MOXIFLOXACIN HYDROCHLORIDE tablet film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Avera McKennan Hospital

INN (International Nazwa):

MOXIFLOXACIN HYDROCHLORIDE

Skład:

MOXIFLOXACIN 400 mg

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM
COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOXIFLOXACIN HYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOXIFLOXACIN HYDROCHLORIDE
TABLETS.
MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM-COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
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 MOXIFLOXACIN HYDROCHLORIDE, 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 MOXIFLOXACIN HYDROCHLORIDE IMMEDIATELY AND AVOID THE USE
OF FLUOROQUINOLONES, INCLUDING
MOXIFLOXACIN HYDROCHLORIDE, IN PATIENTS WHO EXPERIENCE ANY OF THESE
SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN HYDROCHLORIDE, MAY EXACERBATE
MUSCLE WEAKNESS IN PATIENTS
WITH MYASTHENIA GRAVIS. AVOID MOXIFLOXACIN HYDROCHLORIDE IN PATIENTS
WITH KNOWN HISTORY OF
MYASTHENIA GRAVIS (5.5).
BECAUSE FLUOROQUINOLONES, INCLUDING MOXIFLOXACIN HYDROCHLORIDE, HAVE
BEEN ASSOCIATED WITH SERIOUS
ADVERSE REACTIONS (5.1 TO 5.13), RESERVE MOXIFLOXACIN HYDROCHLORIDE
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
Boxed Warning 7/2016
Indications and Usage, Acute Bacterial Sinusitis (1.6) 7/2016
Indications and Usage, Acute Bacterial Exacerbation of Chronic
Bronchitis (1.7) 7/2016
Dosage and Administration, Dosage in Adult Patients(2.1) 7/2016
Warnings and Precautions (5)
INDICATIONS AND USAGE
Moxifloxacin hydrochloride