Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction
Company name: Janssen Animal Health
A division of Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
Telephone: 01494 567555
Fax: 01494 567556
Email: ahealth@its.jnj.com
Presentation
Tablets: Round, pink tablet with break line on one side and inscription ENURACE 10 on the other side.
Each tablet contains 10 mg Ephedrine Hydrochloride equivalent to 8.1 mg Ephedrine. The tablet can be divided into two equal parts, each containing 5 mg Ephedrine HCl.
Uses
Treatment of unwanted loss of urine (urinary incontinence) due to too low tension in the circular muscles closing the urethra (urethral sphincter mechanism incompetence) in ovariohysterectomised female dogs.
Dosage and administration
For oral administration only.
A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended. Dogs can be dosed according to the following table:
Weight
(kg)
| Dose
(mg/day)
| Dose (number of tablets)
|
per day
| 1st
| 2nd
|
5
| 10
| 1
| ½
| ½
|
7.5
| 15
| 1 ½
| ½
| 1
|
10
| 20
| 2
| 1
| 1
|
12.5
| 25
| 2½
| 1
| 1 ½
|
15
| 30
| 3
| 1 ½
| 1 ½
|
17.5
| 35
| 3½
| 1 ½
| 2
|
For weights of 20 kg or above use Enurace 50
Desired therapeutic effect and occurrence of adverse effects have to be monitored approximately at 14 days, 1 month, 3 months and 6 months after the start. Based on the observed effect in comparison with the expected effect and taking into account the occurrence of adverse effects, the individual dose should be adjusted. The dose should be adjusted to find the lowest effective dose.
Once the effective dose has been established, dogs should still be monitored at regular intervals, e.g. every six months.
The product should be administered before meals in a piece of food.
A maximum dose of 5 mg/ kg of bodyweight per day has to be respected.
Contra-indications, warnings, etc
Do not use in dogs with glaucoma
Do not use in case of hypersensitivity to Ephedrine or to any of the excipients.
Do not use in dogs under 5 kg of body weight.
This product is not suitable for treatment of inappropriate urination resulting from behaviour problems.
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.
Adverse reactions
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.
Operator warnings
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.
Use during pregnancy, lactation or lay
The safety of the product has not been established during pregnancy and lactation.
Do not use during the pregnancy and lactation.
Do not use in breeding animals.
Interactions
Ephedrine may interact with other sympathomimetics.
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.
Overdose
The signs of overdose resemble those of the adverse reactions as described above. In case of overdose, it is useful to accelerate excretion of ephedrine by acidification of the urine and enhanced diuresis.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
For animal treatment only. Keep out of the reach and sight of children.
Pharmaceutical precautions
Do not store above 25 °C.
Store in the original container. Divided tablets should be returned in the original package and used in the subsequent dose. Close the cap to click.
Legal category
POM-V
Packaging Quantities
White LDPE container containing 60 tablets with polyurethane cover-up and cap with a child-resistant closure.
Further information
Ephedrine directly stimulates alpha- and beta-adrenergic receptors, present in all organ systems. It also stimulates the release of catecholamines from sympathetic neurons. Since Ephedrine passes the blood-brain barrier, it also induces effects that are mediated through the central nervous system.
Ephedrine specifically causes a contraction of the internal urethral sphincter muscles and a relaxation of the bladder muscles through a sympathicomimetic action on the adrenergic receptors.
Marketing authorisation number
Vm 35163/4001.
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.
Introduction
Company name: Janssen Animal Health
A division of Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
Telephone: 01494 567555
Fax: 01494 567556
Email: ahealth@its.jnj.com
Presentation
Tablets: Round, white tablet with break line on one side and inscription ENURACE 50 on the other side.
Each tablet contains 40.7 mg Ephedrine equivalent to 50 mg Ephedrine Hydrochloride. The tablet can be divided into two equal parts, each containing 25 mg Ephedrine HCl.
Uses
Treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovariohysterectomised female dogs.
Dosage and administration
For oral administration only.
A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended. Dogs can be dosed according to the following table:
Weight
(kg)
| Dose
(mg/day)
| Dose (number of tablets)
|
per day
| 1st
| 2nd
|
20-30
| 50
| 1
| ½
| ½
|
31-40
| 75
| 1 ½
| ½
| 1
|
41-50
| 100
| 2
| 1
| 1
|
Desired therapeutic effect and occurrence of adverse effects have to be monitored approximately at 14 days, 1 month, 3 months and 6 months after the start. Based on the observed effect in comparison with the expected effect and taking into account the occurrence of adverse effects, the individual dose should be adjusted. The dose should be adjusted to find the lowest effective dose.
Once the effective dose has been established, dogs should still be monitored at regular intervals, e.g. every six months.
The product should be administered before meals in a piece of food.
A maximum dose of 5 mg/ kg of bodyweight per day has to be respected.
Contra-indications, warnings, etc
Do not use in dogs with glaucoma
Do not use in case of hypersensitivity to Ephedrine or to any of the excipients.
Do not use the product in dogs under 20 kilogram of bodyweight.
This product is not suitable for treatment of inappropriate urination resulting of behaviour problems.
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 Enurace 50 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.
Adverse reactions
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.
Operator warnings
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.
Use during pregnancy, lactation or lay
The safety of the product has not been established during pregnancy and lactation.
Do not use during the pregnancy and lactation.
Do not use in breeding animals.
Interactions
Ephedrine may interact with other sympathomimetics.
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.
Overdose
The signs of overdose resemble those of the adverse reactions as described above. In case of overdose, it is useful to accelerate excretion of ephedrine by acidification of the urine and enhanced diuresis.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
For animal treatment only. Keep out of the reach and sight of children.
Pharmaceutical precautions
Do not store above 25 °C.
Store in the original container. Divided tablets should be returned in the original package and used in the subsequent dose. Close the cap to click.
Legal category
POM-V
Packaging Quantities
White LDPE container containing 100 tablets with polyurethane cover-up and cap with a child-resistant closure.
Further information
Ephedrine directly stimulates alpha- and beta-adrenergic receptors, present in all organ systems. It also stimulates the release of catecholamines from sympathetic neurons. Since Ephedrine passes the blood-brain barrier, it also induces effects that are mediated through the central nervous system.
Ephedrine specifically causes a contraction of the internal urethral sphincter muscles and a relaxation of the bladder muscles through a sympathicomimetic action on the adrenergic receptors.
Marketing authorisation number
Vm 35163/4000.
