LEVAQUIN- levofloxacin tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

PD-Rx Pharmaceuticals, Inc.

INN (Међународно име):

LEVOFLOXACIN

Састав:

LEVOFLOXACIN ANHYDROUS 750 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

LEVAQUIN ® is 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)] . LEVAQUIN ® is 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 isolates ar

Резиме производа:

LEVAQUIN ® Tablets are supplied as 750 mg capsule-shaped, coated tablets. LEVAQUIN ® Tablets are packaged in bottles in the following configurations: LEVAQUIN ® Tablets should be stored at 15° to 30°C (59° to 86°F) in well-closed containers.

Статус ауторизације:

New Drug Application

Информативни летак

PD-Rx Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration Revised: 07/2018
MEDICATION GUIDE
LEVAQUIN ® (Leave ah kwin)
(levofloxacin)
tablets
What is the most important information I should know about LEVAQUIN?
LEVAQUIN, 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
LEVAQUIN, you should stop
taking LEVAQUIN immediately and get medical help right away.
•
Tendon rupture or swelling of the tendon (tendinitis).
•
Tendon problems can happen in people of all ages who take LEVAQUIN.
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 LEVAQUIN 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 LEVAQUIN.
•
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 LEVAQUIN 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
LEVAQUIN. Tendon ruptures can happen within hours or days of taking
LEVAQUIN
and have

Карактеристике производа

LEVAQUIN- LEVOFLOXACIN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, 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) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION
OF
MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FLUOROQUINOLONES, INCLUDING LEVAQUIN
, HAVE BEEN ASSOCIATED WITH DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER (
5.1), INCLUDING:
TENDINITIS AND TENDON RUPTURE ( 5.2)
PERIPHERAL NEUROPATHY ( 5.3)
CENTRAL NERVOUS SYSTEM EFFECTS ( 5.4)
DISCONTINUE LEVAQUIN IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES, INCLUDING LEVAQUIN
, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS ( 5.1)
FLUOROQUINOLONES, INCLUDING LEVAQUIN
, MAY EXACERBATE MUSCLE WEAKNESS IN PATIENTS WITH MYASTHENIA
GRAVIS. AVOID LEVAQUIN IN PATIENTS WITH A KNOWN HISTORY OF MYASTHENIA GRAVIS _[SEE WARNINGS
AND_
_PRECAUTIONS (5.5)] _.
BECAUSE FLUOROQUINOLONES, INCLUDING LEVAQUIN , HAVE BEEN ASSOCIATED
WITH SERIOUS ADVERSE REACTIONS
(5.1–5.14), RESERVE LEVAQUIN FOR USE IN PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE
FOLLOWING INDICATIONS:
UNCOMPLICATED URINARY TRACT INFECTION ( 1.12)
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS ( 1.13)
ACUTE BACTERIAL SINUSITIS ( 1.14)
RECENT MAJOR CHANGES
Indications and Usage – oral solution and injection dosage forms
related uses removed (1)
7/2018
Dosage and Administration - oral solution and injection dosage forms
related uses removed (2)
7/2018
Warnings and Precautions -psychiatric adverse reactions ( 5.4)
10/2018
Warnings and Precautions – hypoglycemic coma or death ( 5.12)
10/2018
INDICATIONS AND USAGE
LEVAQUIN
is a fluoroquinolone antibacterial indicated in adults (1