LEVOFLOXACIN tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Blenheim Pharmacal, Inc.

INN (इंटरनेशनल नाम):

Levofloxacin

रचना:

LEVOFLOXACIN ANHYDROUS 500 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4

उत्पाद समीक्षा:

Levofloxacin tablets 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 10. Bottles of 10; NDC 10544-558-10 Levofloxacin tablets 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 10. Bottles of 10; NDC 10544-245-10 Levofloxacin tablets should be stored at 20° to 25°C (68° to 77°F) (See Controlled Room Temperature) in well-closed containers. Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally – 500 090 INDIA Packaged/ Marketed by: Blenheim Pharmacal, Inc. North Blenheim, New York (NY) 12131, (USA)

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Blenheim Pharmacal, Inc.
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MEDICATION GUIDE
Levofloxacin Tablets, 500 mg and 750 mg Tablets
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 could result
in death.
If you have any of the following serious side effects while you take
levofloxacin tablets, get medical help
right away. Talk with your healthcare provider about whether you
should continue to take levofloxacin
tablets.
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 inflammation
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).
•
Call your healthcare provider right away at the first sign of tendon
pain, swelling or inflammation.
Stop taking levofloxacin tablets until tendinitis or tendon rupture
has been ruled out by your
healthcare provider. Avoid exercise and using the affected area.
The most common area of pain

उत्पाद विशेषताएं

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
BLENHEIM PHARMACAL, 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:
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, ARE ASSOCIATED WITH AN
INCREASED RISK OF TENDINITIS AND TENDON
RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN OLDER PATIENTS
USUALLY OVER 60 YEARS OF AGE, IN PATIENTS
TAKING CORTICOSTEROID DRUGS, AND IN PATIENTS WITH KIDNEY, HEART OR
LUNG TRANSPLANTS [SEE WARNINGS AND
PRECAUTIONS (5.1)].
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS WITH MYASTHENIA
GRAVIS. AVOID LEVOFLOXACIN IN PATIENTS WITH A KNOWN HISTORY OF
MYASTHENIA GRAVIS [SEE WARNINGS AND
PRECAUTIONS (5.2)].
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of levofloxacin and other antibacterial
drugs, levofloxacinshould be used only to treat or prevent infections
that are proven or strongly suspected to be caused by
bacteria. (1)
RECENT MAJOR CHANGES
Warnings and Precautions
•
INDICATIONS AND USAGE
Levofloxacin is a fluoroquinolone antibacterial indicated in adults
(≥18 years of age) with infections caused by designated,
susceptible bacteria (1, 12.4).
•
•
•
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
1. TYPE OF INFECTION
DOSE EVERY 24 HOURS
DURATION (DAYS)
Nosocomial Pneumonia (1.1)
750 mg
7 to 14
Community Acquired Pneumonia (1.2)
500 mg
7 to 14
Community Acquired Pneumonia (1.3)
750 mg
5
Acute Bacterial Sinusitis (1.4)
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis (1.5)
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI) (1.6)
750 mg
7 to 14
Uncomplicated SSSI (1.7)
500 mg
7 to 10
Chronic Bacterial Prostatitis (1.8)
500 mg
28
Complicated Urinary Tract Infecti