LEVOFLOXACIN tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

REMEDYREPACK INC.

INN (Isem Internazzjonali):

LEVOFLOXACIN

Kompożizzjoni:

LEVOFLOXACIN ANHYDROUS 500 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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) ]. 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 ,

Sommarju tal-prodott:

Levofloxacin tablets, USP 500 mg are peach coloured, capsule shaped, biconvex, debossed 'ML 63' on one side and plain on other side. NDC: 70518-0387-00 30 in 1 BLISTER PACK NDC: 70518-0387-01 10 in 1 BOTTLE PLASTIC NDC: 70518-0387-02 7 in 1 BOTTLE PLASTIC 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
REMEDYREPACK INC.
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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 tablets.
Tendon ruptures can happen within hours or days of takin

Karatteristiċi tal-prodott

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
REMEDYREPACK INC.
----------
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
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 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- 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
• Indications and Usage – Oral solution and Injection Dosage Forms
Removed ( 1) 7/2018
• Dosage and Administration – Oral Solution and Injection Dosage
Forms Removed ( 2) 7/2018
• Warnings and Precautions,-Central Nervous System Effects ( 5.4)
10/2018
• Warnings and Precautions,- Risk of Aortic Aneurysm and Dissection
( 5.9) 05/2019
• Warnings and Precautions,- Blood Gl