MITOTOX

Drug

D1394 | Dronedarone

Properties

Molecular Formula	C31H44N2O5S
Molecular Weight	556.8
Structure
State	solid
Clearance	Plasma clearance = 130-150 L/h.
Volume of distribution	When intravenously administered, the volume of distribution is 1400 L.
Route of elimination	6% of the dose was excreted in the urine, mainly as metabolites (no unchanged compound excreted in urine), and 84% was excreted in feces, mainly as metabolites.
Protein binding	Dronedarone and its N-debutyl metabolite is >98% protein bound - mainly to albumin.
Half life	Elimination half-life: 13-19 hours
Absorption	Because of presystemic first pass metabolism the absolute bioavailability of dronedarone without food is low, about 4%. It increases to approximately 15% when dronedarone is administered with a high fat meal. After oral administration in fed conditions, peak plasma concentrations of dronedarone and the main circulating active metabolite (N-debutyl metabolite) are reached within 3 to 6 hours. After repeated administration of 400 mg twice daily, steady state is reached within 4 to 8 days of treatment. The steady state Cmax and exposure of the main N-debutyl metabolite is similar to that of the parent compound.
Description	antiarrhythmic drug with benzofuran structure

Therapeutic Classification Source: DrugBank

C01BD07 Dronedarone

[C01BD] Antiarrhythmics, class III

[C01B] ANTIARRHYTHMICS, CLASS I AND III

[C01] CARDIAC THERAPY

[C] Cardiovascular system

Mitochondrial Toxicity Evaulation

Toxicity	Dose	Time	Species	Model	Method	Action	Positive criterion	Reference
FATTY ACID METABOLISM	10µM	24hr		isolated rat liver mitochondria, and the human hepatoma cell line HepG2		inhibit		271

GHS Hazard Tables Source: PubChem

Pictogram	Signal	Statements	Precautionary Statement Codes
	Danger	Aggregated GHS information provided by 5 companies from 3 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies. H360 (40%): May damage fertility or the unborn child [Danger Reproductive toxicity] H373 (40%): Causes damage to organs through prolonged or repeated exposure [Warning Specific target organ toxicity, repeated exposure] H400 (40%): Very toxic to aquatic life [Warning Hazardous to the aquatic environment, acute hazard] H410 (60%): Very toxic to aquatic life with long lasting effects [Warning Hazardous to the aquatic environment, long-term hazard] Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown.	P201, P202, P260, P273, P281, P308+P313, P314, P391, P405, and P501; (The corresponding statement to each P-code can be found at the GHS Classification page.)

Pictogram

Signal

Statements

Precautionary Statement Codes

Danger

Aggregated GHS information provided by 5 companies from 3 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

H360 (40%): May damage fertility or the unborn child [Danger Reproductive toxicity]

H373 (40%): Causes damage to organs through prolonged or repeated exposure [Warning Specific target organ toxicity, repeated exposure]

H400 (40%): Very toxic to aquatic life [Warning Hazardous to the aquatic environment, acute hazard]

H410 (60%): Very toxic to aquatic life with long lasting effects [Warning Hazardous to the aquatic environment, long-term hazard]

Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown.

P201, P202, P260, P273, P281, P308+P313, P314, P391, P405, and P501; (The corresponding statement to each P-code can be found at the GHS Classification page.)

Indications Source: SIDER

External IDs

DrugBank	DB04855
CAS Number	141625-93-6, 141626-36-0
PubChem Compound	208898