Azulfidine EN-tabs

Sulfasalazine is also used to treat bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain in Crohn's disease. Talk to your doctor about the possible risks of using this drug for your condition.

Sulfasalazine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Sulfasalazine is used to treat moderate to severe ulcerative colitis.

Sulfasalazine is also used to treat rheumatoid arthritis in children and adults who have used other arthritis medicines without successful treatment of symptoms.

Sulfasalazine may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Sulfasalazine can weaken your immune system. Your blood may need to be tested often.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using sulfasalazine.

Take this medicine after a meal.

Do not crush, chew, or break an enteric coated pill. Swallow it whole. The pill has a special coating to protect your stomach. Breaking the pill will damage this coating.

For best results, keep using this medicine as directed. Sulfasalazine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

If you are treating arthritis, do not stop using any of your other arthritis medicines until your doctor tells you to. Your symptoms may not improve right away when you start taking sulfasalazine, and you may still need your other medicines for awhile.

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with sulfasalazine. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• sudden weakness or ill feeling, fever, chills, cold or flu symptoms;

• sore throat, cough, trouble breathing;

• stabbing chest pain, cough with yellow or green mucus, wheezing;

• pain when swallowing, painful mouth sores, red or swollen gums;

• rapid heart rate, rapid and shallow breathing, fainting;

• skin sores, pale skin, easy bruising, unusual bleeding; or

• jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

• severe nausea or vomiting when you first start taking sulfasalazine;

• the first sign of any skin rash, no matter how mild;

• signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, upset stomach, loss of appetite;

• headache; or

• low sperm count in men.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

AZULFIDINE EN-tabs Tablets contain sulfasalazine, formulated in a delayed release tablet (enteric-coated), 500 mg, for oral administration.

AZULFIDINE EN-tabs Tablets are film coated with cellulose acetate phthalate to retard disintegration of the tablet in the stomach and reduce potential irritation of the gastric mucosa.

Therapeutic Classification: Anti-inflammatory agent and/or immunomodulatory agent.

Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid.

Chemical Structure:

Molecular Formula: C18H14N4O5S

Patients should be informed of the possibility of adverse effects and of the need for careful medical supervision. The occurrence of sore throat, fever, pallor, purpura or jaundice may indicate a serious blood disorder. Should any of these occur, the patient should seek medical advice.

Patients should be instructed to take AZULFIDINE EN-tabs in evenly divided doses, preferably after meals, and to swallow the tablets whole. Additionally, patients should be advised that sulfasalazine may produce an orange-yellow discoloration of the urine or skin.

Ulcerative Colitis

Patients with ulcerative colitis should be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be substantially reduced by continued administration of AZULFIDINE EN-tabs at a maintenance dosage.

Rheumatoid Arthritis

Rheumatoid arthritis rarely remits. Therefore, continued administration of AZULFIDINE EN-tabs is indicated. Patients requiring sulfasalazine should follow up with their physicians to determine the need for continued administration.

• Asacol
• Colazal
• Lotronex

• Pentasa
• Rhinocort Aqua

© Azulfidine EN-tabs Patient Information is supplied by Cerner Multum, Inc. and Azulfidine EN-tabs Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.