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DETOGESIC 10 mg/ml Solution for Injection for Horses
- Contains detomidine hydrochloride, an alpha-2 agonist that leads to predictable sedation of treated animals and relieves pain, with duration and intensity of effect being dose related.
- For use alone, or in combination with butorphanol for profound sedation. In some European countries also licensed for use with Ketaset for short acting anaesthesia.
- Reversible with alpha-2 antagonist
Description
Detogesic is a clear, almost colourless solution that contains by ml:
| Active substance: | |
|---|---|
| Detomidine hydrochloride | 10 mg |
| Excipient: | |
| Methyl parahydroxybenzoate (E218) | 1 mg |
Detomidine acts on peripheral alpha-adrenoceptors, therefore an increase in blood glucose level. An initial increase in mean blood pressure is observed, which returns to normal or slightly below and heart rate decreases. The ECG shows an enlarged PR-interval, and mild atrio-ventricular blocks may be observed. These changes are transient. Respiratory response includes an initial decrease in respiration rate, increasing to normal or slightly higher values within a few minutes.
Detomidine is absorbed rapidly after intramuscular injection, with a Tmax of 15-30 minutes. Bioavailability after intramuscular administration is 66-85 %. After rapid distribution of detomidine into the tissues, with a half life of 0.15 hours post intravenous injection, detomidine is almost completely metabolized, mainly in the liver - t½ is 1 to 2 hours. The volume of distribution ranges from 0.75 to 1.89 l/kg, and protein binding is 75-85 %. The elimination half life in the horse was 1.19 hours, with less than 1% parent compound present in urine. Metabolites are mainly excreted via urine and faeces.
INDICATIONS
For the sedation and analgesia of horses to facilitate physical examinations and treatments,
such as minor surgical interventions.
The product can be used for:
- Examinations (e.g. endoscopic, rectal and gynaecological examinations, X-rays).
- Minor surgical procedures (e.g. treatment of wounds, dental treatment, tendon treatment, excision of skin tumours, teat treatment).
- Before treatment and medication (e.g. stomach tube, horse shoeing).
CONTRAINDICATIONS
Do not use in animals with cardiac abnormalities or respiratory disease.
Do not use in animals with liver insufficiency or renal failure
Do not use in animals with general health problems (e. g. dehydrated animals).
Do not use in mares in the last 3 months of pregnancy. During the remaining months, use only
according to a risk/benefit analysis by the responsible veterinary surgeon. Use during lactation
should also be the subject of risk/benefit analysis by the responsible veterinary surgeon.
Do not use in combination with butorphanol in horses suffering from colic.
Do not use in combination with butorphanol in pregnant mares.
ADVERSE REACTIONS
Injection of detomidine may cause the following side effects:
- Bradycardia.
- Transient hypo- or hypertension.
- Respiratory depression, rarely hyperventilation.
- Increase in blood glucose.
- As with other sedatives, in rare cases paradoxical reactions (excitations) can develop.
- Ataxia.
- Cardiac arrhythmia, atrioventricular and sino-atrial block.
At doses above 40 mcg/kg bodyweight, the following symptoms can also be observed:
sweating, pilo-erection and tremor of muscles, transient penis prolapse in stallions and
geldings.
In very rare cases horses may show mild symptoms of colic following administration of
alpha-2 sympathomimetics because substances of this class transiently inhibit the motility of
the intestines. The product should be prescribed with caution in horses which present with
signs of colic or impaction.
A diuretic effect is usually observed within 45 to 60 minutes after treatment.
TARGET SPECIES
Horse
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
For intravenous (IV) use only. The product should be injected slowly. Onset of effect is more
rapid following intravenous use.
Amount(s) to be administered
Use alone for sedation: dosage table
| Dosage in mcg/kg | Dosage in ml/100 kg | Level of sedation | Commencement of effect (min) | Duration of effect(hrs) |
| 10-20 | 0.1-0.2 | Light | 3-5 | 0.5-1 |
| 20-40 | 0.2-0.4 | Moderate | 3-5 | 0.5-1 |
For combination with other products to intensify sedation or for premedication prior to general anaesthesia, doses of 10 to 30 mcg/kg can be used. Prior to use in combination with other products such as butorphanol or ketamine, consult the appropriate product details for dose rates Allow 5 minutes after the administration of detomidine for the horse to become deeply sedated before any subsequent treatment.
The bodyweight of the animal to be treated should be determined as accurately as possible to avoid overdosing.
Overdose:
In the event of an accidental overdose, cardiac arrhythmias, hypotension, delayed recovery
and profound CNS and respiratory depression may occur. Should the effects of detomidine
become life-threatening, administration of an alpha-2-adrenergic antagonist is recommended.
WITHDRAWAL PERIOD
Meat and offal: 2 days
Milk: 12 hours
SHELF LIFE
Shelf-life of the veterinary medicinal product as packaged for sale: 36 months.
Shelf life after first opening the immediate packaging: 28 days.
SPECIAL STORAGE PRECAUTIONS
Do not store above 25ºC.
Store in the original carton in order to protect from light.
Store in a dry place.
SPECIAL WARNINGS
Special precautions for use in animals
As sedation begins, horses may start to sway and lower the head rapidly while they remain
standing. To prevent injuries in horse and people while treating horses, the location for
treatment should be chosen carefully. Usual precautionary measures should be taken to
prevent self-injury.
Animals suffering from shock or liver or kidney disease should only be treated according to
the benefit/risk assessment by the responsible veterinary surgeon. The product should not be
used in animals suffering from cardiac diseases (with pre-existing bradycardia and risk of
atrioventricular block), respiratory, liver or renal insufficiencies or any other extraordinary
stress conditions.
It is recommended that feed should be withheld for at least 12 hours prior to anaesthesia.
Water or food should not be offered to treated animals until the drug effect has passed.
In painful procedures detomidine should be used only in combination with an analgesic or a
local anaesthetic.
While waiting for the onset of sedation, animals should remain in calm surroundings.
Detomidine/butorphanol combinations should not be used in horses with a history of liver
disease or cardiac irregularities.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
This product should be administered with caution, and care taken to avoid accidental selfinjection.
In the event 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.
Avoid skin, eye or mucosal contact.
Wash exposed skin immediately after exposure with large amounts of water.
Remove contaminated clothes that are in direct contact with skin.
In the event of accidental contact of the product with the eyes, rinse abundantly with fresh
water. If symptoms occur, seek the advice of a physician.
The product should not be handled or administered by pregnant women, as uterine
contractions and decreased foetal blood pressure may occur after accidental systemic
exposure.
Any unused veterinary medicinal product or waste materials derived from such veterinary
medicinal products should be disposed of in accordance with local requirements.
Advice to doctors:
Detomidine is an alpha-2-adrenoreceptor agonist; symptoms after absorption may involve
clinical effects including dose-dependent sedation, respiratory depression, loss of
consciousness, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular
arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be
treated symptomatically.
Interaction with other medicinal products and other forms of interaction
Concurrent use of other sedatives should proceed only after consultation of the warnings and
precautions for the product(s) concerned.
Detomidine should not be used in combination with sympathomimetic amines such as
adrenaline, dobutamine and ephedrine, except as required in anaesthetic emergencies.
The concurrent use of certain potentiated sulphonamides may cause cardiac arrhythmia with
fatal outcome. Do not use in combination with sulphonamides.
Detomidine in combination with other sedatives and anaesthetics should be used carefully
because additive/synergistic effects may be possible. Where anaesthesia is induced with a
combination of detomidine and ketamine, prior to maintenance with halothane, the effects of
halothane may be delayed and care must be taken to avoid overdosage. When detomidine is
used as a premedicant prior to general anaesthesia, it may delay the onset of induction.
OTHER INFORMATION
ATCv code: QN05 CM90
Nature and composition of immediate packaging
Multidose, type I, clear glass container with pierceable red bromobutyl rubber bung,
containing 10ml.
