LEVOFLOXACIN solution

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:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levofloxacin oral solution 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 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 Pseudomonasaeruginosa 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 Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumon

Product summary:

Levofloxacin Oral Solution is supplied in a 100 mL bottle, 200 mL bottle, 480 mL bottle, 10 mL unit dose and 20 mL unit dose, in trays of ten cups, 25 mg/mL Levofloxacin Oral Solution. Levofloxacin Oral Solution should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [refer to USP controlled room temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- LEVOFLOXACIN SOLUTION
Akorn
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MEDICATION GUIDE
MEDICATION GUIDE
Levofloxacin Oral Solution
25 mg/mL
(LEE-voe-FLOX-a-sin)
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 different antibiotic that is
not

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN SOLUTION
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN.
LEVOFLOXACIN ORAL SOLUTION
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 IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING
LEVOFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE
REACTIONS (5.1)
•
•
•
•
•
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of levofloxacin and
other antibacterial drugs, levofloxacin should be used only to treat
or prevent infections that are proven or
strongly suspected to be caused by bacteria (1.15). (1)
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). (2)
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DOSAGE AND ADMINISTRATION
•
TYPE OF INFECTION (3)
DOSE EVERY 24 HOURS (3)
DURATION (DAYS) (3)
Nosocomial Pneumonia (1.1) (3)
750 mg (3)
7-14 (3)
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)
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 ALTER