AVELOX

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

MOXIFLOXACIN HYDROCHLORIDE

Tersedia dari:

BAYER INDONESIA - Indonesia

INN (Nama Internasional):

MOXIFLOXACIN HYDROCHLORIDE

Dosis:

436.8 Mg

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 1 BLISTER @ 5 TABLET SALUT SELAPUT

Diproduksi oleh:

BAYER HEALTHCARE MANUFACTURING S.R.L - Italy

Tanggal Otorisasi:

2020-10-31

Karakteristik produk

AVELOX
®
ANTIBACTERIAL FILM-COATED TABLET
Important information, please read carefully! COMPOSITION
Avelox 400mg film coated-tablets: 1 film-coated tablet contains 400 mg
moxifloxacin (as hydrochloride). PROPERTIES
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMYC PROPERTIES
PHARMACOTHERAPEUTIC GROUP: Quinolone antibacterials, fluoroquinolones
ATC CODE: J01MA 14
Moxifloxacin is a fluoroquinolone antibacterial.
MECHANISM OF ACTION
_In vitro, _ moxifloxacin has been shown to have activity against a
wide range of Gram-positive and Gram-negative
pathogens.
The bacterial action results from the interference with topoisomerase
II (DNA Gyrase) and IV. Topoisomerases are
essential enzymes which play a crucial part in the replication,
transcription and repair of bacterial DNA. Topoisomerase IV
is also known to influence bacterial chromosome division.
Kinetic investigations have demonstrated that moxifloxacin exhibits a
concentration dependent killing rate. Minimum
bacterial concentrations (MBC) were found to be the range of the
minimum inhibitory concentration (MIC).
INTERFERENCE WITH CULTURE TEST
Moxifloxacin therapy may give false negative culture results for _
Mycobacterium spp_. By suppression of mycobacterial
growth.
Effect on the intestinal flora in humans
The following changes in the intestinal flora were seen in volunteers
following administration of moxifloxacin: _ E. coli, _
_Bacillus _
_spp_.,
_Enterococci,_
and
_Klebsiella _
_spp. _
were
reduced,
as
were
the
anaerobes
_Bacteroides _
_vulgatus, _
_Bifidobacterium_, _Eubacterium_, and _Peptostreptococcus_. For _B.
fragilis_ there was an increase. These changes returned to
normal within two weeks. There was no selection of _ Clostridium
difficile _ (MIC
90
2 mg/l) and its toxin under the
administration of moxifloxacin. Moxifloxacin is no t indicated for the
treatment of _Clostridium difficile_.
The prevalence of resistance may vary geographically and with time for
selected species and local area i n fo rmati o n o n
resistance is desirable, particularly when treating s