MedPath

Tedizolid

Generic Name
Tedizolid
Brand Names
Sivextro
Drug Type
Small Molecule
Chemical Formula
C17H15FN6O3
CAS Number
856866-72-3
Unique Ingredient Identifier
97HLQ82NGL

Overview

Drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and penicillin-resistant Streptococcus penumoniae, represent a massive public health threat. Tedizolid is a member of the oxazolidinone class of antibiotics, which includes the previously approved linezolid and is generally effective against multidrug-resistant Gram-positive bacteria. Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is generally more effective and more tolerable than linezolid. Tedizolid was approved by the FDA on June 20, 2014, for sale by Cubist Pharmaceuticals as tedizolid phosphate (SIVEXTRO®). This product is currently available as both an oral tablet and as a powder for intravenous injection.

Background

Drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and penicillin-resistant Streptococcus penumoniae, represent a massive public health threat. Tedizolid is a member of the oxazolidinone class of antibiotics, which includes the previously approved linezolid and is generally effective against multidrug-resistant Gram-positive bacteria. Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is generally more effective and more tolerable than linezolid. Tedizolid was approved by the FDA on June 20, 2014, for sale by Cubist Pharmaceuticals as tedizolid phosphate (SIVEXTRO®). This product is currently available as both an oral tablet and as a powder for intravenous injection.

Indication

用于特定的敏感细菌引起的成人急性细菌性皮肤和皮肤结构感染(ABSSSI)。抗菌谱为金黄色葡萄球菌(包括耐甲氧西林和甲氧西林敏感菌株),化脓性链球菌,无乳链球菌,咽峡炎链球菌群(包括咽峡炎链球菌、中间型链球菌、星群链球菌),粪肠球菌。

Associated Conditions

  • Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

FDA Approved Products

SIVEXTRO
Manufacturer:Nabriva Therapeutics US, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2022/07/25
NDC:72000-310
SIVEXTRO
Manufacturer:Nabriva Therapeutics US, Inc.
Route:INTRAVENOUS
Strength:200 mg in 4 mL
Approved: 2022/07/25
NDC:72000-320
SIVEXTRO
Manufacturer:Merck Sharp & Dohme LLC
Route:INTRAVENOUS
Strength:200 mg in 4 mL
Approved: 2023/03/10
NDC:67919-040
SIVEXTRO
Manufacturer:Merck Sharp & Dohme LLC
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/03/10
NDC:67919-041

Singapore Approved Products

SIVEXTRO LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION 200MG PER VIAL
Manufacturer:Patheon Italia S.p.A.
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:200mg
Online:Yes
Approved: 2015/09/16
Approval:SIN14851P
SIVEXTRO FILM-COATED TABLET 200MG
Manufacturer:Patheon Inc.
Form:TABLET, FILM COATED
Strength:200mg
Online:Yes
Approved: 2015/09/16
Approval:SIN14850P

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