Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Tedizolid phosphate film-coated tablets or powder for concentrate for solution for infusion may be used as initial therapy. Patients who commence treatment on the parenteral formulation may be switched to the oral presentation when clinically indicated.
The recommended dosage for adults and adolescents 12 years of age and older is 200 mg once daily for 6 days.
The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established (see section 4.4).
If a dose is missed, it should be taken as soon as possible anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remains before the next dose, then the patient should wait until the next scheduled dose. Patients should not take a double dose to compensate for a missed dose.
No dosage adjustment is required (see section 5.2). The clinical experience in patients ≥75 years is limited.
No dosage adjustment is required (see section 5.2).
No dosage adjustment is required (see section 5.2).
The safety and efficacy of tedizolid phosphate in children below 12 years of age have not yet been established. Currently available data are described in section 5.2, but no recommendation on a posology for children below 12 years of age can be made.
For oral use. The film-coated tablets can be taken with or without food. The time to tedizolid peak concentration with oral administration under fasting conditions is 6 hours faster than when administered with a high-fat, high-calorie meal (see section 5.2). If a rapid antibiotic effect is needed, the intravenous administration should be considered.
In the event of overdose, Sivextro should be discontinued and general supportive treatment given. Haemodialysis does not result in meaningful removal of tedizolid from systemic circulation. The highest single dose administered in clinical studies was 1,200 mg. All adverse reactions at this dose level were mild or moderate in severity.
3 years.
This medicinal product does not require any special storage conditions.
6 × 1 tablets in aluminum/Polyethylene Terephthalate (PET)/Paper foil and polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) clear film perforated child-resistant unit-dose blisters.
No special requirements.
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