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:

0.436 G

Bentuk farmasi:

INFUS

Unit dalam paket:

DUS, 1 BOTOL @ 250 ML

Diproduksi oleh:

FRESENIUS KABI ITALI S.R.L - Italy

Tanggal Otorisasi:

2021-05-26

Karakteristik produk

Avelox
®
IV/Moxifloxacin HCl/infusion/CCDS#23/ BEC 18031-Fresenius Kabi
1
AVELOX
®
IV
ANTIBACTERIAL INFUSION SOLUTION FOR INTRAVENOUS INJECTION
Important information, please read carefully! COMPOSITION
1 single bottle of 250 mL infusion solution containing 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).
POOLED DATA OF PHARMACOKINETIC
_ _
_AUC (MG.H/L) _
_C MAX (MG/L) _
_ _
_Moxifloxacin 400 mg i.v. single dose _
_ _
_First dose: _
_39.3 + 8.6 _
_within 60 minutes _
_3.9 + 0.9 _
_within 30 minutes _
_4.4 + 0.1 _
_ _
_Moxifloxacin 400 mg i.v. multiple dose _
_ _
_US study _
_38.0 _
_European study _
_48.2 _
_US study _
_4.1 _
_European study _
_6.0 _
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 increas