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Azulfidine

Generic name: Sulfasalazine
Brand names: Azulfidine

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

GENERIC NAME: sulfasalazine
BRAND NAME: Azulfidine

DRUG CLASS AND MECHANISM: Sulfasalazine is a prodrug, that is, it is not active in its ingested form. It is broken down by bacteria in the colon into two products: 5-aminosalicylic acid (5ASA), and sulfapyridine. There is some controversy as to which of these two products are responsible for the activity of azulfidine. Whereas it is known that 5ASA has therapeutic benefit, it is not clear whether sulfapyridine adds any further benefit. In the colon, the products created by the breakdown of sulfasalazine work as anti-inflammatory agents for treating inflammation of the colon. The beneficial effect of sulfasalazine is believed to be due to a local effect on the bowel, although there may also be a beneficial systemic immune-suppressant effect as well. Following oral administration, 33% of the sulfasalazine is absorbed, all of the sulfapyridine is absorbed, and about 33% of the 5ASA is absorbed. Sulfasalazine was approved by the FDA in 1950.

PRESCRIPTION: yes

GENERIC AVAILABLE: yes

PREPARATIONS: Uncoated and enteric coated tablets, each containing 500mg.

STORAGE: The tablets should be kept at room temperature, 15-30C (59-86F).

PRESCRIBED FOR: Sulfasalazine is used for the treatment of mild to moderate ulcerative colitis; as adjunctive therapy (i.e. with other medications) in the treatment of severe ulcerative colitis; for the treatment of Crohn's disease; for the treatment of rheumatoid arthritis or ankylosing spondylitis.

DOSING: Doses range from 500mg to 2000mg, and dosing intervals range from every 6 hours to every 12 hours, depending on the clinical condition of the patient. Higher doses have also been used. Sulfasalazine should be taken with a full glass of water after meals or with food to minimize stomach upset. Patients with kidney diseases may need to use lower doses of sulfasalazine.

DRUG INTERACTIONS: Sulfasalazine may cause reduced absorption of folic acid and of digoxin.

PREGNANCY: In hundreds of pregnant women with ulcerative colitis or Crohn's disease treated with sulfasalazine, there has been no increase in the risk of fetal malformations relative to other women with these illnesses who have not been treated with sulfasalazine. Additionally, there have not been ill effects on pregnant animals given high doses of sulfasalazine. Thus, sulfasalazine may be used during pregnancy if the physician feels the benefit outweighs the possible risk.

It should also be noted, however, that sulfasalazine may reduce sperm count and sperm function in men taking the medication. These effects are reversible upon stopping the medication.

NURSING MOTHERS: Caution should be exercised by women who are nursing their infants. Sulfasalazine and its constituents penetrate into breast milk and may displace bilirubin in the newborn. This can cause jaundice.

SIDE EFFECTS: Gastrointestinal disturbances frequently occur in patients taking sulfasalazine. Nausea, vomiting, gastric distress, and anorexia (loss of appetite) occur in about 1 of every 3 patients receiving the drug. Dizziness can occur during sulfasalazine therapy but does not require medical attention unless it is persistent. Sulfasalazine frequently causes the skin or the urine to change color. Development of an orange-yellow coloration is of no cause for concern.

Several potentially dangerous side effects have been rarely reported with sulfasalazine. A drop in white blood cell count or a type of anemia in which red blood cells are disrupted (hemolyzed) occur more frequently in patients with arthritis who are treated with sulfasalazine (about 6 per 1,000) than in patients with ulcerative colitis or Crohn's disease who are treated with sulfasalazine (about 6 per 10,000). These effects are characterized by fever, pale skin, sore throat, fatigue, and unusual bleeding and bruising, and require discontinuation of the drug.

Continuing headache, allergic reactions, and photosensitivity may develop during sulfasalazine therapy and require medical attention. Some of the allergic reactions may progress from a rash to difficulty in swallowing, blistering, peeling, or loosening of the skin, aching joints and muscles, and unusual tiredness or weakness. It may be accompanied by fever. The more severe allergic reactions are rare.

GENERIC NAME: SULFASALAZINE - ORAL (sull-fuh-SAL-uh-zeen)
BRAND NAME(S): Azulfidine


Medication Uses | Other Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage

USES: Sulfasalazine is used to treat rheumatoid arthritis; or stomach pain, rectal bleeding, and diarrhea caused by ulcerative colitis.

OTHER USES: This medication may also be used for inflammatory bowel disease; or stomach pain, rectal bleeding, and diarrhea caused by Crohn's disease; back pain/inflammation (ankylosing spondylitis); and may be used for other purposes as determined by your doctor.

HOW TO USE: Take this with a full glass of water, with food or after meals to prevent stomach upset. Drink at least 8 glasses of fluid daily unless otherwise directed. The coated tablets must be swallowed whole. Do not crush or chew them. The coating helps to prevent stomach upset. The liquid suspension form of this medicine must be shaken well before measuring each dose.

SIDE EFFECTS: This medication may cause stomach upset, diarrhea, nausea, vomiting, headache, drowsiness, dizziness or trouble sleeping during the first few days as your body adjusts to the medication. If these symptoms persist or become severe, inform your doctor. May cause urine to be orange-brown in color. This is not harmful and will disappear when the medication is stopped. This medication increases sensitivity to sunlight. Notify your doctor if your condition worsens or you develop: easy bruising. Rarely, this medication can cause serious, even fatal, side effects such as a severe peeling skin rash known as Stevens- Johnson syndrome, blood disorders (e.g., agranulocytosis, aplastic anemia), or liver damage. Seek immediate medical attention if you develop any of the following symptoms: skin rash or blisters, unusual fatigue, persistent sore throat or fever, yellowing eyes or skin, dark urine, abdominal pain. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.