LEVOFLOXACIN injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Hospira, Inc.

INN (Tarptautinis Pavadinimas):

LEVOFLOXACIN

Sudėtis:

LEVOFLOXACIN ANHYDROUS 5 mg in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Levofloxacin 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 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-susceptible Stap

Produkto santrauka:

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 (D5 W). Levofloxacin Injection Premix in Flexible Containers should be stored at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Product may also be stored in a refrigerator, 2 to 8°C (36 to 46 °F). Avoid excessive heat and protect from freezing and light. Keep out of reach of children.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

LEVOFLOXACIN- LEVOFLOXACIN INJECTION, SOLUTION
Hospira, Inc.
----------
MEDICATION GUIDE
Levofloxacin [Lee-voe-FLOX-a-sin] (in 5% Dextrose) Injection
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 diffe

Prekės savybės

LEVOFLOXACIN- LEVOFLOXACIN INJECTION, SOLUTION
HOSPIRA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN
INJECTION.
LEVOFLOXACIN 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, 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
(5.1–5.15), RESERVE LEVOFLOXACIN 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Central Nervous System Effects (5.4)
8/2018
Warnings and Precautions, Risk of Aortic Aneurysm and Dissection (5.9)
5/2019
Warnings and Precautions, Blood Glucose Disturbances (5.13)
8/2018
INDICATIONS AND USAGE
Levofloxacin is a fluoroquinolone antibacterial indicated in adults
(≥18 years of age) with infections caused by designated,
susceptible bacteria (1, 12.