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Tedizolid

    Brands

    DEA Class; Rx

    Common Brand Names; Sivextro

    • Oxazolidinones

    Oxazolidinone antibiotic
    Used for acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible gram-positive bacteria in adults and pediatric patients 12 years and older
    As effective as linezolid for the treatment of ABSSSI; safety and efficacy not evaluated in patients with neutropenia

    Indicated for acute bacterial skin and skin structure infections

    Susceptible isolates of gram-positive microorganisms

    • Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates)
    • Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus)
    • Enterococcus faecalis

    None

    • Nausea (8%)
    • Headache (6%)
    • Diarrhea (4%)
    • Hemoglobin <10.1 g/dL (3.1%)
    • Vomiting (3%)
    • Platelets <112 x 10³/mm³ (2.3%)
    • Dizziness (2%)
    • Blood and lymphatic system disorders: Anemia
    • Cardiovascular: Palpitations, tachycardia
    • Eye disorders: Asthenopia, vision blurred, visual impairment, vitreous floaters
    • General disorders and administration site conditions: Infusion-related reactions
    • Immune system disorders: Drug hypersensitivity
    • Infections and infestations: Clostridium difficile colitis, oral candidiasis, vulvovaginal mycotic infection

    Safety and efficacy in patients with neutropenia (<1000 cells/mm³) is uncertain; in animal models of infection, tedizolid antibacterial activity was reduced in animal models with neutropenia

    In postmarketing experience, thrombocytopenia reported in patients receiving therapy; in one postmarketing report, patients who experienced thrombocytopenia were treated with tedizolid for a median duration of 26.5 days; duration of treatment beyond 6 days not approved

    Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria

    Based on animal reproduction studies, may cause fetal harm when administered to pregnant females; there are no adequate and well-controlled studies in pregnant women

    Tedizolid is excreted in the breast milk of rats; when drug is present in animal milk, it is likely that the drug will be present in human milk

    Unknown whether tedizolid is excreted in human milk

    Adults

    200 mg/day PO or IV.

    Geriatric

    200 mg/day PO or IV.

    Adolescents

    200 mg/day PO or IV.

    Children

    12 years: 200 mg/day PO or IV.
    1 to 11 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Tedizolid phosphate

    tablet

    • 200mg

    injection, lyophilized powder for reconstitution

    • 200mg/vial