POM-V
Prescription Required
Companion Animal
Dexdormostart 0.5 mg/ml Solution for Injection for Dogs and Cats
Active ingredient: Dexmedetomidine Hydrochloride
Form
Injection
Species
Cats
Dogs
Manufacturer
Alfasan Nederland B.V.
VMD MA No.
36408/5020
What it's used for
Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and...
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Clinical information
Dexdormostart 0.5 mg/ml Solution for Injection for Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.
Non-invasive, mildly to moderately painful, procedures and examinations which
require restraint, sedation and analgesia in dogs and cats.
Deep sedation and analgesia in dogs in concomitant use with butorphanol for
medical and minor surgical procedures.
Premedication in dogs and cats before induction and maintenance of general
anaesthesia.
require restraint, sedation and analgesia in dogs and cats.
Deep sedation and analgesia in dogs in concomitant use with butorphanol for
medical and minor surgical procedures.
Premedication in dogs and cats before induction and maintenance of general
anaesthesia.
Do not use in animals with cardiovascular disorders.
Do not use in animals with severe systemic disease or in animals that are
moribund.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Issued: February 2024
AN: 01702/2022
Do not use in animals with severe systemic disease or in animals that are
moribund.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Issued: February 2024
AN: 01702/2022
Dogs:
Very common (> 1 animal
/ 10 animals treated):
Bradycardia
Pale or cyanotic mucous membranes
Rare
(1 to 10 animals / 10,000
animals treated):
Pulmonary oedema. Undetermined frequency
(cannot be estimated
from the available data)
Change in blood pressure
.
Bradypnoea.
Hypothermia
.
Vomiting
.
Muscle tremor
.
Corneal opacity
.
When dexmedetomidine and butorphanol are used concomitantly:Common (1 to 10
animals / 100 animals
treated):
Arrhythmia
Undetermined frequency
(cannot be estimated
from the available data)
Bradypnoea, tachypnoea, irregular
breathing
, hypoxia.
Muscle twitching or tremor or paddling.
Excitation, sudden arousal, prolonged
sedation.
Hypersalivation.
Retching, vomiting.
Urination.
Erythema.
When dexmedetomidine is used as a pre-medicant:Rare
(1 to 10 animals / 10,000
animals treated):
Arrhythmia
.
Issued: February 2024
AN: 01702/2022
Undetermined frequency
(cannot be estimated
from the available data)
Arrhythmia
.
Bradypnoea, tachypnoea.
Vomiting.
By virtue of the α2-adrenergic activity of dexmedetomidine.
Due to peripheral vasoconstriction and venous desaturation in the presence of
normal arterial oxygenation.
Blood pressure will increase initially and then return to normal or below
normal.
May occur 5–10 minutes after injection. Some dogs and cats may also vomit
at the time of recovery.
May occur during sedation.
May occur if the eyes stay open during sedation. The eyes should be
protected by a suitable eye lubricant (see also section 3.5).
Brady- and tachyarrhythmias. These may include profound sinus bradycardia,
1st and 2nd degree AV block, sinus arrest or pause, as well as atrial,
supraventricular and ventricular premature complexes.
20-30 sec apnoea followed by several rapid breaths.
Supraventricular and ventricular premature complexes, sinus pause and 3rd
degree AV block.
Brady- and tachyarrhythmias have been reported and include profound sinus
bradycardia, 1st and 2nd degree AV block and sinus arrest.
Cats:
Very common (> 1 animal
/ 10 animals treated):
Bradycardia
.
Vomiting
.
Pale or cyanotic mucous membranes
.
Rare
(1 to 10 animals / 10,000
animals treated):
Pulmonary oedema. Undetermined frequency
(cannot be estimated from
the available data)
Change in blood pressure
.
Bradypnoea.
Hypothermia
.
Muscle tremor
.
Corneal opacity
.
When dexmedetomidine and ketamine are used sequentially (with a 10
min interval):
Very common (> 1 animal
/ 10 animals treated):
AV-block.Common
(1 to 10 animals / 100
animals treated):
Hypoxia/Decreased pulse oxygenation
.
Hypothermia.
Uncommon
(1 to 10 animals / 1,000
animals treated)
Apnoea.Undetermined frequency
(cannot be estimated from
the available data)
Bradypnoea, irregular breathing,
hypoventilation.
Vomiting.
Extrasystole.
Nervousness.
When dexmedetomidine is used as a pre-medicant:Very commonArrhythmia
8, 9
.
Issued: February 2024
AN: 01702/2022
(> 1 animal / 10 animals
treated):
Common
(1 to 10 animals / 100
animals treated)
Sinus bradycardia
, sinus arrhythmia
,
supraventricular and nodal arrhythmia.
Retching.
Uncommon
(1 to 10 animals / 1,000
animals treated)
1st degree AV block
.Undetermined frequency
(cannot be estimated from
the available data)
Vomiting.
Pale mucous membranes.
Hypothermia.
By virtue of the α2-adrenergic activity of dexmedetomidine.
May occur 5–10 minutes after injection. Some dogs and cats may also vomit
at the time of recovery.
Due to peripheral vasoconstriction and venous desaturation in the presence of
normal arterial oxygenation.
Blood pressure will increase initially and then return to normal or below
normal.
May occur during sedation.
May occur if the eyes stay open during sedation. The eyes should be
protected by a suitable eye lubricant (see also section 3.5).
Especially within the 15 first minutes of anaesthesia.
After intramuscular dosing at 40 micrograms/kg (followed by ketamine or
propofol).
Supraventricular premature complexes, atrial bigeminy, sinus pauses, 2nd
degree AV block, escape beats/rhythms.
Reporting adverse events is important. It allows continuous safety monitoring of
a veterinary medicinal product. Reports should be sent, preferably via a
veterinarian, to either the marketing authorisation holder or its local
representative or the national competent authority via the national reporting
system. See the package leaflet for respective contact details.
Very common (> 1 animal
/ 10 animals treated):
Bradycardia
Pale or cyanotic mucous membranes
Rare
(1 to 10 animals / 10,000
animals treated):
Pulmonary oedema. Undetermined frequency
(cannot be estimated
from the available data)
Change in blood pressure
.
Bradypnoea.
Hypothermia
.
Vomiting
.
Muscle tremor
.
Corneal opacity
.
When dexmedetomidine and butorphanol are used concomitantly:Common (1 to 10
animals / 100 animals
treated):
Arrhythmia
Undetermined frequency
(cannot be estimated
from the available data)
Bradypnoea, tachypnoea, irregular
breathing
, hypoxia.
Muscle twitching or tremor or paddling.
Excitation, sudden arousal, prolonged
sedation.
Hypersalivation.
Retching, vomiting.
Urination.
Erythema.
When dexmedetomidine is used as a pre-medicant:Rare
(1 to 10 animals / 10,000
animals treated):
Arrhythmia
.
Issued: February 2024
AN: 01702/2022
Undetermined frequency
(cannot be estimated
from the available data)
Arrhythmia
.
Bradypnoea, tachypnoea.
Vomiting.
By virtue of the α2-adrenergic activity of dexmedetomidine.
Due to peripheral vasoconstriction and venous desaturation in the presence of
normal arterial oxygenation.
Blood pressure will increase initially and then return to normal or below
normal.
May occur 5–10 minutes after injection. Some dogs and cats may also vomit
at the time of recovery.
May occur during sedation.
May occur if the eyes stay open during sedation. The eyes should be
protected by a suitable eye lubricant (see also section 3.5).
Brady- and tachyarrhythmias. These may include profound sinus bradycardia,
1st and 2nd degree AV block, sinus arrest or pause, as well as atrial,
supraventricular and ventricular premature complexes.
20-30 sec apnoea followed by several rapid breaths.
Supraventricular and ventricular premature complexes, sinus pause and 3rd
degree AV block.
Brady- and tachyarrhythmias have been reported and include profound sinus
bradycardia, 1st and 2nd degree AV block and sinus arrest.
Cats:
Very common (> 1 animal
/ 10 animals treated):
Bradycardia
.
Vomiting
.
Pale or cyanotic mucous membranes
.
Rare
(1 to 10 animals / 10,000
animals treated):
Pulmonary oedema. Undetermined frequency
(cannot be estimated from
the available data)
Change in blood pressure
.
Bradypnoea.
Hypothermia
.
Muscle tremor
.
Corneal opacity
.
When dexmedetomidine and ketamine are used sequentially (with a 10
min interval):
Very common (> 1 animal
/ 10 animals treated):
AV-block.Common
(1 to 10 animals / 100
animals treated):
Hypoxia/Decreased pulse oxygenation
.
Hypothermia.
Uncommon
(1 to 10 animals / 1,000
animals treated)
Apnoea.Undetermined frequency
(cannot be estimated from
the available data)
Bradypnoea, irregular breathing,
hypoventilation.
Vomiting.
Extrasystole.
Nervousness.
When dexmedetomidine is used as a pre-medicant:Very commonArrhythmia
8, 9
.
Issued: February 2024
AN: 01702/2022
(> 1 animal / 10 animals
treated):
Common
(1 to 10 animals / 100
animals treated)
Sinus bradycardia
, sinus arrhythmia
,
supraventricular and nodal arrhythmia.
Retching.
Uncommon
(1 to 10 animals / 1,000
animals treated)
1st degree AV block
.Undetermined frequency
(cannot be estimated from
the available data)
Vomiting.
Pale mucous membranes.
Hypothermia.
By virtue of the α2-adrenergic activity of dexmedetomidine.
May occur 5–10 minutes after injection. Some dogs and cats may also vomit
at the time of recovery.
Due to peripheral vasoconstriction and venous desaturation in the presence of
normal arterial oxygenation.
Blood pressure will increase initially and then return to normal or below
normal.
May occur during sedation.
May occur if the eyes stay open during sedation. The eyes should be
protected by a suitable eye lubricant (see also section 3.5).
Especially within the 15 first minutes of anaesthesia.
After intramuscular dosing at 40 micrograms/kg (followed by ketamine or
propofol).
Supraventricular premature complexes, atrial bigeminy, sinus pauses, 2nd
degree AV block, escape beats/rhythms.
Reporting adverse events is important. It allows continuous safety monitoring of
a veterinary medicinal product. Reports should be sent, preferably via a
veterinarian, to either the marketing authorisation holder or its local
representative or the national competent authority via the national reporting
system. See the package leaflet for respective contact details.
The administration of dexmedetomidine to puppies younger than 16 weeks and
kittens younger than 12 weeks has not been studied.
i). Special precautions for use in animals
Treated animals should be kept warm and at a constant temperature, both
during the procedure and recovery.
It is recommended that animals are fasted for 12 hours prior to administration of
the veterinary medicinal product. Water may be given.
After treatment, the animal should not be given water or food before it is able to
swallow.
Corneal opacity may occur during sedation. The eyes should be protected by a
suitable lubricant.
To be used with precaution in elderly animals.
Nervous, aggressive or excited animals should be given the possibility to calm
down before initiation of treatment.
Frequent and regular monitoring of respiratory and cardiac function should be
performed. Pulse oximetry may be useful but is not essential for adequate
monitoring. Equipment for manual ventilation should be available in case of
respiratory depression or apnoea when dexmedetomidine and ketamine are
used sequentially to induce anaesthesia in cats. It is also advisable to have
oxygen readily available, should hypoxaemia be detected or suspected.
Sick and debilitated dogs and cats should only be premedicated with
dexmedetomidine before induction and maintenance of general anaesthesia
based on a risk-benefit assessment.
Use of dexmedetomidine as a pre-medicant in dogs and cats significantly
reduces the amount of induction drug required for induction of anaesthesia.
Attention should be given during the administration of intravenous induction
drugs to effect. Volatile anaesthetic requirements for maintenance anaesthesia
are also reduced.
ii). Special precautions to be take by the person administering the veterinary
medicinal product to animals
This veterinary medicinal product is a sedative and can cause skin and/or eye
irritation. Care should be taken to avoid skin, eye, mucosal contact and self-
injection. The use of impermeable gloves is advisable.
In case of accidental contact of the veterinary medicinal product with the skin or
eyes, rinse with large amounts of fresh water. Remove contaminated clothes
that are in direct contact with skin. In case of eye contact, rinse abundantly with
fresh water. If symptoms occur, seek medical advice. In case of accidental oral
exposure or self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician but DO NOT DRIVE as sedation
and changes in blood pressure may occur.
Issued: February 2024
AN: 01702/2022
If pregnant women handle the veterinary medicinal product, special caution
should be observed not to self-inject as uterine contractions and decreased
foetal blood pressure may occur after accidental systemic exposure.
People with known hypersensitivity to the active substance and/or parabens
should administer the veterinary medicinal product with caution.
Advice to physicians: The veterinary medicinal product is an a2-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.
The specific a2- adrenoceptor antagonist, atipamezole, which is approved for
use in animals, has been used in humans only experimentally to antagonize
dexmedetomidine-induced effects.
iii). Other precautions
Not applicable.
kittens younger than 12 weeks has not been studied.
i). Special precautions for use in animals
Treated animals should be kept warm and at a constant temperature, both
during the procedure and recovery.
It is recommended that animals are fasted for 12 hours prior to administration of
the veterinary medicinal product. Water may be given.
After treatment, the animal should not be given water or food before it is able to
swallow.
Corneal opacity may occur during sedation. The eyes should be protected by a
suitable lubricant.
To be used with precaution in elderly animals.
Nervous, aggressive or excited animals should be given the possibility to calm
down before initiation of treatment.
Frequent and regular monitoring of respiratory and cardiac function should be
performed. Pulse oximetry may be useful but is not essential for adequate
monitoring. Equipment for manual ventilation should be available in case of
respiratory depression or apnoea when dexmedetomidine and ketamine are
used sequentially to induce anaesthesia in cats. It is also advisable to have
oxygen readily available, should hypoxaemia be detected or suspected.
Sick and debilitated dogs and cats should only be premedicated with
dexmedetomidine before induction and maintenance of general anaesthesia
based on a risk-benefit assessment.
Use of dexmedetomidine as a pre-medicant in dogs and cats significantly
reduces the amount of induction drug required for induction of anaesthesia.
Attention should be given during the administration of intravenous induction
drugs to effect. Volatile anaesthetic requirements for maintenance anaesthesia
are also reduced.
ii). Special precautions to be take by the person administering the veterinary
medicinal product to animals
This veterinary medicinal product is a sedative and can cause skin and/or eye
irritation. Care should be taken to avoid skin, eye, mucosal contact and self-
injection. The use of impermeable gloves is advisable.
In case of accidental contact of the veterinary medicinal product with the skin or
eyes, rinse with large amounts of fresh water. Remove contaminated clothes
that are in direct contact with skin. In case of eye contact, rinse abundantly with
fresh water. If symptoms occur, seek medical advice. In case of accidental oral
exposure or self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician but DO NOT DRIVE as sedation
and changes in blood pressure may occur.
Issued: February 2024
AN: 01702/2022
If pregnant women handle the veterinary medicinal product, special caution
should be observed not to self-inject as uterine contractions and decreased
foetal blood pressure may occur after accidental systemic exposure.
People with known hypersensitivity to the active substance and/or parabens
should administer the veterinary medicinal product with caution.
Advice to physicians: The veterinary medicinal product is an a2-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.
The specific a2- adrenoceptor antagonist, atipamezole, which is approved for
use in animals, has been used in humans only experimentally to antagonize
dexmedetomidine-induced effects.
iii). Other precautions
Not applicable.
The use of other central nervous system depressants is expected to potentiate
the effects of dexmedetomidine and therefore an appropriate dose adjustment
should be made. Anticholinergics should be used with caution with
dexmedetomidine.
Issued: February 2024
AN: 01702/2022
Administration of atipamezole after dexmedetomidine rapidly reverses the
effects and thus shortens the recovery period. Within 15 minutes dogs and cats
are normally awake and standing.
Cats: After administration of 40 micrograms dexmedetomidine/kg bw
intramuscularly concurrently with 5 mg ketamine/kg bw to cats, the maximum
concentration of dexmedetomidine increased twofold but there was no effect on
T max. The mean half-life of elimination of dexmedetomidine increased to 1.6 h
and the total exposure (AUC) increased by 50%.
A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms
dexmedetomidine/ kg may cause
tachycardia.
the effects of dexmedetomidine and therefore an appropriate dose adjustment
should be made. Anticholinergics should be used with caution with
dexmedetomidine.
Issued: February 2024
AN: 01702/2022
Administration of atipamezole after dexmedetomidine rapidly reverses the
effects and thus shortens the recovery period. Within 15 minutes dogs and cats
are normally awake and standing.
Cats: After administration of 40 micrograms dexmedetomidine/kg bw
intramuscularly concurrently with 5 mg ketamine/kg bw to cats, the maximum
concentration of dexmedetomidine increased twofold but there was no effect on
T max. The mean half-life of elimination of dexmedetomidine increased to 1.6 h
and the total exposure (AUC) increased by 50%.
A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms
dexmedetomidine/ kg may cause
tachycardia.
This veterinary medicinal product does not require any special storage
conditions.
conditions.
weight
(kg)
Dexmedetomidine
300 mcg/m2 intramuscularly
(mcg/kg) (ml)
2-3 240.123-4 230.164-5 22.20.25-10 1
(kg)
Dexmedetomidine
300 mcg/m2 intramuscularly
(mcg/kg) (ml)
2-3 240.123-4 230.164-5 22.20.25-10 1
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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