ENABLEX Now Approved in Malaysia
2 years ago
|Reclassification of MIMS Class – ENABLEX
In MIMS 140th edition (1st Issue 2015), there was an error classifying Enablex under 10f. Other Drugs Acting on the Genito-Urinary System. With effect from MIMS 141st edition (2nd Issue 2015), Enablex will be reclassified under 10e. Drugs for Bladder & Prostate Disorder to reflect a more accurate classification based on its therapeutic use.
ENABLEX – Darifenacin Hydrobromide 7.5mg Prolonged Release Tablet
• A highly selective M3 antagonist developed for treating overactive bladder (OAB) 1, 2
• Improves Incontinence Episodes (IEs) per week, Urgency Episodes (UEs) per day and micturitions per day in OAB patients with 5-50 episodes of incontinence per week 3
• No significant effect on heart rate 4
• Does not prolong the QT/QTc interval 5
• Does not impair memory or other cognitive functions 6
1. KAY G, WESNES K. 2005. Pharmacodynamic effects if darifenacin, a muscarinic M3 selective receptor antagonist for the treatment of overactive bladder, in healthy volunteers. BJU International; 96:1055-62.
2. ENABLEX® Package Insert.
3. CHAPPLE C, STEERS W, NORTON P, MILLARD R, KRALIDIS G, GLAVIND K, et al. 2005. A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder. BJU International; 95:993-1001.
4. OLSHANSKY B, EBINGER U, BRUM J, EGERMARK M, VIEGAS A, REKEDA L. 2008. Differential Pharmacological Effects of Antimuscarinic Drugs on Heart Rate: Double-blind, Crossover Study With Tolterodine and Darifenacin in Healthy Participants ≥50 Years. J Cardiovasc Pharmacol Ther; doi:10.1177/1074248408325404.
5. SERRA D, AFFRIME M, BEDIGIAN M, GREIG G, MILOSAVLJEV S, SKERJANEC A, et al. 2005. QT and QTc Interval With Standard and Supratherapeutic Doses of Darifenacin, a Muscarinic M3 Selective Receptor Antagonist for the Treatment of Overactive Bladder. J Clin Pharmacol ; 45:1038-1047
6. KAY G, EBINGER U. 2008. Preserving cognitive function for patients with overactive bladder: evidence for a differential effect with darifenacin. Int J Clin Pract; 62(11):1792-1800.