LEVOFLOXACIN- levofloxacin injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Sagent Pharmaceuticals

INN（国际名称）:

levofloxacin

组成:

Levofloxacin Anhydrous 5 mg in 1 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Levofloxacin Injection in 5% dextrose 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-suscep

產品總結:

Levofloxacin Injection in 5% dextrose 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). Storage Conditions Store at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container closure is not made with natural rubber latex.

授权状态:

Abbreviated New Drug Application

资料单张

LEVOFLOXACIN- LEVOFLOXACIN INJECTION, SOLUTION
Sagent Pharmaceuticals
----------
MEDICATION GUIDE
LEVOFLOXACIN (lee voe FLOX a sin) INJECTION
in 5% Dextrose
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

产品特点

LEVOFLOXACIN- LEVOFLOXACIN INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
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 INJECTION IN 5% DEXTROSE, 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 IN 5% DEXTROSE,
HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT
HAVE OCCURRED TOGETHER (5.1),
INC LUDING :
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE LEVOFLOXACIN INJECTION IMMEDIATELY AND AVOID USE OF
FLUOROQUINOLONES, INCLUDING
LEVOFLOXACIN INJECTION IN 5% DEXTROSE, IN PATIENTS WHO EXPERIENCE ANY
OF THESE SERIOUS ADVERSE
REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN INJECTION IN 5% DEXTROSE, MAY
EXACERBATE MUSCLE
WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN
INJECTION IN 5% DEXTROSE IN
PATIENTS WITH A KNOWN HISTORY OF MYASTHENIA GRAVIS _[SEE WARNINGS AND
PRECAUTIONS (5.5)]_.
BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN INJECTION IN 5%
DEXTROSE, HAVE BEEN
ASSOCIATED WITH SERIOUS ADVERSE REACTIONS (5.1-5.14), RESERVE
LEVOFLOXACIN INJECTION IN 5%
DEXTROSE 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)
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)