DrugindexOnline^{2nd edition}

Generic name: Sulfasalazine
Brand names: Azulfidine

Why is Azulfidine prescribed?

Azulfidine, an anti-inflammatory medicine, is prescribed for the treatment of mild to moderate ulcerative colitis (a long-term, progressive bowel disease) and as an added treatment in severe ulcerative colitis (chronic inflammation and ulceration of the lining of large bowel and rectum, the main symptom of which is bloody diarrhea). This medication is also prescribed to decrease severe attacks of ulcerative colitis.

Azulfidine EN-tabs are prescribed for people with ulcerative colitis who cannot take the regular Azulfidine tablet because of symptoms of stomach and intestinal irritation such as nausea and vomiting when taking the first few doses of the drug, or for those in whom a reduction in dosage does not lessen the stomach or intestinal side effects. The EN-tabs are also prescribed for adults and children with rheumatoid arthritis who fail to get relief from salicylates (such as aspirin) or other nonsteroidal anti-inflammatory drugs (such as ibuprofen).

Most important fact about Azulfidine

Although ulcerative colitis rarely disappears completely, the risk of recurrence can be substantially reduced by the continued use of Azulfidine.

How should you take Azulfidine?

Take Azulfidine in evenly spaced, equal doses, as determined by your doctor, preferably after meals or with food to avoid stomach upset. Swallow Azulfidine EN-tabs whole.

It is important that you drink plenty of fluids while taking Azulfidine to avoid kidney stones.

If you are taking Azulfidine EN-tabs for rheumatoid arthritis, it may take up to 12 weeks for relief to occur.

--If you miss a dose...

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

--Storage instructions...

Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Azulfidine.

• More common side effects may include:
  Abdominal pain, anemia, bluish skin, fever, headache, hives, inflammation of the mouth, itching, lack of appetite, nausea, rash, stomach distress, vomiting

Why should Azulfidine not be prescribed?

If you are sensitive to or have ever had an allergic reaction to Azulfidine, salicylates (aspirin), or other sulfa drugs, you should not take Azulfidine. Make sure your doctor is aware of any drug reactions you have experienced.

Unless you are directed to do so by your doctor, do not take Azulfidine if you have an intestinal or urinary obstruction or if you have porphyria (an inherited disorder involving the substance that gives color to the skin and iris of the eyes).

Special warnings about Azulfidine

If you have kidney or liver damage or any blood disease, your doctor will check you very carefully before prescribing Azulfidine. Deaths have been reported from allergic reactions, blood diseases, kidney or liver damage, changes in nerve and muscle impulses, and fibrosing alveolitis (inflammation of the lungs due to a thickening or scarring of tissue). Signs such as sore throat, fever, abnormal paleness of the skin, purple or red spots on the skin, or jaundice (yellowing of the skin) may be an indication of a serious blood disorder. Your doctor will do frequent blood counts and urine tests. Use caution taking Azulfidine if you have a severe allergy or bronchial asthma.

If you develop loss of appetite, nausea, or vomiting, report it immediately. The doctor may need to adjust your dosage or change the prescription.

If Azulfidine EN-tabs are eliminated undisintegrated, stop taking the drug and notify your doctor immediately. (You may lack the intestinal enzymes necessary to dissolve Azulfidine.)

Men taking Azulfidine may experience temporary infertility and a low sperm count.

Skin and urine may become yellow-orange in color while taking Azulfidine.

In addition, prolonged exposure to the sun should be avoided.

This drug is generally not prescribed for children under 6. Azulfidine EN-tabs are not recommended for children with the type of juvenile rheumatoid arthritis that affects the whole system, only for children with the type that stays in the joints.

Possible food and drug interactions when taking Azulfidine

If Azulfidine is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Azulfidine with the following:

Digoxin (Lanoxin)
Folic acid (a B-complex vitamin)
Methotrexate (Rheumatrex)

Special information if you are pregnant or breastfeeding

The effects of Azulfidine during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. Azulfidine is secreted in breast milk and could affect a nursing infant. If Azulfidine is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished.

Recommended dosage

Your doctor will carefully individualize your dosage and monitor your response periodically.

ULCERATIVE COLITIS

Adults

The usual recommended initial dose of Azulfidine and Azulfidine EN-tabs is 3 to 4 grams daily divided into smaller doses (intervals between nighttime doses should not exceed 8 hours). In some cases the initial dosage is set at 1 to 2 grams daily to lessen side effects. As therapy continues, the dose is usually reduced to 2 grams daily.

Children Aged 6 and Older

The usual recommended initial dose is 40 to 60 milligrams per 2.2 pounds of body weight in each 24-hour period, divided into 3 to 6 doses. For the longer term, the dose is usually reduced to 30 milligrams per 2.2 pounds of body weight in each 24-hour period, divided into 4 doses.

RHEUMATOID ARTHRITIS

Adults

The usual dose of Azulfidine EN-tabs is 2 grams a day, divided into smaller doses. Your doctor may have you start with a lower dose, then raise the dosage to 3 grams after 12 weeks.

Children aged 6 and older

The typical recommended daily dosage is 30 to 50 milligrams per 2.2 pounds of body weight, up to a maximum of 2 grams, taken in 2 equally divided doses. To reduce the chance of digestive side effects and other reactions, the doctor will probably start with a fraction of the typical dose and build up to it over a period of weeks.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an Azulfidine overdose, seek emergency medical attention immediately.

• Symptoms of Azulfidine overdose may include:
  Abdominal pain convulsions drowsiness nausea stomach upset vomiting