Mesalamine (Rectal route)
Uses of This Medicine:
Mesalamine is used to treat an inflammatory bowel disease, such as ulcerative colitis. Mesalamine suppositories are used to treat mild to moderate active ulcerative proctitis (inflammation of the rectum). It works inside the intestines (bowels) to reduce the inflammation and other symptoms of the disease.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, mesalamine is used in certain patients with the following medical condition:
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of mesalamine in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mesalamine in the elderly. However, elderly patients are more likely to have blood problems (eg, neutropenia, pancytopenia) and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving mesalamine.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine:
Use this medicine exactly as directed by your doctor. Do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.
For best results, empty your bowel just before using the rectal enema or suppository.
If you are using the enema:
If you are using the suppository:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
You may store the suppositories in the refrigerator, but do not freeze them.
Store the enema at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Precautions While Using This Medicine:
It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Urine or blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you have bloody urine, decreased amount of urine, lower back or side pain, swelling of the face, fingers, or lower legs, or unusual tiredness or weakness. These could be symptoms of kidney problems.
Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.
Tell your doctor right away if you experience chest pain or trouble breathing.
Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.
Mesalamine may stain clothing, fabrics, flooring, painted surfaces, marble, granite, vinyl, enamel, or other surfaces it touches.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 6/13/2013
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