SfRowasa

Generic Name: mesalamine (Rectal route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

• Canasa


• Rowasa


• sfRowasa

In Canada

• Mesasal


• Pentasa


• Salofalk

Available Dosage Forms:

• Suppository


• Enema

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For sfRowasa

Mesalamine is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine 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:

• Ulcerative colitis, history of—prevent it from occurring again

Before Using sfRowasa

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:

Allergies

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.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesalamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with Medicines

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.

• Varicella Virus Vaccine

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.

• Ardeparin


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Nadroparin


• Parnaparin


• Reviparin


• Tamarind


• Tinzaparin


• Warfarin

Interactions with Food/Tobacco/Alcohol

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:

• Kidney disease—The use of mesalamine may make this condition worse.

Proper Use of mesalamine

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to sfRowasa. Please read with care.

For best results, empty your bowel just before using the rectal enema or suppository.

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 patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.


• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.


• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.


• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.


• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.


• Avoid excessive handling of the suppository, which is designed to melt at body temperature.


• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

Dosing

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.

• For inflammatory bowel disease:
  
  • For enema dosage form:
    
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For suppository dosage form:
    
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks or 1000 mg, inserted into your rectum, one time a day at bedtime for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using sfRowasa

It is important that your doctor check your progress at regular visits.

Contact your doctor if you develop cramping, acute abdominal pain, bloody diarrhea, fever, headache or rash. These may be symptoms of a serious condition.

Tell your doctor right away if you experience chest pain or shortness of breath.

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 rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

sfRowasa Side Effects

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 as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach cramps or pain (severe)


• anxiety


• back pain (severe)


• bloody, black, or tarry stools


• blue or pale skin


• bright red blood in the stool


• chest pain, possibly moving to the left arm, neck, or shoulder


• chills


• diarrhea (severe)


• fast heartbeat


• fever


• headache (severe)


• nausea or vomiting


• shortness of breath


• skin rash


• stomach cramps, tenderness, pain


• swelling of the stomach


• unusual tiredness or weakness


• watery or bloody diarrhea


• yellow eyes or skin

Incidence not known

• Blood in urine


• change in frequency of urination or amount of urine


• cough


• difficulty in breathing


• drowsiness


• high fever


• increased thirst


• loss of appetite


• lower back or side pain


• painful or difficult urination


• pale skin


• sore throat


• sores, ulcers, or white spots on lips or in mouth


• swelling of feet or lower legs


• swollen glands


• troubled breathing


• unexplained or unusual bleeding or bruising


• weakness

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:

More common

• Abdominal or stomach cramps or pain (mild)


• gas or flatulence


• headache (mild)


• nausea

Less common or rare

• Acne


• diarrhea


• dizziness


• leg or joint pain


• loss of hair


• rectal pain or irritation

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.

See also: sfRowasa side effects (in more detail)

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More sfRowasa resources

• SfRowasa Side Effects (in more detail)
• SfRowasa Use in Pregnancy & Breastfeeding
• SfRowasa Drug Interactions
• SfRowasa Support Group
• 88 Reviews for SfRowasa - Add your own review/rating

• sfRowasa Prescribing Information (FDA)


• Mesalamine Monograph (AHFS DI)


• Mesalamine Prescribing Information (FDA)


• Mesalamine Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Apriso Prescribing Information (FDA)


• Apriso Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Apriso Consumer Overview


• Asacol Prescribing Information (FDA)


• Asacol Consumer Overview


• Asacol Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Asacol HD Prescribing Information (FDA)


• Asacol HD Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Canasa Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)


• Canasa Prescribing Information (FDA)


• Lialda Prescribing Information (FDA)


• Lialda Consumer Overview


• Pentasa Prescribing Information (FDA)


• Pentasa Consumer Overview


• Rowasa Enema MedFacts Consumer Leaflet (Wolters Kluwer)


• Rowasa Prescribing Information (FDA)

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