LEVOFLOXACIN- levofloxacin injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Heritage Pharmaceuticals Inc.

INN (mednarodno ime):

LEVOFLOXACIN

Sestava:

LEVOFLOXACIN ANHYDROUS 25 mg in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 Staphy

Povzetek izdelek:

Levofloxacin Injection is supplied in single-dose vials. Each vial contains a concentrated solution with the equivalent of 500 mg of levofloxacin USP in 20 mL vials and 750 mg of levofloxacin USP 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.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

LEVOFLOXACIN- LEVOFLOXACIN INJECTION
Heritage Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Levofloxacin Injection for Intravenous Use
(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 differen

Lastnosti izdelka

LEVOFLOXACIN- LEVOFLOXACIN INJECTION
HERITAGE PHARMACEUTICALS 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: O TENDINITIS AND TENDON RUPTURE (5.2) O PERIPHERAL NEUROPATHY (5.3) O 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: O UNCOMPLICATED URINARY TRACT INFECTION (1.12) O ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13) O ACUTE BACTERIAL SINUSITIS (1.14)
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).
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-E