AVELOX moxifloxacin hydrochloride tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

MOXIFLOXACIN HYDROCHLORIDE

Composition:

MOXIFLOXACIN 400 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

AVELOX- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
CARDINAL HEALTH
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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.
AVELOX (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM-COATED
AVELOX (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION FOR IV USE.
INITIAL U.S. APPROVAL: 1999
WARNING: TENDINOPATHY
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
Warnings and Precautions (5.6) 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
Complic