POM-V
Prescription Required
Companion Animal
Atipazole 5 mg/ml Solution for Injection for Dogs and Cats
Active ingredient: Atipamezole Hydrochloride
Form
Injection
Species
Cats
Dogs
Manufacturer
Vetpharma Animal Health, S.L
VMD MA No.
32509/4012
What it's used for
Atipamezole is indicated for the reversal of the sedative & analgesic effects of medetomidine or dexmedetomidine in dogs and cats. It also reverses all oth...
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Clinical information
Atipazole 5 mg/ml Solution for Injection for Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Atipamezole is indicated for the reversal of the sedative & analgesic effects of
medetomidine or dexmedetomidine in dogs and cats. It also reverses all other effects
of medetomidine or dexmedetomidine, such as cardiovascular and respiratory
effects.
medetomidine or dexmedetomidine in dogs and cats. It also reverses all other effects
of medetomidine or dexmedetomidine, such as cardiovascular and respiratory
effects.
The dose depends on the previously administered medetomidine or dexmedetomidine
dose.
Dogs
The dose of atipamezole hydrochloride (in µg per kg of body weight) is five times that of
the previous dose of medetomidine hydrochloride or ten times that of the dose of
dexmedetomidine hydrochloride.
AN: 00672/2024 & 00673/2024
Due to the 5-fold higher concentration of the active ingredient (atipamezole
hydrochloride) in this veterinary medicinal product compared to those preparations
containing 1 mg medetomidine hydrochloride per ml, and the 10-fold concentration
compared to those preparations containing 0.5 mg dexmedetomidine hydrochloride, an
equal volume of each preparation is required. Due to the 50-fold concentration compared
to those preparations containing 0.1 mg dexmedetomidine hydrochloride, a volume 5
times lower of the atipamezole preparation is required.
Dosage example dogs
Medetomidine 1.0 mg/ml solution
for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.04 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.5 mg/ml
solution for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.04 ml/kg body weight (bw),
corresponding with 20 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.1 mg/ml
solution for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.2 ml/kg body weight (bw),
corresponding with 20 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Cats
The dose of atipamezole hydrochloride (in µg per kg of body weight) is 2.5 times that of
the previous dose of medetomidine hydrochloride or 5 times that of the dose of
dexmedetomidine hydrochloride.
Due to the 5-fold concentration of the active ingredient (atipamezole hydrochloride) in this
veterinary medicine product compared to those preparations containing 1 mg
medetomidine hydrochloride per ml and the 10-fold concentration compared to those
preparations containing 0.5 mg dexmedetomidine hydrochloride, half the volume of the
product to that of the previously administered medetomidine or dexmedetomidine should
be given. Due to the 50-fold concentration compared to those preparations containing 0.1
mg dexmedetomidine hydrochloride, a volume 10 times lower of the atipamezole
preparation is required.
Dosage example cats
AN: 00672/2024 & 00673/2024
Medetomidine 1.0 mg/ml solution
for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.08 ml/kg body weight (bw),
corresponding with 80 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.5 mg/ml
solution for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.08 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.1 mg/ml
solution for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.4 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Atipamezole hydrochloride is administered 15-60 min after medetomidine or
dexmedetomidine hydrochloride injection. The recovery time for dogs and cats is
shortened to approximately 5 minutes. The animal becomes mobile approximately 10
minutes after administration of the product.
dose.
Dogs
The dose of atipamezole hydrochloride (in µg per kg of body weight) is five times that of
the previous dose of medetomidine hydrochloride or ten times that of the dose of
dexmedetomidine hydrochloride.
AN: 00672/2024 & 00673/2024
Due to the 5-fold higher concentration of the active ingredient (atipamezole
hydrochloride) in this veterinary medicinal product compared to those preparations
containing 1 mg medetomidine hydrochloride per ml, and the 10-fold concentration
compared to those preparations containing 0.5 mg dexmedetomidine hydrochloride, an
equal volume of each preparation is required. Due to the 50-fold concentration compared
to those preparations containing 0.1 mg dexmedetomidine hydrochloride, a volume 5
times lower of the atipamezole preparation is required.
Dosage example dogs
Medetomidine 1.0 mg/ml solution
for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.04 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.5 mg/ml
solution for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.04 ml/kg body weight (bw),
corresponding with 20 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.1 mg/ml
solution for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.2 ml/kg body weight (bw),
corresponding with 20 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Cats
The dose of atipamezole hydrochloride (in µg per kg of body weight) is 2.5 times that of
the previous dose of medetomidine hydrochloride or 5 times that of the dose of
dexmedetomidine hydrochloride.
Due to the 5-fold concentration of the active ingredient (atipamezole hydrochloride) in this
veterinary medicine product compared to those preparations containing 1 mg
medetomidine hydrochloride per ml and the 10-fold concentration compared to those
preparations containing 0.5 mg dexmedetomidine hydrochloride, half the volume of the
product to that of the previously administered medetomidine or dexmedetomidine should
be given. Due to the 50-fold concentration compared to those preparations containing 0.1
mg dexmedetomidine hydrochloride, a volume 10 times lower of the atipamezole
preparation is required.
Dosage example cats
AN: 00672/2024 & 00673/2024
Medetomidine 1.0 mg/ml solution
for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.08 ml/kg body weight (bw),
corresponding with 80 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.5 mg/ml
solution for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.08 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Dexmedetomidine 0.1 mg/ml
solution for injection dosage
Atipamezole hydrochloride
5.0mg/ml solution for injection
dosage
0.4 ml/kg body weight (bw),
corresponding with 40 μg/kg bw
0.04 ml/kg body weight (bw),
corresponding with 200 μg/kg bw
Atipamezole hydrochloride is administered 15-60 min after medetomidine or
dexmedetomidine hydrochloride injection. The recovery time for dogs and cats is
shortened to approximately 5 minutes. The animal becomes mobile approximately 10
minutes after administration of the product.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in breeding animals.
Do not use in animals suffering from hepatic or renal or cardiac diseases.
See also section 3.7.
Do not use in breeding animals.
Do not use in animals suffering from hepatic or renal or cardiac diseases.
See also section 3.7.
Dogs and cats:
AN: 00672/2024 & 00673/2024
Rare
(1 to 10 animals / 10,000
animals treated):
Hyperactivity, impaired vocalisation
Tachycardia
Hypersalivation, vomiting, involuntary
defecation
Muscle tremor
Involuntary urination
Increased respiratory rate
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypotension
.
Sedation
, recovery prolonged
Hypothermia
1
Transient, during the first ten minutes post-injection.
Recurrent sedation may occur, or the recovery time may not be shortened after the
administration of atipamezole.
In cats, when using low doses to partially reverse the effects of medetomidine or
dexmedetomidine, the possibility of hypothermia (even when aroused from sedation)
should be guarded against.
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.
AN: 00672/2024 & 00673/2024
Rare
(1 to 10 animals / 10,000
animals treated):
Hyperactivity, impaired vocalisation
Tachycardia
Hypersalivation, vomiting, involuntary
defecation
Muscle tremor
Involuntary urination
Increased respiratory rate
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypotension
.
Sedation
, recovery prolonged
Hypothermia
1
Transient, during the first ten minutes post-injection.
Recurrent sedation may occur, or the recovery time may not be shortened after the
administration of atipamezole.
In cats, when using low doses to partially reverse the effects of medetomidine or
dexmedetomidine, the possibility of hypothermia (even when aroused from sedation)
should be guarded against.
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.
None.
AN: 00672/2024 & 00673/2024
Special precautions for safe use in the target species:
Atipamezole does not reverse the effect of ketamine, which can cause seizures in dogs
and cause cramps in cats when used alone. Do not administer atipamezole within 30-40
minutes of prior administration of ketamine.
After administration of the veterinary medicinal product, the animals should be allowed to
rest in a quiet place. During the recovery phase, animals should not be left unattended.
Make sure the animal has regained a normal swallowing reflex before any food or drink is
offered.
Due to different dosing recommendations caution should be taken using the product off
label in animals other than the target species.
If other sedatives different than (dex)medetomidine are administered, it must be taken
into account that the effects of these other agents are likely to persist after the reversal of
the effects of (dex)medetomidine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Due to the potent pharmacological activity of atipamezole, contact of the product with
skin, eyes and mucous membranes should be avoided. In case of accidental spillage
onto skin, wash the affected area immediately with clean running water. Seek medical
advice if irritation persists and show the package leaflet or the label to the physician.
Remove contaminated clothes that are in direct contact with skin.
Care should be taken to avoid accidental ingestion or self-injection. In case of accidental
self-injection or ingestion, seek medical advice immediately and show the package leaflet
or the label to the physician. Do not drive. The patient should not be left unattended.
Special precautions for the protection of the environment:
Not applicable.
AN: 00672/2024 & 00673/2024
Special precautions for safe use in the target species:
Atipamezole does not reverse the effect of ketamine, which can cause seizures in dogs
and cause cramps in cats when used alone. Do not administer atipamezole within 30-40
minutes of prior administration of ketamine.
After administration of the veterinary medicinal product, the animals should be allowed to
rest in a quiet place. During the recovery phase, animals should not be left unattended.
Make sure the animal has regained a normal swallowing reflex before any food or drink is
offered.
Due to different dosing recommendations caution should be taken using the product off
label in animals other than the target species.
If other sedatives different than (dex)medetomidine are administered, it must be taken
into account that the effects of these other agents are likely to persist after the reversal of
the effects of (dex)medetomidine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Due to the potent pharmacological activity of atipamezole, contact of the product with
skin, eyes and mucous membranes should be avoided. In case of accidental spillage
onto skin, wash the affected area immediately with clean running water. Seek medical
advice if irritation persists and show the package leaflet or the label to the physician.
Remove contaminated clothes that are in direct contact with skin.
Care should be taken to avoid accidental ingestion or self-injection. In case of accidental
self-injection or ingestion, seek medical advice immediately and show the package leaflet
or the label to the physician. Do not drive. The patient should not be left unattended.
Special precautions for the protection of the environment:
Not applicable.
Simultaneous administration of atipamezole with other centrally acting medicinal products
such as diazepam, acepromazine or opiates is not recommended.
such as diazepam, acepromazine or opiates is not recommended.
This veterinary medicinal product does not require any special storage conditions.
No special storage conditions of medicinal product are required after first opening the
container.
No special storage conditions of medicinal product are required after first opening the
container.
Excipients:
Qualitative composition of
excipients and other
constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary medicinal
product
Methyl parahydroxybenzoate (E
218)
1.0 mgSodium chlorideWater for injections
Clear and colourless solution.
3. CLINICAL INFORMATION
3.1 Target species
Dogs and cats.
3.2 Indications for use for each target species
Reversal of the sedative effects of medetomidine and dexmedetomidine.
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in breeding animals.
Do not use in animals suffering from hepatic or renal or cardiac diseases.
See also section 3.7.
3.4 Special warnings
None.
AN: 00672/2024 & 00673/2024
3.5 Special precautions for use
Special precautions for safe use in the target species:
Atipamezole does not reverse the effect of ketamine, which can cause seizures in dogs
and cause cramps in cats when used alone. Do not administer atipamezole within 30-40
minutes of prior administration of ketamine.
After administration of the veterinary medicinal product, the animals should be allowed to
rest in a quiet place. During the recovery phase, animals should not be left unattended.
Make sure the animal has regained a normal swallowing reflex before any food or drink is
offered.
Due to different dosing recommendations caution should be taken using the product off
label in animals other than the target species.
If other sedatives different than (dex)medetomidine are administered, it must be taken
into account that the effects of these other agents are likely to persist after the reversal of
the effects of (dex)medetomidine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Due to the potent
Qualitative composition of
excipients and other
constituents
Quantitative composition if that
information is essential for proper
administration of the veterinary medicinal
product
Methyl parahydroxybenzoate (E
218)
1.0 mgSodium chlorideWater for injections
Clear and colourless solution.
3. CLINICAL INFORMATION
3.1 Target species
Dogs and cats.
3.2 Indications for use for each target species
Reversal of the sedative effects of medetomidine and dexmedetomidine.
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in breeding animals.
Do not use in animals suffering from hepatic or renal or cardiac diseases.
See also section 3.7.
3.4 Special warnings
None.
AN: 00672/2024 & 00673/2024
3.5 Special precautions for use
Special precautions for safe use in the target species:
Atipamezole does not reverse the effect of ketamine, which can cause seizures in dogs
and cause cramps in cats when used alone. Do not administer atipamezole within 30-40
minutes of prior administration of ketamine.
After administration of the veterinary medicinal product, the animals should be allowed to
rest in a quiet place. During the recovery phase, animals should not be left unattended.
Make sure the animal has regained a normal swallowing reflex before any food or drink is
offered.
Due to different dosing recommendations caution should be taken using the product off
label in animals other than the target species.
If other sedatives different than (dex)medetomidine are administered, it must be taken
into account that the effects of these other agents are likely to persist after the reversal of
the effects of (dex)medetomidine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Due to the potent
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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