Target species
Ovariohysterectomised female dogs.
4.2 Indications for use, specifying the target species
Treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovariohysterectomised female dogs.
4.3 Contraindications
Do not use in dogs with glaucoma.
Do not use in case of hypersensitivity to Ephedrine or to any of the excipients.
4.4 Special warnings for each target species
This product is not suitable for treatment of inappropriate urination resulting of behaviour problems.
4.5 Special precautions for use
i. Special precautions for use in animals
The safety and the efficacy of the product has not been assessed in dogs under 5kg.
Do not use the product in dogs under 5 kilogram of bodyweight.
As ephedrine is an alpha and beta adrenergic receptor agonist, the product should be used with caution in dogs with cardiovascular disease and only after a comprehensive risk/benefit analysis by the attending veterinarian.
The dog’s cardiovascular functionality should be carefully assessed before the start of the treatment with the product and it should be periodically monitored during the treatment.
In addition, a similar approach should be adopted in animals suffering from partial urethral obstruction, hypertension, diabetes mellitus, hyperadrenocorticism, hyperthyroidism or other metabolic disorders. It should be mentioned that the Polyuria/Polydipsia (PU/PD) frequently accompanying the aforementioned conditions may be falsely diagnosed as urinary incontinence.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
Ephedrine hydrochloride could be toxic if ingested. Adverse effects may include insomnia and nervousness, dizziness, headache, increased blood pressure, increased sweating and nausea.
Ingestion may be fatal, especially in children. To avoid accidental ingestion, the product must be used and kept out of the reach of children. Always replace the cap securely after use.
In the event of accidental ingestion, most importantly by children, seek immediate medical attention showing the physician the package insert.
It is strongly recommended that pregnant women should wear gloves for administration.
Wash hands after administration.
4.6 Adverse reactions (frequency and seriousness)
• Cardiovascular effects like tachycardia, atrial fibrillation, stimulation of the heart activity; and vasoconstriction.
• Stimulation of the central nervous system leading to sleeplessness, excitation, anxiety and muscle tremors.
• Panting.
• Mydriasis.
• Cystitis.
• Bronchodilatation and decrease of mucus release in the respiratory mucosal membranes.
• Reduction of the motility and tone of the intestinal wall.
Due to the nature of Ephedrine the mentioned effects can occur at the recommended therapeutic dose, with anxiety and cardiovascular effects being the most prevalent. In 10% of the treatments, side effects have been observed in efficacy studies.
4.7 Use during pregnancy, lactation or lay
Not applicable.
4.8 Interaction with other medicinal products and other forms of interaction
• Ephedrine may interact with other sympathicomimetics.
• Ephedrine may enhance glucocorticoid metabolism.
• Concomitant use with MAO-inhibitors may cause hypertension.
• Ephedrine can enhance the activity of products of the same class as theophylline.
• Volatile anaesthetics may enhance the sensitivity of the myocardium to the cardiovascular effects of Ephedrine.
• Concomitant use with cardiac glycosides, quinine and tricyclic antidepressants can cause arrhythmias.
• Vascular constrictions can occur after concomitant treatment with ergot alkaloids and oxytocin.
• Substances leading to an increase in pH of the urine are able to prolong the excretion of ephedrine, whereas substances leading to a decrease in pH of the urine are able to accelerate the excretion of ephedrine.
