VAMOCIN 500mg (Vancomycin Hydrochloride Powder for Concentrate for Infusion 500mg)

Country: Malaysia

Language: English

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

Active ingredient:

VANCOMYCIN HYDROCHLORIDE

Available from:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Units in package:

10ml x 10 Vials; 10ml x 1 Vials

Manufactured by:

Gufic Biosciences Limited, Unit-2

Summary of Product characteristics

Size:- 150mm x 350mm
Front
COMPOSITION:
Each vial contains:
Active Ingredient:
Vancomycin Hydrochloride EP
equivalent to Vancomycin…………500 mg
DOSAGE FORM: Powder for Solution for Infusion (lyophilised powder)
PRODUCT DESCRIPTION: A white or off white lyophilised powder.
Vancomycin Hydrochloride powder for concentrate for infusion 500mg
should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use
are the responsibility of the user and would normally not be longer
than 24 hours at 2 -
8 degree celcius, unless reconstitution has taken place in controlled
and validated
aseptic conditions.
APPEARANCE OF RECONSTITUTED SOLUTION: Clear transparent solution and
free of visible
particles.
PHARMACODYNAMICS: ATC Code: J01 XA01 for intravenous use
Mechanism of action:
Vancomycin is a tricyclic glycopeptide antibiotic that inhibits the
synthesis of the cell
wall in sensitive bacteria by binding with high affinity to the
D-alanyl-D-alanine
terminus of cell wall precursor units. The drug is slowly bactericidal
for dividing
microorganisms. In addition, it impairs the permeability of the
bacterial cell membrane
and RNA synthesis.
Pharmacokinetic/Pharmacodynamics Relationship
Vancomycin displays concentration-independent activity with the area
under the
concentration curve (AUC) divided by the minimum inhibitory
concentration (MIC) of
the target organism as the primary predictive parameter for efficacy.
On basis of in
vitro, animal and limited human data, an AUC/MIC ratio of 400 has been
established
as a PK/PD target to achieve clinical effectiveness with vancomycin.
To achieve this
target when MICs are ≥ 1.0 mg/l, dosing in the upper range and high
trough serum
concentrations (15-20 mg/l) are required (see section Recommended
Dose).
Mechanism of Resistance
Acquired resistance to glycopeptides is most common in enterococci and
is based on
acquisition of various van gene complexes which modifies the
D-alanyl-D-alanine
target to D-alanyl-D-lactate or D-alanyl-D-serine which bind
vanc