Tedizolid

Tedizolid is used to treat acute bacterial skin and skin structure infections.

Tedizolid is available under the following different brand names: Sivextro.

Dosages of Tedizolid:

Dosage Forms and Strengths

Tablets

• 200 mg

Injection, Lyophilized Powder for Reconstitution

• 200 mg/vial

Dosage Considerations – Should be Given as Follows:

Skin and Skin Structure Infections

• Indicated for acute bacterial skin and skin structure infections
• 200 mg orally/intravenously (IV) once daily for 6 days

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

Dosage Modifications

• Hepatic impairment: No dosage adjustment is required
• Renal impairment or hemodialysis: No dosage adjustment is required
• Children under 18 years: Safety and efficacy not established

Common side effects of Tedizolid include:

• Nausea
• Headache
• Diarrhea
• Hemoglobin less than 10.1 g/dL
• Vomiting
• Platelets less than 112 x 10³/mm³
• Dizziness

Less common side effects of tedizolid include:

• Anemia
• Palpitations, fast heart rate
• Eye strain, vision blurred, visual impairment, vitreous floaters
• Infusion-related reactions
• Drug hypersensitivity
• Clostridium difficile colitis, oral candidiasis, vulvovaginal yeast infection
• Hepatic transaminases increased, decreased white blood cell counts
• Numbness and tingling, seventh nerve paralysis
• Insomnia
• Itching, hives, dermatitis
• Flushing, high blood pressure (hypertension)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of tedizolid include:
  • cyproheptadine
• Tedizolid has serious interactions with at least 57 different drugs.
• Moderate interactions of tedizolid include:
  • levodopa inhaled
• Tedizolid has no listed mild interactions with other drugs.

Warnings

• This medication contains tedizolid. Do not take Sivextro if you are allergic to tedizolid or any ingredients contained in this drug.

Contraindications

• None

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Tedizolid?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Tedizolid?"

Cautions

• Safety and efficacy in patients with neutropenia (less than 1000 cells/mm³) is uncertain; in animal models of infection, tedizolid antibacterial activity was reduced in animal models with neutropenia
• Clostridium difficile-associated diarrhea (CDAD) reported with nearly all systemic antibacterial agents, including tedizolid; evaluate if diarrhea occurs
• 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

Drug interactions overview

• Clinical trials of tedizolid to date have excluded patients receiving MAOIs, SSRIs, and SNRIs and TCAs; however, the risk of serotonin syndrome may be a class effect and appropriate caution should be taken to avoid coadministration of these agents with tedizolid
• Oral tedizolid inhibits breast cancer resistance protein (BCRP) in the intestine, which may increase plasma concentrations and/or adverse reactions of orally administered BCRP substrates; consider avoiding BCRP substrates during oral tedizolid treatment especially for BCRP substrates with a narrow therapeutic index (eg, methotrexate or topotecan); if coadministration cannot be avoided, monitor for adverse reactions related to the concomitantly administered BCRP substrates

Pregnancy and Lactation

• There are no adequate and well-controlled studies of tedizolid in pregnant women. Only use tedizolid during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult your doctor.
  • In embryo-fetal studies in mice and rats, tedizolid was shown to produce fetal developmental toxicities in mice and maternal toxicity and fetal developmental toxicities in rats
  • Tedizolid administered orally during organogenesis to pregnant animals was associated with reduced fetal weights and an increased incidence of costal cartilage anomalies in the absence of maternal toxicity in mice, and maternal toxicity decreased fetal weights, and increased skeletal variations in rats at plasma exposures approximately 4- and 6-times respectively, the human plasma exposure at the maximum recommended human dose (MRHD) of 200 mg/day
  • In female rats, d tedizolid administered during organogenesis through lactation did not show evidence of fetal toxicity, developmental delays, or impaired reproduction in offspring at plasma exposures approximately equivalent to the human plasma exposure at the MRHD
• Tedizolid is excreted in the breast milk of rats. When the drug is present in animal milk, the drug will likely be present in human milk. It is unknown whether tedizolid is excreted in human milk. Exercise caution when administering to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on a breastfed child from tedizolid or the underlying maternal condition.