LINEZOLID- linezolid tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Celltrion, Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4) ]. Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ]. Community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14) ]. 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 Strept

उत्पाद समीक्षा:

Linezolid Tablets are available as follows: 600 mg (white, oval shape, film-coated tablets debossed with "CIC" on one side and "1" on the other side) Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). Protect from light. Keep bottles tightly closed to protect from moisture.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

LINEZOLID- LINEZOLID TABLET
CELLTRION, 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
INDICATIONS AND USAGE
Linezolid 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 (1.1);
Complicated skin and skin structure infections, including diabetic
foot infections, without concomitant osteomyelitis (1.2);
Uncomplicated skin and skin structure infections (1.2);
Vancomycin-resistant _Enterococcus faecium_ infections. (1.3)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of linezolid formulations and other
antibacterial drugs, linezolid should be used only to treat infections
that are proven or strongly suspected to be caused by
bacteria. (1.4)
DOSAGE AND ADMINISTRATION
DOSAGE, ROUTE, AND FREQUENCY OF ADMINISTRATION
INFE C TIO N
PEDIATRIC PATIENTS
(BIRTH THROUGH 11 YEARS OF
AG E)
ADULTS AND
ADO LE SC E NTS
(12 YEARS AND OLDER)
DURATIO N
(DAYS)
Nosocomial pneumonia
10 mg/kg intravenous or oral
every 8 hours
600 mg intravenous or
oral every 12 hours
10 to 14
Community-acquired pneumonia, including
concurrent bacteremia
Complicated skin and skin structure infections
Vancomycin-resistant _Enterococcus faecium_
infections_,_ including concurrent bacteremia
10 mg/kg intravenous or oral
every 8 hours
600 mg intravenous or
oral every 12 hours
14 to 28
Uncomplicated skin and skin structure infections
less than 5 yrs: 10 mg/kg oral
every 8 hours
5–11 yrs: 10 mg/kg oral every
12 hours
Adults: 400 mg oral
every 12 hours
Adolescents: 600 mg
oral every 12 hours
10 to 14
(2)
DOSAGE FORMS AND STRENGTHS
Tablet: 600 mg linezolid. (3)
CONTRAINDICATIONS
Known hypersensitivity to linezolid or any of the other p