LEVOFLOXACIN tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Torrent Pharmaceuticals Limited

INN (इंटरनेशनल नाम):

LEVOFLOXACIN

रचना:

LEVOFLOXACIN ANHYDROUS 250 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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)] . MDRSP iso

उत्पाद समीक्षा:

Levofloxacin Tablets, USP are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: Levofloxacin tablets, USP 250 mg are light pink colored, capsule-shaped, film-coated tablets, debossed with "250" on one side and "1082" on the other side. Bottles of 50                                       NDC 13668-082-50 Bottles of 100                                     NDC 13668-082-01 Bottles of 500                                     NDC 13668-082-05 100 Unit dose tablets                          NDC 13668-082-74 Levofloxacin tablets, USP 500 mg are brick red colored, capsule-shaped, film-coated tablets, debossed with "83" on one side and plain on the other side. Bottles of 50                                       NDC 13668-083-50 Bottles of 100                                     NDC 13668-083-01 Bottles of 500                                     NDC 13668-083-05 100 Unit dose tablets                          NDC 13668-083-74 Levofloxacin tablets, USP 750 mg are white to off-white colored, capsule-shaped, film-coated tablets, debossed with "750" on one side and "1084" on the other side. Bottles of 20                                       NDC 13668-084-21 Bottles of 50                                       NDC 13668-084-50 Bottles of 100                                     NDC 13668-084-01 Bottles of 500                                     NDC 13668-084-05 100 Unit dose tablets                          NDC 13668-084-74 Levofloxacin tablets should be stored at 20° to 25°C (68° to 77°); excursions permitted to  15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container with a child-resistant closure.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Torrent Pharmaceuticals Limited
----------
MEDICATION GUIDE Levofloxacin (lee-voe-FLOX-a-sin)
Tablets, USP
250 mg Tablets, 500 mg Tablets, and 750 mg Tablets
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 rupture

उत्पाद विशेषताएं

LEVOFLOXACIN- LEVOFLOXACIN TABLET
TORRENT PHARMACEUTICALS LIMITED
----------
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 INCLUDINGTENDINITIS, 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:
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, 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 TO 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
• Indications and Usage – oral solution and injection 7/2018
dosage forms removed (1)
• Dosage and Administration – oral solution and injection 7/2018
dosage forms removed (2)
• Warnings and Precautions Central Nervous System Effects 10/2018
(5.4)
• Warnings and Precautions – Risk of Aortic Aneurysm and
Dissection 5/2019
(5.9)
• Warnings and Precautions, Blood Glucose Distur