LEVOFLOXACIN tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Cipla USA Inc.

INN (International Name):

LEVOFLOXACIN

রচনা:

LEVOFLOXACIN ANHYDROUS 250 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Levofloxacin is 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 is 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 isolates are i

পণ্য সারাংশ:

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: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20ºC to 25ºC (68ºF to 77ºF) [See USP Controlled Room Temperature]

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

LEVOFLOXACIN - LEVOFLOXACIN TABLET
Cipla USA Inc.
----------
MEDICATION GUIDE
LEVOFLOXACIN TABLETS, USP
[LEE-voe-FLOX-a-sin]
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 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 ruptures can happen within hours or days of taki

পণ্য বৈশিষ্ট্য

LEVOFLOXACIN - LEVOFLOXACIN TABLET
CIPLA USA 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:
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
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:
UNCOMPLICATED URINARY TRACT INFECTION (1.12)
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS (1.13)
ACUTE BACTERIAL SINUSITIS (1.14)
INDICATIONS AND USAGE
Levofloxacin 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).
Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3)
Skin and Skin Structure Infections (SSSI): Complicated (1.4) and
Uncomplicated (1.5)
Chronic bacterial prostatitis (1.6)
Inhalational Anthrax, Post-Exposure i