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 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 [

Product summary:

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. They are supplied in Bottles of 50 tablets NDC 31722-721-50 Blister card of 10 Unit-dose tablets NDC 31722-721-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-721-32 •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. They are supplied in Bottles of 50 tablets NDC 31722-72-50 Blister card of 10 Unit-dose tablets NDC 31722-722-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-722-32 •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 20 tablets NDC 31722-723-20 Blister card of 10 Unit-dose tablets NDC 31722-723-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-723-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RedPharm Drug, Inc.
----------
MEDGUIDE
17.6 FDA-Approved Medication Guide
MEDICATION GUIDE
Levofloxacin
(LEE-voe-FLOX-a-sin)
Tablets
Read this Medication Guide before you start taking levofloxacin 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?
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, you should stop taking
levofloxacin 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. 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 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.
• 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 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

Summary of Product characteristics

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 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)].
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LEVOFLOXACIN
TABLETS safe