CIPROFLOXACIN EXTENDED-RELEASE tablet film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Par Pharmaceutical, Inc.

INN (Internationale Bezeichnung):

CIPROFLOXACIN HYDROCHLORIDE

Zusammensetzung:

CIPROFLOXACIN 425.2 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CIPROFLOXACIN EXTENDED-RELEASE- CIPROFLOXACIN TABLET, FILM COATED,
EXTENDED RELEASE
PAR PHARMACEUTICAL, INC.
----------
CIPROFLOXACIN* EXTENDED-RELEASE TABLETS
RX ONLY
(Medication Guide enclosed)
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 a matrix type
controlled-release layer. The tablets
contain a combination of two types of ciprofloxacin drug substance,
ciprofloxacin hydrochloride and
ciprofloxacin (base). Ciprofloxacin hydrochloride is
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-
(1-piperazinyl)-3-quinolinecarboxylic acid monohydrochloride,
monohydrate. 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 faintly yellowish to light yellow crystalline substance. The
chemical structure of the monohydrate
is as follows:
Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,
4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. The empirical