Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031, BN Haarlem, The Netherlands
Sivextro tablets are indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in:
See sections 4.4 and 5.1.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Tedizolid phosphate 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, as well as adolescents and children weighing at least 35 kg is 200 mg once daily for 6 days.
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, the n 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).
Tedizolid phosphate 200 mg tablets are intended for adolescents and children weighing at least 35 kg. For adolescents and children weighing less than 35 kg, tedizolid phosphate powder for concentrate for solution for infusion is available.
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 aluminium/Polyethylene Terephthalate (PET)/Paper foil and polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) clear film perforated child-resistant unit-dose blisters.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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