Generic Name: Sulfasalazine

  • What is Azulfidine?

    Azulfidine, an anti-inflammatory medicine, is prescribed to treat mild to moderate ulcerative colitis and as an added treatment in severe ulcerative colitis. This medication is also prescribed to decrease severe attacks of ulcerative colitis.

  • What is the most important information I should know about Azulfidine?

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

    Hypersensitivity reactions, blood diseases, kidney and liver damage, neuromuscular and central nervous system changes, and scarring/thickening of the lungs have occurred.

    Sore throat, fever, paleness, purple spots, or yellowing of the eyes and skin may be signs of blood disorders or liver toxicity. If they occur, seek medical attention.

    Complete blood counts, urinalysis, and liver function tests should be done regularly. Azulfidine should be discontinued while you are waiting for blood test results.

    Low sperm cell count and infertility in men may occur, but will be reversible when the drug is withdrawn.

    Azulfidine may cause orange-yellow discoloration of the urine or skin.

  • Who should not take Azulfidine?

    If you are sensitive to or have ever had an allergic reaction to Azulfidine, salicylates (such as aspirin), or other sulfa drugs, you should not take this medication. 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 production of heme, which carries oxygen throughout the body).

  • What should I tell my doctor before I take the first dose of Azulfidine?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Azulfidine. Also, talk to your doctor about your complete medical history, especially if you have kidney or liver damage, any blood disease, severe allergy or asthma, or glucose-6 phosphate dehydrogenase deficiency.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Ulcerative Colitis

    Adults: The usual recommended initial dose of Azulfidine is 3-4 grams (g) daily divided into smaller doses (intervals between doses should not exceed 8 hours). In some cases the initial dosage is set at 1-2 g daily to lessen side effects. The usual maintenance dose is 2 g daily.

    Children ≥6 years: The usual recommended initial dose is 40-60 milligrams (mg) per 2.2 pounds of body weight in each 24-hour period, divided into 3-6 doses. The usual maintenance dose is 30 mg per 2.2 pounds of body weight in each 24-hour period, divided into four doses.

  • How should I take Azulfidine?

    Take this medication in evenly spaced, equal doses, as determined by your doctor, preferably after meals or with food to avoid stomach upset.

    Your doctor may adjust your dose if you experience side effects.

  • What should I avoid while taking Azulfidine?

    Avoid becoming dehydrated. To avoid kidney stones, drink plenty of fluids while taking this medication.

  • What are possible food and drug interactions associated with 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 digoxin, folic acid (a B-complex vitamin), and methotrexate.

  • What are the possible side effects of Azulfidine?

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

    Side effects may include: anorexia, headache, nausea, vomiting, stomach distress, reversible low sperm count

  • Can I receive Azulfidine if I am pregnant or breastfeeding?

    The effects of Azulfidine during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

  • What should I do if I miss a dose of Azulfidine?

    If you miss a dose of Azulfidine, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take two doses at once. If you are unsure, ask your doctor or pharmacist for advice.

  • How should I store Azulfidine?

    Store at room temperature.

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