DrugindexOnline^{2nd edition}

Generic Name: Sulfasalazine Delayed-Release Tablets (SULL-fuh-SAL-uh-zeen)
Brand Name: Azulfidine EN-tabs

Azulfidine EN-tabs Delayed-Release Tablets is used for:

Treating ulcerative colitis and reducing the frequency of attacks. It may also be used for other conditions as determined by your doctor.

Azulfidine EN-tabs Delayed-Release Tablets is a sulfonamide. How it works is unclear. It is thought to decrease inflammation and help regulate the immune system in various areas of the body.

Do NOT use Azulfidine EN-tabs Delayed-Release Tablets if:

• you are allergic to any ingredient in Azulfidine EN-tabs Delayed-Release Tablets or to a salicylate (eg, aspirin) or a sulfonamide (eg, sulfisoxazole)
• you have the blood disease porphyria or a blockage of the intestine or urinary tract

Contact your doctor or health care provider right away if any of these apply to you.

Before using Azulfidine EN-tabs Delayed-Release Tablets:

Some medical conditions may interact with this medicine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney or liver problems, a blood disorder, a gastrointestinal infection, glucose-6-phosphate dehydrogenase deficiency, or asthma

Some MEDICINES MAY INTERACT with Azulfidine EN-tabs Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) or methotrexate because the actions and side effects of these medicines may be increased
• Anticoagulants (eg, warfarin) or beta-blockers (eg, propranolol) because their effectiveness may be decreased by Azulfidine EN-tabs Delayed-Release Tablets
• Methenamine because the risk of crystals in the urine is increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Azulfidine EN-tabs Delayed-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Azulfidine EN-tabs Delayed-Release Tablets:

Use Azulfidine EN-tabs Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Azulfidine EN-tabs Delayed-Release Tablets after meals.
• Drink plenty of fluids while taking Azulfidine EN-tabs Delayed-Release Tablets. Drink at least 8 ounces (240 mL) of water with each dose of Azulfidine EN-tabs Delayed-Release Tablets.
• Swallow Azulfidine EN-tabs Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Stop taking Azulfidine EN-tabs Delayed-Release Tablets and contact your doctor at once if Azulfidine EN-tabs Delayed-Release Tablets passes through your bowels undissolved.
• Space your doses evenly over the hours you are awake. If possible, try not to space any dose more than 8 hours from the last dose.
• Take Azulfidine EN-tabs Delayed-Release Tablets regularly to receive the most benefit from it.
• The amounts of folic acid and digoxin may be reduced when taken with Azulfidine EN-tabs Delayed-Release Tablets. Do not take them within 1 hour before or 2 hours after taking Azulfidine EN-tabs Delayed-Release Tablets.
• If you miss a dose of Azulfidine EN-tabs Delayed-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Azulfidine EN-tabs Delayed-Release Tablets.

Important safety information:

• Azulfidine EN-tabs Delayed-Release Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Azulfidine EN-tabs Delayed-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
• Azulfidine EN-tabs Delayed-Release Tablets may cause a harmless, yellow-orange discoloration of the urine or skin. This is normal and not a cause for concern.
• If sore throat, fever, yellowing, paleness, or bleeding underneath the skin occurs, contact your doctor. This could be the sign of a serious side effect.
• LAB TESTS, including liver or kidney function tests or complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Azulfidine EN-tabs Delayed-Release Tablets is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Azulfidine EN-tabs Delayed-Release Tablets, discuss with your doctor the benefits and risks of using Azulfidine EN-tabs Delayed-Release Tablets during pregnancy. Azulfidine EN-tabs Delayed-Release Tablets is excreted in breast milk. If you are or will be breast-feeding while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Azulfidine EN-tabs Delayed-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; indigestion; infertility and drop in sperm count (reversible); loss of appetite; mild diarrhea; mild stomach discomfort or pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters; dark urine; fever; itching; pale skin; persistent sore throat; red or purple spots under the skin; severe headache; severe peeling skin; sore throat; stomach pain; unusual tiredness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include drowsiness; nausea; seizures; stomach pain; vomiting.

Proper storage of Azulfidine EN-tabs Delayed-Release Tablets:

Store Azulfidine EN-tabs Delayed-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Azulfidine EN-tabs Delayed-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Azulfidine EN-tabs Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Azulfidine EN-tabs Delayed-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Azulfidine EN-tabs Delayed-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.