LEVAQUIN- levofloxacin tablet, film coated

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

levofloxacin (UNII: 6GNT3Y5LMF) (levofloxacin - UNII:6GNT3Y5LMF)

Tillgänglig från:

RedPharm Drug Inc.

INN (International namn):

levofloxacin

Sammansättning:

levofloxacin 750 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® 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. LEVAQUIN® Tablets/Injection and Oral Solution are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. LEVAQUIN® Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Culture and susceptibility testing Appropriate culture and

Produktsammanfattning:

LEVAQUIN® Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. LEVAQUIN® Tablets are packaged in bottles and in unit-dose blister strips in the following configurations: LEVAQUIN® Tablets should be stored at 15° to 30°C (59° to 86°F) in well-closed containers. LEVAQUIN® Tablets are manufactured for PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ 08869 by Janssen Ortho LLC, Gurabo, Puerto Rico 00778. LEVAQUIN® Oral Solution is supplied in a 16 oz. multi-use bottle (NDC 50458-170-01). Each bottle contains 480 mL of the 25 mg/mL levofloxacin oral solution. LEVAQUIN® Oral Solution should be stored at 25°C (77°F); excursions permitted to 15° – 30°C (59° to 86°F) [refer to USP controlled room temperature]. LEVAQUIN® Oral Solution is manufactured for PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ 08869 by Janssen Pharmaceutica N.V., Beerse, Belgium. LEVAQUIN® Injection is supplied in single-use vials. Each vial contains a concentrated solution with the equivalent of 500 mg of levofloxacin in 20 mL vials and 750 mg of levofloxacin in 30 mL vials. LEVAQUIN® Injection in Single-Use Vials should be stored at controlled room temperature and protected from light. LEVAQUIN® Injection in Single-Use Vials is manufactured for Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ 08869 by Janssen Pharmaceutica N.V., Beerse, Belgium. LEVAQUIN® (levofloxacin in 5% dextrose) Injection is supplied as a single-use, premixed solution in flexible containers. Each bag contains a dilute solution with the equivalent of 250, 500, or 750 mg of levofloxacin, respectively, in 5% Dextrose (D5W). LEVAQUIN® Injection Premix in Flexible Containers should be stored at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat and protect from freezing and light. LEVAQUIN® Injection Premix in Flexible Containers is manufactured for Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ 08869 by Hospira, Inc., Austin, TX 78728.

Bemyndigande status:

New Drug Application

Bipacksedel

LEVAQUIN - LEVOFLOXACIN TABLET, FILM COATED
RedPharm Drug Inc.
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MEDICATION GUIDE
LEVAQUIN® [Leave ah kwin]
(levofloxacin)
250 mg Tablets, 500 mg Tablets, and 750 mg Tablets
And
LEVAQUIN® (levofloxacin) Oral Solution, 25 mg/mL
And
LEVAQUIN® (levofloxacin) Injection, for Intravenous Use
And
LEVAQUIN® (levofloxacin in 5% dextrose) Injection, for Intravenous
Use
Read the Medication Guide that comes with LEVAQUIN® before you start
taking it 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 LEVAQUIN®?
LEVAQUIN® belongs to a class of antibiotics called fluoroquinolones.
LEVAQUIN® can cause side
effects that may be serious or even cause death. If you get any of the
following serious side effects, get
medical help right away. Talk with your healthcare provider about
whether you should continue to take
LEVAQUIN®.
•
Tendon rupture or swelling of the tendon (tendinitis).
•
Tendons are tough cords of tissue that connect muscles to bones.
•
Pain, swelling, tears, and inflammation of tendons including the back
of the ankle
(Achilles), shoulder, hand, or other tendon sites can happen in people
of all ages who take
fluoroquinolone antibiotics, including LEVAQUIN®. The risk of getting
tendon problems
is higher if you:
•
are over 60 years of age
•
are taking steroids (corticosteroids)
•
have had a kidney, heart or lung transplant.
•
Swelling of the tendon (tendinitis) and tendon rupture (breakage) have
also happened in
patients who take fluoroquinolones who do not have the above risk
factors.
•
Other reasons for tendon ruptures 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 LEVAQUI

Produktens egenskaper

LEVAQUIN - LEVOFLOXACIN TABLET, FILM COATED
REDPHARM DRUG INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVAQUIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEVAQUIN.
LEVAQUIN (LEVOFLOXACIN) TABLET, FILM COATED FOR ORAL USE
LEVAQUIN (LEVOFLOXACIN) SOLUTION FOR ORAL USE
LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION, CONCENTRATE FOR
INTRAVENOUS USE
LEVAQUIN (LEVOFLOXACIN) INJECTION, SOLUTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
WARNING:
FLUOROQUINOLONES, INCLUDING LEVAQUIN , 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 LEVAQUIN , MAY EXACERBATE MUSCLE WEAKNESS
IN PERSONS WITH MYASTHENIA
GRAVIS. AVOID LEVAQUIN 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 LEVAQUIN and other
antibacterial drugs, LEVAQUIN should be used only to treat or prevent
infections that are proven or strongly suspected
to be caused by bacteria. (1)
RECENT MAJOR CHANGES
Warnings and Precautions
Exacerbation of myasthenia gravis (5.2) 01/2011
INDICATIONS AND USAGE
LEVAQUIN 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
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). Not tested in h