TP-DOXY 500MGG POWDER

Country: Malaysia

Language: English

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

Active ingredient:

Doxycycline Hyclate

Available from:

Thye Pharma Sdn. Bhd

INN (International Name):

Doxycycline Hyclate

Manufactured by:

Thye Pharma Sdn. Bhd

Summary of Product characteristics

…g product
per
kg
body
weight per day
x
Mean
body
weight
(kg)
animals to
be treated
=
…g of
product per l
drinking water
Mean daily water consumption
(l) per animal
Veterinary Package Insert
TP-DOXY
500MG/G
POWDER
(50%
Doxycycline Hyclate)
PRODUCT DESCRIPTION
Yellow
colour
powder,
which
contains
50%
of
doxycycline hyclate in 500gm or 1kg sachet.
PHARMACODYNAMICS & PHARMACOKINETICS
_Pharmacodynamics: _
Doxycycline
is
a
semisynthetic
tetracycline
derivative. It acts by inhibiting protein synthesis at
the ribosomal level, predominantly by binding to
the
30S
ribosomal
subunits
of
bacteria.
Doxycycline
is
a
broad-spectrum
antibiotic.
It
exhibits
a
wide
range
of
activity
against
gram-
positive and gram-negative, aerobic and anaerobic
pathogens,
especially
against
Pasteurella
multocida
and
Mycoplasma
hyopneumoniae
isolated
from
pig
respiratory
infections
and
Mycoplasma gallisepticum associated with clinical
respiratory infections in chickens and turkeys.
_Pharmacokinetics: _
After
oral
administration
to
pigs,
doxycycline
is
substantially
absorbed
from
the
gastrointestinal
tract. The binding rate to plasma proteins is 93%. It
is widely distributed in the organisms.
Pharmacokinetics of doxycycline after single oral
administration to chickens is characterised by a
quite rapid and substantial absorption from the
gastrointestinal
tract
providing
peak
plasma
concentrations
between
0.4
and
3.3
hours
depending on age and the presence of food.
Pharmacokinetics of doxycycline after single oral
administration
to
turkeys
is
characterised
by
a
quite rapid and substantial absorption from the
gastrointestinal
tract
providing
peak
plasma
concentrations
between
1.5
and
7.5
hours
depending on age and the presence of food. The
protein
binding
ratio
at
therapeutic
plasma
concentrations
is
in
the
range
of
70-85%.
The
bioavailability may vary between 25 and 64%, also
depending on the age and feeding. The presence of
food
in
the
gastrointestinal
tract
determines
a
lower bioavailability compared to that obtained in
the fasted state.
INDICA