Dexdomitor 0.5 mg / ml (Dexdomitor 0.5), 10 ml
Solution for injection is transparent, colorless.
Structure
- dexmedetomidine hydrochloride – 0.5 mg, which corresponds to the content of dexmedetomidine – 0.42 mg.
Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium chloride, water d / i.
Pharmacological (biological) properties and effects
Dexmedetomidine, which is part of the drug Dexdomitor®, is a potent selective alpha2-adrenergic agonist, the main effect of which is to inhibit the transmission of nerve impulses in adrenergic synapses by competing with norepinephrine. Under the action of the drug in animals, depression of the central nervous system develops, the pain threshold rises. The action of dexmedetomidine is dose dependent: small doses have moderate sedation without analgesia, while high doses cause significant sedation and analgesia.
Dexmedetomidine is well absorbed after injection, quickly distributed in the body and easily overcomes the BBB. The concentration of the drug in the blood reaches a maximum after 15-30 minutes. More than 90% of the drug binds to blood plasma proteins. The half-life in dogs is 40-50 minutes, in cats – 60 minutes. Dexmedetomidine is metabolized in the liver and excreted mainly by the kidneys.
According to the degree of exposure to the body, dexmedetomidine is classified as a highly hazardous substance (hazard class 2).
Indications for use
- to obtain sedation and analgesia in dogs and cats during surgical operations, various clinical studies;
- to prevent the aggressiveness of animals.
It is recommended to use the premedication medication under general anesthesia.
Application procedure
Dexdomitor® is administered intravenously or intramuscularly to dogs, intramuscularly to cats.
The dose of the drug is selected depending on the desired effect, individual characteristics and breed of animal. High doses cause pronounced sedation and analgesia, low doses only have a sedative effect. Small breed dogs require a higher dose of the drug than large dogs.
The use of dexmedetomidine as a sedative in dogs and cats significantly reduces the amount of drug needed to induce anesthesia, so intravenous anesthetics should be administered with caution and the animal’s condition should be closely monitored.
The amount of inhaled anesthetics to maintain anesthesia is also reduced.
To achieve sedation and analgesia, Dexdomitor® containing 0.1 mg / ml dexmedetomidine is used in the following doses: for dogs – 0.5-2 ml / 10 kg of body weight; cats – 0.5 ml / kg body weight; Dexdomitor® containing 0.5 mg / ml dexmedetomidine in the following doses: for dogs – 0.1-0.8 ml / 10 kg body weight; cats – 0.1 ml / kg body weight.
Doses of dexmedetomidine in dogs are calculated per unit of body surface area (μg / m2): i / v – up to 375 μg / m2 of body surface area; i / m – up to 500 μg / m2 of body surface area.
When administered together with butorphanol (0.1 mg / kg) for deep sedation and analgesia, the dose of dexmedetomidine for intramuscular administration is 300 μg / m2 of body surface area. The dose of dexmedetomidine as a drug for premedication is 125-375 μg / m2 body surface area, it is administered 20 minutes before induction for procedures requiring anesthesia. The dose should be adjusted depending on the type of surgery, the duration of the procedure, and the temperament of the animal.
The combined use of dexmedetomidine and butorphanol causes a sedative and analgesic effect, starting no later than 15 minutes after administration, and reaching a maximum within 30 minutes after administration. The sedative effect lasts for at least 120 minutes after administration, the analgesic effect lasts for at least 90 minutes. Full recovery of consciousness occurs within 3 hours.
Premedication with dexmedetomidine significantly reduces the dose of inducing agent needed and reduces the amount of inhaled anesthetic to maintain anesthesia. To achieve anesthesia, together with propofol and thiopental, their doses are reduced by 30% and 60%, respectively. Dexmedetomidine helps to achieve postoperative analgesia within 0.5-4 hours, but this period depends on a number of factors, and the next dose of analgesics should be administered according to clinical judgment.
Doses based on dog weight are shown in the following tables.
The use of a calibrated syringe is recommended to ensure accurate dosing for small volumes.
Doses of the drug Dexdomitor® containing 0.1 mg / ml dexmedetomidine for premedication in dogs
Dog weight (kg) | dexmedetomidine 125 mcg / m2 | dexmedetomidine 375 mcg / m2 | dexmedetomidine 500 mcg / m2 | |||
(μg / kg) | (ml) | (μg / kg) | (ml) | (μg / kg) | (ml) | |
2-3 | 9.4 | 0.2 | 28.1 | 0.6 | 40 | 0.75 |
3-4 | 8.3 | 0.25 | 25 | 0.85 | 35 | one |
4-5 | 7.7 | 0.35 | 23 | one | thirty | 1.5 |
5-10 | 6.5 | 0.5 | 19.6 | 1.45 | 25 | 2 |
10-13 | 5.6 | 0.65 | 16.8 | 1.9 | ||
13-15 | 5.2 | 0.75 | ||||
15-20 | 4.9 | 0.85 |
Doses of the drug Dexdomitor® with a dexmedetomidine content of 0.5 mg / ml for premedication in dogs
Dog weight (kg) | dexmedetomidine 125 mcg / m2 | dexmedetomidine 375 mcg / m2 | dexmedetomidine 500 mcg / m2 | |||
(μg / kg) | (ml) | (μg / kg) | (ml) | (μg / 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 | thirty | 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 | twenty | 0.7 |
20-25 | 4.5 | 0.2 | 13.4 | 0.6 | eighteen | 0.8 |
25-30 | 4.2 | 0.23 | 12.6 | 0.69 | 17 | 0.9 |
30-33 | four | 0.25 | 12 | 0.75 | sixteen | 1.0 |
33-37 | 3.9 | 0.27 | 11.6 | 0.81 | fifteen | 1.1 |
37-45 | 3.7 | 0.3 | eleven | 0.9 | 14.5 | 1.2 |
45-50 | 3.5 | 0.33 | 10.5 | 0.99 | fourteen | 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 |
Doses of the drug Dexdomitor® for deep sedation and analgesia with butorphanol in dogs
Dog weight (kg) | Dexmedetomidine 300 mcg / m2 IM | ||
dexmedetomidine (mcg / kg) | Dexdomitor® 0.1 mg / ml (ml) | Dexdomitor® 0.5 mg / ml (ml) | |
2-3 | 24 | 0.6 | 0.12 |
3-4 | 23 | 0.8 | 0.16 |
4-5 | 22.2 | one | 0.2 |
5-10 | 16.7 | 1.25 | 0.25 |
10-13 | 13 | 1.5 | 0.3 |
13-15 | 12.5 | 1.75 | 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 | one | |
70-80 | 7.3 | 1.1 | |
>80 | 7 | 1.2 |
Doses of dexmedetomidine for cats are calculated in μg per kg of animal weight.
When using Dexdomitor® for non-invasive interventions, operations that cause mild to moderate pain, as well as procedures and examinations that require retention, sedation and pain relief, the dose for cats is 40 μg dexmedetomidine per kg of body weight, which is equivalent to 0.4 ml of Dexdomitor® with a dexmedetomidine content of 0.1 mg / ml per kg of body weight or 0.08 ml of Dexdomitor® with a dexmedetomidine content of 0.5 mg / ml per kg of animal weight.
The use of the drug Dexdomitor® for anesthesia in conjunction with propofol reduces the dose of the latter by 50%. All anesthetics used to induce or maintain anesthesia should be administered in the amount necessary to achieve an effect.
Anesthesia can be induced 10 minutes after intramuscular administration of ketamine to cats at a dose of 5 mg / kg or intravenous administration of propofol.
Cat weight (kg) | Dexmedetomidine 40 μg / kg IM | ||
dexmedetomidine (mcg / kg) | Dexdomitor® containing 0.1 mg / ml dexmedetomidine, ml | Dexdomitor® with a dexmedetomidine content of 0.5 mg / ml, ml | |
1-2 | 40 | 0.5 | 0.1 |
2-3 | 40 | one | 0.2 |
3-4 | 40 | 1.5 | 0.3 |
4-6 | 40 | 2 | 0.4 |
6-7 | 40 | 2.5 | 0.5 |
7-8 | 40 | 3 | 0.6 |
8-10 | 40 | 3.5 | 0.7 |
The planned sedative and analgesic effect is achieved within 15 minutes after administration and is maintained for 60 minutes after administration of the drug. To maintain a sedative and analgesic effect, the drug can be re-administered 10-15 minutes after the first injection. The dose of repeated administration is determined by the veterinarian, depending on the condition of the animal.
If necessary, sedation can be reversed with Antisedan®.
A suitable lubricant should be used to prevent dry eyes.
After using the drug, animals should be kept warm and at a constant temperature, both during the procedure and during the recovery of consciousness.
It is recommended not to give the animals food for 12 hours before the administration of Dexdomitor®, water intake is not limited.
After administration of the drug, the animal should not be given water or food until the ability to swallow is restored.
Nervous, aggressive or agitated animals should be allowed to calm down before administration of the drug.
Respiratory and cardiac activity should be monitored regularly. Pulse oximetry can be useful, but not essential for adequate monitoring. When dexmedetomidine and ketamine are used sequentially to induce anesthesia in cats, manual ventilation equipment should be available in the event of respiratory depression or apnea. It is also recommended to have oxygen available in case of suspicion or detection of hypoxemia.
Sick and debilitated animals should be premedicated with Dexdomitor® prior to induction and maintenance of general anesthesia only on the basis of an assessment of the risk-benefit ratio.
Avoid violation of the dosage regimen
Side effects
Immediately after the administration of the drug, a decrease in blood pressure is possible, which is then restored to normal values or values slightly below normal. In dogs, and especially in cats, vomiting is possible in the first minutes after the injection of Dexdomitor®.
With the introduction of the drug Dexdomitor®, a decrease in heart rate and respiratory movements, hypothermia is possible. Blood pressure first rises and then returns to normal or falls below normal.
Vomiting may occur 5-10 minutes after administration. In some dogs and cats, vomiting may occur when consciousness regains consciousness.
Sometimes pallor and / or cyanosis of the mucous membranes develops. Drying of the mucous membranes of the eyes and cornea is often possible in cats.
During sedation, muscle tremor may occur, in rare cases – corneal opacity, pulmonary edema.
When using the drug Dexdomitor® as a means of premedication in dogs, bradypnea, tachypnea, and vomiting are possible. Bradyarrhythmias and tachyarrhythmias may also occur, including deep sinus bradycardia, AV block (grade I and II), and sinus arrest. In rare cases, there are premature supraventricular and ventricular extrasystoles, pause of the sinus node and AV block of the III degree.
When using the drug Dexdomitor® as a means of premedication in cats, vomiting, urge to vomit, pallor of the mucous membranes and low body temperature are possible. When administered intramuscularly at a dose of 40 μg / kg (followed by administration of ketamine or propofol), sinus bradycardia and sinus arrhythmia often occurred, sometimes I degree AV block and rarely premature supraventricular depolarization, atrial bigeminia, sinus pause, AV block II degree or delayed ventricular contractions.
With the simultaneous administration of ketamine at a dose of 10 mg / kg to cats and dexmedetomidine at a dose of 40 μg / kg, tachycardia may develop.
With the sequential use of the drug Dexdomitor® and ketamine with an interval of 10 minutes in cats, sometimes AV-blockade or extrasystole may occur. The expected phenomena are infrequent breathing, intermittent breathing, hypoventilation, apnea. Hypoxemia is noted, especially in the first 15 minutes of dexmedetomidine-ketamine anesthesia. After such procedures, vomiting, a decrease in body temperature and nervousness were observed.
With the simultaneous use of the drug Dexdomitor® and butorphanol, dogs may experience rare breathing, rapid breathing, irregular breathing (apnea for 20-30 seconds followed by several quick breaths), hypoxemia, muscle cramps or tremors, floundering, agitation, increased salivation, urging vomiting, vomiting, urination, cutaneous erythema, sudden awakening or prolonged sedation. Bradyarrhythmias and tachyarrhythmias are possible, which may include sinus bradycardia, grade I and II AV block, sinus node arrest or pause, and premature atrial, supraventricular, and ventricular premature beats.
Overdose
Overdose of the drug can lead to a delay in awakening after anesthesia and sedation. In some cases, depression of blood circulation and respiration is possible. In case of an overdose or if the effect of Dexdomitor® becomes potentially life-threatening for the animal, an appropriate dose of Antisedan® must be administered.
Antisedan® is administered intramuscularly once.
For dogs, the dose of Antisedan® in ml is equal to 1/5 of the dose of Dexdomitor® with a dexmedetomidine content of 0.1 mg / ml and a dose of Dexdomitor® with a dexmedetomidine content of 0.5 mg / ml.
For cats, the dose of Antisedan® in ml is equal to 1/10 of the dose of Dexdomitor® with a dexmedetomidine content of 0.1 mg / ml and half the dose of Dexdomitor® with a dexmedetomidine content of 0.5 mg / ml.
In case of continued depression in the animal, Antisedan® can be injected again after 10-15 minutes.
Contraindications for use
- severe systemic diseases;
- heart failure;
- impaired liver or kidney function;
- pregnancy and lactation;
- the age of the dogs is less than 4 months;
- cats are younger than 3 months old;
- increased individual sensitivity to the components of the drug.
Special instructions and measures for personal prevention
The safety of Dexdomitor® for pregnant and lactating animals has not been established, therefore it is not recommended to use the drug in pregnant and lactating animals.
Dexdomitor® potentiates the effect of drugs that depress the central nervous system: tranquilizers, sedatives, drugs for general anesthesia. Therefore, it is necessary to adjust the dose accordingly.
Dexdomitor® is not intended for use in productive animals.
Personal prevention measures
When working with Dexdomitor®, you should follow the general rules of personal hygiene and safety measures provided for when working with medicines. At the end of work, you should thoroughly wash your hands with warm water and soap.
In case of accidental contact of the drug with the skin or mucous membranes of the eyes, they should be rinsed with plenty of water. People with hypersensitivity to the components of Dexdomitor® should avoid direct contact with the drug. In case of allergic reactions or accidental ingestion of the drug into the human body, you should immediately contact a medical institution (you should have instructions for use or a label with you), you should not drive a car.
Empty vials from under the medicinal product must not be used for domestic purposes, they must be disposed of with household waste.
Storage conditions
The drug should be stored in the manufacturer’s sealed packaging in a dry place, protected from direct sunlight, out of reach of children, separately from food and feed, at a temperature of 2 ° C to 25 ° C.
Dispose of unused product in accordance with legal requirements.
Packaging
Packaged in 10 ml glass bottles, sealed with rubber stoppers, reinforced with aluminum caps, equipped with plastic caps for the first opening control. Vials are packed in individual cardboard boxes complete with instructions for use.
Shelf life
The shelf life under the storage conditions is 3 years from the date of production, after the first opening of the bottle – 28 days, after mixing in one syringe with ketamine and / or butorphanol – no more than 2 hours. Do not use Dexdomitor® after the expiration date.