Intravenous nicardipine medicines

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European Medicines Agency gives recommendations on the use of intravenous nicardipine

On 24 October 2013, the European Medicines Agency completed a benefit-risk review of intravenous (given into a vein) nicardipine medicines. The Agency’s Committee on Medicinal Products for Human Use (CHMP) concluded that these medicines should only be used to treat acute (sudden) life-threatening high blood pressure and to control high blood pressure after an operation. Use of intravenous nicardipine medicines in other indications is no longer recommended.

The CHMP also recommended that these medicines should only be given by continuous infusion (drip) into a vein by a specialist in a hospital or intensive care unit.

Detailed information on the recommended uses of intravenous nicardipine, including instructions on how to use these medicines, can be found below.

The review of intravenous nicardipine was triggered by the UK medicines regulatory agency (MHRA), following submission in the UK of an application for a generic intravenous nicardipine medicine. The MHRA was concerned that the clinical data submitted were inadequate to determine the benefits and risks of the generic medicine in the proposed indications. It also noted that medicines containing nicardipine given intravenously had been authorised in other EU countries but that the authorised uses differed between countries. The MHRA therefore decided to request an EU-wide review of these medicines.

Having assessed the available evidence on the safety and effectiveness of intravenous nicardipine from published studies and post-marketing data, the CHMP concluded that an intravenous formulation of nicardipine is a useful treatment for high blood pressure in specific settings and with appropriate specialist intervention and monitoring.

The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 20 December 2013.

Information to patients
  • An EU-wide review of medicines containing nicardipine given into a vein has been carried out and recommendations have been given to ensure the safe and effective use of these medicines.
  • Medicines containing nicardipine given into a vein should be used to treat very severe high blood pressure, or to control high blood pressure after an operation.
  • These medicines will be given to you in hospital as a drip into a vein, and your blood pressure will be regularly monitored.
  • If you have any questions or concerns, speak to your doctor, pharmacist or nurse.
Information to healthcare professionals

The EU-wide review of intravenous nicardipine has resulted in updated prescribing information for these medicines.

The recommended therapeutic indications of intravenous nicardipine are now:

  • treatment of acute life-threatening hypertension, particularly in the event of:
    • malignant arterial hypertension/hypertensive encephalopathy;
    • aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective;
    • severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated;
  • treatment of post-operative hypertension.

Nicardipine was also used in some EU countries for controlled hypotension during anaesthesia, for controlling hypertension during surgery and for treating acute severe hypertension with left ventricular decompensation and pulmonary oedema. These uses are no longer recommended because the available data are insufficient to support use in these conditions.

Regarding the posology, nicardipine should be administered by continuous intravenous infusion. It should only be administered by specialists in well controlled environments, with continuous monitoring of blood pressure.
In adults, treatment should start with a continuous administration of nicardipine at a rate of 3-5 mg/h. The rate can then be increased but should not exceed 15 mg/h. When the target blood pressure is reached, the dose should be reduced progressively. Nicardipine should be used with caution and at lower doses in specific patient populations, including patients with liver and kidney problems and children.

More about the medicine

Nicardipine is an ‘antihypertensive’ medicine that reduces blood pressure by allowing the blood vessels to relax. It works as a ‘calcium-channel blocker’: this means that it blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, nicardipine prevents the cells from contracting and this helps the blood vessels to relax.

Medicines containing nicardipine given into a vein are authorised in the following EU Member States: Belgium, France, Luxemburg, the Netherlands and Spain.

More about the procedure

The review of intravenous nicardipine was initiated in July 2012 at the request of the United Kingdom, under Article 31 of Directive 2001/83/EC. The UK medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance of intravenous nicardipine and to issue an opinion on whether the marketing authorisations of these medicines should be maintained, varied, suspended or withdrawn across the European Union.

The CHMP recommendation was sent to the European Commission, which issued a final decision on 20 December 2013.

Name Language First published Last updated
European Medicines Agency gives recommendations on the use of intravenous nicardipine BG = bălgarski 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine ES = español 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine CS = čeština 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine DA = dansk 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine DE = Deutsch 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine ET = eesti keel 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine EL = elliniká 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine EN = English 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine FR = français 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine IT = italiano 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine LV = latviešu valoda 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine LT = lietuvių kalba 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine HU = magyar 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine MT = Malti 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine NL = Nederlands 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine PL = polski 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine PT = português 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine RO = română 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine SK = slovenčina 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine SL = slovenščina 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine FI = suomi 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine SV = svenska 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine HR = Hrvatski 2014-03-12  

Key facts

Approved nameIntravenous nicardipine medicines
International non-proprietary name (INN) or common name

nicardipine

Associated namesCardene IV, Loxen, Nicardipine Aguettant, Nicardipine Arrow, Rydene, Vasonase
ClassAntihypertensive
Reference numberEMEA/H/A-31/1339
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusEuropean Commission final decision
Opinion date24/10/2013

All documents

Name Language First published Last updated
European Medicines Agency gives recommendations on the use of intravenous nicardipine BG = bălgarski 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine ES = español 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine CS = čeština 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine DA = dansk 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine DE = Deutsch 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine ET = eesti keel 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine EL = elliniká 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine EN = English 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine FR = français 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine IT = italiano 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine LV = latviešu valoda 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine LT = lietuvių kalba 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine HU = magyar 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine MT = Malti 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine NL = Nederlands 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine PL = polski 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine PT = português 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine RO = română 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine SK = slovenčina 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine SL = slovenščina 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine FI = suomi 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine SV = svenska 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine HR = Hrvatski 2014-03-12  
European Medicines Agency gives recommendations on the use of intravenous nicardipine (English only) 2013-10-25  
Nicardipine Article-31 referral - Assessment report (English only) 2014-03-12  
Nicardipine Article-31 referral - Annex I BG = bălgarski 2014-03-12  
Nicardipine Article-31 referral - Annex I ES = español 2014-03-12  
Nicardipine Article-31 referral - Annex I CS = čeština 2014-03-12  
Nicardipine Article-31 referral - Annex I DA = dansk 2014-03-12  
Nicardipine Article-31 referral - Annex I DE = Deutsch 2014-03-12  
Nicardipine Article-31 referral - Annex I ET = eesti keel 2014-03-12  
Nicardipine Article-31 referral - Annex I EL = elliniká 2014-03-12  
Nicardipine Article-31 referral - Annex I EN = English 2014-03-12  
Nicardipine Article-31 referral - Annex I FR = français 2014-03-12  
Nicardipine Article-31 referral - Annex I IT = italiano 2014-03-12  
Nicardipine Article-31 referral - Annex I LV = latviešu valoda 2014-03-12  
Nicardipine Article-31 referral - Annex I LT = lietuvių kalba 2014-03-12  
Nicardipine Article-31 referral - Annex I HU = magyar 2014-03-12  
Nicardipine Article-31 referral - Annex I MT = Malti 2014-03-12  
Nicardipine Article-31 referral - Annex I NL = Nederlands 2014-03-12  
Nicardipine Article-31 referral - Annex I PL = polski 2014-03-12  
Nicardipine Article-31 referral - Annex I PT = português 2014-03-12  
Nicardipine Article-31 referral - Annex I RO = română 2014-03-12  
Nicardipine Article-31 referral - Annex I SK = slovenčina 2014-03-12  
Nicardipine Article-31 referral - Annex I SL = slovenščina 2014-03-12  
Nicardipine Article-31 referral - Annex I FI = suomi 2014-03-12  
Nicardipine Article-31 referral - Annex I SV = svenska 2014-03-12  
Nicardipine Article-31 referral - Annex I HR = Hrvatski 2014-03-12  
Nicardipine Article-31 referral - Annex II BG = bălgarski 2014-03-12  
Nicardipine Article-31 referral - Annex II ES = español 2014-03-12  
Nicardipine Article-31 referral - Annex II CS = čeština 2014-03-12  
Nicardipine Article-31 referral - Annex II DA = dansk 2014-03-12  
Nicardipine Article-31 referral - Annex II DE = Deutsch 2014-03-12  
Nicardipine Article-31 referral - Annex II ET = eesti keel 2014-03-12  
Nicardipine Article-31 referral - Annex II EL = elliniká 2014-03-12  
Nicardipine Article-31 referral - Annex II EN = English 2014-03-12  
Nicardipine Article-31 referral - Annex II FR = français 2014-03-12  
Nicardipine Article-31 referral - Annex II IT = italiano 2014-03-12  
Nicardipine Article-31 referral - Annex II LV = latviešu valoda 2014-03-12  
Nicardipine Article-31 referral - Annex II LT = lietuvių kalba 2014-03-12  
Nicardipine Article-31 referral - Annex II HU = magyar 2014-03-12  
Nicardipine Article-31 referral - Annex II MT = Malti 2014-03-12  
Nicardipine Article-31 referral - Annex II NL = Nederlands 2014-03-12  
Nicardipine Article-31 referral - Annex II PL = polski 2014-03-12  
Nicardipine Article-31 referral - Annex II PT = português 2014-03-12  
Nicardipine Article-31 referral - Annex II RO = română 2014-03-12  
Nicardipine Article-31 referral - Annex II SK = slovenčina 2014-03-12  
Nicardipine Article-31 referral - Annex II SL = slovenščina 2014-03-12  
Nicardipine Article-31 referral - Annex II FI = suomi 2014-03-12  
Nicardipine Article-31 referral - Annex II SV = svenska 2014-03-12  
Nicardipine Article-31 referral - Annex II HR = Hrvatski 2014-03-12  
Nicardipine Article-31 referral - Annex III BG = bălgarski 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III ES = español 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III CS = čeština 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III DA = dansk 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III DE = Deutsch 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III ET = eesti keel 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III EL = elliniká 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III EN = English 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III FR = français 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III IT = italiano 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III LV = latviešu valoda 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III LT = lietuvių kalba 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III HU = magyar 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III MT = Malti 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III NL = Nederlands 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III PL = polski 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III PT = português 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III RO = română 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III SK = slovenčina 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III SL = slovenščina 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III FI = suomi 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III SV = svenska 2013-10-25 2014-03-12
Nicardipine Article-31 referral - Annex III HR = Hrvatski 2013-10-25 2014-03-12

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

More information on intravenous nicardipine medicines