Detomax200 mcg/2 ml

Detomax 200 mcg/2 ml Injection is a central alpha-2 adrenergic agonist indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures

Miscellaneous sedatives & hypnotics

Dexmedetomidine is a specific and selective alpha-2 adrenoceptor agonist. By binding to the presynaptic alpha-2 adrenoceptors, it inhibits the release if norepinephrine, therefore, terminate the propagation of pain signals. Activation of the postsynaptic alpha-2 adrenoceptors inhibits the sympathetic activity decreases blood pressure and heart rate.

Dilute in 0.9% Sodium Chloride Injection to concentration of 4 mcg/mL prior to administration.To be administered only by health care providers skilled in the management of patients in the operating room setting.Administer intravenously using a controlled infusion device. Administration duration should not exceed 24 hours.Continuously monitor blood pressure, heart rate, and oxygen levels during administration and as clinically appropriate after discontinuation.Initiation of Procedural Sedation: More invasive procedures or awake fiberoptic intubation: 1 mcg/kg over 10 minutes Less invasive procedures such as ophthalmic surgery: 0.5 mcg/kg over 10 minutes Maintenance of Procedural Sedation All procedures except awake fiberoptic intubation: Generally, initiate at 0.6 mcg/kg/hour and titrate to achieve desired clinical effect with dosages ranging from 0.2 to 1 mcg/kg/hour.  Awake fiberoptic intubation: Administer 0.7 mcg/kg/hour until the endotracheal tube is secured 

Dilute in 0.9% Sodium Chloride Injection to concentration of 4 mcg/mL prior to administration.To be administered only by health care providers skilled in the management of patients in the operating room setting.Administer intravenously using a controlled infusion device. Administration duration should not exceed 24 hours.Continuously monitor blood pressure, heart rate, and oxygen levels during administration and as clinically appropriate after discontinuation.Initiation of Procedural Sedation: More invasive procedures or awake fiberoptic intubation: 1 mcg/kg over 10 minutes Less invasive procedures such as ophthalmic surgery: 0.5 mcg/kg over 10 minutes Maintenance of Procedural Sedation All procedures except awake fiberoptic intubation: Generally, initiate at 0.6 mcg/kg/hour and titrate to achieve desired clinical effect with dosages ranging from 0.2 to 1 mcg/kg/hour.  Awake fiberoptic intubation: Administer 0.7 mcg/kg/hour until the endotracheal tube is secured 

Anesthetics, sedatives/hypnotics, opioids: Can potentiate sedating effects. Consider reducing dosage of dexmedetomidine HCl or co-administered drug.

None

The most common adverse reactions (incidence greater than 10%) were hypotension, respiratory depression, and bradycardia.

Pregnancy: There are no studies conducted with Detomax 200 mcg/2 ml in pregnant women to inform any drug-associated risks.Lactation: There is no information regarding the presence of Detomax 200 mcg/2 ml in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

Bradycardia and Sinus Arrest: Consider decreasing or stopping dexmedetomidine HCl infusion; decreasing or stopping other medications that depress sinus node function; administering anticholinergic agents (e.g., glycopyrrolate, atropine); and/or administering pressor agents.  Hypotension: Consider decreasing or stopping dexmedetomidine HCl infusion; increasing rate of intravenous fluid administration; elevating lower extremities, and/or administering pressor agents.Transient Hypertension: Observed primarily during administration of loading dose. Consider reducing loading infusion rate.Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy.Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events.

Geriatric patients (age greater than 65 years): Recommended loading infusion dosage for initiation of procedural sedation is 0.5 mcg/kg over 10 minutes. Consider dosage reduction for maintenanceHepatic impairment: Consider dosage reduction for initiation and maintenance of procedural sedation.

Miscellaneous sedatives & hypnotics

Dexmedetomidine is a specific and selective alpha-2 adrenoceptor agonist. By binding to the presynaptic alpha-2 adrenoceptors, it inhibits the release if norepinephrine, therefore, terminate the propagation of pain signals. Activation of the postsynaptic alpha-2 adrenoceptors inhibits the sympathetic activity decreases blood pressure and heart rate.

Pregnancy: There are no studies conducted with Detomax 200 mcg/2 ml in pregnant women to inform any drug-associated risks.Lactation: There is no information regarding the presence of Detomax 200 mcg/2 ml in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.

Geriatric patients (age greater than 65 years): Recommended loading infusion dosage for initiation of procedural sedation is 0.5 mcg/kg over 10 minutes. Consider dosage reduction for maintenanceHepatic impairment: Consider dosage reduction for initiation and maintenance of procedural sedation.