Ketoconazole HRA (ketoconazole, 200mg tablets) *

  • Company:

    HRA Pharma UK and Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 05 October 2020

File name

Ketoconazole- SmPC - Sep 2020_1601933934.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 October 2020

File name

Ketoconazole - Package leaflet - Sept 2020_1601933785.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 12 December 2019

File name

Keto SmPC - renewal 01-11-2019_1576160868.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 April 2019

File name

PI- Keto- Clean-19.11.2018_1556287118.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to date of revision

Updated on 26 April 2019

File name

SmPC - Keto - clean- 19.11.2018_1556287059.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 18 September 2017

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.5 Interaction with other medicinal products and other forms of interaction

Addition of:

Edoxaban under Anticoagulants and Antiplatelet Drugs and Isavuconazole under Anti-Infectives in Table 1

Medicinal product by therapeutic area

Expected effect on drug levels

Recommendation for co-administration

Edoxaban

AUC: ↑ 1.8-fold

Cmax: ↑ 1.8-fold

Dose of edoxaban needs to be reduced when used concomitantly, please consult edoxaban SmPC.

Isavuconazole

AUC: ↑ 5-fold

Cmax: ↑ 1.1 -fold

Not recommended due to increased risk of isavuconazole adverse reactions, please consult isavuconazole SmPC

 


Section 10: Date of revision of text: 22/08/2017

Updated on 18 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 18 September 2017

File name

PIL_16379_655.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 September 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 09 March 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

4.5 Interaction with other medicinal products and other forms of interaction

Change of:                           

Data of inhibition indicate that there is no risk of interaction with BCRP substrates at the systemic level with very high doses of ketoconazole.

Change to:

Data of inhibition indicate that risk of interaction with BCRP substrates cannot be excluded at the systemic level with very high doses of ketoconazole.

 

Addition of:

Naloxegol under Gastrointestinal Drugs in Table 1

Medicinal product by therapeutic area

Expected effect on drug levels

Recommendation for co-administration

Naloxegol

Naloxegol

AUC ↑ 12.9 fold

Cmax ↑ 9.6 fold

Not recommended

 

5.2 Pharmacokinetic properties

Addition of:

In vitro data indicate that ketoconazole is a potent inhibitor of OATP1B1, OATP1B3, OAT3, OTC1 and OTC2 and to a lesser extent of OAT1 and BSEP. Inhibition of these transporters at clinically relevant concentrations of ketoconazole cannot be excluded.

Updated on 01 March 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 21 September 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 5.1 Interaction with other medicinal products: additional information :

-          In vitro data indicate that ketoconazole is an inhibitor of CYP1A2 and does not significantly inhibit CYP 2A6 and 2E1. At clinically relevant concentrations inhibition of CYP2B6, 2C9/C8, 2C19 and 2D6 by ketoconazole cannot be excluded.


    - additional product in the table: Tolbutamide

In section 5.1 information regarding the pharmacotherapeutic group and ATC code added.

Update of the revision of the text date

Updated on 20 September 2016

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change of distributor details

Updated on 09 March 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The PI updates are linked to the assessment of the 1st PSUR by CHMP/PRAC and include new drug-drug interactions in section 4.5 of the SmPC (apixaban, dabrafenib, cabozantinib and cabazitaxel) as well as a correction for indinavir.

Updated on 03 March 2016

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 30 June 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 25 June 2015

Reasons for updating

  • New PIL for new product