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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.

36408/3024

What it's used for

Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs and cats before in...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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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 27 Mar 2026.

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.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Dosage: the following doses are recommended:
Dogs:
Dexmedetomidine doses are based on body surface area:
Intravenously: up to 375 micrograms/square metre body surface area
Intramuscularly: up to 500 micrograms/square metre body surface area
When administering in conjunction with butorphanol (0.1 mg/kg) for deep sedation
and analgesia, the intramuscular dose of dexmedetomidine is 300
micrograms/square metre body surface area. The premedication dose of
dexmedetomidine is 125–375 micrograms/square metre body surface area,
administered 20 minutes prior to induction for procedures requiring anaesthesia. The
dose should be adjusted to the type of surgery, length of procedure and patient
temperament.
Concomitant use of dexmedetomidine and butorphanol produces sedative and
analgesic effects beginning no later than 15 minutes after administration. The peak
sedative and analgesic effects are reached within 30 minutes after administration.
Sedation lasts for at least 120 minutes post administration and analgesia lasts for at
least 90 minutes. Spontaneous recovery occurs within 3 hours.
Premedication with dexmedetomidine will significantly reduce the dosage of the
induction agent required and will reduce volatile anaesthetic requirements for
maintenance anaesthesia. In a clinical study, the requirement for propofol and
thiopental was reduced by 30% and 60% respectively. All anaesthetic agents used
for induction or maintenance of anaesthesia should be administered to effect. In a
clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5–4
hours. However this duration is dependent on a number of variables and further
analgesia should be administered in accordance with clinical judgement.
The corresponding doses based on body weight are presented in the following
tables. Use of an appropriately graduated syringe is recommended to ensure
accurate dosing when administering small volumes.
Dog
weight
(kg)
Dexmedetomidine
125 mcg/m
(mcg/kg) (ml)
Dexmedetomidine
375 mcg/m
(mcg/kg) (ml)
Dexmedetomidine
500 mcg/m
(mcg/kg) (ml)
2-3 9.40.0428.10.12400.153-4 8.30.05250.17350.24-5 7.70.07230.2300.35-10 6.50.119.60.29250.410-13 5.60.1316.80.38230.513-15 5.20.1515.70.44210.615-20 4.90.1714.60.51200.720-25 4.50.213.40.6180.825-30 4.20.2312.60.69170.930-33 40.25120.75161.033-37 3.90.2711.60.81151.137-45 3.70.3110.914.51.245-50 3.50.3310.50.99141.350-55 3.40.3510.11.0613.51.455-60 3.30.389.81.13131.560-65 3.20.49.51.1912.81.665-70 3.10.429.31.2612.51.770-80 30.4591.3512.31.8>80 2.90.478.71.42121.9 For deep sedation and analgesia with butorphanolDog
weight
(kg)
Dexmedetomidine
300 mcg/m
intramuscularly
(mcg/kg) (ml)
2-3 240.123-4 230.164-5 22.20.25-10 16.70.2510-13 130.313-15 12.50.3515-20 11.40.420-25 11.10.525-30 100.5530-33 9.50.633-37 9.30.6537-45 8.50.745-50 8.40.850-55 8.10.8555-60 7.80.960-65 7.60.9565-70 7.4170-80 7.31.1>80 71.2
Cats:
The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal
to a dose volume 0.08 ml product/kg bw when used for non-invasive, mildly to
moderately painful procedures requiring restraint, sedation and analgesia.
When dexmedetomidine is used for premedication in cats, the same dose is used.
Premedication with dexmedetomidine will significantly reduce the dosage of the
induction agent required and will reduce volatile anaesthetic requirements for
maintenance anaesthesia. In a clinical study, the requirement for propofol was
reduced by 50%. All anaesthetic agents used for induction or maintenance of
anaesthesia should be administered to effect.
Anaesthesia can be induced 10 minutes after premedication by intramuscular
administration of a target dose of 5 mg ketamine/ kg bw or by intravenous
administration of propofol to effect. Dosing for cats is presented in the following table.
Cat
weight
(kg)
Dexmedetomidine 40 mcg/kg intramuscularly
(mcg/kg) (ml)
1-2 400.12-3 400.23-4 400.34-6 400.46-7 400.57-8 400.68-10 400.7
The expected sedative and analgesic effects are reached within 15 minutes after
administration and are maintained up to 60 minutes after administration. Sedation
may be reversed with atipamezole. Atipamezole should not be administered prior to
30 minutes following ketamine administration.
The stoppers should not broached more than 30 times.
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.
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):
Arrhythmias
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
.
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 common
(> 1 animal / 10 animals
treated):
Arrhythmia
8, 9
.
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.

Special precautions for safe use in the target species
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.
Special precautions to be taken 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. 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.
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.
Special precautions for the protection of the environment:
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.
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 Tmax. 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.
Not applicable.

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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