LEVOFLOXACIN tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

NuCarePharmaceuticals, Inc.

INN (Nama Antarabangsa):

LEVOFLOXACIN

Komposisi:

LEVOFLOXACIN ANHYDROUS 500 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Levofloxacin tablets 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 tablets are indicated 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 for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multidrug-resistant Stre

Ringkasan produk:

16.1 Levofloxacin Tablets, USP Levofloxacin, USP is supplied as 500 mg capsule-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: Levofloxacin tablets, USP 500 mg are peach coloured, capsule shaped, biconvex, debossed ML 63 on one side and plain on other side. bottles of 2 NDC 68071-3236-2 bottles of 3 NDC 68071-3236-3 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. Keep out of reach of children.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

LEVOFLOXACIN- levofloxacin tablet, film coated
NuCarePharmaceuticals, Inc.
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Medication Guide
Levofloxacin Tablets
(LEE-voe-FLOX-a-sin)
Read this 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 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 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 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. 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
h

Ciri produk

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
NUCAREPHARMACEUTICALS, 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
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- 5.14), 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
Boxed Warning 6/2016
Indications and Usage ( 1) 6/2016
Dosage and Administration ( 2) 6/2016
Warnings and Precautions ( 5) 2/2017
INDICATIONS AND USAGE
Levofloxacin tablets are 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,