Dexmedetomidine Hydrochloride in Sodium Chloride

2. DOSAGE AND ADMINISTRATION Individualize and titrate dexmedetomidine HCl in 0.9% sodium chloride injection dosing to desired clinical effect. ( 2.1 ) Administer dexmedetomidine HCl in 0.9% sodium chloride injection using a controlled infusion device. ( 2.1 ) The 80 mcg/20 mL single-dose vial, 200 mcg/50 mL, and 400 mcg/100 mL single-dose bottles do not require further dilution prior to administration. ( 2.4 ) For Adult Intensive Care Unit Sedation: Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion of 0.2 to 0.7 mcg/kg/ hour . ( 2.2 ) For Adult Procedural Sedation: Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion initiated at 0.6 mcg/kg/ hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/ hour . ( 2.2 ) Alternative Doses: Recommended for patients over 65 years of age and awake fiberoptic intubation patients. ( 2.2 ) 2.1. Administration Instructions Dexmedetomidine HCl in 0.9% sodium chloride injection dosing should be individualized and titrated to desired clinical response. Dexmedetomidine HCl in 0.9% sodium chloride injection is not indicated for infusions lasting longer than 24 hours. Dexmedetomidine HCl in 0.9% sodium chloride injection should be administered using a controlled infusion device. 2.2. Recommended Dosage Table 1 Recommended Dosage in Adult Patients INDICATION DOSAGE AND ADMINISTRATION Initiation of Intensive Care Unit Sedation For adult patients: a loading infusion of one mcg/kg over 10 minutes . For adult patients being converted from alternate sedative therapy: a loading dose may not be required. For patients over 65 years of age: Consider a dose reduction [ see Use in Specific Populations (8.5) ]. For adult patients with impaired hepatic function: Consider a dose reduction [ see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ]. Maintenance of Intensive Care Unit Sedation For adult patients: a maintenance infusion of 0.2 to 0.7 mcg/kg/ hour . The rate of the maintenance infusion should be adjusted to achieve the desired level of sedation. For patients over 65 years of age: Consider a dose reduction [ see Use in Specific Populations (8.5) ]. For adult patients with impaired hepatic function: Consider a dose reduction [ see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ]. Initiation of Procedural Sedation For adult patients: a loading infusion of one mcg/kg over 10 minutes . For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable. For awake fiberoptic intubation in adult patients: a loading infusion of one mcg/kg over 10 minutes . For patients over 65 years of age: a loading infusion of 0.5 mcg/kg over 10 minutes [ see Use in Specific Populations (8.5) ]. For adult patients with impaired hepatic function: consider a dose reduction [ see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ]. Maintenance of Procedural Sedation For adult patients: the maintenance infusion is generally initiated at 0.6 mcg/kg/ hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/ hour . Adjust the rate of the maintenance infusion to achieve the targeted level of sedation. For awake fiberoptic intubation in adult patients: a maintenance infusion of 0.7 mcg/kg/ hour is recommended until the endotracheal tube is secured. For patients over 65 years of age: Consider a dose reduction [ see Use in Specific Populations (8.5) ]. For adult patients with impaired hepatic function: Consider a dose reduction [ see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ]. Pediatric use information is approved for Hospira Inc.'s PRECEDEX™ (dexmedetomidine hydrochloride) injection and PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. 2.3. Dosage Adjustment Due to possible pharmacodynamic interactions, a reduction in dosage of dexmedetomidine HCl in 0.9% sodium chloride injection or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [ see Drug Interactions (7.1) ]. Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients [ see Warnings and Precautions (5.8) , Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ]. 2.4. Preparation of Solution Strict aseptic technique must always be maintained during handling of dexmedetomidine HCl in 0.9% sodium chloride injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine HCl in 0.9% sodium chloride injection, 80 mcg/20 mL (4 mcg/mL), 200 mcg/50 mL (4 mcg/mL), and 400 mcg/100 mL (4 mcg/mL) Dexmedetomidine HCl in 0.9% sodium chloride injection is supplied in glass containers containing a premixed, ready to use dexmedetomidine hydrochloride solution in 0.9% sodium chloride in water. No further dilution of these preparations is necessary. 2.5. Administration with Other Fluids Dexmedetomidine HCl in 0.9% sodium chloride injection infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established. Dexmedetomidine HCl in 0.9% sodium chloride injection has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam. Dexmedetomidine HCl in 0.9% sodium chloride injection has been shown to be compatible when administered with the following intravenous fluids: 0.9% sodium chloride in water 5% dextrose in water 20% mannitol Lactated Ringer's solution 100 mg/mL magnesium sulfate solution 0.3% potassium chloride solution 2.6. Compatibility with Natural Rubber Compatibility studies have demonstrated the potential for absorption of dexmedetomidine HCl in 0.9% sodium chloride injection to some types of natural rubber. Although dexmedetomidine HCl in 0.9% sodium chloride injection is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.

See official label

1.