AVELOX moxifloxacin hydrochloride tablet film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)

Tilgængelig fra:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Sammensætning:

MOXIFLOXACIN 400 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

New Drug Application

Produktets egenskaber

AVELOX- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AVELOX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AVELOX.
INITIAL U.S. APPROVAL: 1999
WARNING:
FLUOROQUINOLONES, INCLUDING AVELOX , ARE ASSOCIATED WITH AN INCREASED
RISK OF TENDINITIS AND TENDON
RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN OLDER PATIENTS
USUALLY OVER 60 YEARS OF AGE, IN PATIENTS
TAKING CORTICOSTEROID DRUGS, AND IN PATIENTS WITH KIDNEY, HEART OR
LUNG TRANSPLANTS _[SEE WARNINGS AND_
_PRECAUTIONS (5.1)]_.
FLUOROQUINOLONES, INCLUDING AVELOX, MAY EXACERBATE MUSCLE WEAKNESS IN
PERSONS WITH MYASTHENIA
GRAVIS. AVOID AVELOX IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA
GRAVIS _[SEE WARNINGS AND PRECAUTIONS_
_(5.2).]_
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AVELOX and other antibacterial
drugs, AVELOX should be used only to treat or prevent infections that
are proven or strongly suspected to be caused by
susceptible bacteria. (1)
RECENT MAJOR CHANGES
Boxed Warning 02/11
Warnings and Precautions (5.2, 5.6) 02/11, 10/11
INDICATIONS AND USAGE
AVELOX is a fluoroquinolone antibacterial indicated for treating
infections in adults ≥ 18 years of age caused by
designated, susceptible bacteria. (1, 12.4)
Acute Bacterial Sinusitis (1.1)
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
Community Acquired Pneumonia (1.3)
Skin and Skin Structure Infections: Uncomplicated (1.4) and
Complicated (1.5)
Complicated Intra-Abdominal Infections (1.6)
DOSAGE AND ADMINISTRATION
TYPE OF INFECTION
DOSE EVERY 24
HO URS
DURATIO N
(DAYS)
Acute Bacterial Sinusitis (1.1)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
400 mg
5
Community Acquired Pneumonia (1.3)
400 mg
7-14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7-21
Complicated Intra-Abdominal Infections (1.6)