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trademark for a preparation of sulfasalazine, used in the treatment of inflammatory bowel disease and rheumatoid arthritis.


APO Sulfasalazine (CA), Azulfidine, Azulfidine EN-tabs, PMS-Sulfasalazine (CA), PMS-Sulfasalazine-E.C. (CA), Salazopyrin (CA) (UK), Salazopyrin EN-Tabs (CA), SAS Tab (CA), Sulazine (UK), Sulfazine, Sulfazine EC

Pharmacologic class: Sulfonamide

Therapeutic class: Anti-infective, GI tract anti-inflammatory, antirheumatic

Pregnancy risk category B


Unknown. Thought to inhibit prostaglandin synthesis by interfering with secretions in colon and causing local anti-inflammatory action.


Tablets: 500 mg

Tablets (Azulfidine EN-tabs-delayed-release, enteric-coated): 500 mg

Indications and dosages

Ulcerative colitis

Adults: Initially, 1 to 2 g P.O. daily in equally divided doses q 6 to 8 hours, then 3 to 4 g P.O. daily in equally divided doses q 6 to 8 hours. For maintenance, 500 mg q 6 hours.

Children ages 6 and older: 40 to 60 mg/kg P.O. daily in three to six divided doses. For maintenance, 30 mg/kg P.O. q 6 hours in four divided doses.

Acute rheumatoid arthritis

Adults: Initially, 500 mg to 1 g (delayed-release) P.O. daily for 1 week; then increase by 500 mg/day P.O. q week up to 2 g/day in two divided doses. If no benefit after 12 weeks, increase to 3 g/day given in two divided doses.

Polyarticular-course juvenile rheumatoid arthritis

Children ages 6 and older: 30 to 50 mg/kg P.O. daily in two evenly divided doses. Maximum dosage is 2 g daily.

Off-label uses

• Ankylosing spondylitis
• Crohn's disease
• Psoriatic arthritis


• Hypersensitivity to drug, its metabolites, other sulfonamides, or salicylates
• Porphyria
• Urinary tract or intestinal obstruction


Use cautiously in:
• renal or hepatic disease, bronchial asthma, G6PD deficiency, group A beta-hemolytic streptococcal infections, blood dyscrasias
• history of multiple allergies
• pregnant or breastfeeding patients
• children younger than age 2.


• Give after meals and space doses evenly to reduce GI effects.
• Give with a full glass of water.
• Administer delayed-release tablets whole. Don't let patient crush or chew them.

Adverse reactions

CNS: headache, depression, hallucinations, insomnia, drowsiness, vertigo, fatigue, apathy, anxiety, ataxia, polyneuritis, peripheral neuropathy, seizures

CV: allergic myocarditis or pericarditis

EENT: periorbital edema, optic neuritis, transient myopia, tinnitus

GI: nausea, vomiting, abdominal pain, stomatitis, glossitis, pancreatitis, dry mouth, anorexia, pseudomembranous colitis

GU: hematuria, proteinuria, orange-yellow urine, reversible oligospermia, crystalluria, toxic nephrosis with oliguria and anuria, renal failure

Hematologic: megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia

Hepatic: jaundice, hepatitis, hepato-cellular necrosis

Respiratory: shortness of breath, pleuritis, cyanosis, allergic pneumonitis, pulmonary infiltrates, fibrosing alveolitis

Skin: generalized skin eruption, urticaria, pruritus, alopecia, local irritation, orange-yellow skin discoloration, exfoliative dermatitis, photosensitivity reaction, erythema multiforme, epidermal necrolysis, Stevens-Johnson syndrome

Other: reversible immunoglobulin suppression, chills, drug fever, hypersensitivity reactions including anaphylaxis, serum sickness, lupuslike syndrome


Drug-drug.Digoxin, folic acid: reduced absorption of these drugs

Drug-diagnostic tests.Bilirubin, blood urea nitrogen, creatinine, eosinophils, transaminases: increased levels

Granulocytes, hemoglobin, platelets, white blood cells: decreased levels

Urine glucose test: false-positive result

Drug-food.Folic acid: decreased folic acid absorption

Drug-herbs.Dong quai, St. John's wort: increased risk of photosensitivity

Drug-behaviors.Sun exposure: increased risk of photosensitivity

Patient monitoring

Monitor CBC with white cell differential. Watch for evidence of blood dyscrasias.

Stay alert for signs of erythema multiforme. Report early signs before condition can progress to Stevens-Johnson syndrome.
• Monitor patient for signs and symptoms of superinfection, including fever, tachycardia, and chills.

Monitor liver function tests; watch for signs and symptoms of hepatitis.

Check kidney function tests weekly. Evaluate patient's fluid intake, urine output, and urine pH. Report hematuria, oliguria, or anuria right away.
• Monitor neurologic status. Report seizures, hallucinations, or depression.
• If patient takes drug for rheumatoid arthritis, monitor therapeutic response 4 to 12 weeks after therapy begins.

Patient teaching

• Tell patient to take on regular schedule as prescribed, along with a full glass of water. Instruct him to drink plenty of fluids to minimize crystal formation in urine.
• Urge patient to complete full course of treatment, even if he feels better after a few days.

Instruct patient to watch for and immediately report signs and symptoms of hypersensitivity reaction, especially rash.

Tell patient drug can cause blood disorders, GI and liver problems, serious skin reactions, and other infections. Describe key warning signs and symptoms (easy bruising or bleeding, severe diarrhea, unusual tiredness, yellowing of skin or eyes, sore throat, rash, cough, mouth sores, fever). Instruct him to report these right away.

Advise patient to promptly report scant or bloody urine or inability to urinate.
• Instruct patient to contact prescriber if he develops depression.
• Teach patient effective ways to counteract photosensitivity effect. Tell him that dong quai and St. John's wort increase phototoxicity risk and should be avoided during therapy.
• Inform patient that drug may discolor skin and body fluids orange-yellow and may permanently stain contact lenses.
• Advise female patient to inform pre-scriber if she is pregnant. Caution her not to take drug near term or when breastfeeding.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.


A trademark for the drug sulfasalazine.


a trademark for a sulfonamide antibacterial (sulfasalazine) used to treat ulcerative colitis and rheumatoid arthritis.
References in periodicals archive ?
CELEBREX(R), ARTHROTEC(R), and AZULFIDINE EN-tabs(R) are registered trademarks of Pharmacia Corporation.
The FDA's approval of AZULFIDINE EN-tabs for juvenile rheumatoid arthritis gives clinicians in pediatric rheumatology an important new option to effectively manage this condition," said Arthur Weaver, M.
In the treatment of adult RA, sulfasalazine, the active ingredient in AZULFIDINE EN-tabs, has been classified by the American College of Rheumatology as part of a group of compounds called disease-modifying anti-rheumatic drugs (DMARDs).
Patients with intestinal or urinary obstructions, porphyria (pigment disorder) or hypersensitivity to sulfasalazine, sulfonamides or salicylates, should not use AZULFIDINE EN-tabs.
AZULFIDINE EN-tabs is a registered trademark of Pharmacia.
Blitzer, MGI PHARMA's president and chief executive officer said, "MGI's field sales force is now fully trained for promoting Azulfidine EN-tabs to the rheumatology community and is excited about its growth potential in the United States.
Clinical studies have proven that Azulfidine EN-tabs can significantly improve morning stiffness, grip strength and pain.
Factors that might cause such differences include, but are not limited to the success or failure of various sales and marketing programs related to Azulfidine EN-tabs, future revenues and earnings associated with Azulfidine EN-tabs, and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission.
Blitzer, MGI PHARMA's president and chief executive officer, stated: "By entering into this co-promotion arrangement for Azulfidine EN-tabs with Pharmacia & Upjohn, we have further strengthened our commercial presence in the rheumatology marketplace.
Azulfidine EN-tabs, which are already available for the treatment of RA in 43 countries including the United Kingdom, Canada, Germany, Sweden and France, have been available in the U.
Azulfidine EN-tabs have been shown to be effective and generally well- tolerated when used in combination therapy with salicylates or other NSAIDs.
In clinical trials, the effects of Azulfidine EN-tabs were measured by the degree of improvement in the number and extent of actively inflamed joints.