A clear, colourless solution for injection containing atipamezole hydrochloride 5 mg/ml. Methylparahydroxybenzoate 1mg/ml is included as an antimicrobial preservative.

Atipamezole is a selective alpha-2 adrenergic receptor antagonist which is capable of reversing the sedative and analgesic effects of medetomidine (Domitor™) or dexmedetomidine (Dexdomitor®) in dogs and cats. It also reverses all other effects of medetomidine or dexmedetomidine, such as the cardiovascular and respiratory effects.

For intramuscular injection. Atipamezole (Antisedan) is quickly absorbed and is generally administered 15–60 minutes after the medetomidine or dexmedetomidine.
Dogs
The optimal dose of Antisedan, in micrograms per kilogram (mcg/kg) is five times that of the previous medetomidine dose or 10 times that of the previous dexmedetomidine. Thus an equal volume of Antisedan to that of the previously administered medetomidine or dexmedetomidine should be given.
Where Domitor (medetomidine) or Dexdomitor (dexmedetomidine) has been used, with or without butorphanol, as a premedicant to thiopentone, halothane anaesthesia in dogs, or as a premedicant to propofol anaesthesia in dogs, Antisedan may be administered in the post-operative phase to reverse the effects of Domitor or Dexdomitor and hasten recovery. Thus an equal volume of Antisedan to that of the previously administered medetomidine should be given. Antisedan in the post-operative phase rapidly causes arousal to full awareness and thus radically reduces the period of possible cardiovascular depression and hypothermia.
Cats
The optimal dose of Antisedan, in micrograms per kilogram (mcg/kg) is two-and-a-half times that of the previous medetomidine dose or 5 times that of the previous dexmedetomidine dose. Thus half the volume of Antisedan to that of the previously administered medetomidine or dexmedetomidine should be given.
The dose of Antisedan, in micrograms per kilogram (mcg/kg) should not exceed four times that of the previously administered medetomidine or 8 times that of dexmedetomidine.
When cats have been anaesthetised with Domitor (medetomidine) or Dexdomitor (dexmedetomidine), with or without butorphanol, and ketamine, or Domitor or Dexdomitor and alfaxalone/alfadolone, Antisedan 5 mg/ml solution may be administered to reverse the effects of Domitor or Dexdomitor and so speed recovery from anaesthesia. Thus half the volume of Antisedan to that of the previously administered Domitor (medetomidine) or Dexdomitor (dexmedetomidine) should be given.

Antisedan has only been administered to a limited number of pregnant dogs and cats and therefore cannot be recommended in pregnancy.
In dogs, a transient hypotensive effect has been observed during the first ten minutes post-injection.
Vomiting, panting, defaecation and muscle tremors (possibly shivering) have been reported, but these effects appear to be rare.
In dogs when a combination of butorphanol, Domitor or Dexdomitor and ketamine has been used Antisedan should not be used.
In cats, when using low doses of Antisedan to partially reverse the effects of medetomidine or Dexmedetomidine, the possibility of hypothermia (even when aroused from sedation) should be guarded against.
No harmful interactions with other agents have been encountered in clinical trials. However, concurrent use of drugs affecting the CNS is not recommended, apart from those in the data sheet.
Transient over-alertness and tachycardia may be observed after a possible overdosage. Over-alertness in the cat is best handled by minimising external stimuli.
Due to the potent pharmacological effect of Antisedan, skin contact should be avoided and impervious gloves should be worn during administration. Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek immediate medical attention showing a copy of the product literature. Do not drive. The patient should not be left unattended. In case of accidental spillage, wash the affected area immediately with clean running water. Seek medical attention if irritation persists. In case of accidental ingestion, seek medical advice immediately.

Do not store above 25°C. Protect from light.
Following withdrawal of the first dose use the product within 28 days. Discard any unused material.
Avoid the introduction of contamination during use.
Keep out of reach of children.
For animal treatment only.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

POM-V (previously POM)

Antisedan is provided in 10 ml vials.

Nil.