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:

Mylan Pharmaceuticals Inc.

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 pyo

Product summary:

Linezolid Tablets are available containing 600 mg of linezolid. The 600 mg tablets are yellow, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and L77 on the other side. They are available as follows: NDC 0378-7077-94 bottles of 20 tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LINEZOLID- LINEZOLID TABLET, FILM COATED
MYLAN 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
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
(1.1); 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 tablets 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 FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
Dosage, Route, and Frequency of Administration
Infe ction
Pediatric Patients
(Birth through 11
years of Age)
Adults and Adolescents
(12 years and Older)
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-acquire d
pneumonia, including
concurrent bacteremia
Complicated skin and skin
structure infections
Vancomycin-re sistant
_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
Tablet: 600 mg linezolid. (3)
Known hypersensitivity to l