LEVOFLOXACIN- levofloxacin tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Preferred Pharmaceuticals, Inc.

ІПН (Міжнародна Ім'я):

LEVOFLOXACIN

Склад:

LEVOFLOXACIN ANHYDROUS 750 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

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 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. Bottle of 5 - 68788-9695-5 Bottle of 7 - 68788-9695-7 Bottle of 10 - 68788-9695-1 Bottle of 14 - 68788-9695-4 Bottle of 20 - 68788-9695-2 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.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Preferred Pharmaceuticals, Inc.
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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 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

Характеристики продукта

LEVOFLOXACIN- LEVOFLOXACIN TABLET
PREFERRED PHARMACEUTICALS, INC.
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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_.
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DISCONTINUE LEVOFLOXACIN TABLETS IMMEDIATELY AND AVOID THE USE OF
FLUOROQUINOLONES, INCLUDING
LEVOFLOXACIN, IN PATIENTS WHO EXPERIENCE ANY
OF THESE SERIOUS ADVERSE REACTIONS (5.1)
•
•
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RECENT MAJOR CHANGES
• Indications and Usage – oral solution and injection 7/2018
dosage forms related uses removed (1)
• Dosage and Administration – oral solution and injection 7/2018
Dosage forms related uses removed (2)
INDICATIONS AND USAGE
Levofloxacin tablets are 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). (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE IN ADULT AND PEDIATRIC PATIENTS WITH CREATININE CLEARANCE
GREATER THAN OR EQUAL TO 50 ML/MINUTE (2.1.
2.2)
(2)
TYPE OF INFECTION
(2)
DOSE EVERY
24 HOURS
(2)
DURATION
(DAYS)
(2)
Nosocomial Pneumonia (1.1)
(2)
750 mg
(2)
7 to 14
(2)
Community Acquired Pneumonia (1.2)
(2)
500 mg
(2)
7 to 14
(2)
Community Acquired Pneumonia (1.3)
(2)
750 mg
(2)
5
(2)
Complicated (SSSI) (1.4)
(2)
750 mg
(2)
7 to 14
(2)
TYPE OF INFECTION
DOSE EVERY
DURATION
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)
CENT