ZYVOX- linezolid injection, solution ZYVOX- linezolid granule, for suspension ZYVOX- linezolid tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J)

Boleh didapati daripada:

Pharmacia & Upjohn Company LLC

INN (Nama Antarabangsa):

LINEZOLID

Komposisi:

LINEZOLID 200 mg in 100 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

ZYVOX is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ]. ZYVOX is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14) ]. ZYVOX is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , or Streptococcus agalactiae . ZYVOX has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14) ]. ZYVOX is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyog

Ringkasan produk:

ZYVOX I.V. Injection is available in single-dose, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are not made with natural rubber latex. The infusion bags are available in the following package sizes: 200 mg/100 mL (2 mg/mL) linezolid × 10 NDC 0009-5137-04 600 mg/300 mL (2 mg/mL) linezolid × 10 NDC 0009-5140-04 ZYVOX Tablets are available as follows: 600 mg (white, capsule-shaped, film-coated tablets debossed with "ZYV" on one side and "600" on the other) 20 tablets in HDPE bottle NDC 0009-5138-02 Unit dose packages of 30 tablets NDC 0009-5138-03 ZYVOX for Oral Suspension is available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL. ZYVOX for Oral Suspension is supplied as follows: 100 mg/5 mL in 240 mL glass bottles NDC 0009-5136-01 100 mg/5 mL in 240 mL glass bottles NDC 0009-5136-04 Store at 25ºC (77ºF). Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.

Status kebenaran:

New Drug Application

Ciri produk

ZYVOX- LINEZOLID INJECTION, SOLUTION
ZYVOX- LINEZOLID GRANULE, FOR SUSPENSION
ZYVOX- LINEZOLID TABLET, FILM COATED
PHARMACIA & UPJOHN COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZYVOX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZYVOX.
ZYVOX (LINEZOLID) INJECTION, FOR INTRAVENOUS USE
ZYVOX (LINEZOLID) TABLETS, FOR ORAL USE
ZYVOX (LINEZOLID) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Myelosuppression (5.1)
7/2023
INDICATIONS AND USAGE
ZYVOX is an oxazolidinone-class antibacterial indicated in adults and
children for the treatment of the
following infections caused by susceptible Gram-positive bacteria:
Nosocomial pneumonia (1.1);
Community-acquired pneumonia (1.2); Complicated skin and skin
structure infections, including diabetic
foot infections, without concomitant osteomyelitis (1.3);
Uncomplicated skin and skin structure infections
(1.4); Vancomycin-resistant _Enterococcus faecium_ infections. (1.5)
Limitations of Use (1.6):
•
•
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ZYVOX
formulations and other antibacterial drugs, ZYVOX should be used only
to treat or prevent infections that
are proven or strongly suspected to be caused by bacteria. (1.7)
DOSAGE AND ADMINISTRATION
DOSAGE, ROUTE, AND FREQUENCY OF
ADMINISTRATION
INFECTION
PEDIATRIC PATIENTS
(BIRTH THROUGH 11
YEARS OF AGE)
ADULTS AND
ADOLESCENTS
(12 YEARS AND
OLDER)
DURATION
(DAYS)
Nosocomial pneumonia (2)
10 mg/kg intravenous or
oral every 8 hours (2)
600 mg
intravenous or oral
every 12 hours (2)
10 to 14 (2)
Community-acquired pneumonia,
including concurrent bacteremia (2)
Complicated skin and skin structure
infections (2)
Vancomycin-resistant _Enterococcus_
_faecium_ infections_,_ including concurrent
bacteremia (2)
10 mg/kg intravenous or
oral every 8 hours (2)
600 mg
intravenous or oral
every 12 hours (2)
14 to 28 (2)
Uncomplicated skin and skin structure
i