LEVOFLOXACIN- levofloxacin tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Preferred Pharmaceuticals Inc.

INN (International Nazwa):

LEVOFLOXACIN

Skład:

LEVOFLOXACIN ANHYDROUS 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Levofloxacin tablets, USP are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin tablets, USP are indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. Levofloxacin tablets, USP are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenz

Podsumowanie produktu:

16.1 Levofloxacin Tablets, USP  Levofloxacin tablets, USP are supplied as 250, 500 and 750 mg capsule-shaped, coated tablets.  Levofloxacin tablets, USP are packaged in bottles Levofloxacin tablets, USP 500 mg are peach coloured, capsule shaped, biconvex, debossed 'ML 63' on one side and plain on other side. -   bottles of 7s (NDC 68788-6858-7) -   bottles of 10s (NDC 68788-6858-1) -   bottles of 14s (NDC 68788-6858-4) -   bottles of 20s (NDC 68788-6858-2)   Levofloxacin tablets, USP should be stored at 20º to 25ºC (68º to 77°F); excursions permitted to 15º to 30ºC (59º to 86°F) in well-closed containers.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

Preferred Pharmaceuticals Inc.
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Revised: 9/2018
Document Id: 8ebb386f-5193-49a7-b31a-2abd5660cee2
34391-3
Set id: e1ca278e-ee0b-464c-961b-8cde9779a17b
Version: 3
Effective Time: 20180919
Preferred Pharmaceuticals Inc.

Charakterystyka produktu

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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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:
o TENDINITIS AND TENDON RUPTURE (5.2)
o PERIPHERAL NEUROPATHY (5.3)
o 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 FOR USE IN PATIENTS WHO
HAVE NO ALTERNATIVE TREATMENT OPTIONS FOR
THE FOLLOWING INDICATIONS:
o UNCOMPLICATED URINARY TRACT INFECTION (1.12)
o ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13)
o ACUTE BACTERIAL SINUSITIS (1.14)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of levofloxacin and other
antibacterial drugs, levofloxacin tablets 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 a