Composition
Each Balsinova capsule contains balsalazide Disodium
Dihydrate 750 mg.
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Indications
Treatment of mild-to-moderate active ulcerative
colitis and maintenance of remission.
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Dosage
Adults:
Treatment of active disease:
- 2.25 gm Balsalazide disodium (3 capsules) three times daily (6.75 gm daily) until remission or for 12 weeks maximum.
- Rectal or oral steroids can be given concomitantly if necessary.
Maintenance treatment:
The recommended starting dose is 1.5 gm Balsalazide disodium (2 capsules) twice daily (3 gm daily). The dose can be adjusted based on each patient's response; there may be an additional benefit with a dose up to 6 gm daily.
Elderly:
No dose adjustment is anticipated.
Children:
Balsinova is not recommended in children.
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How Supplied
Box of 1, 2 or 3 (AL/colorless transparent PVC) strips,
each of 10 hard gelatin capsules and an inner leaflet.
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Clinical Pharmacology
Balsalazide consists of mesalazine linked to a carrier molecule (4-aminobenzoyl-ß-alanine) via an azo bond.
Bacterial azo-reduction releases mesalazine as an active metabolite in the colon. Mesalazine is an intestinal anti-inflammatory agent acting locally on the colonic mucosa. Its precise mechanism of action is unknown. Balsalazide and the carrier do not contribute to the pharmacodynamic action.
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