Ketoconazole HRA (ketoconazole, 200mg tablets)
*Company:
Esteve RD UK & Ireland (Formerly HRA Pharma UK and Ireland Limited)Status:
No Recent UpdateLegal 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
Updated on 05 October 2020
File name
Ketoconazole- SmPC - Sep 2020.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.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.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.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.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
File name
PIL_16379_655.pdf
Reasons for updating
- New PIL for new product
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
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
- 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 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
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
Updated on 25 June 2015
Reasons for updating
- New PIL for new product