LEVOFLOXACIN injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

levofloxacin (UNII: 6GNT3Y5LMF) (Levofloxacin Anhydrous - UNII:RIX4E89Y14)

Prieinama:

WG Critical Care, LLC

INN (Tarptautinis Pavadinimas):

levofloxacin

Sudėtis:

Levofloxacin Anhydrous 5 mg in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Levofloxacin Injection in 5% dextrose 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 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 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 (14.1)] . Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-suscep

Produkto santrauka:

Levofloxacin Injection in 5% dextrose is supplied as a single-dose, 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 (D5 W). NDC Strength Package 44567-435-24 250 mg per 50 mL 24 bags per carton 44567-436-24 500 mg per 100 mL 24 bags per carton 44567-437-24 750 mg per 150 mL 24 bags per carton Storage Conditions Store at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Keep out of reach of children. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container closure is not made with natural rubber latex.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

LEVOFLOXACIN- LEVOFLOXACIN INJECTION, SOLUTION
WG Critical Care, LLC
----------
MEDICATION GUIDE
LEVOFLOXACIN (lee voe FLOX a sin) INJECTION
in 5% Dextrose
For Intravenous Use
Read this Medication Guide before you start taking LEVOFLOXACIN 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?
LEVOFLOXACIN, 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, you should stop
taking LEVOFLOXACIN immediately 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.
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 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.
•
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 immediately and get medical help right away
at the first sign
of tendon pain, swelling or inflammation. Avoid exercise and using the
affected area.
The most common area of pain and swelling is the Achilles tendon at
the back of your ankle.
This can also happen with other tendons. You may need a

Prekės savybės

LEVOFLOXACIN- LEVOFLOXACIN INJECTION, SOLUTION
WG CRITICAL CARE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN INJECTION
IN 5% DEXTROSE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LEVOFLOXACIN
INJECTION IN 5% DEXTROSE.
LEVOFLOXACIN INJECTION IN 5% DEXTROSE, 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._
•
DISCONTINUE LEVOFLOXACIN INJECTION IMMEDIATELY AND AVOID USE OF
FLUOROQUINOLONES,
INCLUDING LEVOFLOXACIN INJECTION IN 5% DEXTROSE, IN PATIENTS WHO
EXPERIENCE ANY OF
THESE SERIOUS ADVERSE REACTIONS (5.1)
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.4, 5.8, 5.13)
3/2019
INDICATIONS AND USAGE
Levofloxacin is a fluoroquinolone antibacterial indicated in adults
(≥18 years of age) with infections caused
by designated, susceptible bacteria (1, 12.4).
•
•
•
•
•
•
•
•
•
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN INJECTION IN 5% DEXTROSE,
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)
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN INJECTION IN 5% DEXTROSE, MAY
EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID
LEVOFLOXACIN INJECTION IN 5% DEXTROSE IN PATIENTS WITH A KNOWN HISTORY
OF
MYASTHENIA GRAVIS _[SEE WARNINGS AND PRECAUTIONS (5.5)]_.
BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN INJECTION IN 5%
DEXTROSE,
HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1 TO 5.15),
RESERVE
LEVOFLOXACIN INJECTION IN 5% DEXTROSE FOR USE IN PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE FOLLOWING INDICATIONS:
•
•
•
UNCOMPLICATED URINARY TRACT