Product Information
Registration Status: ActiveCORDARONE TABLET 200mg is approved to be sold in Singapore with effective from 1998-05-27. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN09784P.
This product contains Amiodarone 200mg in the form of TABLET. It is approved for ORAL use.
This product is manufactured by SANOFI WINTHROP INDUSTRIE in FRANCE.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
An antianginal and antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting Na,K-activated myocardial adenosine triphosphatase. There is a resulting decrease in heart rate and in vascular resistance.
Indication
Intravenously, for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Orally, for the treatment of life-threatening recurrent ventricular arrhythmias such as recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia.
Mechanism of Action
The antiarrhythmic effect of amiodarone may be due to at least two major actions. It prolongs the myocardial cell-action potential (phase 3) duration and refractory period and acts as a noncompetitive a- and b-adrenergic inhibitor.
Pharmacokinetics
- Absorption
- Slow and variable (about 20 to 55% of an oral dose is absorbed).
- Distribution
- Metabolism
- Amiodarone is extensively metabolized in the liver via CYP2C8 (under 1% unchanged in urine), and can effect the metabolism of numerous other drugs. The major metabolite of amiodarone is desethylamiodarone (DEA), which also has antiarrhythmic properties. The metabolism of amiodarone is inhibited by grapefruit juice, leading to elevated serum levels of amiodarone.
- Elimination
Clearance
* 90-158 mL/h/kg [Healthy with a single dose IV (5 mg/kg over 15 min)] * 100 mL/h/kg [Normal subjects > 65 yrs] * 150 mL/h/kg [younger subjects] * 220 and 440 mL/h/kg [patients with VT and VF]
Toxicity
Intravenous, mouse: LD50 = 178 mg/kg. Some side effects have a significant mortality rate: specifically, hepatitis, exacerbation of asthma and congestive failure, and pneumonitis.
Active Ingredient/Synonyms
2-Butyl-3-(3,5-diiodo-4-(2-diethylaminoethoxy)benzoyl)benzofuran | 2-Butyl-3-benzofuranyl 4-(2-(diethylamino)ethoxy)-3,5-diiodophenyl ketone | 2-n-Butyl-3',5'-diiodo-4'-N-diethylaminoethoxy-3-benzoylbenzofuran | Amiodarona | Amiodaronum | Amiodarone |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.