LEVOFLOXACIN tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Preferred Pharmaceuticals Inc.

Designación común internacional (DCI):

LEVOFLOXACIN

Composición:

LEVOFLOXACIN ANHYDROUS 750 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli,Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including  multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)]. MDRSP isolat

Resumen del producto:

Levofloxacin Tablets USP, 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18' on one side and 'I' on the other side. They are supplied in    Bottles of 5 tablets                                              NDC 68788-7037-5    Bottles of 7 tablets                                              NDC 68788-7037-7    Bottles of 10 tablets                                              NDC 68788-7037-1    Bottles of 14 tablets                                              NDC 68788-7037-4    Bottles of 20 tablets                                              NDC 68788-7037-2 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Preferred Pharmaceuticals Inc.
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SPL MEDGUIDE SECTION
Levofloxacin
(LEE-voe-FLOX-a-sin)
Tablets USP
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.
Tendon ruptures can happen within hours or days of taking levofloxacin
tablets and

Ficha técnica

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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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
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER
(5.1), INCLUDING:
O TENDINITIS AND TENDON RUPTURE (5.2)
O PERIPHERAL NEUROPATHY (5.3)
O CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE LEVOFLOXACIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PATIENTS WITH MYASTHENIA
GRAVIS. AVOID LEVOFLOXACIN IN PATIENTS WITH A KNOWN HISTORY OF
MYASTHENIA GRAVIS _[SEE WARNINGS AND_
_PRECAUTIONS (5.5)]. _
BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, HAVE BEEN ASSOCIATED
WITH SERIOUS ADVERSE REACTIONS
(5.1 TO 5.15), RESERVE LEVOFLOXACIN FOR USE IN PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE
FOLLOWING INDICATIONS:
O UNCOMPLICATED URINARY TRACT INFECTION (1.12)
O ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13)
O ACUTE BACTERIAL SINUSITIS (1.14)
RECENT MAJOR CHANGES
• Warnings and Precautions -psychiatric adverse reactions (5.4)
10/2018
• Warnings and Precautions – hypoglycemic coma or
death 10/2018
(5.13)
• Warnings and Precautions - Risk of Aortic Aneurysm and 12/2018
Dissection (5.9)
INDICATIONS AND USAGE
Levofloxacin is a fluoroquinolone antibacterial indicated in adults
(18 years of age and older) with infections caused by
designated, susceptible bacteria and in pediatric patients where
indicated (1, 12.4).
• Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3)
• Skin and Skin Structure Infections (SSSI): Complicated (1.4) and
Uncomplicated