Target species
Dogs and Cats.
Indications for use for each target species
Dogs: For restraint, sedation and analgesia associated with clinical examinations and procedures, minor surgery and as premedication prior to general anaesthesia.
In combination with butorphanol for sedation and analgesia.
Cats: For restraint and sedation.
In combination with ketamine for the induction of general anaesthesia prior to surgical procedures.
In combination with butorphanol for sedation and analgesia, and combined with both butorphanol and ketamine for general anaesthesia.
As a premedicant before alfaxalone/alfadolone for general anaesthesia.
Contraindications
Do not use in animals with heart failure, respiratory disease or impaired liver or kidney function, animals in shock, seriously debilitated animals, or animals that are stressed due extreme heat, cold or fatigue. Do not use in conjunction with sympathomimetic amines.
Do not use in dogs under 12 weeks of age.
Special warnings
When the veterinary medicinal product is administered, the animal should be allowed to rest in a maximally quiet place. Before any procedure is started or other drugs are administered, sedation should be allowed to reach its peak effect, which occurs at about 10 to 30 min, depending on route of administration.
In extremely nervous, excited or agitated animals, the levels of endogenous catecholamines may be high. The pharmacological response elicited by alpha-2 agonists (e.g. medetomidine) in such animals is often reduced, with depth and duration of sedative and analgesic effects ranging from slightly diminished to non-existent. Highly agitated animals should therefore be put at ease and allowed to rest quietly prior to receiving the veterinary medicinal product. Allowing animals to rest quietly for 10 to 15 minutes after injection may improve the response to the veterinary medicinal product.
Special precautions for use
Special precautions for safe use in the target species:
A clinical examination should be carried out in all animals before the use of drugs for sedation and/or general anesthesia.
Care should be taken when using the veterinary medicinal product in animals with cardiovascular disease.
Care should be taken when combining medetomidine with other anaesthetics or sedatives. Before using any combinations consult the contraindications and warnings that appear on the concomitant product’s data sheet.
Medetomidine has marked anaesthetic sparing effects. The dose of the anaesthetic should be reduced accordingly (see section Administration routes and dosage).
Special care is recommended when treating very young animals and older animals. The veterinary medicinal product, ketamine and propofol are metabolised in the liver and excreted primarily via the kidneys. Pre-existing liver or kidney pathology should be carefully evaluated to confirm adequate function prior to using these products.
Fasting is recommended before Domitor administration. After treatment, the animal should not be given water or food before it is able to swallow properly.
Treated animals should be kept in a warm and even temperature during the procedure and for 12 hours after sedation.
During prolonged procedures an ophthalmic preparation should be administered at regular intervals to lubricate the cornea especially in cats and sometimes also in dogs if their eyes remain open.
In cats, when the veterinary medicinal product is used in combination with ketamine, laryngeal and pharyngeal reflexes are retained during anaesthesia.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the case of accidental oral intake or self-injection, seek medical advice immediately and show the package leaflet to the doctor but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Immediately after exposure, wash the exposed skin with large amounts of fresh water.
Remove contaminated clothes that are in direct contact with skin.
In the case of accidental contact of the product with eyes, rinse with large amounts of fresh water. If symptoms occur, seek the advice of a doctor.
If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
To the physician:
Medetomidine hydrochloride is an alpha-2 adrenoreceptor agonist. Symptoms after absorption may involve clinical effects including dose dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dog
Very common (>1 animal / 10 animals treated): | Bradycardia1 |
Common (1 to 10 animals / 100 animals treated): | Vomiting2 Muscle tremor Decreased respiratory rate3 Cyanosis |
Undetermined frequency (cannot be estimated for the available data): | Excitation Heart block NOS1 Cardiac arrest4 High blood pressure5 Low blood pressure5 Hypersensitivity reaction Hyperglycaemia Recovery prolonged6 Sedation prolonged7 Increased sensitivity to sound Urination8 Apnoea3 Hypoxia9 Pulmonary oedema Death10 Decreased body temperature Hypothermia6 Lack of efficacy - NOS |
1Bradycardia with occasional atrioventricular block may occur.
2Some dogs vomit 5 to 15 minutes after injection.
3Decreased respiratory rates with or without transient apnoea periods may occur.
4If the animal has a pre-existing subclinical respiratory disease, administration of the veterinary medicinal product can cause significant respiratory depression which could predispose to cardiac arrest.
5Blood pressure will increase initially and then return to normal or slightly below normal.
6Prolonged recovery may lead to hypothermia.
7Recurrence of sedation after initial recovery has also been reported.
8Urination typically occurs during recovery at about 90 to 120 minutes post-treatment.
9In some cases at higher dosages, a decline in arterial oxygen tension may occur.
10Death from circulatory failure with severe congestion of the lungs, liver, or kidney has been reported.
When the veterinary medicinal product is used in combination with propofol, movement of the forelegs may occur during induction of anaesthesia.
Cat
Common (1 to 10 animals / 100 animals treated): | Vomiting1 |
Undetermined frequency (cannot be estimated for the available data): | Excitation Bradycardia2 Heart block NOS2 Cardiac arrest3 High blood pressure4 Low blood pressure4 Hypersensitivity reaction Hyperglycaemia Recovery prolonged5 Sedation prolonged6 Muscle tremor Increased sensitivity to sound Urination7 Apnoea8 Decreased respiratory rate8,9 Pulmonary oedema Death10 Cyanosis Decreased body temperature Hypothermia5 Lack of efficacy – NOS |
1Most cats vomit 5 to 15 minutes after injection, some cats may also vomit upon recovery.
2Bradycardia with occasional atrioventricular block may occur.
3If the animal has a pre-existing subclinical respiratory disease, administration of the veterinary medicinal product can cause significant respiratory depression which could predispose to cardiac arrest.
4Blood pressure will increase initially and then return to normal or slightly below normal.
5Prolonged recovery may lead to hypothermia.
6Recurrence of sedation after initial recovery has also been reported.
7Urination typically occurs during recovery at about 90 to 120 minutes post-treatment.
8Decreased respiratory rates with or without transient apnoea periods may occur.
9In some cats very slow respiratory rates are observed (4-6 breaths per minute).
10Death from circulatory failure with severe congestion of the lungs, liver, or kidney has been reported. When the veterinary medicinal product is used in combination with ketamine, the combination is reported to elicit a pain response in some cats when administered intramuscularly.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Interaction with other medicinal products and other forms of interaction
Medetomidine should not be used in conjunction with sympathomimetic amines. The concomitant use of other central nervous system depressants should be expected to potentiate the effect of either product and appropriate dose adjustment should be made. Medetomidine must not be mixed with other products, with the exception of Vetalar and Ketaset Injection and Torbugesic injection.
Medetomidine has marked anaesthetic sparing effects. The dose of compounds such as propofol and volatile anaesthetics should be reduced accordingly, by up to 50 – 90 %, depending on the individual animal.
Although bradycardia may be partially prevented by prior administration (at least 5 minutes before Domitor) of an anticholinergic agent, the administration of anticholinergic agents to treat bradycardia either simultaneously with medetomidine or following sedation with medetomidine could lead to adverse cardiovascular effects.
Administration routes and dosage
An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes. Administration by intramuscular (IM), intravenous (IV) and subcutaneous (SC) routes are possible. The effect is most rapid after IV administration and slowest after SC administration. The dosage is dependent on the degree of sedation and analgesia required.
Domitor | Dose mcg/kg |
Dogs | 10-80 |
Cats | 50-150 |
For sedation, small dogs require more Domitor per kg of bodyweight than large dogs thus the dosage per square meter of body surface could be more accurate. If this approach is used the dosage is 750 to 1,000 mcg/square meter.
The following table gives the dosage for dogs on the basis of body weight.
Body weight (kg) IV administration | Injection volume (ml) | Body weight (kg) IM/ SC/ administration |
1.5-2.2 | 0.1 | |
2.3-3.5 | 0.15 | 1.8-2.3 |
3.6-5.1 | 0.2 | 2.4-3.3 |
5.2-6.9 | 0.25 | 3.4-4.5 |
7.0-9.9 | 0.3 | 4.6-6.4 |
10.0-14.4 | 0.4 | 6.5-9.4 |
14.5-19.5 | 0.5 | 9.5-12.7 |
19.6-25.1 | 0.6 | 12.8-16.3 |
25.2-31.1 | 0.7 | 16.4-20.2 |
31.2-37.6 | 0.8 | 20.3-24.4 |
37.7-44.4 | 0.9 | 24.5-28.9 |
44.5-55.3 | 1.0 | 29.0-36.1 |
55.4-71.1 | 1.2 | 36.2-46.3 |
71.2-88.2 | 1.4 | 46.4-57.3 |
88.3+ | 1.6 | 57.4-75.8 |
| 2.0 | 75.9+ |
Anesthesia:
Domitor is suitable for use as an anesthetic premedication prior to general anesthesia.
Premedication dosing guide: Medetomidine has marked anaesthetic-sparing effects. It is essential to reduce appropriately the dose of anaesthetic induction and maintenance agents in animals that have been given the product.
Combinant | Dosage (Dogs) | | Dosage (Cats) | |
| Domitor (mcg/kg) | Combinant (mg/kg) | Domitor (mcg/kg) | Combinant (mg/kg) |
Propofol | 10-40 | 1-4 | NA | NA |
Butorphanol | 10-25 | 0.1 | 50 | 0.4 |
Ketamine | | | 80 | 2.5-7.5 |
Butorphanol + Ketamine | NA | NA | 40-80 | But: 0.1-0.4 Ket: 1.25-5.0 |
Alfaxalone /alfadolone | NA | NA | 80 | 2.5-5.0 |
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Overdose is mainly manifested by delayed recovery after sedation or anesthesia. In a few individuals, circulatory and respiratory depression may occur.
The effects of Domitor can be eliminated using the specific alpha-2 adrenergic antagonist atipamezole (Antisedan). In the dog, the Antisedan dosage expressed in mcg is 5 times that of Domitor. In the cat, the Antisedan dosage expressed in mcg is 2.5 times that of Domitor.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.