Cordarone X Intravenous, 150mg/3ml, Concentrate for solution for infusion or slow injection

Product Information *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 02 September 2020

File name

Ireland Cordarone X IV PIL (1)_1599050212.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose

Updated on 17 August 2020

File name

1.3.1.1 Ireland Cordarone X IV SmPC_1597675447.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 June 2020

File name

1.3.2.1 Ireland Cordarone IV PIL_1591359171.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company


 

Updated on 05 June 2020

File name

1.3.1.1 Ireland Cordarone X IV SmPC_1591359012.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 September 2019

File name

1.3.2.1 Ireland IE925 CCDS v21 Aug 19 Cordarone X IV PIL HPRA Approved (25-Sep-2019)_1569836232.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 30 September 2019

File name

1.3.1.1 Ireland IE925 CCDS v21 Aug 19 Cordarone X IV SmPC HPRA Approved (25-Sep-2019)_1569836115.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Anaesthesia (see sections 4.5 and 4.8):

Before surgery, the anaesthetist should be informed that the patient is taking amiodarone. 

Primary Graft Dysfunction post cardiac transplant

In retrospective studies, amiodarone use in the transplant recipient prior to heart transplant has been associated with an increased risk of primary graft dysfunction (PGD).
PGD is a life-threatening complication of heart transplantation that presents as left, right or biventricular dysfunction occurring within the first 24 hours of transplant surgery for which there is no identifiable secondary cause (see Section 4.8). Severe PGD may be irreversible.

For patients who are on the heart transplant waiting list, consideration should be given to use an alternative antiarrhythmic drug as early as possible before transplant.

Section 4.8

Musculoskeletal and Connective Tissue Disorders:

  • Not known
    Lupus like syndrome.
     Injury, poisoning and procedural complications
  • Frequency not known:
    Primary graft dysfunction post cardiac transplant (see Section 4.4)

Updated on 07 May 2019

File name

PIL Cordarone X IV IE805 _1557241563.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 28 November 2016

File name

PIL_13362_196.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 November 2016

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 03 August 2016

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 June 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 June 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

variation update

Updated on 12 February 2016

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

    Section 4.8

Gastrointestinal disorders:
Common- constipation
Unommon- dry mouth
Not know- pancreatitis/ acute pancreatitis

Updated on 22 October 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 17 September 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 updated with the following:


Severe bradycardia

Cases of severe, potentially life-threatening bradycardia and heart block have been observed when amiodarone is used in combination with sofosbuvir alone or in combination with another hepatitis C virus (HCV) direct acting antiviral (DAA), such as daclatasvir, simeprevir, or ledipasvir.   Therefore, coadministration of these agents with amiodarone is not recommended.

 

If concomitant use with amiodarone cannot be avoided, it is recommended that patients are closely monitored when initiating sofosbuvir alone or in combination with other DAAs.  Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for at least 48 hours in an appropriate clinical setting after initiation of the concomitant treatment with sofosbuvir.

 

Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on sofosbuvir alone or in combination with other direct DAA’s.

 

Patients receiving these hepatitis C medicines with amiodarone, with or without other medicines that lower heart rate, should be warned of the symptoms of bradycardia and heart block and should be advised to seek urgent medical advice if they experience them.

Section 4.5 updated with the following:

 

OTHER DRUG INTERACTIONS WITH CORDARONE

 

Coadministration of amiodarone with sofosbuvir alone or in combination with another HCV direct acting antiviral (such as daclatasvir, simeprevir or ledipasvir) is not recommended as it may lead to serious symptomatic bradycardia.

 

If coadministration cannot be avoided, cardiac monitoring is recommended.

 

Updated on 30 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 11 May 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 updated to include the following under 'Endocrine disorders':

·         Very rare

Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Updated on 07 November 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 updated to include:

Severe bullous reactions

Life threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) (see section 4.8).  If symptoms or signs of SJS, TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present amiodarone treatment should be discontinued immediately.


Section 4.5 updated to add 'e.g. rhabdomyolsis' under CYP P450 3A4 substrates, Statins.

Section 4.8 to add the following:

Under 'Blood and lymphatic system disorders': Neutropenia,  agranulocytosis as Not known.
Under 'Gastrointestinal disorders': Pancreatitis/acute pancreatitis, dry mouth, constipation as Not known.
Under 'Nervous system disorders': Parkinsomism, parosmia as Not known.
New paragraph 'Psychiatric disorders' which includes Confusional state/delirium, hallucination as not known.
Under 'Reproductive system and breast disorders': Libido decreased as not known.
Under 'Skin and subcutaneous tissue disorders, new text after urticaria.
Under 'Immune system disorders': anaphylactic/anaphylactoid reaction including shock as not known
New paragraph 'Metabolism and nutrition disorders'.

Reporting of suspected adverse reactions updated.



Updated on 05 November 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 01 July 2014

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IA.C.1.z variation following the PRAC decision to implement safety updates to section 5.3 of the SmPC for the amoidarone product range.

Updated on 13 December 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Bulk Type II. I.C.4 variation submitted following a Global Labelling Review for Amiodarone.   The updates reflect safety data presented in CCDS versions 14 & 15 and  relate to sections 4.4, 4.5, 4.8 & 5.2 of the SPC.

Updated on 09 December 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 10 September 2013

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Bulk Type IB variation to update the SPCs in line with Article 45

Updated on 29 August 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 - paragraph Paediatric patients updated:

The safety and efficacy of Cordarone X Intravenous in children has not  been established. Currently available data are described in sections 5.1 and 5.2.

 

Due to the presence of benzyl alcohol, Cordarone X Intravenous administration is contraindicated in newborns or premature neonates, infants and children up to 3 years old.

The safety and efficacy of amiodarone in paediatric patients have not been established. It is not recommended for use in children and is contra-indicated for children under the age of 3 years (see section 4.3).


Section 4.3 updated to include:
Due to the presence of benzyl alcohol, which has been associated with reports of fatal 'gasping syndrome' in neonates, Cordarone X Intravenous is contraindicated in newborns or premature neonates, infants and young children up to 3 years old. (One ampoule contains 60mg of benzyl alcohol)

Section 4.4 - Paediatric patients section updated:

Cordarone X IV contains benzyl alcohol (20 mg/ml).

Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old.

 

The safety and efficacy of amiodarone in paediatric patients have not been established. Therefore its use in paediatric patients is not recommended.

 

Cordarone X IV ampoules contain benzyl alcohol.There have been reports of fatal 'gasping syndrome' in neonates (children less than one month of age) following the administration of intravenous solutions containing this preservative benzyl alcohol. Symptoms include a striking onset of gasping syndrome, hypotension, bradycardia, and cardiovascular collapse (see section 4.3).


Section 5.1 updated to include:

No controlled paediatric studies have been undertaken.

In published studies the safety of amiodarone was evaluated in 1118 paediatric patients with various arrhythmias.  The following doses were used in paediatric clinical trials.

 

Oral

- Loading dose: 10 to 20 mg/kg/day for 7 to 10 days (or 500 mg/m2/day if expressed per square meter)

- Maintenance dose: the minimum effective dosage should be used; according to individual response, it may range between 5 to 10 mg/kg/day (or 250 mg/m2/day if expressed per square meter)

 

            Intravenous

- Loading dose: 5 mg/kg body weight over 20 minutes to 2 hours,

- Maintenance dose: 10 to 15 mg/kg/day from few hours to several days

If needed oral therapy may be initiated concomitantly at the usual loading dose.



Section 5.2 updated to include:

 No controlled paediatric studies have been undertaken. In the limited published data available in paediatric patients, there were no differences noted compared to adults.






Updated on 23 August 2013

Reasons for updating

  • Change to, or new use for medicine

Updated on 27 November 2012

Reasons for updating

  • Change of manufacturer

Updated on 13 April 2012

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Incorrect SPC previously uploaded.

Updated on 08 April 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4: Special Warnings and Precautions for use

Section 4.5: Interaction with other medicinal products and other forms of interaction

Updated on 07 April 2011

Reasons for updating

  • Change to drug interactions

Updated on 21 July 2009

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Section 4.5 - addition of interaction with statins
Update Section 4.8 - addition of urticaria as side effect

Updated on 17 July 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 July 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Section 7, 8 and 10.

Updated on 14 July 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 March 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2 Posology and method of administration
4.3 Contraindication
4.4 Special Warnings and Precautions
4.5 Interactions
5.1 Pharmacodynamic Properties

Updated on 12 February 2008

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update
Section 4.5: Addition of warning regarding grapefruit juice
Section 4.8: Addition of angioneurotic oedema (under Immune System Disorders)

Updated on 06 February 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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Update
Section 1 - Addition of pharmaceutical form to name
2 - Addition of excipients
9 - Date of renewal
10 - Date of revision

Updated on 21 November 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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Update Section -
1.  Trade name to include concentrate
3. Pharmaceutical form to include concentrate
10. Date of revision

Updated on 06 July 2007

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 March 2007

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4:
-Updating of section relating to liver disorders
-Update to section relating to pentamide injection and when it is parenterally administered
-Inclusion of warning regarding combined use with flouroquinolones.
-Changing of BAN to INNs for ciclosporin and tectrsactide
-Inclusion of reference to Fentanyl in section  on drugs metabolised by cytochrome P45 3A4.

Updated on 17 May 2005

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 August 2004

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 June 2003

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)