LEVOFLOXACIN tablet film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)

Disponibil de la:

Unit Dose Services

INN (nume internaţional):

LEVOFLOXACIN

Compoziție:

LEVOFLOXACIN ANHYDROUS 750 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
UNIT DOSE SERVICES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN
TABLETS.
LEVOFLOXACIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION
OF
MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER
(5.1), INCLUDING:
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE LEVOFLOXACIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PATIENTS WITH
MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN IN PATIENTS WITH A KNOWN HISTORY
OF MYASTHENIA GRAVIS _[SEE_
_WARNINGS AND PRECAUTIONS (5.5)]_ .
BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, HAVE BEEN ASSOCIATED
WITH SERIOUS ADVERSE
REACTIONS (5.1-5.14), RESERVE LEVOFLOXACIN OR USE IN PATIENTS WHO HAVE
NO ALTERNATIVE TREATMENT OPTIONS
FOR THE FOLLOWING INDICATIONS:
UNCOMPLICATED URINARY TRACT INFECTION (1.12)
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13)
ACUTE BACTERIAL SINUSITIS (1.14)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of levofloxacin and other
antibacterial drugs, levofloxacin should be used only to treat or
prevent infections that are proven or strongly
suspected to be caused by bacteria
(1.15).
RECENT MAJOR CHANGES
Boxed Warning
06/2016
Indications and Usage (1)
06/2016
Dosage and Administration (2)
06/2016
Warnings and Precautions (5)
02/2017
INDICATIONS AN