CIPROFLOXACIN hydrochloride tablet film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Lake Erie Medical DBA Quality Care Products LLC

DCI (Dénomination commune internationale):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 500 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIPROFLOXACIN TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN
TABLETS, USP.
CIPROFLOXACIN TABLETS, USP (CIPROFLOXACIN HYDROCHLORIDE) TABLET FOR
ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, 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 CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS WITH
MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY
OF MYASTHENIA GRAVIS [_SEE_
_WARNINGS AND PRECAUTIONS ( 5.2) _].
RECENT MAJOR CHANGES
Indications and Usage, Plague ( 1.14)
09/2015
Dosage and Administration, Adult ( 2.1), Pediatrics ( 2.2)
09/2015
INDICATIONS AND USAGE
Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg is a fluoroquinolone
antibacterial indicated in adults (≥18 years of age)
with infections caused by designated, susceptible bacteria and in
pediatric patients where indicated.
Urinary tract infections ( 1.1) and acute uncomplicated cystitis (
1.2)
Chronic bacterial prostatitis ( 1.3)
Lower respiratory tract infections ( 1.4)
Acute sinusitis ( 1.5)
Skin and skin structure infections ( 1.6)
Bone and joint infections ( 1.7)
Complicated intra-abdominal infections ( 1.8)
Infectious diarrhea ( 1.9)
Typhoid fever (enteric fever) ( 1.10)
Uncomplicated cervical and urethral gonorrhea ( 1.11)
Complicated urinary tract infections and pyelonephritis in pediatric
patients ( 1.12)
Inhalational anthrax postexposure in a