Leaflet SEDACORON 50mg / ml concentrate for solution for infusion

Product code:
W13267001
Quantity:
5
Indicated for:
cardiac arrhythmias
Route of administration:
infusion
Substance:
amiodarone (antiarrhythmic)
ATC
C01BD01 — Cardiovascular system | Antiarrhythmics, class I and III | Antiarrhythmics, class III

Precautions:

Photosensitivity

Photosensitivity

Avoid excessive exposure to sunlight or UV radiation.

Cardiac risk / QT prolongation / arrhythmias

Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Amiodarone is an antiarrhythmic medication used for the treatment and prevention of various types of cardiac arrhythmias, including atrial fibrillation, ventricular tachycardia, and ventricular fibrillation. It works by prolonging the action potential duration of cardiac cells and slowing the conduction of electrical impulses, helping to restore normal heart rhythm.

Amiodarone can be administered orally in tablet form or intravenously in acute cases. The initial dose is usually higher and is gradually reduced to maintain the therapeutic effect.

Common side effects include nausea, vomiting, photosensitivity, skin pigmentation, and thyroid dysfunction (hypothyroidism or hyperthyroidism). In rare cases, severe adverse reactions such as pulmonary toxicity, liver damage, or proarrhythmic effects may occur.

Patients taking amiodarone should undergo regular monitoring for thyroid, liver, and lung function. Additionally, the medication may interact with other drugs, such as anticoagulants or digoxin, requiring dose adjustments. Amiodarone is an effective option for managing severe arrhythmias, but its use requires careful medical supervision.

General data about SEDACORON 50mg / ml

Substance:
amiodarone
Date of latest medicines list:
01-06-2018
Product code:
W13267001
Concentration:
50mg / ml
Pharmaceutical form:
concentrate for solution for infusion
Packing volume:
3 ml
Product type:
Generic medicine
Prescription status:
S — Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Marketing authorisation

Manufacturer:
EBEWE PHARMA GMBH NFG. KG - AUSTRIA
Holder:
EBEWE PHARMA GES.M.B.H. NFG. KG - AUSTRIA
Number:
11443/2019/01
Shelf life:
3 years

Concentrations available for amiodarone

  • 150mg/3ml
  • 200mg
  • 30mg/ml
  • 50mg/ml