Kabimidine

Kabimidine Dosage/Direction for Use

dexmedetomidine

Manufacturer:

Gland Pharma

Distributor:

Fresenius Kabi
Full Prescribing Info
Dosage/Direction for Use
Dexmedetomidine should be administered using a controlled infusion device. Add 2 mL of the preparation to 48 mL of sterile 0.9% sodium chloride solution to obtain a total of 50 mL solution with a concentration of 4 mcg/mL of Dexmedetomidine. This solution is to be used for both initiation and maintenance of sedation. Dose reduction is necessary in patients who are elderly or with impaired hepatic or renal function. Patients receiving Dexmedetomidine have been observed to be rousable and alert when stimulated. This is an expected component of Dexmedetomidine sedation and should not be considered a lack of efficacy in the absence of other clinical signs and symptoms.
Adults: Initiation of Intensive care unit sedation: Dose of Dexmedetomidine Hydrochloride should be individualized and titrated to the desired clinical effect. For adult patients, it is recommended to initiate Dexmedetomidine hydrochloride with a loading dose of 1.0 mcg/kg over 10 minutes, followed by a maintenance infusion in the range of 0.2 to 0.7 mcg/kg/hr. The rate of the maintenance infusion can be adjusted in order to achieve the desired level of sedation. As a guide, it is recommended that 0.4 mcg/kg/hr should be the initial maintenance infusion. The dose should be titrated against the response of the patient. If after approximately 5 minutes sedation is not adequate, the rate of infusion can be increased in increments of 0.1 mcg/kg/hr or higher.
Dosage for initiation of procedural sedation: For adult patients: a loading infusion of 1 mcg/kg over 10 minutes. For less invasive procedures, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable.
For patients over 65 years of age: a loading infusion of 0.5 mcg/kg over 10 minutes.
Dosage for maintenance of procedural sedation: For adult patients: the maintenance infusion is generally initiated at 0.6 mcg/kg/hr and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hr.
For awake fiberoptic intubation patient: a maintenance infusion of 0.7 mcg/kg/hr is recommended until the endotracheal tube is secured.
Impaired Hepatic Function: Dosage reduction is needed for patients with hepatic impairment, as Dexmedetomidine Hydrochloride is metabolized primarily in the liver.
Impaired Renal Function: Dosage reduction is needed for patients with renal impairment, as the majority of metabolites are excreted in the urine.
Elderly: Dexmedetomidine should be titrated against the response of the patient. Elderly patients (over 65 years) often require lower doses of Dexmedetomidine.
Children: Safety and efficacy of Dexmedetomidine Hydrochloride has not been studied in children.
Preparation of Infusion: To prepare the infusion, withdraw 2 mL of Dexmedetomidine Hydrochloride concentrate for solution for infusion and add to 48 mL of 0.9% sodium chloride to total 50 mL. Shake gently to mix well. A controlled infusion device should be used to administer Dexmedetomidine Hydrochloride.
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