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sulfasalazine

Pronunciation

Generic Name: sulfasalazine (SUL fa SAL a zeen)
Brand Name: Azulfidine, Azulfidine EN-tabs, Sulfazine

What is sulfasalazine?

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.

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

You should not use sulfasalazine if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfa drugs, aspirin, or similar medicines called salicylates.

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What should I discuss with my healthcare provider before taking sulfasalazine?

You should not use sulfasalazine if you are allergic to it, or if you have:

  • a blockage in your bladder or intestines;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);

  • if you are allergic to sulfa drugs (such as Bactrim, SMX-TMP, SMZ-TMP, and others); or

  • if you are allergic to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure sulfasalazine is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease, or a history of kidney stones;

  • a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency;

  • a blood cell disorder;

  • weak immune system (caused by disease or by using certain medicine);

  • heart disease;

  • asthma; or

  • history of chronic infections.

FDA pregnancy category B. Sulfasalazine is not expected to harm an unborn baby. However, you may need to take folic acid supplements if you take sulfasalazine during pregnancy. Follow your doctor's instructions. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Sulfasalazine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Sulfasalazine should not be given to a child younger than 2 years old.

How should I take sulfasalazine?

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.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking sulfasalazine?

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

Sulfasalazine side effects

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.

See also: Side effects (in more detail)

Sulfasalazine dosing information

Usual Adult Dose for Ulcerative Colitis -- Active:

3 to 4 g/day orally in evenly divided doses

Comments:
-To reduce possible GI intolerance, a lower starting dose (e.g., 1 to 2 g/day) may be considered.
-If GI intolerance occurs after the first few doses, symptoms may be reduced by halving the daily dose and then increasing it gradually over several days; if intolerance continues, the drug should be stopped for 5 to 7 days then restarted at a lower daily dose.
-Increased toxicity risk should be considered if more than 4 g/day is needed to reach desired therapeutic effect.
-Clinical criteria, sigmoidoscopy, and biopsy samples should be evaluated to determine response of acute ulcerative colitis to drug therapy.
-When adequate improvement is confirmed by endoscopy, dose should be reduced to maintenance level; if diarrhea recurs, dose should be increased to previously effective levels.

Uses: In the treatment of mild to moderate ulcerative colitis; as adjunctive therapy in severe ulcerative colitis

Usual Adult Dose for Ulcerative Colitis -- Maintenance:

2 g/day orally in evenly divided doses

Comments:
-Drug therapy often needs to be continued, even when clinical symptoms are controlled.

Use: To prolong the remission period between acute attacks of ulcerative colitis

Usual Adult Dose for Rheumatoid Arthritis:

Delayed-release tablets: 1000 mg orally twice a day

Suggested dosing regimen:
Week 1: 500 mg orally once a day in the evening
Week 2: 500 mg orally twice a day (morning and evening)
Week 3: 500 mg orally in the morning and 1000 mg in the evening
Week 4: 1000 mg orally twice a day (morning and evening)

Comments:
-To reduce possible GI intolerance, a lower starting dose (e.g., 0.5 to 1 g/day) is recommended; a suggested dosing regimen is provided above.
-Degree of improvement in number and extent of actively inflamed joints can be evaluated to determine efficacy of drug therapy.
-This drug does not produce an immediate response. Concomitant analgesics and/or NSAIDs are recommended (at least until the effect of this drug is evident).
-Therapeutic response has been seen 4 weeks after starting therapy; 12 weeks of therapy may be needed before clinical benefit is noticed.
-Increasing the daily dose to 3 g/day may be considered if clinical response is inadequate after 12 weeks; careful monitoring suggested for doses over 2 g/day.

Use: In the treatment of patients with rheumatoid arthritis who responded inadequately to salicylates or other NSAIDs (e.g., insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of 1 or more NSAIDs)

Usual Adult Dose for Crohn's Disease -- Acute:

3 to 6 g/day orally in divided doses

Comments:
-This dose has been recommended for mild to moderate active ileocolonic or colonic disease; not approved by US FDA.
-Maintenance benefits have not been consistent after medical inductive therapy.

Usual Adult Dose for Uveitis:

Study (n=10) - Acute anterior recurrent uveitis
Initial dose: 500 mg/day, then increased by 500 mg/week
Maintenance dose: 1 g twice a day for 1 year; in cases of new flare, dose was increased by 500 mg/week up to 3 g/day

Usual Pediatric Dose for Ulcerative Colitis:

6 years or older:
Initial therapy: 40 to 60 mg/kg/day orally divided into 3 to 6 doses
Maintenance therapy: 30 mg/kg/day orally divided into 4 doses

Comments:
-If GI intolerance occurs after the first few doses, symptoms may be reduced by halving the daily dose and then increasing it gradually over several days; if intolerance continues, the drug should be stopped for 5 to 7 days then restarted at a lower daily dose.
-Clinical criteria, sigmoidoscopy, and biopsy samples should be evaluated to determine response of acute ulcerative colitis to drug therapy.
-When adequate improvement is confirmed by endoscopy, dose should be reduced to maintenance level; if diarrhea recurs, dose should be increased to previously effective levels.
-Drug therapy often needs to be continued, even when clinical symptoms are controlled.

Uses: In the treatment of mild to moderate ulcerative colitis; as adjunctive therapy in severe ulcerative colitis; to prolong the remission period between acute attacks of ulcerative colitis

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

Delayed-release tablets:
6 years or older: 30 to 50 mg/kg/day orally in 2 equally divided doses
Maximum dose: 2 g/day (normally)

Comments:
-To reduce possible GI intolerance, dosing should be started at 1/4 to 1/3 the planned maintenance dose and increased weekly until maintenance dose is reached at 1 month.

Use: In the treatment of patients with polyarticular-course juvenile rheumatoid arthritis who responded inadequately to salicylates or other NSAIDs

What other drugs will affect sulfasalazine?

Other drugs may interact with sulfasalazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about sulfasalazine.
  • 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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2014-11-12, 4:13:52 PM.

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