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:

DirectRx

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

1.1 Nosocomial Pneumonia 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)]. 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen 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 pneumon

ملخص المنتج:

•Levofloxacin Tablets USP, 250 mg are pink colored, capsule shaped, biconvex, film coated tablets debossed with '25' on one side and 'I' on the other side. They are supplied in Bottles of 50 tablets NDC 31722-721-50 Blister card of 10 Unit-dose tablets NDC 31722-721-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-721-32 •Levofloxacin Tablets USP, 500 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with '26' on one side and 'I' on the other side. They are supplied in Bottles of 50 tablets NDC 31722-72-50 Blister card of 10 Unit-dose tablets NDC 31722-722-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-722-32 •Levofloxacin Tablets USP, 750 mg are white colored, capsule shaped, biconvex, film coated tablets debossed with '18' on one side and 'I' on the other side. They are supplied in Bottles of 20 tablets NDC 31722-723-20 Blister card of 10 Unit-dose tablets NDC 31722-723-31 Blister pack of 100 (10x10) Unit-dose tablets NDC 31722-723-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

DirectRx
----------
Levofloxacin
(LEE-voe-FLOX-a-sin)
Tablets USP
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 is 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 days of taking levofloxacin
tablets and have happened up to
several months after p

خصائص المنتج

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
DIRECTRX
----------
LEVOFLOXACIN
1.1 Nosocomial Pneumonia
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)].
1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen
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 isolates are isolates resistant to two or more of the following
antibacterials:
penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g.,
cefuroxime,
macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen
Levofloxacin tablets are indicated in adult patients for the treatment
of community-
acquired pneumonia due to Streptococcus pneumoniae (excluding
multi-drug-resistant
isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae,
Mycoplasma
pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration
(2.1) and
Clinical Studies (14.3)].
1.4 Complicated Skin and Skin Structure Infections
Levofloxacin tablets are indicated in adult patients for the treatment
of complicated skin
and skin structure infections due to methicillin-susceptible
Staphylococcus aureus,
Enter