SULFASALAZINE

Indications & Dose:

Treatment of acute attack of mild to moderate and severe ulcerative colitis | Active Crohn’s disease

• BY MOUTH

 Adult: 1–2 g 4 times a day until remission occurs, corticosteroids may also be given, if necessary

• BY RECTUM

Adult: 0.5–1 g twice daily, administered alone or in conjunction with oral therapy, morning and night after a bowel movement continued.

Maintenance of remission of mild to moderate and severe ulcerative colitis

• BY MOUTH

Adult: 500 mg 4 times a day

• BY RECTUM

Adult: 0.5–1 g twice daily, administered alone or in conjunction with oral therapy, morning and night after a bowel movement.

Active rheumatoid arthritis (administered on expert advice)

BY MOUTH

 Adult: Initially 500 mg daily, increased in steps of 500 mg every week, increased to 2–3 g daily in divided doses, enteric coated tablets to be administered

Children: Over 2 years: Acute attack 40-60mg/kg body-wt. daily; maint.: 20-30mg/kg body-wt. daily in 4 div. doses.

Contraindications:

 Infants <2 yr, porphyria, intestinal or urinary tract obstructions

Side Effects:

Cautions:

Precautions:

Renal or hepatic function impairment, allergy or asthma, G 6 PD deficiency, blood dyscrasias, slow acetylator phenotypes,

Children, old age: May be used.

Pregnancy ; Excreted into breast milk; should be given to nursing mothers with caution because significant adverse effects (bloody diarrhea) may occur in some nursing infants

Interaction:

Drugs

Digoxin: Sulfasalazine reduces digoxin serum concentrations

Methenamine: Combination of sulfadiazine and methenamine can result in erystalluria

Phenytoin: Some sulfonamides (sulfaphenazole, sulmethoxazoie) increase phenytoin concentrations, requiring dosage adjustment

Tolbutamide: Several sulfonamides (sulfamethizole, sulfaphenazole, sulfisoxasole) can increase plasma sulfonylurea levels and enhance their hypoglycemic effects

Warfarin: Several sulfonamides (trimethoprim sulfamethoxazole, sulfamethoxazole, sulfamethizole, sulfaphenazole) increase the hypoprothrombinemic response to warfarin via inhibition of metabolism

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Ataxia, cauda equina syndrome, drowsiness, fever, Guillain Barre syndrome, hallucinations, headache, insomnia; mental depression, peril neuropathy, seizures, transient lesions of the posterior spinal column, transversemyelitis, vertigo

CV:  Allergic myocarditis, pericarditis with or without tamponade, vasculitis

EENT: Conjunctival and scleral infection, hearing loss, periorbital edema, tinnitus

GI: Abdominal pains, anorexia, bloody diarrhea, diarrhea, gastric distress, hepatic necrosis, hepatitis, impaired folic acid absorption, nausea, neutropenic enterocolitis, pancreatitis, stomatitis, vomiting

GU: Crystalluria, hematuria, hemolytic uremic syndrome, nephritis, nephrotic syndrome, proteinuria, reversible, oligospermia, toxic nephrosis with oliguria and anuria

HEME: Agranulocytosis, aplastic anemia, congenital neutropenia, Heinzbody anemia, hemolytic anemia,  hypoprothrombinemia, leukopenia, megaloblastic anemia, methemoglobinemia, myelodysplastic syndrome, purpura, thrombocytopenia

MS: Arthralgias, rhabdomyolysis

RESP: Cyanosis, fibrosing alveolitis, pleuritis, pneumonitis with or without eosinophilia

SKIN: Alopecia, epidermal neurolysis (Lyell’s syndrome) with corneal damage, erythema multiforme, exfoliative dermatitis, parapsoriasis varioliformis acuta (Mucha Habermann syndrome), photosensitization, pruritus, skin rash, Stevens Johnson syndrome, urticaria

MISC:Anaphylaxis, polyaneritis nodosa, serum sickness syndrome

Patient And Carer Advice: