Classes
DEA Class; Rx
Common Brand Names; Sivextro
- Oxazolidinones
Description
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
Indications
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
Contraindications
None
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
200 mg/day PO or IV.
200 mg/day PO or IV.
200 mg/day PO or IV.
12 years: 200 mg/day PO or IV.
1 to 11 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tedizolid phosphate
tablet
- 200mg
injection, lyophilized powder for reconstitution
- 200mg/vial
