Monograph Details
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Gastrointestinal Tract
> Colorectal disorders
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AZULFIDINE |
| Manufacturer |
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Pfizer Labs |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Salicylate-sulfonamide. |
| Generic Name |
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Sulfasalazine 500mg; scored tabs. |
| Also |
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• AZULFIDINE EN-tabs
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| Indications |
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Ulcerative colitis. |
| Children |
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<2yrs: not recommended. ≥2yrs: initially 40–60mg/kg per day in 3–6 doses. Maintenance: 30mg/kg per day in 4 doses. |
| Adults |
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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. |
| Contraindications |
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Intestinal or urinary obstruction. Porphyria. |
| Precautions |
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Hepatic or renal dysfunction or blood dyscrasias: usually not recommended. Discontinue if toxic or hypersensitivity reactions occur. Severe allergy. Asthma. G6PD deficiency. Lack of intestinal esterases. 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, renal function, and serum sulfapyridine periodically. Maintain adequate hydration. Continue medication after symptoms controlled. See literature for desensitizing regimen. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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Reduces absorption of digoxin, folic acid. |
| Adverse Reactions |
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Anorexia, headache, GI upset, oligospermia, infertility in men, pruritus, urticaria, rash, fever, hemolytic anemia, other blood dyscrasias, urine or skin discoloration, cyanosis; CNS, renal, or hypersensitivity reactions. |
| How Supplied |
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Tabs—100, 300 |
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