LEVOFLOXACIN tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Proficient Rx

INN (International Adı):

LEVOFLOXACIN

Kompozisyon:

LEVOFLOXACIN ANHYDROUS 500 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tabletsand other antibacterial drugs, levofloxacin tablets 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 tablets are 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 MICR

Ürün özeti:

Levofloxacin tablets are supplied as 500 mg, and 750 mg octagonal, biconvex, film-coated tablets. Levofloxacin tablets are packaged in bottles in the following configurations:

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Proficient Rx
----------
Medication Guide
Levofloxacin Tablets
250 mg, 500 mg, and 750 mg
Read this Medication Guide before you start taking levofloxacin
tablets 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 tablets? Levofloxacin tablets, 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 tablets, get medical help
right away. Talk with your healthcare provider about whether you
should continue to take levofloxacin
tablets.
1. Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take levofloxacin
tablets. 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
tablets 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 tablets.
•
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 tablets until tendinitis or tendon rupture
has been ruled out by your
healthcare provider. Avoid exercise and using the affected area. The
most common area o

Ürün özellikleri

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PROFICIENT RX
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LEVOFLOXACIN TABLETS.
LEVOFLOXACIN TABLETS
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 LEVOFLOXACININ 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 tabletsand other
antibacterial drugs, levofloxacin tabletsshould 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
•
•
•
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
TYPE OF INFECTION
DOSE EVERY
24 HOURS
DURATION (DAYS)
Nosocomial Pneumonia (1.1)
750 mg
7 to 14
Community Acquired Pneumonia (1.2)
500 mg
7 to 14
Community Acquired Pneumonia (1.3)
750 mg
5
Acute Bacterial Sinusitis (1.4)
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic
Bronchitis (1.5)
500 mg
7
Complicated Skin and Skin Structure
750 mg
7 to 14
Warnings and Precautions
Peripheral Neuropathy (5.8) 07/2013
LEVOFLOXACIN TABLETS ARE 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 bacte