Azulfidine En-tabs

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Colorectal disorders

Azulfidine En-tabs Generic Name & Formulations

General Description

Sulfasalazine 500mg; e-c tabs.

Pharmacological Class

DMARD (salicylate-sulfonamide).

See Also

    How Supplied

    Tabs—100, 300

    Manufacturer

    Generic Availability

    YES

    Azulfidine En-tabs Indications

    Indications

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

    Azulfidine En-tabs Dosage and Administration

    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.

    Azulfidine En-tabs Contraindications

    Contraindications

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

    Azulfidine En-tabs Boxed Warnings

    Not Applicable

    Azulfidine En-tabs Warnings/Precautions

    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 Pharmacokinetics

    Metabolism

    Intestinal bacteria, hepatic. >99.3% plasma protein bound.

    Elimination

    Renal (37%).

    Azulfidine En-tabs Interactions

    Interactions

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

    Azulfidine En-tabs Adverse Reactions

    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.

    Azulfidine En-tabs Clinical Trials

    See Literature

    Azulfidine En-tabs Note

    Not Applicable

    Azulfidine En-tabs Patient Counseling

    See Literature

    Azulfidine En-tabs Generic Name & Formulations

    General Description

    Sulfasalazine 500mg; e-c tabs.

    Pharmacological Class

    Salicylate-sulfonamide.

    See Also

    How Supplied

    Tabs—100, 300

    Manufacturer

    Generic Availability

    YES

    Azulfidine En-tabs Indications

    Indications

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

    Azulfidine En-tabs Dosage and Administration

    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.

    Azulfidine En-tabs Contraindications

    Contraindications

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

    Azulfidine En-tabs Boxed Warnings

    Not Applicable

    Azulfidine En-tabs Warnings/Precautions

    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 Pharmacokinetics

    Metabolism

    Intestinal bacteria, hepatic. >99.3% plasma protein bound.

    Elimination

    Renal (37%).

    Azulfidine En-tabs Interactions

    Interactions

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

    Azulfidine En-tabs Adverse Reactions

    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.

    Azulfidine En-tabs Clinical Trials

    See Literature

    Azulfidine En-tabs Note

    Not Applicable

    Azulfidine En-tabs Patient Counseling

    See Literature