Cepedex 0.5 mg/ml Solution for Injection for Dogs and Cats
Active ingredient: Dexmedetomidine Hydrochloride
Form
Injection
Species
Manufacturer
CP Pharma Handelsgesellschaft mbH
VMD MA No.
20916/5001
What it's used for
Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats. Deep sedation and...
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Cepedex 0.5 mg/ml Solution for Injection for Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 18 Mar 2026.
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.
- Dogs: intravenous or intramuscular use.
- Cats: intramuscular use.
The veterinary medicinal product is not intended for repeat injections.
The stopper may be safely punctured up to 100 times.
Dexmedetomidine, butorphanol and/or ketamine can be mixed in the same syringe
as they have been shown to be pharmaceutically compatible.
The following doses are recommended:
Dogs:
Dexmedetomidine doses are based on body surface area.
For non-invasive, mildly to moderately painful procedures and examinations requiring
restraint, sedation and analgesia:
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 bw) 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 after administration. 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 dose 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 bodyweight are presented in the following tables.
Use of an appropriately graduated syringe is recommended to ensure accurate
dosing when administering small volumes.
Issued: February 2022
AN: 00961/2021Page 6 of 10
For non-invasive, mildly to moderately painful procedures and examinations
requiring restraint, sedation and analgesia and for premedication
Dog
bodyweight
Dexmedetomidine
125 micrograms/m
Dexmedetomidine
375 micrograms/m
Dexmedetomidine
500 micrograms/m
2*
(kg)(mcg/kg)(mL)(mcg/kg)(mL)(mcg/kg)(mL)2-39.40.0428.10.12400.153.1-48.30.05250.17350.24.1-57.70.07230.2300.35.1-106.50.119.60.29250.410.1-135.60.1316.80.38230.513.1-155.20.1515.70.44210.615.1-204.90.1714.60.51200.720.1-254.50.213.40.6180.825.1-304.20.2312.60.69170.930.1-3340.25120.75161.033.1-373.90.2711.60.81151.137.1-453.70.3110.914.51.245.1-503.50.3310.50.99141.350.1-553.40.3510.11.0613.51.455.1-603.30.389.81.13131.560.1-653.20.49.51.1912.81.665.1-703.10.429.31.2612.51.770.1-8030.4591.3512.31.8>802.90.478.71.42121.9
*only IM
For deep sedation and analgesia with butorphanol
Dog
bodyweight
Dexmedetomidine
300 micrograms/m
intramuscularly
(kg)(mcg/kg)(mL)2-3 240.123.1-4 230.164.1-522.20.25.1-1016.70.2510.1-13130.313.1-1512.50.3515.1-2011.40.420.1-2511.10.525.1-30100.5530.1-339.50.633.1-379.30.6537.1-458.50.745.1-508.40.850.1-558.10.8555.1-607.80.960.1-657.60.9565.1-707.41
Issued: February 2022
AN: 00961/2021Page 7 of 10
70.1-807.31.1>80 71.2
Cats:
The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a
dose volume of 0.08 ml Cepedex/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 dose 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
bodyweight
Dexmedetomidine 40 micrograms/kg intramuscularly
(kg)(mcg/kg)(mL)1-2 400.12.1-3 400.23.1-4 400.34.1-6 400.46.1-7 400.57.1-8 400.68.1-10 400.7
Dogs and cats
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 (see section 4.10). Atipamezole should not be
administered prior to 30 minutes following ketamine administration.
Do not use in animals with severe systemic disease or in animals that are moribund.
Issued: February 2022
AN: 00961/2021Page 2 of 10
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
rate and body temperature.
A decrease in respiratory rate may occur in some dogs and cats. Pulmonary oedema
has been reported rarely. Blood pressure will increase initially and then return to
normal or below normal. Due to peripheral vasoconstriction and venous desaturation
in the presence of normal arterial oxygenation, the mucous membranes may appear
pale and/or with a blue tinge.
Vomiting may occur 5-10 minutes after injection. Some dogs and cats may also vomit
at the time of recovery.
Muscle tremors may occur during sedation.
Corneal opacities may occur during sedation (see also section 4.5).
When dexmedetomidine and ketamine are used sequentially, with a 10- minute
interval, cats may occasionally experience atrioventricular (AV)-block or extrasystole.
Expected respiratory events are bradypnoea, intermittent respiratory patterns,
hypoventilation, and apnoea. The incidence of hypoxaemia was common in clinical
trials, especially within the first 15 minutes of dexmedetomidine-ketamine
anaesthesia. Vomiting, hypothermia and nervousness have been reported after such
use.
When dexmedetomidine and butorphanol are used concomitantly in dogs,
bradypnoea, tachypnoea, an irregular respiratory pattern (20-30 sec apnoea followed
by several rapid breaths), hypoxaemia, muscle twitch or tremor or paddling,
excitation, hypersalivation, retching, vomiting, urination, skin erythema, a sudden
Issued: February 2022
AN: 00961/2021Page 4 of 10
arousal, or prolonged sedation may occur. Brady- and tachyarrhythmias have been
reported. These may include profound sinus bradycardia, first and second degree
AV-block, sinus arrest or pause, as well as atrial, supraventricular and ventricular
premature complexes.
When dexmedetomidine is used as a premedicant in dogs bradypnoea, tachypnoea
and vomiting may occur. Brady- and tachyarrhythmias have been reported and
include profound sinus bradycardia, first and second degree AV block and sinus
arrest. Supraventricular and ventricular premature complexes, sinus pause and third
degree AV block may be observed in rare cases.
When dexmedetomidine is used as a premedicant in cats, vomiting, retching, pale
mucous membranes, and low body temperature may occur. Intramuscular dosing at
40 micrograms/kg bodyweight (bw) (followed by ketamine or propofol) frequently
resulted in sinus bradycardia and sinus arrhythmia, occasionally resulted in first
degree AV-block, and rarely resulted in supraventricular premature depolarisations,
atrial bigeminy, sinus pauses, second degree AV-block, or escape beats/rhythms.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
kittens younger than 12 weeks has not been studied.
Special precautions for use in animals
Treated animals should be kept warm and at a constant temperature, both during the
procedure and recovery.
It is recommended that animals are fasted for 12 hours prior to Cepedex
administration. Water may be given.
After treatment, the animal should not be given water or food before it is able to
swallow.
Corneal opacities may occur during sedation. The eyes should be protected by a
suitable eye lubricant.
To be used with precaution in elderly animals.
The safety of dexmedetomidine has not been established in males intended for
breeding.
Nervous, aggressive or excited animals should be given the possibility to calm down
before initiation of treatment.
Frequent and regular monitoring of respiratory and cardiac function should be
performed. Pulse oximetry may be useful but is not essential for adequate
monitoring. Equipment for manual ventilation should be available in case of
respiratory depression or apnoea when dexmedetomidine and ketamine are used
sequentially to induce anaesthesia in cats. It is also advisable to have oxygen readily
available, should hypoxaemia be detected or suspected.
Sick and debilitated dogs and cats should only be premedicated with
dexmedetomidine before induction and maintenance of general anaesthesia based
on a risk-benefit assessment.
Use of dexmedetomidine as a premedicant in dogs and cats significantly reduces the
amount of induction medicinal product required for induction of anaesthesia. Attention
should be given during the administration of intravenous induction medicinal products
to effect. Volatile anaesthetic requirements for maintenance anaesthesia are also
reduced.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Dexmedetomidine is a sedative and sleep-inducing drug. Care should be taken to
avoid self-injection. In case of accidental oral intake or self-injection, seek medical
advice immediately and show the package leaflet or the label to the physician but DO
NOT DRIVE as sedation and changes in blood pressure may occur.
Issued: February 2022
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Pregnant women should administer the product with special caution to avoid self-
injection since uterine contractions and decreased foetal blood pressure may occur
after accidental systemic exposure.
Avoid skin, eye or mucosal contact; the use of impermeable gloves is advisable. In
case of skin or mucosal contact, wash the exposed skin immediately after exposure
with large amounts of water and remove contaminated clothes that are in direct
contact with skin. In case of eye contact, rinse abundantly with fresh water. If
symptoms occur, seek the advice of a physician.
People with known hypersensitivity to the active substance or any of the excipients
should administer the veterinary medicinal product with caution.
Advice to physicians: dexmedetomidine is an
after absorption may involve clinical effects including dose-dependent sedation,
respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Ventricular arrhythmias have also been reported. Respiratory and haemodynamic
symptoms should be treated symptomatically. The specific α2-adrenoceptor
antagonist, atipamezole, which is approved for use in animals, has been used in
humans only experimentally to antagonise dexmedetomidine-induced effects.
effects of dexmedetomidine and therefore an appropriate dose adjustment should be
made. Anticholinergics should be used with caution with dexmedetomidine.
Administration of atipamezole after dexmedetomidine rapidly reverses the effects and
thus shortens the recovery period. Within 15 minutes dogs and cats are normally
awake and standing.
Cats: After administration of 40 micrograms dexmedetomidine/kg bw intramuscularly
concurrently with 5 mg ketamine/kg bw to cats, the maximum concentration of
dexmedetomidine increased twofold but there was no effect on Tmax. The mean half-
life of elimination of dexmedetomidine increased to 1.6 h and the total exposure
(AUC) increased by 50%.
A dose of 10 mg ketamine/kg bw used concurrently with 40 micrograms
dexmedetomidine/kg bw may cause tachycardia.
Atipamezole does not reverse the effect of ketamine.
Issued: February 2022
AN: 00961/2021Page 5 of 10
For deep sedation and analgesia with butorphanol
Dog
bodyweight
Dexmedetomidine
300 micrograms/m
intramuscularly
(kg)(mcg/kg)(mL)2-3 240.123.1-4 230.164.1-522.20.25.1-101
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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