LEVOFLOXACIN tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Zydus Pharmaceuticals (USA) Inc.

INN (Rahvusvaheline Nimetus):

LEVOFLOXACIN

Koostis:

LEVOFLOXACIN ANHYDROUS 250 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Levofloxacin tablet 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)] .   Levofloxacin tablet 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 isolat

Toote kokkuvõte:

Levofloxacin Tablets USP, 250 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC55' on one side and plain on other side and are supplied as follows: NDC 68382-015-18 in bottles of 50 tablets NDC 68382-015-01 in bottles of 100 tablets NDC 68382-015-05 in bottles of 500 tablets Levofloxacin Tablets USP, 500 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC56' on one side and plain on other side and are supplied as follows: NDC 68382-016-18 in bottles of 50 tablets NDC 68382-016-01 in bottles of 100 tablets NDC 68382-016-05 in bottles of 500 tablets NDC 68382-016-10 in bottles of 1,000 tablets Levofloxacin Tablets USP, 750 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC57' on one side and plain on other side and are supplied as follows: NDC 68382-017-18 in bottles of 50 tablets NDC 68382-017-01 in bottles of 100 tablets NDC 68382-017-05 in bottles of 500 tablets Storage Store at 20°C to 25° C (68°F to 77° F) [see USP Controlled Room Temperature]. Dispense in a well closed container as described in the USP.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Zydus Pharmaceuticals (USA) Inc.
----------
SPL MEDGUIDE
MEDICATION GUIDE
Levofloxacin (lee" voe flox' a sin) Tablets, USP
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 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 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 taking
levofloxa

Toote omadused

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
ZYDUS PHARMACEUTICALS (USA) 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:
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), RESERVE LEVOFLOXACIN FOR USE IN PATIENTS WHO HAVE NO ALTERNATIVE
TREATMENT OPTIONS FOR THE FOLLOWING
INDIC ATIO NS:
UNCOMPLICATED URINARY TRACT INFECTION (1.12)
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13)
ACUTE BACTERIAL SINUSITIS (1.14)
INDICATIONS AND USAGE
Levofloxacin is a fluoroquinolone antibacterial indicated in adults
(18 years of age and older) with infections caused by
designated, susceptible bacteria and in pediatric patients where
indicated (1, 12.4).
Pneumonia: Nosocomial (1.1) and Community Acquired (1.2,1.3)
Skin and Skin Structure Infections (SSSI): Complicated (1.4) and
Uncomplicated (1.5)
Chronic bacterial prostatitis (1.6)
Inhalationa