Generic Name: sulfasalazine (Oral route, Rectal route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Gastrointestinal Agent
Chemical Class: Sulfonamide
Sulfasalazine , a sulfa medicine, is used to prevent and treat inflammatory bowel disease, such as ulcerative colitis. It works inside the bowel by helping to reduce the inflammation and other symptoms of the disease. Sulfasalazine is sometimes given with other medicines to treat inflammatory bowel disease.
Sulfasalazine is also used to treat rheumatoid arthritis in patients who have not been helped by or who cannot tolerate other medicines for rheumatoid arthritis.
Sulfasalazine 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 these uses are not included in product labeling, sulfasalazine is used in certain patients with the following medical conditions:
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.
Sulfasalazine should not be used in children up to 2 years of age because it may cause brain problems. However, sulfasalazine has not been shown to cause different side effects or problems in children over the age of 2 years than it does in adults.
This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
|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.|
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.
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.
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:
This section provides information on the proper use of a number of products that contain sulfasalazine. It may not be specific to Azulfidine Entabs. Please read with care.
Do not give sulfasalazine to infants and children up to 2 years of age, unless otherwise directed by your doctor. It may cause brain problems.
Sulfasalazine is best taken right after meals or with food to lessen stomach upset. If stomach upset continues or is bothersome, check with your doctor.
Each dose of sulfasalazine should also be taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects of the sulfa medicine.
For patients taking the enteric-coated tablet form of this medicine:
Keep taking this medicine for the full time of treatment , even if you begin to feel better after a few days. Do not miss any doses.
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.
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.
It is very important that your doctor check your progress at regular visits. This medicine may cause blood problems, especially if it is taken for a long time.
If your symptoms (including diarrhea) do not improve within 1 or 2 months, or if they become worse, check with your doctor.
Sulfasalazine may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.
Sulfasalazine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:
If you have a severe reaction from the sun, check with your doctor.
This medicine may also cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If this reaction is especially bothersome, check with your doctor.
Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of the bentiromide (e.g., Chymex) test for pancreas function are affected by 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:More common
Check with your doctor as soon as possible if any of the following side effects occur:More common
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
In some patients this medicine may also cause the urine or skin to become orange-yellow. This side effect does not need medical attention.
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.
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