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 Injection, 200 mcg/2 mL (100 mcg/mL)
PRECEDEX must be diluted with 0.9% sodium chloride injection to achieve required concentration (4 mcg/mL) prior to administration. Preparation of solutions is the same, whether for the loading dose or maintenance infusion.
To prepare the infusion, withdraw 2 mL of PRECEDEX Injection, and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.
PRECEDEX in 0.9% Sodium Chloride Injection, 80 mcg/20 mL (4 mcg/mL), 200 mcg/50 mL (4 mcg/mL), 400 mcg/100 mL (4 mcg/mL), and 1,000 mcg/250 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 is 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:
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- 0.9% sodium chloride in water
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- 5% dextrose in water
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- 20% mannitol
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- Lactated Ringer's solution
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- 100 mg/mL magnesium sulfate solution
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- 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.