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Sulfasalazine

Sulfasalazine is a sulfa drug used primarily in the treatment of inflammatory bowel disease. It is a 5-aminosalicylic acid derivative. It is sold as Azulfidine in the United States. It is also used for rheumatoid arthritis (see Disease-modifying antirheumatic drugs). It is usually not given to children under 2 years of age. more...

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Side effects

  1. diarrhea
  2. headache

Brand Names

  • Azulfidine ®
  • Salazopyrin ®
  • Pyralin ®

MIMS Guide to Sulfasalazine

Section: 1(d) Antidiarrhoeals Pregnancy Category: A

Sport Category: Permitted in sport

Uses/Indications: Ulcerative colitis; Inflammatory Bowel Syndrome; Crohn's disease; rheumatoid arthritis unresponsive to NSAIDs

Contraindications: Haematological, renal or hepatic dysfunction; hypersensitivity to salicylates or sulfonamide derivatives; GI or urinary tract obstruction; porphyria; children < 2 yrs

Precautions: Perform blood counts, urinalysis before and during treatment; maintain fluid intake; G-6-PD deficiency; atopy; slow acetylators; lactation

Adverse Reactions: Hypersensitivity; GI upset; fever; rash; headache; oligospermia; folate deficiency; others, see full PI

Drug Interactions: Oral anticoagulants; methotrexate; sulfonylurea hypoglycaemics; urinary acidifiers; phenylbutazone; indomethacin; sulfinpyrazone; salicylates; antacids, ferrous sulfate (concurrent); penicillins, oxacillin; some local anaesthetics; digoxin

PYRALIN EN (Tablets) Prescription required. S4 Sulfasalazine; yellow e-c tab; Dose: Should be taken with food. GI disease. Initial dosage. Adults: 1-2 g 4 times daily; children: 40-60 mg/kg daily in 3-6 divided doses. Maintenance. Adults: 2 g daily in 4 divided doses; children: 40 mg/kg daily in 4 divided doses. Rheumatoid arthritis. Adults: 1 g 2-3 times daily Pack: 500 mg x2 Brand substitution is permitted. : PBS/RPBS (Rp 5) PBS: $58.15

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Pharmacodynamics.

Sulfasalazine has, among others, an immunosuppressive effect and has shown affinity to connective tissue. It has also been shown to have a wide range of effects in other biological systems. It is, however, difficult to judge the clinical relevance of its various pharmacological actions since the aetiology of rheumatoid arthritis is largely unknown. Moreover, the mode of action of sulfasalazine in the treatment of ulcerative colitis is also not known. A metabolite of the drug may have an inhibitory effect on an antigen-antibody process occurring in the intestinal wall and the salicylate component may act as an anti-inflammatory agent. The drug does not appear to have any long-term antibacterial effect on the stool flora of patients with ulcerative colitis (see Antibacterial effect, below).

The following effects have been found in vitro: inhibition of bacterial growth; inhibition of prostaglandin synthesis; increased intestinal cytoprotection due to inhibition of prostaglandin degradation; reduction of leukotriene formation; modulation of polymorphonuclear leucocyte function; inhibition of proteolytic enzymes; inhibition of DNA synthesis; and impairment of folate absorption and metabolism.

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Sulfasalazine-induced pulmonary disease
From CHEST, 10/1/05 by Victor K. Salloum

INTRODUCTION: Sulfasalazine-induced pulmonary disease is a rare entity. We describe the first patient with psoriatic arthritis to develop pulmonary toxicity with unique pathology and an interesting clinical course.

CASE PRESENTATION: A 38 year old Caucasian woman with psoriatic arthritis presented with a five month history of progressively worsening dyspnea on exertion and dry cough. Of note, her psoriatic arthritis was initially diagnosed in September 2000, and sulfasalazine (3 grams/day) was started in October 2000. She was evaluated in February 2002, 17 months after her initial diagnosis, and 16 months after initiation of therapy. Initial pulse oximetry on room air was 95%, however with ambulation, desaturation to 91% was noted. Physical examination revealed bibasflar inspiratory crackles in the posterior lung fields and psoriatic plaques over the extensor surfaces of the elbows. Chest radiograph displayed bilateral patchy infiltrates in the lower lobes. Pulmonary function tests demonstrated restrictive lung disease with a significantly reduced diffusion capacity (44% of predicted). Subsequent chest computed tomography showed bilateral lower lobes ground glass alveolar opacities. Transbronchial biopsy revealed pulmonary parenchyma with the interstitium fraught with granulomas. Several granuloma giant cells contained refractile and calcified material, resembling Schaumann bodies. Stains and culture for acid fast bacilli and fungi were negative. Given the possibility of sulfasalazine toxicity, the medication was discontinued. Significant improvement of symptoms was noted within four days after cessation of the drug. Repeat pulmonary function tests two months after intervention demonstrated improvement of the total lung capacity and diffusion capacity (69% predicted). Repeat chest computed tomography also showed clearing of the ground glass opacities. Pulmonary function tests obtained three years after intervention showed a near normal diffusion capacity (74% of predicted).

DISCUSSIONS: Review of the literature between 1972 and 1999 identified 50 patients with possible sulfasalazine-induced lung toxicity. The daily dose of sulfasalazine ranged from 1 to 8 grams (mean of 3 grams). The average duration of exposure to sulfasalazine was 17.8 months with a range of 0.5 to 120 months. Sulfasalazine toxicity may present in a variety of distinct forms including: subacute cellular interstitial pneumonitis, pulmonary infiltrates with eosinophilia, desquamative interstitial pneumonia bronchiolitis obliterans organizing pneumonia, pulmonary, fibrosis, acute pulmonary edema, eosinophilic pleural effusion, pleural/ pericardial thickening or effusion with positive antinuclear/antihistone antibodies, and vasculitis. The majority of patients recovered after termination of the drug. Clinical improvement usually occurs between 1 and 32 weeks, with an average time of 6.5 weeks. In contrast, our patient rapidly improved in only four days after termination of the drug. Sequential pulmonary function tests up to three years after intervention clearly exhibited improvement and stabilization of lung function and diffusion capacity. More importantly, pathology demonstrating well formed granulomas and Schaumann bodies mimicking sarcoidosis has not previously been described.

CONCLUSION: Sulfasalazine-induced pulmonary disease may masquerade in different forms. The importance of early recognition remains paramount. Proper identification may not only spare the patient from severe lung damage, but also prevent an untimely death and unnecessary complications from other drug therapies. Prompt recognition of the disease, followed by immediate cessation of the drug, should result in an excellent prognosis.

DISCLOSURE: Rosa Estrada-Y-Martin, None.

Victor K. Salloum MD Sam Ancheril MD Rosa Estrada-Y-Martin MD * University of Texas Health Science Center Houston, Houston, TX

COPYRIGHT 2005 American College of Chest Physicians
COPYRIGHT 2005 Gale Group

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