LEVOFLOXACIN tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Advanced Rx Pharmacy of Tennessee, LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

1 INDICATIONS & USAGE 1.1 Nosocomial Pneumonia Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillinsusceptible 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 antipseudomonal β-lactam is recommended [see Clinical Studies (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or

Обзор продуктов:

Levofloxacin, USP is supplied as 750 mg capsule-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles in the following configurations: Bottles of 14: NDC 80425-0076-01 Levofloxacin tablets, USP should be stored at 20º to 25ºC (68º to 77°F); excursions permitted to 15º to 30ºC (59º to 86°F) in well-closed containers.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE SECTION
MEDICATION GUIDE
MEDICATION GUIDE
Levofloxacin Tablets
(LEE-voe-FLOX-a-sin)
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 ta

Характеристики продукта

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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LEVOFLOXACIN 750MG TABLETS
BOXED WARNING
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF MYASTHENIA GRAVIS
• Fluoroquinolones, including levofloxacin, have been associated
with disabling and
potentially irreversible serious adverse reactions that have occurred
together [see
Warnings and Precautions (5.1)], including:
o Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
o Peripheral neuropathy [see Warnings and Precautions (5.3)]
o Central nervous system effects [see Warnings and Precautions (5.4)]
Discontinue levofloxacin immediately and avoid the use of
fluoroquinolones,
including levofloxacin, in patients who experience any of these
serious adverse
reactions [see Warnings and Precautions (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 [see Warnings and Precautions (5.1-5.15)],
reserve
levofloxacin for use in patients who have no alternative treatment
options for the
following indications:
o Uncomplicated urinary tract infection [see Indications and Usage
(1.12)]
o Acute bacterial exacerbation of chronic bronchitis [see Indications
and Usage
(1.13)]
o Acute bacterial sinusitis [see Indications and Usage (1.14)].
INDICATIONS AND USAGE SECTION
1 INDICATIONS & USAGE
1.1 Nosocomial Pneumonia
Levofloxacin tablets are indicated in adult patients for the treatment
of nosocomial
pneumonia due to methicillinsusceptible Staphylococcus aureus,
Pseudomonas
aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella
pneumoniae, Haemophilus
influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be
used as
clinically in