Target species
Dogs, cats and horses.
Indications for use for each target species
Dog:
As an analgesic:
- For relief of mild to moderate visceral pain.
As a sedative:
- For sedation, when used in combination with certain alpha2-adrenoceptor agonists (medetomidine).
As a premedicant prior to general anaesthesia:
- For use in combination with acepromazine to provide analgesia and sedation prior to induction of general anaesthesia. A dose-related reduction in the dose of induction-anaesthetic agent (propofol or thiopentone) is also provided.
- For premedication, give as the sole pre-anaesthetic agent.
As an anaesthetic:
- For anaesthesia, when used in combination with medetomidine and ketamine
Cat:
As an analgesic for the relief of moderate pain:
- For pre-operative use to provide analgesia during surgery.
- For post-operative analgesia after small surgical procedures.
As a sedative:
- For sedation when used in combination with certain alpha2-adrenoceptor agonists (medetomidine).
As an anaesthetic:
- For anaesthesia, when used in combination with medetomidine and ketamine, suitable for short painful anaesthetic procedures.
Horse:
As an analgesic:
- For the relief of moderate to severe abdominal pain associated with colic of gastrointestinal origin.
As a sedative:
- For sedation, given after the administration of certain alpha2-adrenoceptor agonists (detomidine, romifidine).
Contraindications
All target species:
Do not use in animals with severe dysfunction of the liver or kidneys.
Do not use in animals with cerebral injury or organic brain lesions.
Do not use in animals with obstructive respiratory disease, heart dysfunction or spastic conditions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Horse:
Butorphanol/detomidine hydrochloride combination:
Do not use in horses with a pre-existing cardiac dysrhythmia or bradycardia.
Do not use in cases of colic associated with impaction as the combination will cause a reduction in gastrointestinal motility.
Do not use in horses with emphysema due to a possible depressive effect on the respiratory system.
Do not use in pregnant mares.
Butorphanol/romifidine combination:
Do not use during the last month of pregnancy.
Special warnings
Butorphanol is intended for use where short duration analgesia (horse, dog) or short to medium duration analgesia (cat) is required (see Pharmacodynamic properties). In cases where longer duration analgesia is likely to be required, an alternative therapeutic agent should be used.
Marked sedation does not occur when butorphanol is used as a sole agent in cats.
In cats, individual response to butorphanol may be variable. In the absence of an adequate analgesic response, an alternative analgesic agent should be used.
In cats increasing of the dose will not increase intensity or duration of desired effects.
Special precautions for safe use in the target species
All target species:
Due to its antitussive properties, butorphanol may lead to an accumulation of mucous in the respiratory tract. Therefore, in animals with respiratory diseases associated with increased mucous production, butorphanol should only be used according to a benefit-risk assessment by the responsible veterinary surgeon.
Prior to use of the veterinary medicinal product in combination with α2-adrenoreceptor agonists routine cardiac auscultation should be performed and the concurrent use of anticholinergic drugs, e.g. atropine should be considered.
The combination of butorphanol and an α2-adrenoceptor agonists should be used with caution in animals with mild to moderate dysfunction of the liver or kidney.
Take care when administering butorphanol to animals concurrently treated with other central nervous depressants (see Interactions).
The safety of the veterinary medicinal product in puppies, kitten and foals has not been established and therefore in these animals the veterinary medicinal product should only be used according to a benefit-risk assessment by the responsible veterinary surgeon.
Dog:
When administering as an intravenous injection, do not inject rapidly as a bolus.
In dogs with MDR1 mutation reduce dose by 25-50%
Cat:
Use of either insulin syringes or 1 ml graduated syringes is recommended.
Horse:
The use of the veterinary medicinal product at the recommended dose may lead to transient ataxia and/or excitement. Therefore, to prevent injuries, in the patient and people when treating horses, the location for the treatment should be chosen carefully.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Butorphanol has opioid activity.
The most frequent adverse effects of butorphanol in humans are drowsiness, sweating, nausea, dizziness and vertigo and these may occur following unintended self-injection. Care should be taken to avoid accidental injection/self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Do not drive. An opioid antagonist (e.g. naloxone) may be used as an antidote.
Wash any splashes from skin and eyes immediately.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Horses:
Very common (>1 animal / 10 animals treated): | Sedationa |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site painb Ataxiac, Increased motor activityd, Shivering Restlessness, Excitatory locomotor effects (e.g. pacing)e Digestive tract hypomotilityf |
Undetermined frequency (cannot be estimated from the available data): | Cardiac depressiong Respiratory depressiong |
a Mild sedation may occur in approximately 15% of horses following administration of butorphanol as a sole agent.
b On intramuscular injection.
c Mild ataxia may persist for 3 to 10 minutes but ataxia can also last for 1 – 2 hours in some cases. Mild to severe ataxia may be encountered in combination with detomidine, but horses are unlikely to collapse. Normal precautions should be observed to prevent injury (see section 3.5).
d Can last for 1-2 hours in some cases.
e After a bolus i.v. injection at the maximum label dose (0.1 mg/kg body weight) in clinically normal horses.
f In normal horses, although there is no decrease in gastrointestinal transit time. These effects are dose-related, and generally minor and transient.
g When used in combination with alpha2-adrenoceptor agonists, cardiopulmonary system depression may be fatal in rare cases.
Dogs:
Rare (1 to 10 animals / 10,000 animals treated): | Ataxiaa Anorexiaa Diarrhoeaa |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Sedation Respiratory depressionb (e.g. decreased respiratory rate) Cardiac depressionb (e.g. bradycardiac, low blood pressured) |
Undetermined frequency (cannot be estimated from the available data): | Injection site paine Digestive tract hypomotility |
a Transient.
b The degree of depression is dose-dependent. If respiratory depression occurs, naloxone may be used as an antidote. Moderate to marked cardiopulmonary depression may occur if butorphanol is given rapidly by intravenous injection.
c When using butorphanol as a pre-anaesthetic, the use of an anticholinergic such as atropine, will protect the heart against possible narcotic-induced bradycardia.
d A decrease in diastolic pressure (see section Special precautions for use).
e On intramuscular injection.
Cats:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Respiratory depressiona Mydriasis Excitation |
Undetermined frequency (cannot be estimated from the available data): | Injection site painb Sedation, Disorientation Anxiety Dysphoria |
a Naloxone may be used as an antidote.
b On intramuscular injection.
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.
Pregnancy and lactation:
The use is not recommended during pregnancy and lactation.
See also section Contraindications.
Interactions with other medicinal products and other forms of interaction
When butorphanol is used in combination with certain α2-adrenoceptor agonists (romifidine or detomidine in horses, medetomidine in dogs and cats) synergistic effects occur requiring a butorphanol dose reduction (see Amounts to be administered and administration route).
Butorphanol is antitussive and should not be used in combination with an expectorant as it may lead to an accumulation of mucous in the airways.
Butorphanol has antagonist properties at the opiate mu (μ) receptor which may remove the analgesic effect of pure opioid mu (μ) agonists (e.g. morphine/oxymorphine) in animals that have already received these agents.
The concomitant use of other central nervous depressants would be expected to potentiate the effects of butorphanol and such drugs should be used with caution. A reduced butorphanol dose should be used when administering these agents concurrently.
Amounts to be administered and administration route
Dog and cat: Intravenous, intramuscular and subcutaneous use.
Horse: Intravenous use.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Dog: For analgesia: |
Route | Dose butorphanol | Dose product |
IV,IM or SC | 0.20-0.30 mg/kg bw | 0.02-0.03 ml/kg bw |
Comment | IV injection should be slow. Analgesic effects are seen within 15 minutes of injection. Administer 15 minutes before terminating anaesthesia to provide analgesia in the recovery phase. For continuous analgesia repeat dose as required. |
For sedation in combination with medetomidine hydrochloride: |
|
Route | Dose butorphanol | Dose product | Dose medetomidine hydrochloride |
IM or IV | 0.1 mg/kg bw | 0.01 ml/kg bw | 0.01*-0.025**mg/kg bw |
Comment | Allow 20 minutes for profound sedation to develop before commencing the procedure. Where compatibility is accepted, products containing medetomidine and butorphanol may be combined and administered in the same syringe (see Incompatibilities). |
*Depending on degree of sedation required: 0.01 mg/kg: For sedation and as a premedicant to barbiturate anaesthesia. **Depending on degree of sedation required 0.025 mg/kg: For profound sedation and as a premedicant to ketamine anaesthesia. |
For use as a premedicant/pre-anaesthetic: 1. When the veterinary medicinal product is used as the sole agent: |
Route | Dose butorphanol | Dose product |
IV, IM or SC | 0.1-0.20 mg/kg bw | 0.01-0.02 ml/kg bw |
Comment | 15 minutes prior to induction. |
2. When the veterinary medicinal product is used together with 0.02 mg/kg acepromazine: |
Route | Dose butorphanol | Dose product |
IV or IM | 0.10 mg/kg bw* | 0.01 ml/kg bw* |
Comment | Allow at least 20 minutes before the onset of action but the time between pre-medication and induction is flexible from 20-120 minutes. Where compatibility is accepted, products containing butorphanol and acepromazine may be combined and administered in the same syringe (see Incompatibilities). |
* The dose may be increased to 0.2 mg/kg (equivalent to 0.02 ml/kg) if the animal is already experiencing pain before the procedure commences or if a higher plane of analgesia is required during surgery. |
For anaesthesia in combination with medetomidine and ketamine: |
|
Route | Dose butorphanol | Dose product | Dose medetomidine | Dose ketamine |
IM | 0.10 mg/kg body weight | 0.01 ml/kg bw | 0.025mg/kg bw | 5.0mg/kg bw* |
Comment | Reversal with atipamezole is not recommended Where compatibility is accepted, products containing medetomidine and butorphanol may be combined and administered in the same syringe (see Incompatibilities). |
* Ketamine should be administered 15 minutes after the IM administration of the butorphanol/medetomidine combination. |
Cat: For pre-operative analgesia: |
Route | Dose butorphanol | Dose product |
IM or SC | 0.4 mg/kg bw | 0.04 ml/kg bw |
Comment | Administer 15-30 minutes prior to the administration of IV induction anaesthetic agents. Administer 5 minutes before induction with IM induction anaesthetic agents such as combinations of IM acepromazine/ ketamine or xylazine/ketamine. |
For post-operative analgesia: |
Route | Dose butorphanol | Dose product |
SC or IM | 0.4 mg/kg bw | 0.04 ml /kg bw |
IV | 0.1 mg/kg bw | 0.01 ml /kg bw |
Comment | Administer 15 minutes before recovery. |
For sedation in combination with medetomidine hydrochloride: |
|
Route | Dose butorphanol | Dose product | Dose medetomidine hydrochloride |
IM or SC | 0.4 mg/kg bw | 0.04 ml/kg bw | 0.05 mg/kg bw |
Comment | Local anaesthetic infiltration should be used for wound suturing. Where compatibility is accepted, products containing medetomidine and butorphanol may be combined and administered in the same syringe (see Incompatibilities). |
For anaesthesia in combination with medetomidine and ketamine: |
|
Route | Dose butorphanol | Dose product | Dose medetomidine | Dose ketamine |
IM | 0.40 mg/kg bw | 0.04 ml/kg bw | 0.08 mg/kg bw | 5.0 mg/kg bw* |
IV | 0.10 mg/kg bw | 0.01 ml/kg bw | 0.04 mg/kg bw | 1.25-2.50 mg/kg bw (depending on depth of anaesthesia required) |
Comment | Where compatibility is accepted, products containing medetomidine, butorphanol and ketamine may be combined and administered in the same syringe (see Incompatibilities). |
Horse: For analgesia: |
Route | Dose butorphanol | Dose product |
IV | 0.10 mg/kg bw | 1 ml/100 kg bw |
Comment | Analgesic effects are seen within 15 minutes of injection. Dose may be repeated as required. |
For sedation in combination with detomidine hydrochloride: |
Route | Dose of detomidine hydrochloride | Dose butorphanol* | Dose product |
IV | 0.012 mg/kg bw | 0.025 mg/kg bw | 0.25 ml/100 kg bw |
Comment | Detomidine should be administered up to 5 minutes before the butorphanol dose. |
*Clinical experience has shown that a total dose rate of 5 mg detomidine hydrochloride and 10 mg butorphanol affords effective, safe sedation in horses above 200 kg body weight. |
For sedation in combination with romifidine: |
Route | Dose of romifidine | Dose butorphanol | Dose product |
IV | 0.04-0.12 mg/kg bw | 0.02 mg/kg bw | 0.2 ml/100 kg bw |
Comment | Romifidine should be administered up to 5 minutes before the butorphanol dose. |
Before this veterinary medicinal product is combined and administered in the same syringe as another veterinary medicinal product always refer to the section on Major incompatibilities.
The maximum number of vial punctures when using needle sizes 21G and 23G should not exceed 100 and when using a 18G needle, the maximum should not exceed 40.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
The main sign of overdose is respiratory depression, which can be reversed with naloxone.
To reverse the sedative effect of butorphanol/alpha-2 adrenoceptor agonist combinations, atipamezole may be used. To reverse adverse cardiopulmonary effects of these combinations, higher atipamezole doses may be required. Atipamezole should not be used in dogs treated with a combination of butorphanol, medetomidine, and ketamine used intramuscularly to produce anaesthesia.
Other possible signs of overdose in the horse include restlessness/excitability, muscle tremor, ataxia, hypersalivation, decrease of gastrointestinal motility and seizure. In the cat, the main signs of overdose are incoordination, salivation, and mild convulsions.
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
Meat and offal: zero days.
Not authorised for use in mares producing milk for human consumption.