LINEZOLID tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Alembic Pharmaceuticals Inc.

INN (mednarodno ime):

LINEZOLID

Sestava:

LINEZOLID 600 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Linezolid tablets are indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ]. Linezolid tablets are 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) ]. Linezolid tablets are 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 . Linezolid has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14) ]. Linezolid tablets are indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (meth

Povzetek izdelek:

Linezolid tablets 600 mg are available as “White to off white, oval shaped, film-coated tablets debossed with “L340” on one side and plain on the other side. 20 tablets in HDPE bottle                   NDC 62332-183-20 30 tablets in HDPE bottle                   NDC 62332-183-30 100 tablets in HDPE bottle                 NDC 62332-183-31 1000 tablets in HDPE bottle               NDC 62332-183-91 Store at 25ºC (77ºF); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

LINEZOLID - LINEZOLID TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LINEZOLID TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LINEZOLID TABLETS.
LINEZOLID TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1.6) 8/2020
Dosage and Administration, Intravenous Administration (2.2) 8/2020
Warnings and Precautions, Risks in Patients with Phenylketonuria
(5.10) 8/2020
INDICATIONS AND USAGE
Linezolid tablets are 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):
• Linezolid tablets are not indicated for the treatment of
Gram-negative infections.
• The safety and efficacy of ¬linezolid tablets formulations given
for longer than 28 days have not been evaluated in
controlled clinical trials.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of linezolid tablets and other
antibacterial drugs, linezolid tablets should be used only to treat or
prevent infections that are proven or strongly
suspected to be caused by bacteria. (1.7) (1)
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)
DURATIO N
(DAYS)
Nosocomial pneumonia
10 mg/kg oral every 8 hours
600 mg oral every 12 hours
10 to 14
Community-acquired pneumonia,
including concurrent bacteremia
Complicated skin and skin structure
infe ctions
Vancomycin-resistant _Enterococcus_
_f