Indication:
Treatment of mild to modate ulcerative colitis and maintenance of remission
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Balsezide disodium 12-11- 2002
For ulcerative colitis
Adverse Reaction:
Diarrhea, nausea, vomiting, abdominal pain, exacerbation of symptoms of colitis Headache, hypsersensitivity reactions (including rash and urticaria)
Rarely- acute pancreastitis, heaptistis, myocarditis, pericarditis, Lung disorders, including eosinophillia andfibrosing alveolitis)
Peripheral neuropathy, blood disoreders( including agarnulocytosis, aplastic anemia, leucopenia, methaemoglobinemia, neutropenia, and thrombocytopenia
Renal dyfunction(intestinal nephritis, nephrottic lupus erythematosus-like syndrome. Steven-Johnson syndrome,alopecia
Contra-Indications:
Amonisalicylates should be avoided in salicylate hypersensitivity
Special Precautions-
Used with caution inrenal impairment ,during pregnancy,breast-feeding blood disorders can occur
Dosages/ Overdosage Etc:
Indication-
Treatment of mild to modate ulcerative colitis and maintenance of remission
Dosage-
2.25g 3 times daily, until remission occurs or up to max 12 weeks
Maintenance- 1.5g twice daily adjustedacording to response- max 6g daily
Patient Information:
Instruct patients not to take balsalzide if they have a hypersensitivity to salicylates eg. Aspirin
Consult doctor if they experience a worsening of ulcerative colotis, if they are diagnosied with pyloric stenosis as balsazide capsules may be slow to pass through their digestive tract.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Mechnasm of action of 5ASSA is unknown,but it appears to be topical rather than systemic. It diminishes inflammation by blocking mucosal productin of arachiodic acid metabiolites in the colon which is produced by nboth the cyclogenase pathways i.e. prostanoids and the lipoxygenase pathways i.e leukotrienes and hydroxyeicostatetraenoic acids is increased in pts with chronic inflammatory bowel disease
Pharmacokinetics-
The absorption of intact balasazide is very low and variable. The mean Cmax occurs approx 1-2 hrs after single oral doses of 1.5 g or 2.25 g. It shows plasma proteins binding of > 99% . It undergoes azoreduction to give 5-aminosalicylic acid and 4-aminobenzoyl-(beta)-alanine and their N-acretylylateded metabolites which are present in plasma, urine and faeces.
Interaction with Food:
Take with or immediately after meals
Pregnancy and lactation:
Use with caution during pregnancy and breast feeding
Manufacturer Details