LEVOFLOXACIN- levofloxacin tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Levofloxacin (UNII: 6GNT3Y5LMF) (Levofloxacin Anhydrous - UNII:RIX4E89Y14)

Saadav alates:

Jubilant Cadista Pharmaceuticals Inc.

INN (Rahvusvaheline Nimetus):

Levofloxacin

Koostis:

Levofloxacin Anhydrous 250 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Levofloxacin tablets are indicated in adult patients 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)] . 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 Dosage and Administration (2.1) and Clinical Studies (14.2)] .   MDR

Toote kokkuvõte:

Levofloxacin Tablets, USP, 250 mg are light peach colored, capsule shaped, film coated tablets, debossed with '513 ' on one side of tablets and 'C' on the other side.   Bottles of 50’s                              NDC 59746-513-14 Bottles of 100’s                            NDC 59746-513-06 30’s Blister (3 X 10’s)                   NDC 59746-513-32 Levofloxacin Tablets, USP, 500 mg are light peach colored, capsule shaped, film coated tablets, debossed with '514' on one side of tablets and 'C' on the other side.   Bottles of 50’s                              NDC 59746-514-14 Bottles of 100’s                            NDC 59746-514-06 30’s Blister (3 X 10’s)                   NDC 59746-514-32   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] in well-closed containers.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

LEVOFLOXACIN - LEVOFLOXACIN TABLET, FILM COATED
Jubilant Cadista Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Levofloxacin Tablets, USP
(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 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 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. 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 ruptu

Toote omadused

LEVOFLOXACIN - LEVOFLOXACIN TABLET, FILM COATED
JUBILANT CADISTA PHARMACEUTICALS 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, FILM COATED 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 TABLETS, HAVE BEEN ASSOCIATED
WITH DISABLING AND POTENTIALLY
IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT HAVE OCCURRED TOGETHER
(5.1), INCLUDING:
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE LEVOFLOXACIN TABLETS IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING
LEVOFLOXACIN TABLETS, IN PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS
ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN TABLETS, MAY EXACERBATE
MUSCLE WEAKNESS IN PATIENTS WITH
MYASTHENIA GRAVIS. AVOID LEVOFLOXACIN TABLETS IN PATIENTS WITH A KNOWN
HISTORY OF MYASTHENIA GRAVIS _[SEE_
_WARNINGS AND PRECAUTIONS (5.5)]_.
BECAUSE FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN TABLETS, HAVE BEEN
ASSOCIATED WITH SERIOUS ADVERSE
REACTIONS (5.1-5.15), RESERVE LEVOFLOXACIN TABLETS FOR USE IN PATIENTS
WHO HAVE NO ALTERNATIVE TREATMENT
OPTIONS FOR THE FOLLOWING INDICATIONS:
UNCOMPLICATED URINARY TRACT INFECTION (1.12)
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13)
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 (5.13) 10/2018
INDICATIONS AND USAGE
Levofloxacin tablets are fluoroquinolone antibacterial indicated in
adults (18 years of age and older) with infections caused
by designated, susceptible bact