LEVOFLOXACIN- levofloxacin tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Preferred Pharmaceuticals, Inc.

INN (mednarodno ime):

Levofloxacin

Sestava:

LEVOFLOXACIN ANHYDROUS 750 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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 ClinicalStudies (14.1 ) ]. Levofloxacin tablets are indicated 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, Klebsie

Povzetek izdelek:

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; Bottle of 5 - 68788-9268-5 Bottle of 7 - 68788-9268-7 Bottle of 10 - 68788-9268-1 Bottle of 14 - 68788-9268-4 Bottle of 20 - 68788-9268-2 Levofloxacin tablets should be stored at 20° to 25°C (68° to 77°F) (See Controlled Room Temperature) in well-closed containers.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Preferred Pharmaceuticals, Inc.
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MEDICATION GUIDE
Levofloxacin Tablets, 250 mg, 500 mg and 750 mg Tablets
(lee'' voe flox' a sin)
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 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).
1.
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 swelling of
tendons including the back of the
ankle (Achilles), shoulder, hand, or other tendon sites.
1.
The risk of getting tendon problems while you take levofloxacin if
you:
1.
are over 60 years of age
2.
are taking steroids (corticosteroids)
3.
have had a kidney, heart, or lung transplant.
1.
Tendon problems can happen in people who do not have the above risk
factors when they take
levofloxacin tablets.
2.
Other reasons that can increase your risk of tendon problems can
include:
1.
physical activity or exercise
2.
kidney failure
3.
tendon problems in the past, such as in people with rheumatoid
arthritis (RA).
1.
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.

Lastnosti izdelka

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, 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:
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
(5.1-5.14), 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
Boxed Warning 6/2016
Indications and Usage (1) 6/2016
Dosage and Administration (2) 6/2016
Warnings and Precautions (5) 2/2017
INDICATIONS AND USAGE
Levofloxacin tablets is a fluoroquinolone antibacterial indicated in
adults (≥18 years of age) with infections caused by
designated, susceptible bacteria (1, 12.4).
• Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1