LEVOFLOXACIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

INN (International Name):

Levofloxacin

Composition:

Levofloxacin Anhydrous 25 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Staphyloc

Product summary:

Levofloxacin Injection is supplied in single-dose vials. Each vial contains a concentrated solution with the equivalent of 500 mg of levofloxacin in 20 mL vials or 750 mg of levofloxacin in 30 mL vials. Levofloxacin Injection in Single-dose Vials should be stored at controlled room temperature and protected from light. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- LEVOFLOXACIN INJECTION
Akorn
----------
MEDICATION GUIDE
Levofloxacin (LEE-voe-FLOX-a-sin) Injection, for Intravenous Use Read
this Medication Guide before you
start taking Levofloxacin 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 Injection?
Levofloxacin, a fluoroquinolone antibiotic, can cause serious side
effects. Some of these serious side effects
could result in death.
If you have any of the following serious side effects while you take
Levofloxacin Injection, you should stop
taking Levofloxacin Injection 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
Injection. Tendons are
tough cords of tissue that connect muscle 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 Injection 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 different an

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN INJECTION
AKORN
----------
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 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 INJECTION IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES,
INCLUDING LEVOFLOXACIN INJECTION, IN PATIENTS WHO EXPERIENCE ANY OF
THESE SERIOUS
ADVERSE REACTIONS (5.1).
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN INJECTION, MAY EXACERBATE
MUSCLE WEAKNESS IN
PATIENTS WITH MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN INJECTION IN
PATIENTS WITH A KNOWN
HISTORY OF MYASTHENIA GRAVIS [SEE _WARNINGS AND PRECAUTIONS (5.5)_].
BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN INJECTION, HAVE BEEN
ASSOCIATED WITH
SERIOUS ADVERSE REACTIONS (5.1 TO 5.15), RESERVE LEVOFLOXACIN
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)
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