Names and pronunciation
(sul-fa-sal′a-zeen) Azulfidine, Azulfidine EN-tabs
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Drug reference
(sul-fa-sal′a-zeen) Azulfidine, Azulfidine EN-tabs
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Func. class.: GI antiinflammatory, antirheumatic (DMARD)
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Chem. class.: Sulfonamide
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Do not confuse: sulfaSALAzine/sulfiSOXAZOLE
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ACTION: Prodrug to deliver sulfapyri- dine and 5-aminosalicylic acid to colon; antiinflammatory in connective tissue also
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USES: Ulcerative colitis; RA; juvenile RA (Azulfidine EN-tabs)
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Unlabeled uses: Crohn’s disease
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CONTRAINDICATIONS: Preg- nancy at term, children <2 yr; hypersen- sitivity to sulfonamides or salicylates; intestinal, urinary obstruction; porphyria Precautions: Pregnancy, breastfeeding, impaired renal/hepatic function, severe allergy, bronchial asthma, megaloblastic anemia
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SIDE EFFECTS CNS: Headache, neuropathy GI: Nausea, vomiting, abdominal pain, stomatitis, hepatitis, glossitis, pancreati- tis, diarrhea GU: Orange-colored urine HEMA: Leukopenia, neutropenia, throm- bocytopenia, agranulocytosis, hemolytic anemia INTEG: Rash, dermatitis, urticaria, Stevens-Johnson syndrome, erythema, photosensitivity SYST: Anaphylaxis
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INTERACTIONS Increase: leukopenia risk—thiopurines (azaTHIOprine, mercaptopurine) Increase: hypoglycemic response—oral hypoglycemics Increase: anticoagulant effects—oral anticoagulants Decrease: effect of cycloSPORINE, digoxin, folic acid Decrease: renal excretion of methotrexate Drug/Food Decrease: iron/folic acid absorption Drug/Lab Test False positive: urinary glucose test
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DOSAGE AND ROUTES Ulcerative colitis • Adult: PO 3-4 g/day in divided doses; maintenance 2 g/day in divided doses q6hr • Child ≥2 yr: PO 40-60 mg/kg/day in 4-6 divided doses, then 30 mg/kg/day in 4 doses, max 2 g/day Rheumatoid arthritis • Adult: PO 0.5-1 g/day, then increase daily dose by 500 mg/wk to 2 g/day in 2-3 divided doses Juvenile rheumatoid arthritis • Child ≥6 yr: PO 30-50 mg/kg/24 hr in 2 divided doses Renal dose • Modify dose based on renal impair- ment, response Crohn’s disease (unlabeled) • Adult: PO 1 g/15 kg, max 5 g/day
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Available forms: Tabs 500 mg; oral susp 250 mg/5 mL; del rel tabs 500 mg
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Administer: • Do not break, crush, chew del rel tabs • With full glass of water to maintain adequate hydration; increase fluids to 2 L/day to decrease crystallization in kidneys • Total daily dose in evenly spaced doses and after meals to help minimize GI intol- erance • Store in tight, light-resistant container at room temperature
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Assess: • Ulcerative colitis, proctitis, other in- flammatory bowel disease: character, amount, consistency of stools; abdominal pain, cramping, blood, mucus • Rheumatoid arthritis: assess mobility, joint swelling, pain, ability to complete activities of daily living • Renal studies: BUN, creatinine, urinal- ysis (long-term therapy) • Blood dyscrasias: skin rash, fever, sore throat, bruising, bleeding, fatigue, joint pain; monitor CBC before therapy and q3mo • Allergic reaction: rash, dermatitis, ur- ticaria, pruritus, dyspnea, bronchospasm; identify sulfa, salicylate allergy • Pregnancy/breastfeeding: use only if clearly needed; cautious use in breastfeeding, excreted in breast milk
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Evaluate: • Therapeutic response: absence of fe- ver, mucus in stools, pain in joints
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To take each oral dose with full glass of water to prevent crystalluria • That contact lenses, urine, skin may be yellow-orange • To avoid sunlight or use sunscreen to prevent burns • To notify prescriber of skin rash, sore throat, fever, mouth sores, unusual bruis- ing, bleeding S • That decreased sperm production may occur; that it resolves after completion of medication • To notify prescriber if enteric-coated tab- lets are seen in stool; discontinue if present
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PHARMACOKINETICS PO: Partially absorbed; peak 1½-6 hr; duration 6-12 hr; half-life 6 hr; excreted in urine as sulfaSALAzine (15%), sulfa- pyridine (60%), 5-aminosalicylic acid, metabolites (20%-33%); excreted in breast milk; crosses placenta
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• Child ≥2 yr: PO 40-60 mg/kg/day in 4-6 divided doses, then 30 mg/kg/day in 4 doses, max 2 g/day Rheumatoid arthritis
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• Child ≥6 yr: PO 30-50 mg/kg/24 hr in 2 divided doses Renal dose
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