LEVOFLOXACIN tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Apotheca Inc.

DCI (Dénomination commune internationale):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 750 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

16.1 Levofloxacin Tablets, USP Levofloxacin tablets, USP 750 mg are white colored, capsule shaped, biconvex, debossed ‘ML 64´ on one side and plain on other side. They are supplied as follows; NDC 12634-674-00 Bottles of 10 NDC 12634-674-01 Bottles of 100 NDC 12634-674-09 Bottles of 35 NDC 12634-674-12 Bottles of 120 NDC 12634-674-18 Bottles of 180 NDC 12634-674-40 Bottles of 40 NDC 12634-674-42 Bottles of 42 NDC 12634-674-45 Bottles of 45 NDC 12634-674-50 Bottles of 50 NDC 12634-674-52 Blister Pack of 12 NDC 12634-674-54 Blister Pack of 14 NDC 12634-674-57 Blister Pack of 20 NDC 12634-674-59 Blister Pack of 30 NDC 12634-674-60 Bottles of 60 NDC 12634-674-61 Blister Pack of 10 NDC 12634-674-63 Blister Pack of 3 NDC 12634-674-66 Blister Pack of 6 NDC 12634-674-67 Blister Pack of 7 NDC 12634-674-69 Blister Pack of 9 NDC 12634-674-71 Bottles of 30 NDC 12634-674-74 Bottles of 24 NDC 12634-674-78 Bottles of 28 NDC 12634-674-79 Bottles of 25 NDC 12634-674-80 Bottles of 20 NDC 12634-674-81 Bottles of 21 NDC 12634-674-82 Bottles of 12 NDC 12634-674-84 Bottles of 14 NDC 12634-674-85 Bottles of 15 NDC 12634-674-90 Bottles of 90 NDC 12634-674-91 Blister Pack of 1 NDC 12634-674-92 Bottles of 2 NDC 12634-674-93 Bottles of 3 NDC 12634-674-94 Bottles of 4 NDC 12634-674-95 Bottles of 5 NDC 12634-674-96 Bottles of 6 NDC 12634-674-97 Bottles of 7 NDC 12634-674-98 Bottles of 8 NDC 12634-674-99 Bottles of 9 Levofloxacin tablets, USP should be stored at 20° to 25°C (68°to 77°F); excursions permitted to 15°to 30°C (59°to 86°F) in well-closed containers.

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

Apotheca Inc.
----------
.
Revised: 1/2017
Document Id: 47533163-35dc-00ae-e054-00144ff8d46c
Set id: 47079bd9-8d75-0c03-e054-00144ff8d46c
Version: 2
Effective Time: 20170126
Apotheca Inc.

Résumé des caractéristiques du produit

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
APOTHECA INC.
----------
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 and