SULFASALAZINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Azulfidine
• Azulfidine EN-Tabs

In Canada?

• Alti-Sulfasalazine
• PMS-Sulfasalazine
• PMS-Sulfasalazine E.C.
• Salazopyrin
• Salazopyrin EN-Tabs
• S.A.S.-500
• S.A.S. Enteric-500

Generic name product may be available in the U.S. and Canada.

Other commonly used names are salazosulfapyridine, salicylazosulfapyridine, and sulphasalazine.

Category

• Antirheumatic, disease-modifying
• Bowel disease, inflammatory, suppressant

Description

Sulfasalazine (sul-fa-SAL-a-zeen), a sulfa medicine,is used to prevent and treat inflammatory bowel disease, such as ulcerativecolitis. It works inside the bowel by helping to reduce the inflammation andother symptoms of the disease. Sulfasalazine is sometimes given with othermedicines to treat inflammatory bowel disease.

Sulfasalazine is also used to treat rheumatoid arthritis in patients whohave not been helped by or who cannot tolerate other medicines for rheumatoidarthritis.

Sulfasalazine is available only with your doctor's prescription, in thefollowing dosage forms:

Oral
• Tablets (U.S. and Canada)
• Enteric-coated tablets (U.S. and Canada)

Rectal
• Enema (Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For sulfasalazine, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to any of the sulfa medicines, furosemide (e.g., Lasix)or thiazide diuretics (water pills), oral antidiabetics (diabetes medicineyou take by mouth), glaucoma medicine you take by mouth (for example, acetazolamide[e.g., Diamox], dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazane]),or salicylates (for example, aspirin). Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Sulfasalazine has not been studied in pregnant women.However, reports on women who took sulfasalazine during pregnancy have notshown that it causes birth defects or other problems. In addition, sulfasalazinehas not been shown to cause birth defects in studies in rats and rabbits givendoses of up to 6 times the human dose.

Breast-feeding?Sulfa medicines pass into the breast milk in smallamounts and have been shown to cause unwanted effects in nursing babies withglucose-6-phosphate dehydrogenase (G6PD) deficiency. It may be necessary foryou to take another medicine or to stop breast-feeding during treatment. Besure you have discussed the risks and benefits of the medicine with your doctor.

Children?Sulfasalazine should not be used in children up to2 years of age because it may cause brain problems. However, sulfasalazinehas not been shown to cause different side effects or problems in childrenover the age of 2 years than it does in adults.

Older adults?This medicine has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingsulfasalazine, it is especially important that your health care professionalknow if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g.,Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Ethionamide (e.g., Trecator-SC) or
• Etretinate (e.g., Tegison) or
• Fat emulsions, intravenous (e.g., Intralipid) (with prolonged use)or
• Fluconazole (e.g., Diflucan) or
• Gold salts (medicine for arthritis) or
• Inflammation or pain medicine, except narcotics or
• Iron (with overdose) or
• Labetalol (e.g., Normodyne) or
• Lovastatin (e.g., Mevacor) or
• Mercaptopurine (e.g., Purinethol) or
• Methimazole (e.g., Tapazole) or
• Naltrexone (e.g., ReVia) (with long-term, high-dose use) or
• Niacin (with high doses, sustained release, and antihyperlipidemicuse) or
• Nitrofurans or
• Other anti-infectives by mouth or by injection (medicine for infection)or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g.,Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil],perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine[e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine[e.g., Temaril]) or
• Plicamycin (e.g., Mithracin) or
• Pravastatin (e.g., Pravachol) or
• Propylthiouracil (e.g., Propyl-Thyracil) or
• Simvastatin (e.g., Zocor) or
• Troleandomycin or
• Valproic acid (e.g., Depakene) or
• Vitamin A (with chronic overdose)?Use of sulfasalazine withthese medicines may increase the chance of side effects affecting the liver

• Acetohydroxamic acid (e.g., Lithostat) or
• Dapsone or
• Furazolidone (e.g., Furoxone) or
• Menadiol (e.g., Synkavite) or
• Nitrofurantoin (e.g., Furadantin) or
• Primaquine or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Quinine (e.g., Quinamm) or
• Sulfoxone (e.g., Diasone)?Use of sulfasalazine with these medicinesmay increase the chance of side effects affecting the blood

• Anticoagulants (blood thinners) or
• Ethotoin (e.g., Peganone) or
• Mephenytoin (e.g., Mesantoin)?Use of sulfasalazine with thesemedicines may increase the chance of side effects of these medicines

• Antidiabetics, oral (diabetes medicine you take by mouth)?Useof oral antidiabetics with sulfasalazine may increase the chance of side effectsaffecting the blood and/or increase the side effects of oral antidiabetics

• Methotrexate (e.g., Mexate)?Use of methotrexate with sulfasalazinemay increase the chance of side effects affecting the liver and/or increasethe side effects of methotrexate

• Methyldopa (e.g., Aldomet)?Use of methyldopa with sulfasalazinemay increase the chance of side effects affecting the liver and/or the blood

• Phenytoin (e.g., Dilantin)?Use of phenytoin with sulfasalazinemay increase the chance of side effects affecting the liver and/or increasethe side effects of phenytoin

Other medical problems?The presence of other medicalproblems may affect the use of sulfasalazine. Make sure you tell your doctorif you have any other medical problems, especially:

• Allergies, severe or
• Asthma, bronchial?The risk of an allergic reaction to sulfasalazinemay be increased
• Blood problems or
• Glucose-6-phosphate dehydrogenase deficiency (lack of G6PD enzyme)?Patientswith these problems may have an increase in side effects affecting the blood

• Intestinal blockage?Sulfasalazine will not reach the site ofaction in the bowel

• Kidney disease or
• Liver disease?Patients with kidney disease or liver diseasemay have an increased chance of side effects

• Porphyria?Use of sulfasalazine may cause an attack of porphyria

• Urinary blockage?Sulfasalazine may not be eliminated properly,causing an increased risk of side effects

Proper Use of This Medicine

Do not give sulfasalazine to infants and children up to 2 years of age,unless otherwise directed by your doctor. It may cause brain problems.

Sulfasalazine is best taken right after meals or with food to lessen stomachupset. If stomach upset continues or is bothersome, check with your doctor.

Each dose of sulfasalazine should also be taken witha full glass (8 ounces) of water. Several additional glasses of water shouldbe taken every day, unless otherwise directed by your doctor. Drinkingextra water will help to prevent some unwanted effects of the sulfa medicine.

For patients taking the enteric-coated tabletform of this medicine:

• Swallow tablets whole. Do not break or crush.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Dosing?The dose of sulfasalazine will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of sulfasalazine. If your dose is different,do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are taking sulfasalazine.

• For prevention or treatment of inflammatory bowel disease:
  • For oral dosage forms (tablets, enteric-coatedtablets):
    • Adults and teenagers?To start, 500 milligrams (mg) to 1000mg (1 gram) every six to eight hours. Your doctor may then decrease the doseto 500 mg every six hours. Later, your doctor may change your dose as needed.
    • Children 2 years of age and over?Dose is based on body weightand must be determined by your doctor.
      • To start, the dose is usually:
        • 6.7 to 10 mg per kilogram (kg) (3.05 to 4.55 mg per pound) of bodyweight every four hours or
        • 10 to 15 mg per kg (4.55 to 6.82 mg per pound) of body weight everysix hours or
        • 13.3 to 20 mg per kg (6.05 to 9.09 mg per pound) of body weight everyeight hours.
      • Then, the dose is usually 7.5 mg per kg (3.41 mg per pound) of bodyweight every six hours.
    • Infants and children up to 2 years of age?Use is not recommended.
  • For rectal dosage form (enema):
    • Adults and teenagers?3 grams (1 unit), used rectally as directed,every night.
    • Children 2 years of age and over?Dose must be determined byyour doctor.
    • Infants and children up to 2 years of age?Use is not recommended.
• For treatment of rheumatoid arthritis:
  • For oral dosage forms (tablets, enteric-coatedtablets):
    • Adults and teenagers?To start, 500 mg to 1000 mg (1 gram) daily.Your doctor may increase your dose as needed, but the dose is generally notmore than 3000 mg (3 grams) a day.
    • For children ages 6 and over?30 to 50 mg per kg of body weightdaily, divided into two doses. The medicine is usually started at a loweramount and gradually increased to the actual amount over a month. Typicallythe amount that is needed does not exceed 2 grams per day. The dose must bedetermined by your doctor.
    • Infants and children up to 2 years of age?Use is not recommended.

Missed dose?If you do miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, nearthe kitchen sink, or in other damp places. Heat or moisture may cause themedicine to break down.
• Keep the enema form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits. This medicine may cause blood problems, especiallyif it is taken for a long time.

If your symptoms (including diarrhea) do not improve within 1 or 2 months,or if they become worse, check with your doctor.

Sulfasalazine may cause blood problems. These problems may result in agreater chance of certain infections, slow healing, and bleeding of the gums.Therefore, you should be careful when using regular toothbrushes, dental floss,and toothpicks. Dental work should be delayed until your blood counts havereturned to normal. Check with your medical doctor or dentist if you haveany questions about proper oral hygiene (mouth care) during treatment.

Sulfasalazine may cause your skin to be more sensitive to sunlight thanit is normally. Exposure to sunlight, even for brief periods of time, maycause a skin rash, itching, redness or other discoloration of the skin, ora severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF)of at least 15. Some patients may require a product with a higher SPF number,especially if they have a fair complexion. If you have any questions aboutthis, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check withyour doctor.

This medicine may also cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines,or do anything else that could be dangerous if you are dizzy. If thisreaction is especially bothersome, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you aretaking this medicine. The results of the bentiromide (e.g., Chymex) test forpancreas function are affected by this medicine.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your doctorimmediately if any of the following side effects occur:

More common

Aching of joints; fever; headache (continuing); itching; skin rash; vomiting

Less common or rare

Aching of joints and muscles; back,leg, or stomach pains; bloody diarrhea; bluish fingernails, lips, or skin; chest pain; cough; difficultbreathing; difficulty in swallowing; chills, or sore throat; general feelingof discomfort or illness; loss of appetite; pale skin; redness, blistering, peeling,or loosening of skin; unusual bleeding or bruising; unusual tiredness or weakness; yellow eyes or skin

Also, check with your doctor as soon as possible if the followingside effect occurs:

More common

Increased sensitivity of skin to sunlight

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

More common

Abdominal or stomach pain or upset; diarrhea; loss of appetite; nausea

In some patients this medicine mayalso cause the urine or skin to become orange-yellow. This side effect doesnot need medical attention.

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, sulfasalazine is used in certain patients with the following medicalconditions:

• Ankylosing spondylitis

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.