LEVOFLOXACIN tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Proficient Rx LP

INN (Nama Antarabangsa):

LEVOFLOXACIN

Komposisi:

LEVOFLOXACIN ANHYDROUS 500 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets, USP and other antibacterial drugs, levofloxacin tablets, USP  should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets, USP 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. Culture and susceptibility testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to l

Ringkasan produk:

16.1 Levofloxacin Tablets, USP  Levofloxacin tablets, USP are supplied as 500 mg capsule-shaped, coated tablets.  Levofloxacin tablets, USP are packaged in bottles and in unit-dose blister strips in the following configurations: 500 mg tablets are:  peach coloured, capsule shaped, biconvex, debossed 'ML 63' on one side and plain on other side. Levofloxacin Tablets, USP should be stored at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86 °F)  in well-closed containers. Levofloxacin Tablets are manufactured by Macleods Pharmaceutical Limited, Village Theda, Post Office Lodhimajra, Tehsil Nalagarh, District Solan, Himachal Pradesh – 174101, India.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Proficient Rx LP
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MEDICATION GUIDE
MEDICATION GUIDE
Levofloxacin Tablets
(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 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

Ciri produk

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOFLOXACIN TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVOFLOXACIN TABLETS, USP.
LEVOFLOXACIN TABLET, USP FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions
• Peripheral Neuropathy (5.8) 07/2013
INDICATIONS AND USAGE
Levofloxacin USP 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, 1.3)
• Acute bacterial sinusitis (1.4)
• Acute bacterial exacerbation of chronic bronchitis (1.5)
• Skin and skin structure infections: complicated (1.6) and
uncomplicated (1.7)
• Chronic bacterial prostatitis (1.8)
• Urinary tract infections: complicated (1.9, 1.10) and
uncomplicated (1.12)
• Acute pyelonephritis (1.11)
• Inhalational anthrax, post-exposure (ERROR! HYPERLINK REFERENCE
NOT VALID.)
• Plague (ERROR! HYPERLINK REFERENCE NOT VALID.)
DOSAGE AND ADMINISTRATION
• TYPE OF INFECTION
DOSE EVERY 24 HOURS DURATION (DAYS)
Nosocomial Pneumonia (1.1)
750 mg
7–14
Community Acquired Pneumonia
(1.2)
500 mg
7–14
Community Acquired Pneumonia
(1.3)
750 mg
5
Acute Bacterial Sinusitis (1.4)
750 mg
5
500 mg
10-14
Acute Bacterial Exacerbation of
Chronic Bronchitis (1.5)
500 mg
7
Complicated Skin and Skin
Structure Infections (SSSI) (1.6)
750 mg
7-14
Uncomplicated SSSI (1.7)
500 mg
7-10
Chronic Bacterial Prostatitis (1.8)
500 mg
28
Complicated Urinary Tract
Infection (1.9) or Acute
Pyelonephritis (1.11)
750 mg
5
Complicated Urinary Tract
Infection (1.10) or Acute
Pyelonephritis (1.11)
250 mg
10
Uncomplicated Urinary Tract
Infection (1.12)
250 mg
3
Inhalational Anthrax (Post-
Exposure) (ERROR! HYPERLINK
REFERENCE NOT VALID.)
Adults and Pediatric Patients > 50
kg
Pediatric Pa