LEVOFLOXACIN tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Proficient Rx LP

INN (इंटरनेशनल नाम):

LEVOFLOXACIN

रचना:

LEVOFLOXACIN ANHYDROUS 750 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 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, Klebsiella pneumoniae,

उत्पाद समीक्षा:

•Levofloxacin Tablets USP, 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18' on one side and 'I' on the other side. They are supplied in    Bottles of 5 tablets                                              NDC 63187-833-05    Bottles of 7 tablets                                              NDC 63187-833-07 Bottles of 10 tablets                                              NDC 63187-833-10    Bottles of 30 tablets                                              NDC 63187-833-30    Bottles of 60 tablets                                              NDC 63187-833-60    Bottles of 90 tablets                                              NDC 63187-833-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Proficient Rx LP
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MEDICATION GUIDE
Levofloxacin
(LEE-voe-FLOX-a-sin)
Tablets USP
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 taking levofloxacin
tablets and have happened up

उत्पाद विशेषताएं

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PROFICIENT RX LP
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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 TABLET, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of levofloxacin and
other antibacterial drugs, levofloxacin should be used only to treat
or prevent infections that are proven or
strongly suspected to be caused by bacteria (1.15).
RECENT MAJOR CHANGES
Boxed Warning 06/2016
Indications and Usage (1) 06/2016
Dosage and Administration (2) 06/2016
Warnings and Precautions (5) 06/2016
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 (1.4) and
Uncomplicated (1.5)
• Chronic bacterial prostatitis (1.6)
• Inhalational Anthrax, Post-Exposure (1.7)
• Plague (1.8)
• Urinary Tract Infections: Complicated (1.9, 1.10) and
Uncomplicated (1.12)
• Acute Pyelonephritis (1.11)
• Acute Bacterial Exacerbation of Chronic Bronchitis (1.13)
• Acute Bacterial Sinusitis (1.14)
DOSAGE AND ADMINISTRATION
• Dosage in patients with normal renal function (2.1)
TYPE OF INFECTION
DOSE EVERY
24 HOURS
DURATION
(DAYS)
Nosocomial Pneumonia (1.1)
750 mg
7-14
Community Acquired Pneumonia
(1.2)
500 mg
7-14
Community Acquired Pneumonia
(1.3)
750 mg
5
Complicated Skin and Skin
Structure Infections (SSSI) (1.6)
750 mg
7-14
Uncomplicated SSSI (1.7)
500 mg
7-10
Chronic Bacterial Prostatitis (1.8)
500 mg
28
Inhalational Anthrax (Post-
Exposure) (1.13)
Adults and Pediatric Patients > 50
kg
500 mg
8 mg/kg BID
(not to exceed 250 mg/dose)
60
60
kg
Pediatric Patients < 50 kg and ≥ 6
months of age
Plague (1.14)
Adults