LEVOFLOXACIN tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

ACETRIS HEALTH, LLC

INN (الاسم الدولي):

LEVOFLOXACIN

تركيب:

LEVOFLOXACIN ANHYDROUS 250 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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. Levofloxacin  injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). Levofloxacin tablets are indicated 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 for the treatment of community-acquired pneumonia due to methicillin-sus

ملخص المنتج:

Levofloxacin Tablets, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side. Bottles of 50                  NDC 52343-119-50 Levofloxacin Tablets, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side. Bottles of 50                  NDC 52343-120-50 Levofloxacin Tablets, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side.                         Bottles of 20               NDC 52343-121-20 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in well-closed containers.

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

LEVOFLOXACIN - LEVOFLOXACIN TABLET, FILM COATED
ACETRIS HEALTH, LLC
----------
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:
o pain
o swelling
o 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 are higher if you:
o are over 60 years of age
o are taking steroids (corticosteroids)
o 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:
o physical activity or exercise
o kidney failure
o 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 da

خصائص المنتج

LEVOFLOXACIN - LEVOFLOXACIN TABLET, FILM COATED
ACETRIS HEALTH, LLC
----------
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 TO 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 10/2018
adverse reactions (5.4)
Warnings and Precautions – aortic aneurysm
and dissection (5.9) 5/2019
Warnings and Precautions – hypoglycemic 10/2018
coma or death (5.13)
INDICATIONS AND USAGE
Levofloxacin tablets are a fluoroquinolone antibacterial indicated in
adults (18 years of age and older) with infections caused
by designated, susceptible bacter