Sulfasalazine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat inflammation in the large intestine caused by colitis, or to treat rheumatoid arthritis. Take it exactly as directed.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a severe skin reaction or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: anti-inflammatory

Generic and brand names: sulfasalazine, oral; Azulfidine; Azulfidine EN-tabs; Sulfazine; Sulfazine EC

What is this medicine used for?

This medicine is used to treat inflammation in the bowel (large intestine) caused by colitis. It is also used to treat rheumatoid arthritis when other treatments fail.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis
• A blood disorder such as G6PD
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Asthma or severe allergies
• Kidney or liver disease
• Porphyria (nerve pain or sensitivity to sunlight)
• Trouble urinating or an enlarged prostate gland

Tell your healthcare provider if you currently have an infection such as the flu or an open cut or sore, or if you often have infections that come back.

Males: This medicine may cause your body to make less sperm than normal. You may not be able to father a child while you are using this medicine. Your sperm should go back to normal after you stop using this medicine. Talk with your healthcare provider about this.

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine for the length of time prescribed, even if you feel better.

Check with your healthcare provider before using this medicine in children under age 6.

This medicine comes in several forms. Enteric-coated tablets must be swallowed whole to be effective. Do not crush or chew them. Your pharmacist can tell you if you are taking enteric-coated tablets.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Take it with a full glass of water (8 ounces). Unless your healthcare provider tells you otherwise, drink more liquids to help prevent side effects.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: dizziness, loss of appetite, nausea, vomiting, stomach pain, yellowing of your skin or eyes, decreased urination, fever, drowsiness, seizures.

What should I watch out for?

This medicine increases your risk for infections. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

Rarely, this medicine may cause a severe skin reaction. If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away. This reaction will continue for some time after you stop taking the medicine.

If your symptoms do not improve in a few weeks, contact your healthcare provider.

Your skin or urine may turn an orange or yellow color while you are using this medicine. This is temporary. This medicine may permanently discolor contact lenses.

You will need to have blood and urine tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat), blistering, peeling and red skin rash.

Serious (Report these to your healthcare provider right away.): Joint or muscle pain; fever; sore throat; blood in urine; trouble urinating; yellowing of your skin or eyes; weakness; severe blistering, peeling, red skin rash; unusual bruising or bleeding.

Other: Diarrhea, dizziness, nausea, vomiting, headache, loss of appetite, pale skin.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cancer medicines such as mercaptopurine (Purinethol) and thioguanine (Tabloid)
• Diabetes medicines such as glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as chlorothiazide (Diuril) and hydrochlorothiazide (Microzide)
• Folic acid or folate
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Iron supplements or multivitamins that contain iron, and iron medicines such as ferric carboxymaltose (Injectafer), ferric gluconate (Ferrlecit), ferumoxytol (Feraheme), and iron sucrose (Venofer)
• Methenamine (Hiprex, Urex)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natural remedies such as dong quai and St. John's wort
• Phenytoin (Dilantin, Phenytek)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.