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tedizolid phosphate

Sivextro · ATC code J01XX11

Also known as: Tedizolidphosphat, Tedizolid fosfat

Key facts
Active substance
tedizolid phosphate
ATC code
J01XX11
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Sivextro 200 mg film-coated tablets · Sivextro 200 mg powder for concentrate for solution for infusion · Sivextro 245 mg powder for oral suspension
Marketing authorisation holder
Merck Sharp & Dohme B.V.
Information as of
2026-10-29

Key facts

Tedizolid phosphate (Sivextro) is an oxazolidinone antibiotic for acute bacterial skin and skin structure infections, available as tablets, oral suspension or infusion.

What it is used for

  • Acute bacterial skin and skin structure infections (ABSSSI).
  • Tablets: adults, adolescents and children weighing at least 35 kg; infusion: from birth; powder for oral suspension: see the full text.
  • Official guidance on antibacterial use should be considered.

Dosing

  • Adults, adolescents and children weighing at least 35 kg: 200 mg once daily for 6 days (oral or intravenous).
  • Infusion in children under 35 kg: weight-based twice daily for 6 days as a 1-hour infusion, e.g. 6 mg (1 to less than 3 kg) up to 60 mg (20 to less than 35 kg).
  • Oral suspension in children under 35 kg: see the full text.
  • No dose adjustment for the elderly or hepatic or renal impairment.
  • Take a missed dose up to 8 hours (twice-daily dosing: 6 hours) before the next dose; no double dose.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Not studied in neutropenia (< 1 000 cells/mm3); consider alternatives.
  • Inhibition of mitochondrial protein synthesis: lactic acidosis, anaemia and neuropathy (optic, peripheral) may occur.
  • Myelosuppression (thrombocytopenia, decreased haemoglobin and neutrophils).
  • Clostridioides difficile-associated diarrhoea.
  • Reversible MAO inhibition; serotonin syndrome reported with serotonergic medicines.

Side effects

  • Most frequent (Phase 3 studies, 200 mg for 6 days): nausea (6.9%), headache (3.5%), diarrhoea (3.2%) and vomiting (2.3%), generally mild to moderate.
  • Uncommon: fungal infections, abscess, Clostridioides difficile colitis, lymphadenopathy.

Interactions

  • Oral tedizolid inhibits intestinal BCRP (raised rosuvastatin levels); consider pausing BCRP substrates such as imatinib, lapatinib, methotrexate, pitavastatin, rosuvastatin, sulfasalazine and topotecan during the 6 days.
  • Caution with serotonergic medicines.

Pregnancy and breastfeeding

  • As a precaution, preferably avoid during pregnancy.
  • Breast-feeding: weigh breast-feeding against therapy.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • SivextroMerck Sharp & Dohme B.V. · EMEA/H/C/002846

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Sivextro
Liechtenstein
Sivextro
Norway
Sivextro

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Sivextro – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/sivextro-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.