CIPROFLOXACIN tablet film coated extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

Beschikbaar vanaf:

Mylan Pharmaceuticals Inc.

INN (Algemene Internationale Benaming):

CIPROFLOXACIN HYDROCHLORIDE

Samenstelling:

CIPROFLOXACIN 287.5 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CIPROFLOXACIN EXTENDED-RELEASE
TABLETS.
CIPROFLOXACIN EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
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._
•
o
o
o
DISCONTINUE CIPROFLOXACIN EXTENDED-RELEASE TABLETS IMMEDIATELY AND
AVOID THE USE OF FLUOROQUINOLONES,
INCLUDING CIPROFLOXACIN EXTENDED-RELEASE TABLETS, IN PATIENTS WHO
EXPERIENCE ANY OF THESE SERIOUS ADVERSE
REACTIONS. (5.1)
•
•
RECENT MAJOR CHANGES
Boxed Warning 4/2016
Indications and Usage (1.1) 4/2016
Warnings and Precautions (5.1) 4/2016
INDICATIONS AND USAGE
Ciprofloxacin extended-release tablets are a fluoroquinolone
antibacterial indicated in adults (≥ 18 years of age) with
infections caused by designated, susceptible bacteria.
•
•
Usage: To reduce the development of drug-resistant bacteria and
maintain the effectiveness of ciprofloxacin extended-
release tablets and other antibacterial drugs, ciprofloxacin
extended-release tablets should be used only to treat infections
that are proven or strongly suspected to be caused by bacteria. (1.4)
DOSAGE AND ADMINISTRATION
•
•
•
•
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN EXTENDED-RELEASE TABLETS,
HAVE BEEN ASSOCIATED WITH
DISABLING AND POTENTIALLY IRREVERSIBLE SERIOUS ADVERSE REACTIONS THAT
HAVE OCCURRED TOGETHER (5.1),
INC LUDING :
TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
FLUOROQUINOLONES, , INCLUDING CIPROFLOXACIN EXTENDED-RELEASE TABLETS,
MAY EXACERBATE MUSCLE
WEAKNESS IN PATIENTS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN
EXTE