CIPROFLOXACIN HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (Ciprofloxacin - UNII:5E8K9I0O4U)

Verfügbar ab:

KAISER FOUNDATION HOSPITALS

INN (Internationale Bezeichnung):

Ciprofloxacin hydrochloride

Zusammensetzung:

Ciprofloxacin 500 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CIPROFLOXACIN HYDROCHLORIDE- CIPROFLOXACIN HYDROCHLORIDE TABLET
KAISER FOUNDATION HOSPITALS
----------
CIPROFLOXACIN TABLETS USP
RX ONLY
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).
FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONS
WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN
HISTORY OF MYASTHENIA
GRAVIS (SEE WARNINGS).
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ciprofloxacin
Tablets USP and other antibacterial drugs, Ciprofloxacin Tablets USP
should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Ciprofloxacin hydrochloride USP is a synthetic broad-spectrum
antimicrobial agent for oral
administration. Ciprofloxacin hydrochloride USP, a fluoroquinolone, is
the monohydrochloride
monohydrate salt of
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-
quinolinecarboxylic acid. It is a faintly yellowish to light yellow
crystalline substance that has the
following chemical structure:
C
H FN O •HCl•H O M.W. 385.8
Each Ciprofloxacin Tablet USP, for oral administration, is available
in 500 mg strength. In addition,
each tablet also contains the following inactive ingredients:
colloidal silicon dioxide, hypromellose,
magnesium stearate, microcrystalline cellulose, polydextrose,
polyethylene glycol, pregelatinized
starch, sodium starch glycolate, talc, titanium dioxide and triacetin.
CLINICAL PHARMACOLOGY
ABS ORPTION
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract after
oral administration. The absolute bioavailability is approximately 70%
with no substantial loss by first
17
18
3
3
2
pass metabolism. Ciprofloxaci