Azulfidine EN

Generic Name: Sulfasalazine

  • What is Azulfidine EN?

    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).

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

    Although ulcerative colitis rarely disappears completely, the risk of recurrence can be substantially reduced by the continued use of this drug. Rheumatoid arthritis rarely remits as well, and so continuous administration of EN-tabs may be needed.

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    Low sperm cell count and infertility in men may occur, but will be reversible when the drug is withdrawn.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

    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 EN 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 EN?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Azulfidine EN. 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.

    Rheumatoid Arthritis

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

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

    Ulcerative Colitis

    Adults: The usual recommended initial dose of Azulfidine EN is 3-4 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 EN?

    Take this medication 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.

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

  • What should I avoid while taking Azulfidine EN?

    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 EN?

    If Azulfidine EN 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 EN with digoxin, folic acid (a B-complex vitamin), and methotrexate.

  • What are the possible side effects of Azulfidine EN?

    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 EN if I am pregnant or breastfeeding?

    The effects of Azulfidine EN during pregnancy 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 EN?

    If you miss a dose of Azulfidine EN, 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 EN?

    Store at room temperature.

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