Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Azulfidine
  2. Azulfidine Entabs
  3. Sulfazine
  4. Sulfazine EC

Canadian Brand Name

  1. Alti-Sulfasalazine
  2. Salazopyrin

Descriptions


Sulfasalazine is used to treat and prevent ulcerative colitis. It works inside the bowels by helping to reduce the inflammation and other symptoms of the disease.

Sulfasalazine enteric-coated tablets are used to treat adults and children with rheumatoid arthritis in patients who have not been helped by or who cannot tolerate other medicines (eg, salicylates or NSAIDs) for rheumatoid arthritis.

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 these uses are not included in product labeling, sulfasalazine is used in certain patients with the following medical conditions:

  • Ankylosing spondylitis.

This product is available in the following dosage forms:

  • Tablet
  • Tablet, Enteric Coated

Before Using

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

Appropriate studies have not been performed on the relationship of age to the effects of sulfasalazine tablets and enteric-coated tablets to treat ulcerative colitis in children younger than 2 years of age. Safety and efficacy have not been established in children younger than 2 years of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfasalazine enteric-coated tablets to treat juvenile rheumatoid arthritis in children. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sulfasalazine in the elderly.

Pregnancy

Information about this sulfasalazine-oral-route
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.

Breastfeeding

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.

Drug Interactions

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Methenamine

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.

  • Riluzole

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.

  • Cyclosporine
  • Digoxin
  • Warfarin

Other Interactions

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:

  • Allergy to sulfa drugs or salicylates or
  • Bowel blockage or
  • Porphyria (enzyme problem) or
  • Urinary bladder blockage—Should not be used in patients with these conditions.
  • Asthma, bronchial—Use with caution. May increase risk of having an allergic reaction.
  • Blood or bone marrow problems (eg, agranulocytosis, aplastic anemia) or
  • Kidney disease or
  • Liver disease—Use with caution. May make these conditions worse.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency (a hereditary metabolic disorder affecting red blood cells)—May cause hemolytic anemia (blood disorder) in patients with this condition.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

It is best to take this medicine right after meals, at evenly spaced times throughout the day and night. Try not to let more than 8 hours go by between doses, even at night.

Swallow the enteric-coated tablet whole. Do not crush, break, or chew it.

Drink extra fluids so you will pass more urine while you are using this medicine. This may help prevent kidney problems.

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.

While using this medicine, part of the enteric-coated tablet may pass into your stools. This is normal and is nothing to worry about.

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 treatment of ulcerative colitis:
    • For oral dosage form (enteric-coated tablets):
      • Adults—At first, 500 to 1000 milligrams (mg) every 6 to 8 hours per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4000 mg per day.
      • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 40 to 60 milligrams (mg) per kilogram (kg) of body weight per day, divided into 3 to 6 doses.
      • Children 2 to 5 years of age—Dose must be determined by your doctor.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—At first, 500 to 1000 milligrams (mg) every 6 to 8 hours per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4000 mg per day.
      • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 40 to 60 milligrams (mg) per kilogram (kg) of body weight per day, divided into 3 to 6 doses.
      • Children 2 to 5 years of age—Dose must be determined by your doctor.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For maintenance treatment of ulcerative colitis:
    • For oral dosage form (enteric-coated tablets):
      • Adults—2000 milligrams (mg) per day.
      • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 milligrams (mg) per kilogram (kg) of body weight per day, divided into 4 doses.
      • Children 2 to 5 years of age—Dose must be determined by your doctor.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—2000 milligrams (mg) per day.
      • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 milligrams (mg) per kilogram (kg) of body weight per day, divided into 4 doses.
      • Children 2 to 5 years of age—Dose must be determined by your doctor.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For treatment of rheumatoid arthritis:
    • For oral dosage form (enteric-coated tablets):
      • Adults—At first, 500 mg to 1000 milligrams (mg) per day, divided into 2 doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 3000 mg per day.
      • Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 30 to 50 milligrams (mg) per kilogram (kg) of body weight per day, divided into 2 doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 2000 mg per day.
      • Children younger than 6 years of age—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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to check if the medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you or your child have a fever and sore throat, pale skin, unusual bruising or bleeding, or unusual tiredness or weakness. These may be symptoms of a blood problem.

This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Your skin or urine may turn an orange or yellow color while you or your child are using this medicine. This is normal and nothing to worry about.

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:

  • Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
  • Wear protective clothing, including a hat. Also, wear sunglasses.
  • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
  • Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
  • Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

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 immediately if any of the following side effects occur:

More common

  1. Aching of joints
  2. fever
  3. headache (continuing)
  4. increased sensitivity of the skin to sunlight
  5. itching
  6. skin rash
  7. vomiting

Less common

  1. Back, leg, or stomach pains
  2. bleeding gums
  3. bluish color of the fingernails, lips, skin, palms, or nail beds
  4. chills
  5. dark urine
  6. difficulty breathing
  7. fever
  8. general body swelling
  9. headache
  10. loss of appetite
  11. nausea
  12. nosebleeds
  13. pale skin
  14. sore throat
  15. troubled breathing with exertion
  16. unusual bleeding or bruising
  17. unusual tiredness or weakness
  18. yellowing of the eyes or skin

Less common or rare

  1. Aching of muscles
  2. black, tarry stools
  3. blistering, peeling, or loosening of the skin
  4. bloating
  5. blood in the urine or stools
  6. bloody diarrhea
  7. bluish fingernails, lips, or skin
  8. chest pain
  9. constipation
  10. cough
  11. difficulty with swallowing
  12. dizziness
  13. fainting spells
  14. fast heartbeat
  15. general feeling of discomfort or illness
  16. general tiredness and weakness
  17. hives
  18. indigestion
  19. inflammation of the joints
  20. irregular heartbeat
  21. light-colored stools
  22. muscle aches
  23. muscle cramps or spasms
  24. muscle pain or stiffness
  25. painful or difficult urination
  26. pains in the stomach, side, or abdomen, possibly radiating to the back
  27. pinpoint red spots on the skin
  28. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  29. rash
  30. red skin lesions, often with a purple center
  31. red, irritated eyes
  32. redness, blistering, peeling, or loosening of the skin
  33. sores, ulcers, or white spots in the mouth or on the lips
  34. swollen or painful glands
  35. tightness in the chest
  36. upper right abdominal or stomach pain

Incidence not known

  1. Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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

  1. Abdominal or stomach pain or upset
  2. decreased weight

Less common

  1. Welts

Less common or rare

  1. Discoloration of the skin or urine
  2. hair loss or thinning of the hair
  3. swelling or inflammation of the mouth

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.