LEVOFLOXACIN tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Proficient Rx LP

INN (nemzetközi neve):

LEVOFLOXACIN

Összetétel:

LEVOFLOXACIN ANHYDROUS 750 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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

Termék összefoglaló:

Levofloxacin Tablets, 750 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of ‘ZC57’ on one side and plain on other side and are supplied as follows: NDC 63187-514-05 in bottles of 05 tablets NDC 63187-514-07 in bottles of 07 tablets NDC 63187-514-10 in bottles of 10 tablets NDC 63187-514-15 in bottles of 15 tablets NDC 63187-514-30 in bottles of 30 tablets NDC 63187-514-60 in bottles of 60 tablets NDC 63187-514-90 in bottles of 90 tablets Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as described in the USP.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Proficient Rx LP
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MEDICATION GUIDE
Levofloxacin (LEE voe FLOX a sin) Tablets, USP
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, 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 different antibiotic
that is not a fluoroquinolone to treat
your infection.
•
Tendon rupture can happen while you are taking or after you have
finished taking levofloxacin.
Tendon ruptures can happen within hours or days of taking levofloxacin
and have happened up to
several months after people have finished taking their
fluoroquinolone.
•
S

Termékjellemzők

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PROFICIENT RX LP
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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
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.
INDICATIONS AND USAGE
Levofloxacinare a fluoroquinolone antibacterial indicated in adults
(≥ 18 years of age) with infections caused by designated,
susceptible bacteria (1, 12.4).
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DOSAGE AND ADMINISTRATION
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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 Infections (SSSI) (1.6)
750 mg
7 to 14
Uncomplicated SSSI (1.7)
500 mg
7 to 10
Chronic Bacterial Prostatitis (1.8)
500 mg
28
Complicated Urinary Tract Infection (1.9) or Acute
Pyelonephritis (1.11)
750 mg
5
Compli