Target species
Dogs and cats.
Indications for use for each target species
Atipamezole hydrochloride is a selective α2-antagonist and is indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in cats and dogs.
Contraindications
Do not use in breeding animals.
Do not use in animals suffering from liver- or renal diseases.
See also section Use during pregnancy, lactation or lay
Special warnings
Make sure the animal has regained a normal swallowing reflex before any food or drink is offered.
Special precautions for use
After administration of the veterinary medicinal product, the animals should be allowed to rest in a quiet place. During recovery time animals should not be left unattended.
Due to different dosing recommendations caution should be taken if using the veterinary medicinal product off-label in animals other than the target species.
If sedatives other than (dex)medetomidine are given, it must be kept in mind that the effects of those other agents may persist after reversal of (dex)medetomidine.
Atipamezole does not reverse the effect of ketamine, which may cause seizures in dogs and elicit cramps in cats when used alone. Do not administer atipamezole within 30 – 40 minutes of prior administration of ketamine.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Due to the potent pharmacological activity of atipamezole, skin-, eye- and mucous membrane- contact with this veterinary medicinal product should be avoided. In case of accidental contact of the veterinary medicinal product with skin or eyes rinse abundantly with fresh water. Seek medical attention if irritation persists. Remove contaminated clothes that are in direct contact with the skin.
Care should be taken to avoid accidental ingestion or self-injection. In case of accidental ingestion or self-injection, seek medical advice immediately and show the package leaflet to the physician.
Special precautions for the protection of the environment
Not applicable.
Adverse events
Dogs and cats:
Rare (1 to 10 animals / 10,000 animals treated) | Hyperactivity, Vocalisation a, Involuntary urination, Involuntary defecation Tachycardia Increased salivation, Vomiting Muscle tremor Increased respiratory rate |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypotension b Sedation c, Recovery prolonged d Hypothermia e |
a Atypical.
b Transient effect that has been observed during the first 10 minutes post-injection of atipamezole hydrochloride.
c Recurrence.
d The recovery time may not be shortened after administration of atipamezole.
e In cats, when using low doses to partially reverse the effects of medetomidine or dexmedetomidine. Should be guarded against, even when aroused from sedation.
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.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore the use is not recommended during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
A simultaneous administration of atipamezole with other centrally acting veterinary medicinal products as diazepam, acepromazine or opiates is not recommended.
Administration routes and dosage
For single intramuscular use in cats and dogs. Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes. Atipamezole is generally administered 15 - 60 minutes after the medetomidine or dexmedetomidine injection.
Dogs: The atipamezole hydrochloride dose (in µg) is five times that of the previous medetomidine hydrochloride dose or ten times that of the dexmedetomidine hydrochloride dose. Due to the 5-fold higher concentration of the active ingredient (atipamezole hydrochloride) in this veterinary medicinal product compared to that of preparations containing 1 mg medetomidine hydrochloride per ml and the 10-fold higher concentration compared to that of preparations containing 0.5 mg dexmedetomidine hydrochloride, an equal volume of each preparation is required.
Dosage example dogs:
Medetomidine 1.0 mg/ml solution for injection Dosage: | Atipam 5.0 mg/ml solution for injection Dosage: |
0.04 ml/kg body weight (bw), i.e. 40 μg/kg bw | 0.04 ml/kg body weight (bw), i.e. 200 μg/kg bw |
Dexmedetomidine 0.5 mg/ml solution for injection Dosage: | Atipam 5.0 mg/ml solution for injection Dosage: |
0.04 ml/kg body weight (bw), i.e. 20 μg/kg bw | 0.04 ml/kg body weight (bw), i.e. 200 μg/kg bw |
Cats: The atipamezole hydrochloride dose (in µg) is two-and-a-half times that of the previous medetomidine hydrochloride dose or five times that of the dexmedetomidine hydrochloride dose. Due to the 5-fold higher concentration of the active ingredient (atipamezole hydrochloride) in this veterinary medicinal product compared to that of preparations containing 1 mg medetomidine hydrochloride per ml and the 10-fold higher concentration compared to that of preparations containing 0.5 mg dexmedetomidine hydrochloride, half the volume of the veterinary medicinal product to that of the previously administered medetomidine or dexmedetomidine should be given.
Dosage example cats:
Medetomidine 1.0 mg/ml solution for injection Dosage: | Atipam 5.0 mg/ml solution for injection Dosage: |
0.08 ml/kg body weight (bw), i.e. 80 μg/kg bw | 0.04 ml/kg body weight (bw), i.e. 200 μg/kg bw |
Dexmedetomidine 0.5 mg/ml solution for injection Dosage: | Atipam 5.0 mg/ml solution for injection Dosage: |
0.08 ml/kg body weight (bw), i.e. 40 μg/kg bw | 0.04 ml/kg body weight (bw), i.e. 200 μg/kg bw |
The recovery time is shortened to approximately 5 minutes. The animals become mobile after approximately 10 minutes after administration of the veterinary medicinal product.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Overdose of atipamezole hydrochloride may result in transient tachycardia and over- alertness (hyperactivity, muscle tremor). If necessary, these symptoms may be reversed by a medetomidine hydrochloride dose which is lower than the usually used clinical dose. If atipamezole hydrochloride is inadvertently administered to an animal not previously treated with (dex)medetomidine hydrochloride, hyperactivity and muscle tremor may occur. These effects may persist for about 15 minutes.
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.