LEVOFLOXACIN solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Department of State Health Services, Pharmacy Branch

INN (nume internaţional):

LEVOFLOXACIN

Compoziție:

LEVOFLOXACIN ANHYDROUS 25 mg in 1 mL

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [ see

Rezumat produs:

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 of the 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].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

LEVOFLOXACIN- LEVOFLOXACIN SOLUTION
Department of State Health Services, Pharmacy Branch
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17.6 FDA-APPROVED MEDICATION GUIDE
MEDICATION GUIDE
LevofloxacinOral Solution
25 mg/mL
Read this Medication Guide Levofloxacin 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, 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, get medical help right
away. Talk with your healthcare provider about whether you should
continue to take Levofloxacin.
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 inflammation
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)
•
Call your healthcare provider right away at the first sign of tendon
pain, swelling or inflammation.
Stop taking Levofloxacin until tendinitis or tendon rupture has been
ruled out by your healthcare
provider. Avoid exercise and using the affected area.
The most common area of pain and swelling i

Caracteristicilor produsului

LEVOFLOXACIN- LEVOFLOXACIN SOLUTION
DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN ORAL
SOLUTION.
INITIAL U.S. APPROVAL: 1996
WARNING
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, ARE ASSOCIATED WITH AN
INCREASED RISK OF TENDINITIS AND TENDON
RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN OLDER PATIENTS
USUALLY OVER 60 YEARS OF AGE, IN PATIENTS
TAKING CORTICOSTEROID DRUGS, AND IN PATIENTS WITH KIDNEY, HEART OR
LUNG TRANSPLANTS [ _SEE WARNINGS AND_
_PRECAUTIONS (5.1)_].
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS WITH MYASTHENIA
GRAVIS. AVOID LEVOFLOXACIN IN PATIENTS WITH A KNOWN HISTORY OF
MYASTHENIA GRAVIS [ _SEE WARNINGS AND_
_PRECAUTIONS (5.2)_]
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)
RECENT MAJOR CHANGES
Indications and Usage
Plague ( 1.14) 04/2012
Dosage and Administration
Dosage in Adult Patients with Normal Renal Function ( 2.1) 04/2012
Dosage in Pediatric Patients ( 2.2) 04/2012
Warnings and Precautions
Musculoskeletal Disorders in Pediatric Patients and Arthropathic
Effects in Animals ( 5.10) 04/2012
Increased intracranial pressure (pseudotumor cerebri) ( 5.6) 10/2011
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)
Acute bacterial sinusitis ( 1.4)
Acute bacterial exacerbation of chronic bronchitis ( 1.5)
Skin and skin structure infections: complicated ( 1.6) and
uncompl