Tedizolid

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
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