Dronedarone Sanofi

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

Dronedarone hydrochloride

Հասանելի է:

Sanofi-Aventis Australia Pty Ltd

Դաս:

Medicine Registered

Ապրանքի հատկությունները

Dronedarone Sanofi CCDS v2 PI v2 13Jan2011 

 Page 
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PRODUCT INFORMATION 
DRONEDARONE SANOFI 
®

WARNING: HEART FAILURE 
DRONEDARONE SANOFI IS CONTRAINDICATED IN PATIENTS WITH NYHA CLASS IV
HEART FAILURE, OR 
NYHA CLASS II - III HEART FAILURE WITH A RECENT DECOMPENSATION
REQUIRING HOSPITALISATION (SEE 
CONTRAINDICATIONS AND PRECAUTIONS). 
IN A PLACEBO-CONTROLLED STUDY IN PATIENTS WITH SEVERE HEART FAILURE
REQUIRING RECENT 
HOSPITALISATION FOR WORSENING SYMPTOMS (THE ANDROMEDA
STUDY), PATIENTS GIVEN 
DRONEDARONE HAD A GREATER THAN TWO-FOLD INCREASE IN MORTALITY. SUCH
PATIENTS SHOULD NOT BE 
GIVEN DRONEDARONE (SEE CLINICAL TRIALS).  
IF HEART FAILURE DEVELOPS OR WORSENS IN ANY PATIENT, CONSIDER THE
SUSPENSION OR 
DISCONTINUATION OF DRONEDARONE SANOFI (SEE PRECAUTIONS). 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Dronedarone hydrochloride.   
CHEMICAL STRUCTURE 
Dronedarone hydrochloride is described chemically
as _N-_{2-butyl-3-[4-(3-dibutylaminopropoxy) 
benzoyl] benzofuran-5-yl} methanesulfonamide, hydrochloride. Its
empirical formula is 
C
31
H
44
N
2
0
5
S.HCl and the chemical structure of dronedarone hydrochloride is: 

CAS NUMBER 
141625-93-6. 
DESCRIPTION 
Dronedarone hydrochloride is a white, to practically white, fine
powder with a molecular weight of 
593.22.  It is practically insoluble in water and soluble in
ethanol and methylene chloride. 
DRONEDARONE SANOFI is available for oral use as a film-coated tablet
containing 400 mg of 
dronedarone (as hydrochloride). DRONEDARONE SANOFI tablets
also contain the following 
inactive ingredients: hypromellose, starch - maize, crospovidone,
poloxamer, lactose, silica - 
colloidal anhydrous, magnesium stearate, titanium dioxide, macrogol
6000 and carnauba wax. 
PHARMACOLOGY 
PHARMACODYNAMICS AND MECHANISM OF ACTION 
Dronedarone is an antiarrhythmic agent with electrophysiological
properties of all four Vaughan-
Williams classes. It is a multiple ion blocker in animal cardiac