosage on your own. Your doctor will routinely reassess the optimal dose for you. As the disease goes into remission, the dose is sometimes reduced to 4 tablets twice a day.

3. Do not skip doses. There is no harm in an occasional missed dose. If you do miss a dose, simply skip the missed dose and then go back to your regular dosing schedule. Do not intentionally double doses.

4. Do not stop taking this medication on your own. Typically, Pentasa is prescribed for long-term treatment of inflammatory bowel disease. Not only does Pentasa help reduce the symptoms of an acute attack, but it also helps to reduce the risk of future attacks. Stopping this medication may trigger another flare up of intestinal inflammation and make you ill. Only stop Pentasa under your doctor's supervision.

5. Patients may sometimes notice what looks like small beads or partially intact tablets in the stool, particularly during times of severe diarrhea. These are just the empty shells that are left after the medicine has been absorbed into the body.

What are the side effects?
All medicines - even those purchased without a prescription - may sometimes produce unwanted side effects. Millions of prescriptions have been written for Pentasa in the United States and Canada and it has been generally well tolerated. Adverse events seen in clinical trials with Pentasa tablets have generally been mild and reversible, and have seldom resulted in discontinuation of treatment.

These side effects should be reported to your doctor:


    * Persistent headaches
    * Skin rash, severe itching
    * Unexplained fever
    * Unusual bleeding or bruising
    * Unexplained skin blistering and peeling
The following side effects usually do not require medical attention. They often will go away as your body becomes used to the medication. However, if they continue or are bothersome, check with your doctor:


    * Mild Headache
    * Upset stomach, heartburn
    * Nausea and vomiting
    * Dizziness

Some patients may experience side effects not listed above. If you notice any other symptoms, simply consult your doctor, nurse, or pharmacist.

Limiting side effects
You can help limit side effects by taking Pentasa exactly as prescribed and by reporting any problems promptly to your doctor. Drink plenty of fluids.

Drug Interactions
There are no known drug interactions with any of the mesalamine products.

Do not take Pentasa if you are allergic to aspirin or have untreated peptic ulcer disease. Inform your doctor if you are pregnant, planning to become pregnant soon, or breast-feeding. Mesalamine has not been studied in pregnant women. However, mesalamine has not been shown to cause birth defects or other problems in animal studies. Mesalamine may pass into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Pentasa is a powerful drug that can be of tremendous benefit to you. As with all medications, however, side effects may occur. You can best limit problems with this medication by taking it exactly as prescribed. If you have any questions or concerns, please do not hesitate to discuss them with your doctor.

Text & Images Courtesy of Three Rivers Endoscopy Center
© Dr. Robert Fusco, Three Rivers Endoscopy Center, All Rights Reserved

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