LOTIFAR 50MGML INJECTION

Country: Malaysia

Language: English

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

Active ingredient:

NETILMICIN SULPHATE

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

NETILMICIN SULPHATE

Units in package:

1ml10Units mL; 1ml30Units mL; 1ml50Units mL; 1ml100Units mL

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Summary of Product characteristics

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[REVISION DATE: 18.02.2022]
[DUOPHARMA (M) SDN BHD]
LOTIFAR 50 MG / ML INJECTION
DESCRIPTION:
LOTIFAR 50 MG / ML INJECTION: A clear, pale straw-coloured liquid.
COMPOSITION:
LOTIFAR 50 MG/ ML INJECTION contains Netilmicin 50 mg / ml as
Netilmicin Sulphate.
Contains: Sodium Metabisulphite 0.24% and Sodium Sulphite 0.08%
Preservative: Methyl Paraben 0.18%; Propyl Paraben 0.02%
PHARMACODYNAMICS:
Netilmicin is an aminoglycoside antibiotic and has a bactericidal
action against many Gram-negative aerobes and against some strains of
staphylococci.
MECHANISM OF ACTION: Aminoglycosides are taken up into sensitive
bacterial cells by an active transport process which is inhibited in
anaerobic, acidic, or hyperosmolar environments. Within the cell they
bind to the 30S, and to some extent to the 50S sub-units of the
bacterial ribosome, inhibiting protein synthesis and generating errors
in the transcription of the genetic code. The manner in which cell
death
is brought about in imperfectly understood, and other mechanisms may
contribute, including effects on membrane permeability.
Netilmicin is an aminoglycoside antibiotic which is active against
many strains of Gram-negative bacteria as well as some other bacteria
including some strains of staphylococci. It exhibits synergy with beta
lactams against many organisms. It is not absorbed by mouth and is
usually given intramuscularly or intravenously in the treatment of
severe infections, often in combination with another agent such as
beta
lactam. Netilmicin is not susceptible to some of the enzymes produced
by organisms with acquired resistance to other aminoglycosides.
PHARMACOKINETICS:
Following intramuscular injection of netilmicin, peak plasma
concentrations are achieved within half to 1 hour, and concentrations
of about 7 µg per ml have been reported following doses of 2 mg per
kg
body-weight: similar concentrations are obtained after intravenous
infusion of the same dose over 1 hour. Administration of standard,
once-daily doses may produce transient peak conce