SIVEXTRO (tedizolid), antibiotic of the oxazolidinone class
INFECTIOLOGY - NEW MEDICINAL PRODUCT
Opinions on drugs -
Posted on
Jan 18 2016
Reason for request
Inclusion
No clinical benefit demonstrated by comparison with linezolid.
A role in non-serious infections of staphylococcal aetiology that are resistant to methicillin
- SIVEXTRO has Marketing Authorisation in the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
- It does not provide any therapeutic benefit by comparison with linezolid, since:
- its in-vitro activity profile, efficacy and safety are comparable with that of linezolid;
- and considering the insufficient documentation of clinical efficacy and safety in severe skin infections and/or skin infections caused by multidrug-resistant bacteria.
- It may be offered in infections regardless of severity for which a staphylococcal aetiology is proven or suspected (suppurative infections) and where resistance to methicillin is proven or strongly suspected.
Clinical Benefit
Substantial |
- |
Clinical Added Value
no clinical added value |
- |
Therapeutic use
- |
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