CIPROFLOXACIN tablet film coated extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Watson Pharma, Inc.

INN (Algemene Internationale Benaming):

CIPROFLOXACIN

Samenstelling:

CIPROFLOXACIN 212.6 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED, EXTENDED RELEASE
WATSON PHARMA, INC.
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CIPROFLOXACIN* EXTENDED-RELEASE TABLETS
RX ONLY
WARNING:
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN EXTENDED-RELEASE TABLETS,
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).
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN EXTENDED-RELEASE TABLETS,
MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN
EXTENDED-RELEASE TABLETS
IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS (SEE WARNINGS).
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 or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Ciprofloxacin* extended-release tablets contain ciprofloxacin, a
synthetic broad-spectrum antimicrobial
agent for oral administration. Ciprofloxacin extended-release tablets
are coated, bilayer tablets
consisting of an immediate-release layer and an erosion-matrix type
controlled-release layer. The
tablets contain a combination of two types of ciprofloxacin drug
substance, ciprofloxacin
hydrochloride and ciprofloxacin betaine (base). Ciprofloxacin
hydrochloride is 1-cyclopropyl-6-
fluoro-1,4-dihydro-4-oxo-7- (1-piperazinyl)-3-quinolinecarboxylic acid
hydrochloride. It is provided
as a monohydrate form. The empirical formula of the monohydrate is C
H FN O • HCl • H O and its
molecular weight is 385.8. The drug substance is a white to pale
yellow crystalline substance. The
chemical structure of the monohydrate is as follows:
Ciprofloxacin betaine is 1-cyclopropyl-6-fluoro-1,
4-dihydro-4-oxo-7-(1-piperazinyl)-3-
quinolinecarboxylic acid. As the anhydrous form, its