Contraindications
Do not use in dogs with cardiovascular disease (i.e. cardiomyopathy, tachycardic arrhythmia, hypertension), hyperthyroidism, diabetes mellitus, impaired renal function or glaucoma.
Do not use concurrently with halogenated narcotics such as halothane or methoxyflurane.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
It is not appropriate to use the product for the behavioural cause of inappropriate urination.
In bitches less than 1 year old the possibility of anatomical disorders contributing to incontinence should be considered prior to treatment.
It is important to identify any underlying disease causing Polyuria/Polydipsia (PU/PD) which may be falsely diagnosed as urinary incontinence.
Special precautions for use
Special precautions for use in animals
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to ephedrine should avoid contact with the veterinary medicinal product.
Ephedrine hydrochloride could be toxic if ingested and ingestion may be fatal, especially to children. Adverse effects may include insomnia and nervousness, dizziness, headache, increased blood pressure, increased sweating and nausea.
To avoid accidental ingestion, particularly by a child, the product must be administered out of the sight of children. Unused tablet parts should be returned to the open blister space and inserted back into the carton and kept in a safe place out of the sight and reach of children.
In case of accidental ingestion, most importantly by children, seek medical advice immediately and show the package leaflet or the label to the physician.
It is strongly recommended that pregnant women should wear gloves for administration.
Wash hands thoroughly after administration of the product.
Adverse reactions (frequency and seriousness)
In rare cases increased pulse frequency, ventricular arrhythmia and central nervous excitation have been observed. These symptoms disappear following dose reduction or termination of treatment.
Due to the pharmacological properties of ephedrine the following effects can occur at the recommended therapeutic dose:
- 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).
- Mydriasis
- Bronchodilatation and decrease of mucus release in the respiratory mucosal membranes.
- Reduction of the motility and tone of the intestinal wall.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Interaction with other medicinal products and other forms of interaction
The potency of ephedrine and the risk of adverse reactions may be increased when administered together with methylxanthines and sympathomimetics.
Ephedrine may enhance glucocorticoid metabolism.
Concomitant use with MAO-inhibitors may cause hypertension.
Ephedrine may increase the risk for theophylline toxicity.
There is a risk of cardiac arrhythmia when combined with cardiac glycosides (e.g. digoxin), quinine, tricyclic antidepressants and halogenated narcotics (see contraindications).
Substances leading to an increase in pH of the urine are able to prolong the excretion of ephedrine, which may lead to an increased risk of adverse reactions. Substances leading to a decrease in pH of the urine are able to accelerate the excretion of ephedrine, which may lead to decreased efficacy.
Vascular constrictions can occur after concomitant treatment with ergot alkaloids and oxytocin.
Sympatholytics may decrease the efficacy of ephedrine.
Overdose (symptoms, emergency procedures, antidotes), if necessary
At high overdoses, the following undesirable effects can occur: tachycardia, tachyarrhythmia, vomiting, increased transpiration, hyperventilation, muscle weakness, tremor with hyperexcitation and restlessness, anxiety and insomnia.
The following symptomatic treatment may be initiated:
- gastric lavage, if necessary
- in case of severe hyperexcitation, administration of sedatives such as diazepam or neuroleptics
- in case of tachyarrhythmia, administration of Beta-Blockers
- accelerated excretion by acidification of the urine and enhanced diuresis.