Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Almirall, S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain
Colazide is indicated for the treatment of mild-to-moderate active ulcerative colitis and maintenance of remission.
2.25g Balsalazide disodium (3 capsules) three times daily (6.75g daily) until remission or for 12 weeks maximum.
Rectal or oral steroids can be given concomitantly if necessary.
The recommended starting dose is 1.5g Balsalazide disodium (2 capsules) twice daily (3g daily). The dose can be adjusted based on each patient’s response; there may be an additional benefit with a dose up to 6g daily.
No dose adjustment is anticipated.
Colazide is not recommended in children.
To be swallowed whole with or after food.
To date, there are no reports of overdosage with mesalazine-releasing products. Overdose with large amounts of balsalazide may result in symptoms resembling mild salicylate intoxication. Treatment should be symptomatic.
3 years.
No special precautions for storage.
High density polyethylene container fitted with tamper-evident, child-resistant, high density polyethylene screw caps.
Pack sizes are: 50, 54, 56, 100, 112, 130, 224 (2 × 112), 260 (2 × 130), 300 (3 × 100), 500 (10 × 50), 672 (6 × 112) and 780 (6 × 130) capsules.
Not all pack sizes may be marketed.
None.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
