LEVOFLOXACIN tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

RedPharm Drug, Inc.

INN (International ime):

LEVOFLOXACIN

Sastav:

LEVOFLOXACIN ANHYDROUS 500 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 tablets are 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 CLINICALSTUDIES (14.1 )]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resista

Proizvod sažetak:

Levofloxacin tablets 250 mg are white colored, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘279’ on other side and are supplied in bottles of 30, 50, 100, 500 and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-279-30 Bottles of 50 NDC 55111-279-50 Bottles of 100 NDC 55111-279-01 Bottles of 500 NDC 55111-279-05 Unit dose packages of 100 (10 x 10) NDC 55111-279-78 Levofloxacin tablets 500 mg are orange colored, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘280’ on other side and are supplied in bottles of 30, 50, 100, 500 and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-280-30 Bottles of 50 NDC 55111-280-50 Bottles of 100 NDC 55111-280-01 Bottles of 500 NDC 55111-280-05 Unit dose packages of 100 (10 x 10) NDC 55111-280-78 Levofloxacin tablets 750 mg are yellow colored, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘281’ on other side and are supplied in bottles of 30, 50, 100, 500 and unit dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-281-30 Bottles of 50 NDC 55111-281-50 Bottles of 100 NDC 55111-281-01 Bottles of 500 NDC 55111-281-05 Unit dose packages of 100 (10 x 10) NDC 55111-281-78 Levofloxacin tablets should be stored at 20° to 25°C (68° to 77°F) (See Controlled Room Temperature) in well-closed containers. 16.1 Levofloxacin Tablets

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

LEVOFLOXACIN- levofloxacin tablet, film coated
RedPharm Drug, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Levofloxacin Tablets, 250 mg, 500 mg and 750 mg 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 takelevofloxacin
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 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 ot

Svojstava lijeka

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF MYASTHENIA 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 (5.1-5.14)],
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)].
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 inf