TEQUIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

GATIFLOXACIN

Доступно од:

BRISTOL-MYERS SQUIBB CANADA

АТЦ код:

J01MA16

INN (Међународно име):

GATIFLOXACIN

Дозирање:

400MG

Фармацеутски облик:

TABLET

Састав:

GATIFLOXACIN 400MG

Пут администрације:

ORAL

Јединице у пакету:

5/50

Тип рецептора:

Prescription

Терапеутска област:

QUINOLONES

Резиме производа:

Active ingredient group (AIG) number: 0142621002; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2006-06-29

Карактеристике производа

PRODUCT MONOGRAPH
Pr
TEQUIN*
(Gatifloxacin)
200 and 400 mg Tablets
Pr
TEQUIN* I.V.*
(Gatifloxacin Injection - 2 mg/mL)
(Gatifloxacin for Injection - 10 mg/mL)
Antibacterial Agent
Bristol-Myers Squibb Canada
Date of Preparation:
Montreal, Canada
January 3, 2001
Date of Revision:
May 8, 2006
*
TM of Bristol-Myers Squibb Company used
under licence by Bristol-Myers Squibb Canada
Control No.: 104074
1
PRODUCT MONOGRAPH
Pr
TEQUIN*
(Gatifloxacin)
200 and 400 mg Tablets
Pr
TEQUIN* I.V.*
(Gatifloxacin Injection - 2 mg/mL)
(Gatifloxacin for Injection - 10 mg/mL)
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTION AND CLINICAL PHARMACOLOGY
TEQUIN (gatifloxacin) is available as TEQUIN Tablets for oral
administration and as TEQUIN I.V. for
intravenous administration.
Gatifloxacin is a synthetic broad-spectrum 8-methoxyfluoroquinolone
antibacterial agent for oral or
intravenous administration, with activity against both gram-negative
and gram-positive microorganisms.
Gatifloxacin has _in vitro _activity against a wide range of
gram-negative and gram-positive aerobic and
anaerobic
microorganisms.
Gatifloxacin
also
has
activity
against
clinically
important
atypical
microorganisms. The antibacterial action of gatifloxacin results from
inhibition of DNA gyrase and
topoisomerase IV. DNA gyrase is an essential enzyme that is involved
in the replication, transcription and
repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a
key role in the partitioning of the
chromosomal DNA during bacterial cell division.
The mechanism of action of fluoroquinolones including gatifloxacin is
different from that of penicillins,
cephalosporins, aminoglycosides, macrolides, and tetracyclines.
Therefore, fluoroquinolones may be active
against
pathogens
that
are
resistant
to
these
antibiotics.
Conversely,
microorganisms
resistant
to
fluoroquinolones may be susceptible to these other classes of
anti-microbial agents (see MICROBIOLOGY).
There is no cross-resistance between gatifloxacin and the mentioned
classes of antibiotics.
CLINICAL P