NOAH Compendium

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Date: Tuesday, July 14, 2020 15:21

Release 2.49
Propalin™ Syrup, 40mg/ml for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Neurological preparations: Others
Active ingredient: Phenylpropanolamine Hydrochloride
Product:Propalin™ Syrup, 40mg/ml for Dogs
Product index: Propalin Syrup
Presentation
Syrup. Colourless to slightly yellow-brown solution.
Uses
Treatment of urinary incontinence associated with urethral sphincter incompetence in the bitch. Efficacy has only been demonstrated in ovariohysterectomised bitches
Dosage and administration
Oral use. The recommended dose is 0.8mg phenylpropanolamine/kg bodyweight (equivalent to 1mg/kg phenylpropanolamine hydrochloride/kg) 3 times daily in the feed, corresponding to 0.1 ml Propalin Syrup/5 kg bodyweight 3 times daily. The absorption rate is increased if the product is administered to fasted dogs.
Contra-indications, warnings, etc
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.
In the course of field clinical trials, loose stools, liquid diarrhoea, decrease in appetite, arrhythmia and collapse were reported in some dogs. Treatment was continued depending on the severity of the undesirable effect observed.
Sympathomimetics may produce a wide range of effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system (e.g. effects on heart rate and blood pressure).
Dizziness and restlessness were also occasionally reported. Hypersensitivity may occur in very rare cases.
Phenylpropanolamine, a sympathomimetic drug, may affect the cardiovascular system, especially blood pressure and heart rate, and should be used with caution in animals with cardiovascular diseases.
Care should be exercised in treating animals with severe renal or hepatic insufficiency, diabetes mellitus, hyperadrenocorticism, glaucoma, hyperthyroidism or other metabolic disorders.
In bitches less than 1 year old the possibility of anatomical disorders contributing to incontinence should be considered prior to treatment.
Do not administer to pregnant or lactating bitches.
Care should be exercised in administering Propalin Syrup with other sympathomimetic drugs, anticholinergic drugs, tricyclic antidepressants or specific type B monoamine oxidase inhibitors. It should not be used in patients treated with non-selective monoamine oxidase inhibitors.
In healthy dogs, no side effects were observed at up to 5 times the recommended dosage. However, an overdose of phenylpropanolamine could produce symptoms of excessive stimulation of the sympathic nervous system. Treatment should be symptomatic. Alpha-adrenergic blockers may be appropriate in the case of severe overdose. However, no specific recommendation on drugs or dosages can be given.
Withdrawal periods
Not applicable
Operator warning
Phenylpropanolamine Hydrochloride is toxic when overdoses are ingested. Adverse effects may include dizziness, headache, nausea, insomnia or restlessness, and increased blood pressure. High overdose may be fatal, especially in children.
To avoid accidental ingestion, the product must be used and kept out of reach of children. Always replace the cap securely after use. In the event of accidental ingestion, seek immediate medical attention showing the physician the package insert.
In the event of accidental skin contact, wash the contaminated area with soap and water. Wash hands after use of the product.
In the event of accidental eye contact, rinse the eye with clean water for about 15 minutes and seek medical advice.
Pharmaceutical precautions
Do not store above 25°C. Do not refrigerate.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 3 months
Any unused products or waste material should be disposed of in accordance with national requirements.
Legal category
Legal category: POM-V
Packaging quantities
30ml and 100 ml: HDPE bottle with LDPE syringe adapter insert and a polypropylene child resistant closure; the package contains also one 1.5ml graduated syringe of LDPE/polystyrene.
Not all pack sizes may be marketed.
Further information
Pharmacological Immunological Properties
Phenylpropanolamine hydrochloride is a sympapathomimetic agent. It is an analogue of the endogenous sympathomimetic amines. ATC Vetcode: QG04BX91.
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.
Pharmacokinetic particulars
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 1mg/phenylpropanolamine hydrochloride/kg 3 times daily over 15 days.
When the product is administered to a fasted dog, bioavailability is increased significantly.
Marketing Authorisation Number
Vm 08007/4035.
Significant changes
GTIN
GTIN description:Propalin Syrup 30ml
GTIN:03605870009794
GTIN description:Propalin Syrup 100ml
GTIN:03605870009800