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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.
• Ankylosing spondylitis
• Crohn's disease
• Psoriatic arthritis
• Hypersensitivity to drug, its metabolites, other sulfonamides, or salicylates
• 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.
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
☞ 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.
• 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.
Azulfidine EN-tabs(trade name),
Time/action profile (blood levels)
|PO||1 hr||1.5–6 hr||6–12 hr|
Adverse Reactions/Side Effects
Central nervous system
- headache (most frequent)
- anorexia (most frequent)
- diarrhea (most frequent)
- nausea (most frequent)
- vomiting (most frequent)
- drug-induced hepatitis
- orange-yellow discoloration of urine
- exfoliative dermatitis (life-threatening)
- stevens-johnson syndrome (life-threatening)
- toxic epidermal necrolysis (life-threatening)
- rash (most frequent)
- yellow discoloration
- agranulocytosis (life-threatening)
- aplastic anemia (life-threatening)
- blood dyscrasias
- hemolytic anemia
- megaloblastic anemia
- peripheral neuropathy
- angioedema (life-threatening) hypersensitivity reactions including:
- anaphylaxis (life-threatening)
- fever (most frequent)
Drug-Drug interactionMay ↑ action/risk of toxicity from oral hypoglycemic agents, phenytoin, methotrexate, zidovudine, or warfarin.↑ risk of drug-induced hepatitis with other hepatotoxic agents.↑ risk of crystalluria with methenamine.May ↓ metabolism and increase effects/toxicity of mercaptopurine or thioguanine.May ↓ iron and folic acid absorption.
Availability (generic available)
- Assess patient for allergy to sulfonamides and salicylates. Therapy should be discontinued if rash, difficulty breathing, swelling of face or lips, or fever occur.
- Monitor intake and output ratios. Fluid intake should be sufficient to maintain a urine output of at least 1200–1500 mL daily to prevent crystalluria and stone formation.
- Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia.
- Ulcerative Colitis: Assess abdominal pain and frequency, quantity, and consistency of stools at the beginning of and during therapy.
- Rheumatoid Arthritis: Assess range of motion and degree of swelling and pain in affected joints before and periodically during therapy.
- Lab Test Considerations: Monitor urinalysis, BUN, and serum creatinine before and periodically during therapy. May cause crystalluria and urinary cell calculi formation.
- Lab Test Considerations: Monitor CBC with differential and liver function tests before and every second wk during first 3 mo of therapy, monthly during the second 3 mo, and every 3 mo thereafter of as clinically indicated Discontinue sulfasalazine if blood dyscrasias occur.
- Lab Test Considerations: Serum sulfapyridine levels may be monitored; concentrations >50 μg/mL may be associated with increased incidence of adverse reactions.
Potential Nursing DiagnosesAcute pain (Indications)
- Do not confuse sulfasalazine with sulfadiazine.
- Varying dosing regimens of sulfasalazine may be used to minimize GI side effects.
- Oral: Administer after meals or with food to minimize GI irritation, with a full glass of water. Do not crush or chew enteric-coated tablets.
- Instruct patient on the correct method of administration. Advise patient to take medication as directed, even if feeling better. Take missed doses as soon as remembered unless almost time for next dose.
- May cause dizziness. Caution patient to avoid driving or other activities that require alertness until response to medication is known.
- Advise patient to notify health care professional if skin rash, sore throat, fever, mouth sores, unusual bleeding or bruising, wheezing, fever, or hives occur.
- Caution patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
- Inform patient that this medication may cause orange-yellow discoloration of urine and skin, which is not significant. May permanently stain contact lenses yellow.
- Instruct patient to notify health care professional if symptoms worsen or do not improve. If symptoms of acute intolerance (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) occur, discontinue therapy and notify health care professional immediately.
- Inform male patient that sulfasalazine may cause infertility.
- Instruct patient to notify health care professional if symptoms do not improve after 1–2 mo of therapy.
- Decrease in diarrhea and abdominal pain.
- Return to normal bowel pattern in patients with ulcerative colitis. Effects may be seen within 3–21 days. The usual course of therapy is 3–6 wk.
- Maintenance of remission in patients with ulcerative colitis.
- Decrease in pain and inflammation and increase in mobility in patients with rheumatoid arthritis.