PROPALIN SYRUP

Country: Malaysia

Language: English

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

Active ingredient:

Phenylpropanolamine hydrochloride

Available from:

Gladron Chemicals Sdn Bhd

INN (International Name):

Phenylpropanolamine hydrochloride

Units in package:

30.00 mcg/mL; 100.00 mcg/mL

Manufactured by:

Vetoquinol

Summary of Product characteristics

PROPALIN SYRUP
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT:
Propalin Syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ml of product contains:
Phenylpropanolamine hydrochloride ..................50 mg
Corresponding to Phenylpropanolamine........40.28 mg
3.
PRODUCT DESCRIPTION:
colourless solution
4.
PHARMACODYNAMIC PROPERTIES:
The clinical effect of phenylpropanolamine in urinary incontinence is
based on
its stimulation effect on
α
-adrenergic receptors. This causes an increase in, and
a stabilisation of, the closure pressure in the urethra, which is
innervated
mainly by adrenergic nerves.
Phenylpropanolamine is a racemic mixture of D and L enantiomers.
4.1
PHARMACOKINETIC PROPERTIES:
In the dog, the mean half life of phenylpropanolamine is approximately
3 hours with maximal plasma concentrations being found after
approximately 1 hour.
No accumulation of phenylpropanolamine has been observed after a dose
of
1 mg/kg 3 times daily over 15 days. When the product is administered
to a
fasted dog, bioavailability is increased significantly.
5.
INDICATIONS:
Treatment
of
urinary
incontinence
associated
with
urethral
sphincter
incompetence
in
the
bitch.
Efficacy
has
only
been
demonstrated
in
ovariohysterectomised bitches.
5.1
RECOMMENDED DOSAGE:
In bitches: 3mg/kg daily in divided dose given with food i.e. 1.5mg/kg
twice
daily or 1.0mg/kg three times daily e.g. for 25kg dog give 0.75ml
twice daily
or 0.5ml three times daily for a total daily dose of 1.5ml (75mg).
5.2
CONTRA-INDICATIONS:
The use of Propalin is not appropriate for the treatment of
behavioural
causes of inappropriate urination. Do not administer to patients
treated with
non-selective monoamine oxidase inhibitors.
Do not use in case of known hypersensitivity to active substance or to
any of
the excipients.
1. Remove the childproof safety cap by pushing
down firmly and turning anti-clockwise.
2. Take the dosage syringe, with plunger pushed inwards,
and insert the end into the opening of the stopper.
Push down firmly.
3. Hold at an angle, do not fully in