LEVOFLOXACIN injection, solution, concentrate

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

AuroMedics Pharma LLC

INN (Nama Internasional):

LEVOFLOXACIN

Komposisi:

LEVOFLOXACIN ANHYDROUS 500 mg in 20 mL

Rute administrasi :

INTRAVENOUS

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 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 (14.1)] . Levofloxacin injection is indicated for the treatment of community-acquired pneumonia due to methicillin-s

Ringkasan produk:

Levofloxacin injection is supplied in single-dose vials. Each vial contains a clear yellow to a clear greenish yellow concentrated solution with the equivalent of 500 mg of levofloxacin in 20 mL vials and 750 mg of levofloxacin in 30 mL vials.    Levofloxacin injection in single-dose vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Retain in Carton until time of use. The vial stopper is not made with natural rubber latex. Keep out of reach of children.

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

LEVOFLOXACIN - levofloxacin injection, solution, concentrate
AuroMedics Pharma LLC
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MEDICATION GUIDE
Levofloxacin (lee voe FLOX a sin)
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

Karakteristik produk

LEVOFLOXACIN - LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE
AUROMEDICS PHARMA LLC
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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, 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)
INDICATIONS AND USAGE
Levofloxacin injection is a fluoroquinolone antibacterial indicated in
adults (≥18 years of age) with
infections caused by designated, susceptible bacteria (1, 12.4).
Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3)
Skin and Skin Structure Infections: Complicated (1.4) and
Uncomplicated (1.5)
Chronic bacterial prostatitis (1.6)
Inhalational Anthrax, Post-Exposure (