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:

PD-Rx Pharmaceuticals, Inc.

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
PD-RX PHARMACEUTICALS, INC.
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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) TABLETS, FOR ORAL USE
AVELOX (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRIAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF
MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON
RUPTURE,
PERIPHERAL NEUROPATHY, CENTRIAL NERVOUS SYSTEM EFFECTS AND
EXACERBATION OF
MYASTHENIA GRAVIS
FLUOROQUINOLONES, INCLUDING AVELOX, 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)
CENTRAL NERVOUS SYSTEM EFFECTS ( 5.4)
DISCONTINUE AVELOX IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES,
INCLUDING AVELOX, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS ( 5.1)
FLUOROQUINOLONES, INCLUDING AVELOX, MAY EXACERBATE MUSCLE WEAKNESS IN
PATIENTS WITH MYASTHENIA
GRAVIS. AVOID AVELOX IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA
GRAVIS ( 5.5).
BECAUSE FLUOROQUINOLONES, INCLUDING AVELOX, HAVE BEEN ASSOCIATED WITH
SERIOUS ADVERSE REACTIONS (
5.1–5.13), RESERVE AVELOX FOR USE IN PATIENTS WHO HAVE NO
ALTERNATIVE TREATMENT OPTIONS FOR THE
FOLLOWING INDICATIONS:
ACUTE BACTERIAL SINUSITIS ( 1.6)
ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS ( 1.7)
RECENT MAJOR CHANGES
1. Boxed Warning 7/2016
1. Indications and Usage ( 1.6, 1.7) 7/2016
1. Dosage and Administration ( 2.1) 7/2016
2. Warnings and Precautions ( 5.1) 7/2016
INDICATIONS AND USAGE
AVELOX is a fluoroquinolone antibacterial indicated for treating
infections in adults 18 years of age and o