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Generic Name: sulfasalazine (sull fa SAH la zeen)
Brand Names: Azulfidine, Azulfidine EN-tabs

What is Azulfidine (sulfasalazine)?

The exact way that sulfasalazine works is unknown, but it is believed to reduce the actions of substances in the body that cause inflammation, tissue damage, and diarrhea.

Sulfasalazine is used to treat ulcerative colitis and to maintain remission. The delayed-release tablets, Azulfidine (EN-tabs), are also used to treat rheumatoid arthritis and juvenile rheumatoid arthritis.

Sulfasalazine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Azulfidine (sulfasalazine)?

Notify your doctor immediately if you develop a sore throat, fever, pale skin, bruising, or yellow skin or eyes. These may be early symptoms of a blood disorder. Do not stop taking sulfasalazine, even if you begin to feel better, without first talking to your doctor. It is very important to continue taking sulfasalazine to control your condition. Do not crush, chew, or break the delayed-release tablets (Azulfidine EN-tabs). Swallow them whole. They are specially formulated to release the medication after they have passed through your stomach.

Call your doctor if you find an undissolved delayed-release (Azulfidine EN-tabs) tablet in your stool.

Who should not take Azulfidine (sulfasalazine)?

Do not take sulfasalazine without first talking to your doctor if you have

• ever had an allergic reaction to sulfasalazine, a sulfa-based antibiotic, or aspirin;

• an obstruction (blockage) in your intestines or urinary tract;

• porphyria;

• liver disease;
• kidney disease;

• asthma; or

• glucose-6-phosphate dehydrogenase deficiency.

You may not be able to take sulfasalazine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Sulfasalazine is in the FDA pregnancy category B. This means that it is not expected to harm an unborn baby. Do not take sulfasalazine without first talking to your doctor if you are pregnant. Sulfasalazine passes into breast milk and the effects of sulfasalazine on a nursing infant are not known. Do not take sulfasalazine without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of sulfasalazine have not been established for children younger than 2 years of age.

How should I take Azulfidine (sulfasalazine)?

Take sulfasalazine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Sulfasalazine is usually taken after meals. Follow your doctor's instructions. Do not crush, chew, or break the delayed-release tablets (Azulfidine EN-tabs). Swallow them whole. They are specially formulated to release the medication after they have passed through your stomach.

Call your doctor if you find an undissolved delayed-release (Azulfidine EN-tabs) tablet in your stool.

Do not stop taking sulfasalazine, even if you begin to feel better, without first talking to your doctor. It is very important to continue taking sulfasalazine to control your condition. Store sulfasalazine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a sulfasalazine overdose include nausea, vomiting, abdominal pain, drowsiness, and seizures.

What should I avoid while taking Azulfidine (sulfasalazine)?

There are no restrictions on foods, beverages, or activities during treatment with sulfasalazine unless your doctor directs otherwise.

Azulfidine (sulfasalazine) side effects

If you experience any of the following serious side effects, stop taking sulfasalazine and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives); or

• worsening colitis (fever, abdominal pain, cramping, or bloody diarrhea); or

• sore throat, fever, pale skin, bruising, or yellow skin or eyes (may indicate a blood disorder).

Other, less serious side effects may be more likely to occur. Continue to take sulfasalazine and talk to your doctor if you experience

• nausea, vomiting, or decreased appetite;

• headache;

• a rash, itching, or hives;

• fever;

• decreased sperm production (uncommon and usually reversible); or

• orange-yellow discoloration of the skin or urine (not harmful).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Azulfidine (sulfasalazine)?

Sulfasalazine may decrease the absorption of digoxin (Lanoxin, Lanoxicaps). Your doctor may want to monitor the digoxin levels in your blood if you are taking this medicine.

Sulfasalazine may also decrease folate (a natural vitamin) in your body. You may need to take folate supplements or eat folate-rich foods.

Drugs other than those listed here may also interact with sulfasalazine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has more information about sulfasalazine written for health professionals that you may read.

What does my medication look like?

Sulfasalazine is available with a prescription under the brand name Azulfidine in regular and enteric-coated tablets. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Azulfidine 500 mg--round, gold, scored tablets

• Azulfidine-EN-tabs (Enteric Coated) 500 mg--elliptical, gold, film-coated tablets

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.03. Revision Date: 2/13/04 4:00:10 PM.