LEVOFLOXACIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 750 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 [seeClinical Studies (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-resistant Streptococ

Product summary:

Levofloxacin tablets are supplied as 250 mg, 500 mg, and 750 mg octagonal, biconvex, film-coated tablets. Levofloxacin tablets are packaged in bottles in the following configurations: • 250 mg tablets: color: light brown, debossing: “SZ 985” on one side. NDC 0781-5790-50, bottles of 50 tablets NDC 0781-5790-01, bottles of 100 tablets NDC 0781-5790-10, bottles of 1000 tablets • 500 mg tablets: color: orange, debossing: “SZ 986” on one side. NDC 0781-5791-50, bottles of 50 tablets NDC 0781-5791-01, bottles of 100 tablets NDC 0781-5791-10, bottles of 1000 tablets • 750 mg tablets: color: yellow, debossing: “SZ 987” on one side. NDC 0781-5792-20, bottles of 20 tablets NDC 0781-5792-50, bottles of 50 tablets NDC 0781-5792-01, bottles of 100 tablets NDC 0781-5792-10, bottles of 1000 tablets Levofloxacin tablets should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers as described in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- levofloxacin tablet, film coated
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Medication Guide
Levofloxacin Tablets
(lee-voe-FLOX-ah-sin)
250 mg, 500 mg, and 750 mg
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:
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 y

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: SERIOUS ADVERS REACTIONS INCLUDING TENDINITIS, TENDON
RUTURE, 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 (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 [seeIndications 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 information for complete boxed warnin