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:

REMEDYREPACK INC.

INN (International Name):

LINEZOLID

Composition:

LINEZOLID 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Linezolid Tablets, 600 mg are white to off white, oval shaped, bevel edged, biconvex film coated tablets, debossed with 'I' on one side and '22' on other side. 20 tablets in HDPE bottle                                   NDC 31722-749-20 30 tablets in HDPE bottle                                   NDC 31722-749-30 100 tablets in HDPE bottle                                 NDC 31722-749-01 Unit-dose package of 150 (15x10) tablets      NDC 31722-749-31 Store at 20º to 25ºC (68º to 77ºF) [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
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LINEZOLID SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LINEZOLID.
LINEZOLID TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Linezolid is an oxazolidinone-class antibacterial indicated in adults
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 or prevent
infections that are proven or strongly suspected to be
caused by bacteria.( 1.4)
DOSAGE AND ADMINISTRATION
Dosage, Route, and Frequency of Administration
Infection
Pediatric Patients
Adults and Adolescents
Duration
(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
DOSAGE FORMS AND STRENGTHS
• Tablet: 600 mg linezolid. (3)
CONTRAINDICATIONS
• Known hypersensitivity to linezolid or any of the other product
components. ( 4.1); Patients taking any monoamine