Biamuline Oral Solution 12.5%

Country: Malaysia

Language: English

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

Active ingredient:

Tiamulin (as Hydrogen Fumarate)

Available from:

Weissen Company (m) Sdn. Bhd.

INN (International Name):

Tiamulin (as Hydrogen Fumarate)

Units in package:

1.00 mcg/mL; 5.00 mcg/mL

Manufactured by:

Laboratoires BIOVE

Summary of Product characteristics

PACKAGE INSERT
Brand or product name
Biamuline Oral Solution 12.5%
Name and Strength of
Active Substance/
Preservative(s)
Composition per 1 ml:
Tiamulin (as hydrogen fumarate)……………....125.00 mg
(equivalent to 101.20 mg tiamulin)
Antimicrobial Preservative (s):
Benzyl alcohol ……….………………………….20.00 mg
Sodium methyl parahydroxybenzoate ……...…….1.00 mg
Sodium propyl parahydroxybenzoate……………..0.20 mg
Product Description
Oral Solution.
Clear colourless to pale yellow solution.
Pharmacodynamics
Tiamulin is a semisynthetic bacteriostatic antibiotic that belongs
to the pleuromutilins class, acting at the ribosomal level by
inhibition of bacterial proteins synthesis.
Tiamulin showed in vitro activity against a large variety of
bacteria
including
_Brachyspira _
_hyodysenteriae, _
_Brachyspira _
_pilosicoli, _
_Lawsonia_
_intracellularis _
and
_Mycoplasma _
_spp._
Tiamulin has a bacteriostatic activity at therapeutic doses and
acts on the ribosomal fraction 70S, the primary binding site is on
the 50S subunit with a potential secondary binding site between
subunits 50S and 30S. It appears to inhibit the production of
microbial protein by forming an initial biochemically inactive
complex,
which
prevents
the
elongation
of
the
polypeptide
chain.
The mechanisms responsible for the development of resistance
to the class of pleuromutilins in _Brachyspira spp_ would be based
on ribosomal target site mutations.
The development of a clinically visible resistance to tiamulin
requires a combination of mutations around its binding site.
Resistance
to
tiamulin
may
be
associated
with
a
decreased
sensitivity towards other pleuromutilins.
Pharmacokinetics
Pig:
Tiamulin
is
rapidly
absorbed
in
pigs
(over
90%)
after
oral
administration and widely distributed in the body. Following
oral administration of a single dose of 10 mg and 25 mg of
tiamulin / kg body weight, the Cmax reached 1.03 µg / ml and
1.82 µg / ml respectively by microbiological assay and the Tmax
is reached in 2 hours for bot