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 500 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. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). 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 CLINICAL STUDIES (14.1)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin tablets ar

Product summary:

16.1 Levofloxacin Tablets Levofloxacin Tablets, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side. Bottles of 50 NDC 65862-536-50 Bottles of 1000 NDC 65862-536-99 10 x 10 Unit-dose Tablets NDC 65862-536-10 Levofloxacin Tablets, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side. Bottles of 50 NDC 65862-537-50 Bottles of 1000 NDC 65862-537-99 10 x 10 Unit-dose Tablets NDC 65862-537-10 Levofloxacin Tablets, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side. Bottles of 20 NDC 65862-538-20 Bottles of 500 NDC 65862-538-05 10 x 10 Unit-dose Tablets NDC 65862-538-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

RedPharm Drug, Inc.
----------
17.6 FDA-APPROVED MEDICATION
GUIDE
MEDICATION GUIDE
Levofloxacin 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 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 are 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
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 other tendons. You may need a different antibiot

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
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 to
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)]
1 INDICATIONS AND USAGE
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. Levofloxacin
injection is indicated
when intravenous administration offers a route of administration
advantageous to the
patient (e.g., patient cannot tolerate an oral dosage form).
1.1 Nosocomial Pneumonia
Levofloxacin table