LINEZOLID- linezolid tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

LINEZOLID

Composition:

LINEZOLID 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablets are 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 py

Product summary:

Linezolid Tablets 600 mg are white to off-white, oval, biconvex, film-coated tablets with ‘G44’ debossed on one side and ‘600’ on the other side, and are available as follows: NDC 68462-291-12 Bottles of 20 Tablets NDC 68462-291-01 Bottles of 100 Tablets NDC 68462-291-05 Bottles of 500 Tablets NDC 68462-291-13 Carton of 30 Tablets (contains 3 cards of 10 unit-dose blisters) Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LINEZOLID- LINEZOLID TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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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 tablets are 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 tablets 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 THROUGH11YEARS OF
AG E)
ADULTS AND ADOLESCENTS
(12 YEARS AND
OLDE R)
DURATION (DAYS)
Nosocomial (2)
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-acquire d
pneumonia, including
concurrent bacteremia (2)
Complicated skin and skin
structure infections (2)
Vancomycin-re sistant
_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 infections (2)
less than 5 yrs: 10 mg/kg oral
every 8 hours
5 to 11 yrs: 10 mg/kg oral
every 12 hours (2)
Adults: 400 mg oral every 12
hours
Adolescents: 600 mg oral
every 12 hours (2)
10 to 14 (2)
DOSAGE FORMS AND STRENGTHS
•
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