Arthritis/rheumatic disorders:
Indications for: AZULFIDINE EN-tabs
Rheumatoid arthritis or polyarticular JRA that has responded inadequately to salicylates or other NSAIDs.
Adult Dosage:
Swallow whole after meals. Initially 500mg in the PM for 1 week, then 500mg in the AM & PM for 1 week, then 500mg in the AM and 1g in the PM for 1 week, then 1g in the AM and PM in 2 evenly divided doses.
Children Dosage:
Swallow whole after meals. <6yrs: not established. ≥6yrs: initially ¼ to ⅓ of maintenance dose; increase weekly. Maintenance: 30–50mg/kg per day in 2 evenly divided doses; max 2g/day.
AZULFIDINE EN-tabs Contraindications:
Intestinal or urinary obstruction. Porphyria. Sulfonamide or salicylate allergy.
AZULFIDINE EN-tabs Warnings/Precautions:
Hepatic or renal dysfunction or blood dyscrasias: usually not recommended. Discontinue if renal function deteriorates while on therapy, toxic or hypersensitivity reactions occur, or if EN-tabs passed undisintegrated. Discontinue at the 1st signs/symptoms of severe cutaneous adverse reactions. Monitor for signs/symptoms of infection before and after therapy; discontinue if serious infection develops. History of recurring or chronic infections. Underlying conditions or concomitant drugs which may predispose to infections. Severe allergy. Asthma. G6PD deficiency. Monitor CBCs, differential WBC, LFTs before starting, every other week for 1st 3 months, then once monthly for next 3 months, then once every 3 months; urinalysis, renal function, and serum sulfapyridine periodically; discontinue while awaiting blood test results. Maintain adequate hydration. Continue medication after symptoms controlled. See full labeling for desensitizing regimen. Elderly. Pregnancy. Nursing mothers: monitor infants.
AZULFIDINE EN-tabs Classification:
DMARD (salicylate-sulfonamide).
AZULFIDINE EN-tabs Interactions:
Reduces absorption of digoxin, folic acid. May cause false (+) test results in urinary normetanephrine.
Adverse Reactions:
Nausea, dyspepsia, rash, headache, abdominal pain, vomiting, fever, dizziness, stomatitis, pruritus, abnormal liver function tests, leukopenia, thrombocytopenia, oligospermia, infertility in men, hemolytic anemia, other blood dyscrasias, urine or skin discoloration, cyanosis; CNS, renal, hypersensitivity, or severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP), hepatotoxicity. Children: also serum sickness reaction.
Drug Elimination:
Renal (37%).
Generic Drug Availability:
YES
How Supplied:
Tabs—100, 300
Colorectal disorders:
Indications for: AZULFIDINE EN-tabs
Mild to moderate ulcerative colitis. Adjunct in severe ulcerative colitis. To prolong the remission period between acute attacks of ulcerative colitis.
Adult Dosage:
Initially 1–2g daily, increase gradually to 3–4g daily in equally divided doses after meals until symptoms controlled. Maintenance 2g daily; max 4g/day. Minimize gastric intolerance by using EN-tabs, dosing more frequently, reducing dose, or discontinuing for 5–7 days and restarting at lower dose. EN-tabs: swallow whole after meals.
Children Dosage:
<6yrs: not established. ≥6yrs: initially 40–60mg/kg per day in 3–6 doses. Maintenance: 30mg/kg per day in 4 doses.
AZULFIDINE EN-tabs Contraindications:
Intestinal or urinary obstruction. Porphyria. Sulfonamide or salicylate allergy.
AZULFIDINE EN-tabs Warnings/Precautions:
Hepatic or renal dysfunction or blood dyscrasias: usually not recommended. Discontinue if renal function deteriorates while on therapy, toxic or hypersensitivity reactions occur, or if EN-tabs passed undisintegrated. Discontinue at the 1st signs/symptoms of severe cutaneous adverse reactions. Monitor for signs/symptoms of infection before and after therapy; discontinue if serious infection develops. History of recurring or chronic infections. Underlying conditions or concomitant drugs which may predispose to infections. Severe allergy. Asthma. G6PD deficiency. Monitor CBCs, differential WBC, LFTs before starting, every other week for 1st 3 months, then once monthly for next 3 months, then once every 3 months; urinalysis, renal function, and serum sulfapyridine periodically; discontinue while awaiting blood test results. Maintain adequate hydration. Continue medication after symptoms controlled. See full labeling for desensitizing regimen. Elderly. Pregnancy. Nursing mothers: monitor infants.
See Also:
AZULFIDINE EN-tabs Classification:
Salicylate-sulfonamide.
AZULFIDINE EN-tabs Interactions:
Reduces absorption of digoxin, folic acid. May cause false (+) test results in urinary normetanephrine.
Adverse Reactions:
Anorexia, headache, nausea, vomiting, gastric distress, oligospermia, infertility in men, pruritus, urticaria, rash, fever, hemolytic anemia, other blood dyscrasias, urine or skin discoloration, cyanosis; CNS, renal, hypersensitivity, or severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP), hepatotoxicity.
Drug Elimination:
Renal (37%).
Generic Drug Availability:
YES
How Supplied:
Tabs—100, 300
