LEVOFLOXACIN injection

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Fresenius Kabi USA, LLC

INN (Nama Internasional):

LEVOFLOXACIN

Komposisi:

LEVOFLOXACIN ANHYDROUS 5 mg in 1 mL

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Levofloxacin in 5% Dextrose Injection is 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 in 5% Dextrose Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).  Levofloxacin in 5% Dextrose Injection is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible 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 anti-pseudomonal β-lactam is recommended [see Clinical Studies (

Ringkasan produk:

Levofloxacin in 5% Dextrose Injection is supplied as a single-use, premixed solution in flexible containers.  Each bag contains a dilute solution with the equivalent of 250, 500, or 750 mg of levofloxacin, respectively, in 5% Dextrose (D5W). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Avoid excessive heat and protect from freezing and light. The container closure is not made with natural rubber latex.  Non-PVC, Non-DEHP, Sterile.

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

LEVOFLOXACIN- LEVOFLOXACIN INJECTION
Fresenius Kabi USA, LLC
----------
MEDICATION GUIDE
Levofloxacin
(LEE-voe-FLOX-a-sin)
in 5% Dextrose Injection, for Intravenous Use
Read this Medication Guide before you start taking Levofloxacin in 5%
Dextrose Injection and each time
you get a refill. There may be new information. This Medication Guide
does not take the place of talking to
your healthcare provider about your medical condition or your
treatment.
What is the most important information I should know about
Levofloxacin in 5% Dextrose Injection?
Levofloxacin in 5% Dextrose Injection, a fluoroquinolone antibiotic,
can cause serious side effects. Some of
these serious side effects can happen at the same time and could
result in death.
If you have any of the following serious side effects while you take
Levofloxacin in 5% Dextrose Injection,
you should stop taking Levofloxacin in 5% Dextrose Injection and get
medical help right away.
1. Tendon rupture or swelling of the tendon (tendinitis).
• Tendon problems can happen in people of all ages who take
Levofloxacin in 5% Dextrose
Injection. Tendons are tough cords of tissue that connect muscles to
bones.
Some tendon problems include pain, swelling, tears, and swelling of
tendons including the back
of the ankle (Achilles), shoulder, hand, or other tendon sites.
• The risk of getting tendon problems while you take Levofloxacin in
5% Dextrose Injection is
higher if you:
• are over 60 years of age
• are taking steroids (corticosteroids)
• have had a kidney, heart or lung transplant
• Tendon problems can happen in people who do not have the above
risk factors when they take
Levofloxacin in 5% Dextrose Injection.
• Other reasons that can increase your risk of tendon problems can
include:
• physical activity or exercise
• kidney failure
• tendon problems in the past, such as in people with rheumatoid
arthritis (RA)
• Stop taking Levofloxacin in 5% Dextrose Injection immediately and
get medical help right away at
the first sign of tendon pain, swelling, or

Karakteristik produk

LEVOFLOXACIN- LEVOFLOXACIN INJECTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN IN 5%
DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LEVOFLOXACIN IN 5% DEXTROSE INJECTION.
LEVOFLOXACIN IN 5% DEXTROSE INJECTION, SOLUTION FOR INTRAVENOUS 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 IN 5% DEXTROSE INJECTION,
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 IN 5% DEXTROSE INJECTION IMMEDIATELY AND
AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN IN 5% DEXTROSE INJECTION, IN
PATIENTS WHO
EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS ( 5.1)
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN IN 5% DEXTROSE INJECTION, MAY
EXACERBATE
MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN
IN 5%
DEXTROSE INJECTION IN PATIENTS WITH A KNOWN HISTORY OF MYASTHENIA
GRAVIS _[SEE_
_WARNINGS AND PRECAUTIONS (_5.5_)]_
BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN IN 5% DEXTROSE
INJECTION, HAVE
BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS( 5.1- 5.15), RESERVE
LEVOFLOXACIN IN
5% DEXTROSE INJECTION FOR 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
in 5% Dextrose Injection and other antibacterial drugs, Levofloxacin
in 5% Dextrose In