CIPRO ciprofloxacin solution concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CIPROFLOXACIN (UNII: 5E8K9I0O4U) (CIPROFLOXACIN - UNII:5E8K9I0O4U)

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

CIPROFLOXACIN

Composition:

CIPROFLOXACIN 2 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

CIPRO- CIPROFLOXACIN SOLUTION, CONCENTRATE
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPRO IV SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CIPRO IV.
CIPRO IV (CIPROFLOXACIN) INJECTION, FOR INTRAVENOUS 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._
Fluoroquinolones, including CIPRO IV , have been associated with
disabling and potentially irreversible serious
adverse reactions that have occurred together (5.1), including:
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INDICATIONS AND USAGE
CIPRO IV is a fluoroquinolone antibacterial indicated in adults (≥18
years of age) with the following infections caused by
designated, susceptible bacteria and in pediatric patients where
indicated:
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Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of CIPRO IV and other antibacterial
®
®
o
o
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TENDINITIS AND TENDON RUPTURE (5.2)
PERIPHERAL NEUROPATHY (5.3)
CENTRAL NERVOUS SYSTEM EFFECTS (5.4)
DISCONTINUE CIPRO IMMEDIATELY AND AVOID THE USE OF FLUOROQUINOLONES,
INCLUDING CIPRO, IN
PATIENTS WHO EXPERIENCE ANY OF THESE SERIOUS ADVERSE REACTIONS (5.1)
FLUOROQUINOLONES, INCLUDING CIPRO IV, MAY EXACERBATE MUSCLE WEAKNESS
IN PATIENTS WITH
MYASTHENIA GRAVIS. AVOID CIPRO IV IN PATIENTS WITH KNOWN HISTORY OF
MYASTHENIA GRAVIS. (5.5)
BECAUSE FLUOROQUINOLONES, INCLUDING CIPRO, HAVE BEEN ASSOCIATED WITH
SERIOUS ADVERSE REACTIONS
(5.1-5.15), RESERVE CIPRO FOR USE IN PATIENTS WHO HAVE NO ALTERNATIVE
TREATMENT OPTIONS FOR THE
FOLLOWING INDICATIONS:
o
o
ACUTE EXACERBATION OF CHRONIC BRONCHITIS (1.9)
ACUTE SINUSITIS (1.11)
Skin and Skin structure Infections (1.1)
Bone and Joint infections (1.2)
Complicated Intra-Abdominal infections (1.3)
Nosocomial Pneumonia (1.4)