PRECEDEX™ IN 0.9% SODIUM CHLORIDE INJECTION 4MCG/ML

1 INDICATIONS AND USAGE

1.1 Intensive Care Unit Sedation

PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours.

PRECEDEX has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue PRECEDEX prior to extubation.

1.2 Procedural Sedation

PRECEDEX is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

4 CONTRAINDICATIONS

Hypersensitivity to PRECEDEX or any of the excipients.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Guidelines

• PRECEDEX dosing should be individualized and titrated to desired clinical response.
• PRECEDEX is not indicated for infusions lasting longer than 24 hours.
• PRECEDEX should be administered using a controlled infusion device.

2.2 Dosage Information

2.3 Dosage Adjustment

Due to possible pharmacodynamic interactions, a reduction in dosage of PRECEDEX or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [ see Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

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 (8.5), Clinical Pharmacology (12.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.4 Preparation of Solution

Strict aseptic technique must always be maintained during handling of PRECEDEX.

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.

PRECEDEX in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg/mL)

PRECEDEX 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 are necessary.

2.5 Administration with Other Fluids

PRECEDEX infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.

PRECEDEX has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.

PRECEDEX 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 PRECEDEX to some types of natural rubber. Although PRECEDEX is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.