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AZULFIDINE EN-tabs
Arthritis/rheumatic disorders
Colorectal disorders
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Drug Name:

AZULFIDINE EN-tabs Rx

Generic Name and Formulations:
Sulfasalazine 500mg; e-c tabs.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for AZULFIDINE EN-tabs:

Rheumatoid arthritis or polyarticular JRA that has responded inadequately to salicylates or other NSAIDs.

Adult:

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:

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.

Contraindications:

Intestinal or urinary obstruction. Porphyria. Sulfonamide or salicylate allergy.

Warnings/Precautions:

Hepatic or renal dysfunction or blood dyscrasias: usually not recommended. Discontinue if toxic or hypersensitivity reactions occur, or if EN-tabs passed undisintegrated. 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 (Cat.B). Nursing mothers: not recommended.

Interactions:

Reduces absorption of digoxin, folic acid. May cause false (+) test results in urinary normetanephrine.

Pharmacological Class:

DMARD (salicylate-sulfonamide).

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, or severe hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS), hepatotoxicity. Children: also serum sickness reaction.

How Supplied:

Tabs—100, 300

Indications for AZULFIDINE EN-tabs:

Treatment of mild-to-moderate ulcerative colitis. Adjunct in severe ulcerative colitis. To prolong the remission period between acute attacks of ulcerative colitis.

Adult:

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:

<6yrs: not established. ≥6yrs: initially 40–60mg/kg per day in 3–6 doses. Maintenance: 30mg/kg per day in 4 doses.

Contraindications:

Intestinal or urinary obstruction. Porphyria. Sulfonamide or salicylate allergy.

Warnings/Precautions:

Hepatic or renal dysfunction or blood dyscrasias: usually not recommended. Discontinue if toxic or hypersensitivity reactions occur, or if EN-tabs passed undisintegrated. 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 (Cat.B). Nursing mothers: not recommended.

Interactions:

Reduces absorption of digoxin, folic acid. May cause false (+) test results in urinary normetanephrine.

See Also:

AZULFIDINE

Pharmacological Class:

Salicylate-sulfonamide.

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, or severe hypersensitivity reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS), hepatotoxicity.

How Supplied:

Tabs—100, 300

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