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 tablet 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 tablet is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcu

Product summary:

16.1 Levofloxacin Tablets Levofloxacin Tablets USP, 250 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC55' on one side and plain on other side and are supplied as follows: NDC 68382-015-18 in bottles of 50 tablets NDC 68382-015-01 in bottles of 100 tablets NDC 68382-015-05 in bottles of 500 tablets Levofloxacin Tablets USP, 500 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC56' on one side and plain on other side and are supplied as follows: NDC 68382-016-18 in bottles of 50 tablets NDC 68382-016-01 in bottles of 100 tablets NDC 68382-016-05 in bottles of 500 tablets NDC 68382-016-10 in bottles of 1000 tablets Levofloxacin Tablets USP, 750 mg are white to off white, modified capsule-shaped, biconvex, film-coated tablets debossed with logo of 'ZC57' on one side and plain on other side and are supplied as follows: NDC 68382-017-18 in bottles of 50 tablets NDC 68382-017-01 in bottles of 100 tablets NDC 68382-017-05 in bottles of 500 tablets Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as described in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RedPharm Drug, Inc.
----------
MEDICATION GUIDE
MEDICATION GUIDE
Levofloxacin Tablets, USP
(LEE voe FLOX a sin)
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, get medical help right
away.
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:
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.
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 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. Tendon
ruptures can happen within hours or day

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 GRAVIS ...
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:
Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
Peripheral neuropathy [see Warnings and Precautions (5.3)]
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:
Uncomplicated urinary tract infection [see Indications and Usage
(1.12)]
Acute bacterial exacerbation of chronic bronchitis [see Indications
and Usage (1.13)]
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 REACTION