ERITROTEX INJECTION 500MG

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

ERYTHROMYCIN LACTOBIONATE

Verfügbar ab:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Internationale Bezeichnung):

ERYTHROMYCIN LACTOBIONATE

Einheiten im Paket:

10 Vials; 1 Vials

Hergestellt von:

FISIOPHARMA SRL

Gebrauchsinformation

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Fachinformation

ERITROTEX INJECTION 500MG
ERYTHROMYCIN LACTOBIONATE 500MG
PRODUCT DESCRIPTION
Dry powder for reconstitution in clear glass vials. The powder is
white to slightly yellow in
colour.
COMPOSITION
Each vial contains 744.1 mg of Erythromycin Lactobionate equal to
500mg of Erythromycin.
PHARMACODYNAMIC
Erythromycin binds to the ribosomes of bacteria and affects protein
synthesis without affecting
nucleic acid synthesis. Erythromycin does not bind to cytoplasmic
membranes of the host cells.
This is a possible explanation of its low toxicity and safety record.
Erythromycin is bacteriostatic and bactericidal depending on its
concentration and the type of
organism. It inhibits protein synthesis by binding to ribosmal
subunits, inhibiting translocation of
aminocyl transfer RNA and inhibiting polypeptide synthesis without
causing any alteration in the
nucleic acid cycle.
PHARMACOKINETICS
_DISTRIBUTION: _
The apparent volume of distribution of Erythromycin is around 45% of
body weight in normal
subjects. This large distribution volume is consistent with the
extensive tissue penetration of
erythromycin.
Erythromycin diffuses readily into most body fluids, except the
cerebrospinal fluid. However, in
cases of meningeal inflammation, higher concentrations are apparent.
_METABOLISM: _
In studies using rabbit microsomes it has been shown that erythromycin
is demethylated to des-
N-methyl Erythromycin and formaldehyde.
_EXCRETION: _
In the presence of normal hepatic function, Erythromycin is
concentrated in the liver and
excreted in the bile; the effect of hepatic dysfunction on excretion
of Erythromycin by the liver is
not known.
From 12% to 15% of intravenously administered Erythromycin is excreted
in active form in the
urine.
The drug is also excreted in the faeces.
_HALF-LIFE: _
The plasma elimination half-life in patients with normal renal
function is about 2 hours. In
severe renal impairment the half-life may be prolonged to between 4
and 7 hours.
INDICATIONS
Erythromycin
Lactobionate
injection
is
indicated
for
treatment
of
upp