LEVOFLOXACIN tablet LEVOFLOXACIN tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

DIRECT RX

INN（国际名称）:

LEVOFLOXACIN

组成:

LEVOFLOXACIN ANHYDROUS 750 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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. 1.1 Nosocomial Pneumonia 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)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [

產品總結:

16.1 Levofloxacin Tablets, USP •Levofloxacin Tablets USP, 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25' on one side and 'I' on the other side. •Levofloxacin Tablets USP, 500 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with '26' on one side and 'I' on the other side. •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. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

资料单张

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
DIRECT RX
----------
Revised: 8/2023
Document Id: 02579894-261f-6c6d-e063-6294a90abbf1
34391-3
Set id: 4f40d5fa-ebcc-516c-e054-00144ff8d46c
Version: 7
Effective Time: 20230807
DIRECT RX

产品特点

LEVOFLOXACIN- LEVOFLOXACIN TABLET
LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
DIRECT RX
----------
LEVOFLOXACIN
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF MYASTHENIA GRAVISWARNING: SERIOUS ADVERSE
REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL
NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF
MYASTHENIA GRAVIS
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OFMYASTHENIA GRAVIS
• Fluoroquinolones, including levofloxacin, have been associated
with disabling and
potentially irreversible serious adverse reactions that have occurred
together [see
Warnings and Precautions (5.1)], including:
o Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
o Peripheral neuropathy [see Warnings and Precautions (5.3)]
o Central nervous system effects [see Warnings and Precautions (5.4)]
Discontinue levofloxacin immediately and avoid the use of
fluoroquinolones,
including levofloxacin, in patients who experience any of these
serious adverse
reactions [see Warnings and Precautions (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 [see Warnings and Precautions (5.1 to
5.14)], reserve
levofloxacin for use in patients who have no alternative treatment
options for the
following indications:
o Uncomplicated urinary tract infection [see Indications and Usage
(1.12)]
o Acute bacterial exacerbation of chronic bronchitis [see Indications
and Usage
(1.13)]
o Acute bacterial sinusitis [see Indications and Usage (1.14)].
Levofloxacin tablets are indicated for the treatment of adults (≥18
years of age) with
mild, moderate, a