LOTIFAR 150MG2ML 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:

10 Ampoules

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Summary of Product characteristics

[DUOPHARMA (M) SDN BHD]
Page 1 of 2
[REVISION DATE: 25.01.2022]
LOTIFAR 150MG/2ML INJECTION
DESCRIPTION: LOTIFAR 150 MG/2 ML INJECTION is a clear, colourless to
pale yellow solution.
COMPOSITION: Each ml contains Netilmicin 75 mg as Netilmicin Sulphate.
Contains: Sodium Metabisulphite 0.24% and Sodium Sulphite 0.08%
Preservatives: Methyl Paraben 0.18% and 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.
PHARMACOKINETICS: ABSORPTION: Netilmicin should be administered only
by the intramuscular or intravenous route, the former being the
preferred route of administration.
INTRAMUSCULAR ADMINISTRATION: In adults with normal renal function, a
single intramuscular dose results in peak serum levels which expressed
as mg/mL are approximately 3 times in the dose expressed
as mg/kg. Peak levels occur 30 to 60 minutes after intramuscular
injection. Significant levels are still to be found in serum 12 hours
post injection.
INTRAVENOUS ADMINISTRATION: Maximum serum levels (7.6, 10.3 and 22.8
mg/mL) were observed one minute after intravenous injection of 0.5, 1
and 2.5 mg/kg respectively. Serum levels were still
measurable after 8 hours. More than 70% of administered dose was
recovered from 24-hour urine samples.
After intravenous infusion (1 mg/kg over one hour), mean serum levels
ranged from 2.8 to 7.4 mg/mL. The maximum level was observed within 3
minutes of t