LEVOFLOXACIN- levofloxacin tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

INN (Διεθνής Όνομα):

LEVOFLOXACIN

Σύνθεση:

LEVOFLOXACIN ANHYDROUS 250 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible S taphylococcus 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 ClinicalStudies (14.1 ) ]. Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Dosageand Administration (2.1) and Clinical Studies (14.2) ]. MDRSP isol

Περίληψη προϊόντος:

Levofloxacin tablets USP, 250 mg are white colored, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘279’ on other side and are supplied in bottles of 30, 50, 100, 500 and unit dose packages of 100 (10 x 10). Bottles of 30                                                                 NDC 55111-279-30 Bottles of 50                                                                 NDC 55111-279-50 Bottles of 100                                                               NDC 55111-279-01 Bottles of 500                                                               NDC 55111-279-05 Unit dose packages of 100 (10 x 10)                NDC 55111-279-78 Levofloxacin tablets USP, 500 mg are orange colored, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘280’ on other side and are supplied in bottles of 30, 50, 100, 500 and unit dose packages of 100 (10 x 10). Bottles of 30                                                                 NDC 55111-280-30 Bottles of 50                                                                 NDC 55111-280-50 Bottles of 100                                                               NDC 55111-280-01 Bottles of 500                                                               NDC 55111-280-05 Unit dose packages of 100 (10 x 10)                NDC 55111-280-78 Levofloxacin tablets USP, 750 mg are yellow colored, modified capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘281’ on other side and are supplied in bottles of 30, 50, 100, 500 and unit dose packages of 100 (10 x 10). Bottles of 30                                                                 NDC 55111-281-30 Bottles of 50                                                                 NDC 55111-281-50 Bottles of 100                                                               NDC 55111-281-01 Bottles of 500                                                               NDC 55111-281-05 Unit dose packages of 100 (10 x 10)                NDC 55111-281-78 Levofloxacin tablets should be stored at 20° to 25°C (68° to 77°F) (See Controlled Room Temperature) in well-closed containers.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
REMEDYREPACK INC.
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MEDICATION GUIDE
Levofloxacin Tablets USP, 250 mg, 500 mg and 750 mg Tablets
(lee'' voe flox' a sin)
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 takelevofloxacin
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 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 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
tablets. Tendon rupture

Αρχείο Π.Χ.Π.

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
REMEDYREPACK INC.
----------
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 WARNING._
• 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 (5.2)
o PERIPHERAL NEUROPATHY (5.3)
o CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE LEVOFLOXACIN IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (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- 5.15), RESERVE LEVOFLOXACIN FOR USE IN PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE
FOLLOWING INDICATIONS:
o UNCOMPLICATED URINARY TRACT INFECTION ( 1.12)
o ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13)
o ACUTE BACTERIAL SINUSITIS ( 1.14)
RECENT MAJOR CHANGES
Warnings and Precautions -psychiatric adverse reactions (5.4) 10/2018
Warnings and Precautions – hypoglycemic coma or death (5.12) 10/2018
INDICATIONS AND USAGE
Levofloxacin tablet is a fluoroquinolone antibacterial indicated in
adults (18 years of age and older) with infections caused
by designated, susceptible bacteria and in pediatric patients where
indicated ( 1, 12.4).
• Pneumo