Medicinal Products

DEXDOR 100 micrograms / mL

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Dexmedetomidine
laboratory: Orion Corporation

Solution for solution for IV infusion
Ampoules of 2 ml
All forms

Indication

ICU (Intensive Care Unit) sedation in adults requiring a state of sedation no deeper than that allowing a response to a verbal stimulus (corresponding to a score of 0-3 on the Richmond Vigilance-Agitation Scale ( RASS)).

Dosage DEXDOR 100 micrograms / mL Concentrate for solution for infusion IV Ampoules of 2 ml

Medication reserved for hospital use. Dexdor should be administered by healthcare professionals who are able to take care of patients in intensive care.

Dosage


Patients already intubated and sedated can be perfused with dexmedetomidine at an initial dose of 0.7 micrograms / kg / h, which can be adjusted in increments of 0.2 to 1.4 micrograms / kg / h to desired sedation, depending on the patient's response. Lower initial dose infusion may be considered for fragile patients. Dexmedetomidine has a powerful effect and the infusion rate is given per hour. After dose adjustment, a new stable level of sedation may not be reached within one hour.

The maximum dose of 1.4 micrograms / kg / h should not be exceeded. In patients who do not reach the appropriate sedation level with the maximum dose of Dexdor, an alternative sedative agent should be used.

The use of a loading dose of Dexdor is not recommended and is associated with an increase in adverse effects. Propofol or midazolam may be given if necessary until the effects of Dexdor appear.

Dexdor usage data is limited to 14 days. The use of Dexdor over a longer period should be re-evaluated regularly.

Population at risk


Elderly: No dose adjustment is necessary in the elderly.

Renal Impairment: No dose adjustment is necessary in patients with renal impairment.

Hepatic impairment: Dexdor is metabolized in the liver and should be used with caution in patients with hepatic impairment. A reduced maintenance dose may be considered (see Warnings and Precautions and Pharmacokinetic Properties section ).

Pediatric population: The safety and efficacy of Dexdor in children aged 0 to 18 years have not been demonstrated. Currently available data are described under Adverse Reactions, Pharmacodynamic Properties and Pharmacokinetic Properties, but no dosage recommendation can be given.

Administration mode

Dexdor should only be administered as a diluted solution by intravenous infusion using a monitored infusion set. For instructions on drug dilution before administration, see section Instructions for use, handling and disposal .

Against indications

Hypersensitivity to the active substance or to any of the excipients. Advanced heart block (level 2 or 3) unless pacemaker. Non-controlled hypotension. Acute cerebrovascular diseases.

Dexdor side effects

Summary of the security profile.

The most common adverse reactions reported with dexmedetomidine are hypotension, hypertension and bradycardia, occurring in approximately 25%, 15% and 13% of patients respectively.

Hypotension and bradycardia were also the most common serious dexmedetomidine-related adverse events occurring in 1.7% and 0.9% of randomized Intensive Care Unit (ICU) patients, respectively.

Summary of adverse effects

The adverse events listed in Table 1 were pooled from data from ICU clinical trials of 3, 137 randomized patients (1, 879 treated with dexmedetomidine, 864 treated with active comparators and 394 treated with placebo).

Adverse reactions are ranked in frequency order, the most common first, according to the following convention: very common (≥ 1/10), common (≥1 / 100, <1/10), uncommon (≥1 / 1) 000, <1/100), rare (≥1 / 10, 000, <1/1000), very rare (<1 / 10, 000).

Table 1: Undesirable effects

Metabolism and nutrition disorders

Frequent

Hyperglycemia, hypoglycemia

Rare :

Metabolic acidosis, hypoalbuminemia

Psychiatric disorders

Frequent

agitation

Rare :

Hallucination

Heart conditions

Very common :

bradycardia *

Frequent

Myocardial ischemia or infarction, tachycardia

Rare :

First-degree atrioventricular block, decreased cardiac output

Vascular disorders

Very common :

Hypotension *, hypertension *

Respiratory, thoracic and mediastinal disorders

Rare :

Dyspnea

Gastrointestinal disorders

Frequent

Nausea, vomiting, dry mouth

Rare :

Abdominal distention

General disorders and administration site conditions

Frequent

Withdrawal syndrome, hyperthermia

Rare :

Inefficient drug, thirst

* See section Description of selected adverse reactions

Description of selected adverse reactions

Clinically significant hypotension or bradycardia should be managed as described in the Warnings and Precautions for Use section .

In the relatively healthy non-ICU subjects treated with dexmedetomidine, bradycardia occasionally resulted in sinus arrest or pause. The symptoms responded to leg elevation and anticholinergics such as atropine or glycopyrrolate. In isolated cases, bradycardia has been transformed into periods of asystole in patients with a history of bradycardia.

Hypertension has been associated with the use of a loading dose and this reaction can be reduced by avoiding this loading dose or by reducing the rate of infusion or the amount of the loading dose.

Pediatric population

Child experience is limited, most data was obtained from short-term exposures. Only one case of hypothermic bradycardia in a newborn has been described in the literature.

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