LEVOFLOXACIN- 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:

Lake Erie Medical DBA Quality Care Products LLC

INN (nemzetközi neve):

LEVOFLOXACIN

Összetétel:

LEVOFLOXACIN ANHYDROUS 250 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 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 [see MI

Termék összefoglaló:

Levofloxacin tablets are supplied as 250 mg, 500 mg, and 750 mg octagonal, biconvex, film-coated tablets. Levofloxacin tablets are packaged in bottles in the following configurations: 250 mg tablets: color: light brown, debossing: “SZ 985” on one side. NDC: 35356-877-07  Bottles of 7 NDC: 35356-877-10  Bottles of 10 NDC: 35356-877-14  Bottles of 14 NDC: 35356-877-20  Bottles of 20 NDC: 35356-877-21  Bottles of 21 500 mg tablets: color: orange, debossing: “SZ 986” on one side. NDC: 35356-923-07  Bottles of 7 NDC: 35356-923-10  Bottles of 10 NDC: 35356-923-14  Bottles of 14 NDC: 35356-923-20  Bottles of 20 NDC: 35356-923-21  Bottles of 21 750 mg tablets: color: yellow, debossing: “SZ 987” on one side. Levofloxacin tablets should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers as described in the USP.

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
----------
Medication Guide
Levofloxacin Tablets
(lee-voe-FLOX-ah-sin)
250 mg, 500 mg, and 750 mg
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 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 tablets, you should stop
taking levofloxacin tablets 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 tablets. Tendons are tough cords of tissue
that connect muscles to bones.
Some tendon problems include: o pain, o swelling, o 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 tablets is higher if you: o are over 60 years of
age o are taking steroids
(corticosteroids) o 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: o physical activity
or exercise o kidney failure o
tendon problems in the past, such as in people with rheumatoid
arthritis (RA) • Stop taking levofloxacin
tablets 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
tablets.

Termékjellemzők

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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
Indication and Usage
•
Dosage and Administration
•
•
Warning and Precautions
•
•
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).
•
•
•
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
TYPE OF INFECTION
DOSE EVERY
24 HOURS
DURATION (DAYS)
Plague (1.14) 04/2012
Dosage in Adult Patients with Normal Renal Function (2.1) 04/2012
Dosage in Pediatric Patients (2.2) 04/2012
Musculoskeletal Disorders in Pediatric Patients and Arthropathic
Effects in Animals (5.10) 04/2012
Increased intracranial pressure (pseudotumor cerebri) (5.6) 10/2011
Pneumonia: nosocomial (1.1) and community acquired (1.2,