ATIPAM

ATIPAM 5.0 mg/ml,

Solution for injection for cats and dogs.

Target species 
Cats and dogs 

Composition 
Each ml contains:
Active ingredients:
Atipamezole hydrochloride 5.0 mg 
(equivalent to 4.27 mg atipamezole base) 
Excipients:
Methyl parahydroxybenzoate (E 218) 1.0 mg 

Pharmaceutical form 
Solution for injection. 
Clear and colourless sterile aqueous solution. 

Indications for use 
Atipamezole hydrochloride is a selective α2-antagonist and indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in cats and dogs. 

Contraindications 
The product should not be used in: 
- Breeding animals 
- Animals suffering from liver- or renal diseases 

Amounts to be administered and administration route 
For single intramuscular injection 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 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. 

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 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 product to that of the previously administered medetomidine or dexmedetomidine should be given. 

The recovery time is shortened to approximately 5 minutes. The animals become mobile after approximately 10 minutes after administration of the product. 

A simultaneous administration of atipamezole with other centrally acting medicinal products as diazepam, acepromazine or opiates is not recommended. 

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 product should be avoided. In case of accidental contact of the 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 oral intake or self-injection, seek medical advice immediately and show the package insert to the physician.  Keep out of reach of children. 

Special precautions for use in animals 
After administration of the 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 product off-label in animals other than the target species. If sedatives other than 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. 

Adverse reactions (frequency and seriousness) 
A transient hypotensive effect has been observed during the first 10 minutes post-injection of atipamezole hydrochloride. In rare cases hyperactivity, tachycardia, salivation, atypical vocalisation, muscle tremor, vomiting, increased respiratory rate, uncontrolled urination and uncontrolled defecation may occur. In very rare cases recurrence of sedation may occur or the recovery time may not be shortened after 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. 

Use during pregnancy or lactation 
The safety of the product has not been documented adequately during pregnancy and lactation. Therefore the use is not recommended during pregnancy and lactation. 

Interactions with other veterinary medicinal products
and other forms of interaction
 
A simultaneous administration of atipamezole with other centrally acting medicinal products as diazepam, acepromazine or opiates is not recommended. 

Overdose (symptoms, emergency procedures, antidotes)
if necessary
 
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. 

Withdrawal periods 
Not applicable

Safety Data Sheet: Atipam_2012 MSDS

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Sedator-Atipam

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