Dexdor
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Dexdor is a drug used for sedation.
Release form and composition
The dosage form of Dexdor is a concentrate for the preparation of a solution for infusion: colorless, transparent (in colorless glass ampoules of 2 ml or bottles of 4 or 10 ml, in a cardboard box of 5 or 25 ampoules or 1 bottle).
Composition of 1 ml of concentrate:
- active substance: dexmedetomidine - 0.1 mg (dexmedetomidine hydrochloride - 0.118 mg);
- auxiliary components: sodium chloride - 8.83 mg; water for injection - up to 1 ml.
Indications for use
Dexdor is prescribed to adults in intensive care for sedation when the required depth of sedation does not exceed arousal in response to vocal stimulation (corresponds to a range of 0-3 on the Richmond Arousal-Sedation Scale).
Contraindications
- acute cerebrovascular pathologies;
- uncontrolled arterial hypotension;
- atrioventricular block II – III degree (in the absence of an artificial pacemaker);
- lactation period;
- age up to 18 years;
- individual intolerance to the components of the drug.
The use of Dexdor in pregnant women is possible only in cases of extreme necessity (due to the lack of data confirming the safety / efficacy of the drug).
Method of administration and dosage
Dexdor should only be used in a hospital setting.
The drug should be administered by a specialist who has experience in intensive care. Patients undergoing artificial lung ventilation can be switched to dexmedetomidine with an initial infusion rate of 0.7 μg / kg / h, followed by a gradual dose adjustment in the range of 0.2-1.4 μg / kg / h (to achieve the required depth of sedation, the dose depends on the patient's response). The initial infusion rate in debilitated patients may be reduced.
Dexdor is one of the powerful tools, therefore, the speed of its introduction is given in the calculation of hours. After adjusting the dose within one hour, the target sedation depth may not be achieved. The introduction of a saturating dose of the drug is not recommended, since this increases the frequency of adverse reactions.
After the introduction of Dexdor, before the onset of the clinical effect, the use of midazolam or propofol is permissible.
There is no experience of using the drug for more than 14 days (in such cases, it is necessary to carry out regular monitoring of the condition).
Dexdor is metabolized in the liver, and therefore, in hepatic insufficiency, it should be used with caution (a decrease in the maintenance dose is indicated).
Side effects
The most common disorders are a decrease / increase in blood pressure and bradycardia. The most serious adverse reactions are lowering blood pressure and bradycardia.
Possible side effects (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):
- digestive system: often - nausea, vomiting, xerostomia; infrequently - bloating;
- respiratory system: often - respiratory depression; infrequently - apnea, shortness of breath;
- metabolism and nutrition: often - hyperglycemia, hypoglycemia; infrequently - hypoalbuminemia, metabolic acidosis;
- cardiovascular system: very often - bradycardia, decrease / increase in blood pressure; often - myocardial infarction or ischemia, tachycardia; infrequently - decreased cardiac output, atrioventricular block I degree;
- psyche: often - agitation; infrequently - hallucinations;
- general disorders and local reactions: often - withdrawal syndrome, hyperthermia; infrequently - thirst, drug ineffectiveness.
special instructions
Dexdor is intended only for use in intensive care, it is not recommended to use it in other conditions. During the administration of the solution, continuous monitoring of cardiac activity must be carried out. In non-intubated patients, breathing should be monitored (associated with the risk of respiratory depression and, in some cases, apnea).
Dexdor should not be used to provide sedation when using muscle relaxants or as a means of inducing intubation.
The drug lowers blood pressure and heart rate, but at higher concentrations it can lead to peripheral vasoconstriction, which in turn can lead to an increase in blood pressure.
Dexdor, as a rule, does not cause deep sedation, so patients can be easily awakened. This must be taken into account in cases of intolerance to such a profile of action, in particular, if deep sedation is necessary or in severe cardiovascular diseases. Bolus administration, as well as the use of a saturating dose of the drug, is not recommended, therefore, if necessary, alternative methods of immediate control of agitation should be used.
Patients with concomitant bradycardia should be careful when administering Dexdor. Information on the use of the drug at a heart rate of <60 is limited, which requires special monitoring of the condition.
Usually, bradycardia does not require treatment, but in most cases it is well controlled by m-anticholinergics or by reducing the dose of the drug. Patients who go in for sports and have a low heart rate may be especially sensitive to the negative chronotropic effect of Dexdor (there is information about stopping the sinus node).
In patients with concomitant arterial hypotension (especially refractory to vasoconstrictors), including chronic, reduced functional reserve or hypovolemia (elderly patients and patients with severe ventricular dysfunction are at risk), the hypotensive effect of Dexdor may be more pronounced, which requires special condition monitoring. Lowering blood pressure usually does not require special measures, but if necessary, you should be ready to reduce the dose, use vasoconstrictors and / or means to replenish the circulating blood volume.
In the presence of lesions of the autonomic system (in particular, those associated with spinal cord injuries), hemodynamic effects after the administration of Dexdor may be more pronounced and require special attention.
With the introduction of a loading dose of the drug, a transient increase in blood pressure may be observed simultaneously with a peripheral vasoconstrictor effect, and therefore the use of a loading dose is not recommended.
Therapy for high blood pressure is not required in most cases, however, it may be necessary to reduce the rate of administration of the solution.
With increased concentration, focal vasoconstriction may be of greater importance in patients with coronary heart disease or severe cerebrovascular disease, therefore, such patients need close supervision.
In patients with signs of cerebral or myocardial ischemia, the likelihood of lowering the dose of Dexdor or canceling its administration should be considered.
The combined use of Dexdor with drugs with a sedative effect or drugs that affect the cardiovascular system requires caution, which is associated with a possible additive effect.
In some cases, there may be a slight awakening, when patients quickly regain consciousness after stimulation. In the absence of other clinical symptoms, this symptom in isolation should not be considered as ineffectiveness of the drug.
In severe hepatic impairment, caution must be exercised, since excessive administration of Dexdor (due to its reduced clearance) can lead to an increased risk of side effects and excessive sedation.
Most likely, Dexdor does not suppress seizure activity, therefore, it should not be used as monotherapy for status epilepticus.
The experience of using the drug in patients with such severe neurological conditions as the period after neurosurgical operations and head trauma is limited. In these cases, caution is required, especially when deep sedation is required.
It should be taken into account that Dexdor lowers intracranial pressure and cerebral blood flow.
With the appearance of agitation and an increase in blood pressure immediately after the cancellation of Dexdor, the possibility of the development of a withdrawal syndrome must be taken into account.
In patients with a tendency to develop malignant hyperthermia, the safety profile has not been studied, and therefore the use of the drug in this group of patients is not recommended. In cases of persistent unexplained fever, Dexdor should be canceled.
Drug interactions
With the combined use of Dexdor with some drugs / substances, the following effects may develop:
- drugs for anesthesia, narcotic analgesics, drugs with sedative and hypnotic effects (isoflurane, propofol, alfentanil, midazolam): enhancement of their effect (dose adjustment of Dexdor or these drugs may be required);
- drugs leading to a decrease in blood pressure and the development of bradycardia, including β-blockers: enhancement of these effects.
Analogs
There is no information on analogues.
Terms and conditions of storage
Store at temperatures up to 25 ° C. Keep out of the reach of children.
The shelf life is 3 years.
After dilution, the solution can be used within 24 hours if it is stored at a temperature of 2–8 ° C.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
