LEVOFLOXACIN tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Aidarex Pharmaceuticals LLC

INN (Nama Internasional):

LEVOFLOXACIN

Komposisi:

LEVOFLOXACIN ANHYDROUS 750 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Levofloxacin are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin is indicated 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 is indicated 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 , Klebsie

Ringkasan produk:

Levofloxacin tablets, USP Levofloxacin  tablet, USP supplied as 750 mg oval-shaped, coated tablets. • 750 mg tablets are White, oval, biconvex, film coated tablets, debossed 750 on one side and "C287" on the other side,             – bottles of 5 Tablets (NDC 53217-0318-05)             – bottles of 7 Tablets (NDC 53217-0318-07)             – bottles of 10 Tablets (NDC 53217-0318-10)             – bottles of 30 Tablets (NDC 53217-0318-30) Dispense in a well-closed container as defined in the USP.  Use child-resistant closure (as required). Store at 20º - 25ºC (68º - 77ºF) [See USP Controlled Room Temperature]. Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

LEVOFLOXACIN- LEVOFLOXACIN TABLET
Aidarex Pharmaceuticals LLC
----------
MEDICATION GUIDE
LEVOFLOXACIN TABLETS, USP
[LEE-voe-FLOX-a-sin]
Read the Medication Guide before you start taking levofloxacin tablets
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
levofloxacin tablets?
Levofloxacin, 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 pain, swelling, tears and inflammation of
tendons including the back
of the ankle (Achilles), shoulder, hand or other tendons sites.
• The risk of getting tendon problems while you take levofloxacin
tablets 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
levofloxacin tablets.
• 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 levofloxacin tablets immediately and get medical help
right away at the first sign of
tendon pain, swelling or inflammation. Stop taking levofloxacin
tablets, USP until tendinitis or tendon
rupture has been ruled out by your healthcare provider. Avoid exercise
and using the affected area.

Karakteristik produk

LEVOFLOXACIN- LEVOFLOXACIN TABLET
AIDAREX PHARMACEUTICALS LLC
----------
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:
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
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
(5.1-5.14), RESERVE LEVOFLOXACIN 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
Boxed Warning 6/2016
Indications and Usage (1) 6/2016
Dosage and Administration (2) 6/2016
Warnings and Precautions (5) 6/2016
INDICATIONS AND USAGE
Levofloxacin 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)
Skin and Skin Structure Infections: Complicated (1