MINT-CIPROFLOXACIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

זמין מ:

MINT PHARMACEUTICALS INC

קוד ATC:

J01MA02

INN (שם בינלאומי):

CIPROFLOXACIN

כמות:

500MG

טופס פרצבטיות:

TABLET

הרכב:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 500MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

QUINOLONES

leaflet_short:

Active ingredient group (AIG) number: 0123207001; AHFS:

מצב אישור:

MARKETED

תאריך אישור:

2008-10-29

מאפייני מוצר

1
PRODUCT MONOGRAPH
MINT-CIPROFLOXACIN
CIPROFLOXACIN TABLETS, USP
250 MG, 500 MG, 750 MG CIPROFLOXACIN AS CIPROFLOXACIN HYDROCHLORIDE
ANTIBACTERIAL AGENT
Manufactured for:
Mint Pharmaceuticals Canada Inc.,
1 First Canadian Place, Suite 5600
100 King Street West
Toronto, Ontario
M5X 1E2
Date of Preparation:
September 29, 2008
CONTROL NO. 124988
2
PRODUCT MONOGRAPH
MINT-CIPROFLOXACIN
CIPROFLOXACIN TABLETS, USP
250 MG, 500 MG, 750 MG CIPROFLOXACIN AS CIPROFLOXACIN HYDROCHLORIDE
THERAPEUTIC CLASSIFICATION
ANTIBACTERIAL AGENT
ACTION AND CLINICAL PHARMACOLOGY
ACTION
Ciprofloxacin, a synthetic fluoroquinolone, has
_in vitro_
activity against a wide range of gram-
negative and gram-positive microorganisms. Its bactericidal action is
achieved through inhibition
of topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II
topoisomerases), which
are required for bacterial DNA replication, transcription, repair, and
recombination.
Ciprofloxacin retained some of its bactericidal activity after
inhibition of RNA and protein
synthesis by rifampin and chloramphenicol, respectively. These
observations suggest
ciprofloxacin may possess two bactericidal mechanisms, one mechanism
resulting from the
inhibition of DNA gyrase and a second mechanism which may be
independent of RNA and
protein synthesis.
The mechanism of actions of fluoroquinolones, including ciprofloxacin,
is different from that of
penicillins, cephalosporins, aminoglycosides, macrolides, and
tetracyclines. Therefore,
microorganisms resistant to these classes of drugs may be susceptible
to ciprofloxacin.
Conversely, microorganisms resistant to fluoroquinolones may be
susceptible to these other
classes of antimicrobial agents, (see
MICROBILOGY
) There is not cross-resistance between
ciprofloxacin and the mentioned classes of antibiotics.
3
CLINICAL PHARMACOLOGY
(See
HUMAN PHARMACOLOGY
)
ABSORPTION
Following oral administration of single doses of 250 mg, 500 mg, and
750 mg of MINT-
Ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and
extensively mainly from