LEVOFLOXACIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug

INN (International Name):

LEVOFLOXACIN

Composition:

LEVOFLOXACIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levofloxacin 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: 7–14 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 [MDRSP]), Hae

Product summary:

16.1 Levofloxacin Tablets, USP Levofloxacin tablets, USP Levofloxacin tablets, USP are supplied as 250, 500, and 750 mg oval-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: • 250 mg tablets are Brownish-pink, oval, biconvex, film coated tablets, debossed 250 on one side and "C282" on the other side. – bottles of 50 Tablets (NDC 69097-282-70) – bottles of 100 Tablets (NDC 69097-282-07) • 500 mg tablets are Yellow, oval, biconvex, film coated tablets, debossed 500 on one side and "C289" on the other side, – bottles of 50 Tablets (NDC 69097-289-70) – bottles of 100 Tablets (NDC 69097-289-07) • 750 mg tablets are White, oval, biconvex, film coated tablets, debossed 750 on one side and "C287" on the other side, – bottles of 20 Tablets (NDC 69097-287-81) – bottles of 100 Tablets (NDC 69097-287-07) Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20º - 25ºC (68º - 77ºF) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVOFLOXACIN- levofloxacin tablet
RedPharm Drug
----------
MEDICATION GUIDE
MEDICATION GUIDE
LEVOFLOXACIN TABLETS, USP
[LEE-voe-FLOX-a-sin]
Read the 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, 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 inflammation of
tendons including the back of the
ankle (Achilles), shoulder, hand or other tendons sites.
• The risk of getting tendon problems while you take levofloxacin
tablets 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
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. Stop taking levofloxacin tablets, USP
until tendinitis or tendon rupture has
been ruled out by your healthcare provider. Avoid exercise and using
the affected ar

Summary of Product characteristics

LEVOFLOXACIN- LEVOFLOXACIN TABLET
REDPHARM DRUG
----------
LEVOFLOXACIN 250MG
BOXED WARNING SECTIONS
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 warning.
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 (5.1-5.14), reserve levofloxacin for use in patients
who have no
alternative treatment options for the following indications:
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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 PRES