Azulfidine (Sulfasalazine)
Class and Category of Drug
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Chemical class: Salicylate, sulfonamide
Therapeutic class: Anti-inflammatory, antirheumatic, immunomodulator
Pregnancy category: B
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Drug Indications and Dosages
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To treat inflammatory bowel diseases, such as ulcerative colitis, and to maintain or prolong remission
Delayed-Release Tablets,Tablets
Adults and adolescents. Initial: 500 to 1,000 mg every 6 to 8 hr. Or 500 mg every 6 to 12 hr to decrease adverse gastrointestinal reactions. Maintenance: 500 mg every 6 hr. Children over age 6. Initial: 6.7 to 10 mg/kg every 4 hr, 10 to 15 mg/kg every 6 hr, or 13.3 to 20 mg/kg every 8 hr. Maintenance: 7.5 mg/kg every 6 hr.
To treat rheumatoid arthritis
Delayed-Release Tablets,Tablets
Adults. Initial: 500 to 1,000 mg daily during wk 1, increased by 500 mg daily every wk, as needed, up to 2,000 mg daily in divided doses. If no response after 12 wk, increased to 3,000 mg daily. Maintenance: 1,000 mg every 12 hr. Maximum: 3,000 mg daily.
To treat juvenile rheumatoid arthritis in patients who have not responded to salicylates or other NSAIDs
Delayed-Release Tablets
Children ages 6 to 16. 30 to 50 mg/kg daily in divided doses b.i.d. Maximum: 2 g daily.
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Contraindications of Drug
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Hypersensitivity to salicylates, sulfasalazine, sulfonamides, chemically related drugs, or their components; intestinal or urinary obstruction; porphyria
Generic Drug Interactions
Drugs
bone marrow depressants: Increased leukopenic and thrombocytopenic effects of both drugs
digoxin: Possibly inhibited absorption and decreased blood level of digoxin
folic acid (vitamin B9): Decreased folic acid absorption
hepatotoxic drugs: Increased risk of hepatotoxicity
hydantoins, oral anticoagulants, oral antidiabetic drugs: Increased, prolonged, or toxic effects of these drugs
methotrexate, phenylbutazone, sulfinpyrazone: Possibly potentiated effects of these drugs
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Drugs Adverse Reactions
Central Nervous System: Ataxia, chills, depression, fatigue, fever, Guillain-Barre syndrome, headache, insomnia, meningitis, peripheral neuropathy, seizures, vertigo, weakness
Cardiovascular: Pericarditis, vasculitis
Eyes, Ears, Nose, And Throat: Hearing loss, orange-yellow tears, pharyngitis, tinnitus
Gastrointestinal: Abdominal pain, anorexia, cirrhosis, diarrhea, elevated liver enzymes, hepatitis, hepatotoxicity, indigestion, jaundice, nausea, pancreatitis, ulcerative colitis exacerbation, vomiting
Genitourinary: Crystalluria, decreased ejaculatory volume, male infertility, nephritis, nephrotic syndrome, orange-yellow urine, toxic nephrosis
Hematologic: Agranulocytosis, aplastic anemia, Heinz body or hemolytic anemia, leukopenia, neutropenia, thrombocytopenia, unusual bleeding or bruising
Musculoskeletal: Arthralgia, rhabdomyolysis
Respiratory: Cyanosis, idiopathic pulmonary fibrosis, lymphocytic interstitial pneumonitis, pleuritis
Skin: Alopecia, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, exfoliative dermatitis, epidermal necrolysis, photosensitivity, pruritus, purpura, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria OTHER: Anaphylaxis, lupus erythematosus-like syndrome, serum sickness syndrome
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Nursing Considerations for Generic Drugs
• Monitor CBC, liver function test results, and BUN and serum creatinine levels before and periodically during prolonged sulfasalazine therapy.
• Be aware that sulfasalazine doses over 4 g or a blood level over 50 mcg/ml increases the risk of adverse and toxic reactions.
• Monitor fluid intake and output and urine color, pH, and consistency. Acidic urine may require alkalization to prevent crystalluria.
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Sulfasalazine
Preparations
International Brand Drug Names
The information about drugs (tablets, pills, capsules, creams, solution, nasal spray, inhaler) around the world.
British Pharmacopoeia, 2008 edition: Sulfasalazine Tablets;
The United States Pharmacopeia 31, 2008: Sulfasalazine Delayed-release Tablets; Sulfasalazine Tablets.
Proprietary Preparations
Argentina: Azulfidine; Flogostop;
Australia: Pyralin; Salazopyrin;
Austria: Colo- Pleon; Salazopyrin;
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