LEVOFLOXACIN tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Medsource Pharmaceuticals

INN (الاسم الدولي):

LEVOFLOXACIN

تركيب:

LEVOFLOXACIN ANHYDROUS 500 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and 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 [

ملخص المنتج:

Levofloxacin tablets are available as follows: 250 mg are available as terra cotta pink, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7291” on the other, in bottles of 50. 500 mg are available as peach-colored, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7292” on the other, in bottles of 50. 750 mg are available as white to off-white, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7293” on the other, in bottles of 50. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Medsource Pharmaceuticals
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MEDICATION GUIDE
LEVOFLOXACIN [lee voe FLOX a sin] TABLETS
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:
1.
are over 60 years of age
2.
are taking steroids (corticosteroids)
3.
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:
1.
physical activity or exercise
2.
kidney failure
3.
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 ar

خصائص المنتج

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
MEDSOURCE PHARMACEUTICALS
----------
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 FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
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.
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_)_] .
RECENT MAJOR CHANGES
Warnings and Precautions
Peripheral Neuropathy ( 5.8) 07/2013
INDICATIONS AND USAGE
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 bacterial exacerbation of chronic bronchitis ( 1.5)
Skin and skin structure infections: complicated ( 1.6) and
uncomplicated ( 1.7)
Chronic bacterial prostatitis ( 1.8)
Urinary tract infections: complicated ( 1.9, 1.10) and uncomplicated (
1.12)
Acute pyelonephritis ( 1.11)
Inhalational anthrax, post-exposure ( 1.13)
Plague ( 1.14)
DOSAGE AND ADMINISTRATION
Dosage in patients with normal renal function ( 2.1)