Dexdomitor
Active substance
ATC code
Species
Dogs and cats.
Indications
Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.
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.
Dose to be administered and administration route
The product is intended for:
- Dogs: intravenous or intramuscular use - Cats: intramuscular use
The product is not intended for repeat injections.
Dexdomitor, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmaceutically compatible.
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. 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 | Dexmedetomidine 125 mcg/m2 | Dexmedetomidine 375 mcg/m2 | Dexmedetomidine 500 mcg/m2 | |||||
(kg) | (mcg/kg) | (ml) | (mcg/kg) | (ml) | (mcg/kg) | (ml) | ||
2–3 | 9.4 | 0.04 | 28.1 | 0.12 | 40 | 0.15 | ||
3–4 | 8.3 | 0.05 | 25 | 0.17 | 35 | 0.2 | ||
4–5 | 7.7 | 0.07 | 23 | 0.2 | 30 | 0.3 | ||
5–10 | 6.5 | 0.1 | 19.6 | 0.29 | 25 | 0.4 | ||
10–13 | 5.6 | 0.13 | 16.8 | 0.38 | 23 | 0.5 | ||
13–15 | 5.2 | 0.15 | 15.7 | 0.44 | 21 | 0.6 | ||
15–20 | 4.9 | 0.17 | 14.6 | 0.51 | 20 | 0.7 | ||
20–25 | 4.5 | 0.2 | 13.4 | 0.6 | 18 | 0.8 | ||
25–30 | 4.2 | 0.23 | 12.6 | 0.69 | 17 | 0.9 | ||
30–33 | 4 | 0.25 | 12 | 0.75 | 16 | 1.0 | ||
33–37 | 3.9 | 0.27 | 11.6 | 0.81 | 15 | 1.1 | ||
37–45 | 3.7 | 0.3 | 11 | 0.9 | 14.5 | 1.2 | ||
45–50 | 3.5 | 0.33 | 10.5 | 0.99 | 14 | 1.3 | ||
50–55 | 3.4 | 0.35 | 10.1 | 1.06 | 13.5 | 1.4 | ||
55–60 | 3.3 | 0.38 | 9.8 | 1.13 | 13 | 1.5 | ||
60–65 | 3.2 | 0.4 | 9.5 | 1.19 | 12.8 | 1.6 | ||
65–70 | 3.1 | 0.42 | 9.3 | 1.26 | 12.5 | 1.7 | ||
70–80 | 3 | 0.45 | 9 | 1.35 | 12.3 | 1.8 | ||
> 80 | 2.9 | 0.47 | 8.7 | 1.42 | 12 | 1.9 | ||
For dee | p sedation and analgesia with butorphanol | |||||||
Dog weight | Dexmedetomidine 300 mcg/m2 intramuscularly | |||||||
(kg) | (mcg/kg) | (ml) | ||||||
2–3 | 24 | 0.12 | ||||||
3–4 | 23 | 0.16 | ||||||
4–5 | 22.2 | 0.2 | ||||||
5–10 | 16.7 | 0.25 | ||||||
10–13 | 13 | 0.3 | ||||||
13–15 | 12.5 | 0.35 | ||||||
15–20 | 11.4 | 0.4 | ||||||
20–25 | 11.1 | 0.5 | ||||||
25–30 | 10 | 0.55 | ||||||
30–33 | 9.5 | 0.6 | ||||||
33–37 | 9.3 | 0.65 | ||||||
37–45 | 8.5 | 0.7 | ||||||
45–50 | 8.4 | 0.8 | ||||||
50–55 | 8.1 | 0.85 | ||||||
55–60 | 7.8 | 0.9 | ||||||
60–65 | 7.6 | 0.95 | ||||||
65–70 | 7.4 | 1 | ||||||
70–80 | 7.3 | 1.1 | ||||||
> 80 | 7 | 1.2 | ||||||
CATS:
The dosage for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume 0.08 ml Dexdomitor/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 | Dexmedetomidine 40 mcg/kg intramuscularly | |
(kg) | (mcg/kg) | (ml) |
1–2 | 40 | 0.1 |
2–3 | 40 | 0.2 |
3–4 | 40 | 0.3 |
4–6 | 40 | 0.4 |
6–7 | 40 | 0.5 |
7–8 | 40 | 0.6 |
8–10 | 40 | 0.7 |
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.
Adverse reactions
Dogs
Very common (> 1 animal / 10 animals treated): | Bradycardia Cyanotic mucous membranes2 Pale mucous membranes2 |
Common (1 to 10 animals / 100 animals treated): | Arrhythmia1 |
Rare (1 to 10 animals / 10 000 animals treated): | Pulmonary oedema |
Undetermined frequency (cannot be estimated from the available data): | Excitation1 Heart block1 High blood pressure3 Low blood pressure3 Premature ventricular contractions1 Supraventricular and nodal arrhythmia1 Hypersalivation1 Retching1 Vomiting4 Corneal opacity Muscle tremor Sedation prolonged1 Bradypnoea1,5 Decreased pulse oxygenation1 Decreased respiratory rate |
Irregular breathing1 Tachypnoea1,5 Erythema1 Decreased body temperature Urination1 |
1When dexmedetomidine and butorphanol are used concomitantly.
2Due to peripheral vasoconstriction and venous desaturation in the presence of normal arterial oxygenation.
3Blood pressure will increase initially and then return to normal or below normal.
4May occur 5–10 minutes after injection. Some dogs may also vomit at the time of recovery.
5When dexmedetomidine is used as a premedicant.
When dexmedetomidine and butorphanol are used concomitantly in dogs, brady- and tachyarrhythmias have been reported. 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.
When dexmedetomidine is used as a premedicant brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest. Supraventricular and ventricular premature complexes, sinus pause and 3rd degree AV block may be observed in rare cases. Cats
Very common (> 1 animal / 10 animals treated): | Arrhythmia1 Bradycardia Heart block2 Vomiting3 Pale mucous membranes4 Cyanotic mucous membranes4 |
Common (1 to 10 animals / 100 animals treated): | Supraventricular and nodal arrhythmia1 Retching1 Decreased pulse oxygenation2 Hypothermia2 |
Uncommon (1 to 10 animals / 1 000 animals treated): | Apnoea2 |
Rare (1 to 10 animals / 10 000 animals treated): | Pulmonary oedema |
Undetermined frequency (cannot be estimated from the available data): | Extrasystole2 High blood pressure5 Low blood pressure5 Corneal opacity Muscle tremor Bradypnoea2 Decreased respiratory rate Hypoventilation2 Irregular breathing2 Agitation2 |
1When dexmedetomidine is used as a premedicant.
2When dexmedetomidine and ketamine are used sequentially.
3May occur 5–10 minutes after injection. Some cats may also vomit at the time of recovery.
4Due to peripheral vasoconstriction and venous desaturation in the presence of normal arterial oxygenation.
5Blood pressure will increase initially and then return to normal or below normal.
Intramuscular dosing at 40 micrograms/kg (followed by ketamine or propofol) frequently resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in 1st degree atrioventricular block, and rarely resulted in supraventricular premature depolarizations, atrial bigeminy, sinus pauses, 2nd degree atrioventricular block, or 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.
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| Art. Nr. | |
| EAN | 6432100010520 |
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