Indication

For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400 mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks. For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months. Crohn`s disease: 800 mg 3 times daily. Hepatic impairment: Avoid in severe impairment.

Administration

Do not give with lactulose or other drugs which lower pH for they prevent release of mesalazine. May decrease digoxin absorption.

Adult Dose

Mild to moderate impaired renal or hepatic function (test serum creatinine before treatment, every 3 mth for 1st yr, every 6 mth for next 4 yr, then annually). Elderly; active peptic ulcer; pregnancy, lactation; patients predisposed to pericarditis or myocariditis. Counsel patients to report any unexplained bleeding, bruising, purpura, sore throat, fever or malaise during treatment; perform blood count and stop treatment if blood dyscrasias suspected. Counsel patients taking delayed release tablets to report repeatedly unbroken or partially broken tablets in their faeces. Pyloric stenosis may delay release into colon.Patients with pulmonary disease, in particular asthma, should be very carefully monitored during a course of treatment.Hypersensitivity to Sulphasalazine.In patients with a history of hypersensitivity to sulphasalazine, therapy should be initiated only under close medical supervision. Treatment must be stopped immediately if acute symptoms of intolerance occur such as abdominal cramps, acute abdominal pain, fever, severe headache and rash.Paediatric populationThere is only limited documentation for an effect in children (age 6-18 years). Lactation: Not known whether drug or metabolites are distributed into breast milk; use caution.

Renal Dose

Anti-inflammatory agent; mesalamine (5-aminosalicylic acid) is the active component of sulfasalazine, but specific MOA is unknown; probably inhibits prostaglandin and leukotriene synthesis and release in colon. Action may be topical in terminal ileum and colon rather than systemic.

Contraindication

Ulcerative colitis: Dose is dependent on preparation and brand used. Tablets: 5-15 yr: Acute attack: 15-20 mg/kg (max: 1 g) tid; maintenance of remission: 10 mg/kg (max: 500 mg) 2-3 times daily.

Mode of Action

May take with or without food.

Precaution

Ulcerative colitis, Ulcerative proctitis, Crohn's Disease.

Side Effect

Renal impairment: CrCl (ml/min) <20 Avoid.

Pregnancy Category Note

Abdominal pain (4-8%), GI discomfort (4-8%),Headache (7%),Flatulence (1-6%),Nausea (1-6%),Fatigue (3%),Asthenia (3%),Malaise (3%),Weakness (3%),Fever (3%),Exacerbation of colitis (3%),Dizziness (2-3%),Rash (1-3%),Pruritus (1-3%),Acne (1-3%) Frequency Not Defined Pericarditis (rare),Pharyngitis,Sensitivity reaction,Cholestatic hepatitis,Creatinine clearance decreased,Flu like syndrome,Discolored urine Potentially Fatal: Blood dyscrasias, aplastic anaemia, agranulocytosis; renal toxicity.

Interaction

Hypersensitivity to salicylates, aminosalicylates, or any component of the product.- Severe renal impairment (GFR less than 30 mL per minute).- Severe liver impairment.- Gastric and duodenal ulcers- Children under the age of 2 years