Dronedarone hydrochloride was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Dronedarone hydrochloride was found to degrade significantly in acid and base stress conditions and to remain stable in thermal, photolytic degradation, oxidative and hydrolytic conditions. As a rate control drug, dronedarone was better than placebo only for a surrogate outcome (heart rate). As a rhythm control drug, dronedarone was associated with 13 (95% CI, -15 to 61) excess deaths per 1000 patients treated as compared with placebo. Compared with amiodarone, dronedarone was less effective (214 [95% CI, 130 to 294] more recurrences of atrial fibrillation per 1000 patients treated) and similarly tolerated (-28 [95% CI, -69 to 33] more serious adverse events requiring compound suspension per 1000 patients treated).
| Molecular Weight | 593.22 |
| Formula | C31H45ClN2O5S |
| CAS Number | 141625-93-6 |
| Form | Solid |
| Solubility (25°C) | DMSO |
| Storage |
Powder -20°C 3 years ; 4°C 2 years In solvent -80°C 6 months ; -20°C 1 month |
| Species | Mouse | Rat | Rabbit | Guinea pig | Hamster | Dog |
| Weight (kg) | 0.02 | 0.15 | 1.8 | 0.4 | 0.08 | 10 |
| Body Surface Area (m2) | 0.007 | 0.025 | 0.15 | 0.05 | 0.02 | 0.5 |
| Km factor | 3 | 6 | 12 | 8 | 5 | 20 |
| Animal A (mg/kg) = Animal B (mg/kg) multiplied by | Animal B Km |
| Animal A Km |
For example, to modify the dose of Compound A used for a mouse (20 mg/kg) to a dose based on the BSA for a rat, multiply 20 mg/kg by the Km factor for a mouse and then divide by the Km factor for a rat. This calculation results in a rat equivalent dose for Compound A of 10 mg/kg.
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