Source: FDA, National Drug Code (US) Revision Year: 2020
Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)4(S)[1(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Precedex has a molecular weight of 236.7 and the empirical formula is C13H16N2∙HCl and the structural formula is:
Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89.
Precedex Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride equivalent to 100 mcg (0.1 mg) of dexmedetomidine and 9 mg of sodium chloride in water and is to be used after dilution. The solution is preservative-free and contains no additives or chemical stabilizers.
Precedex in 0.9% Sodium Chloride Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 8.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. The solution is preservative-free and contains no additives or chemical stabilizers.
| Dosage Forms and Strengths |
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Precedex Injection is clear and colorless and is available as follows. Precedex InjectionPrecedex Injection, 200 mcg dexmedetomidine/2 mL (100 mcg/mL) in a glass vial. To be used after dilution. Precedex in 0.9% Sodium Chloride InjectionPrecedex Injection, 80 mcg dexmedetomidine/20 mL (4 mcg/mL) in a glass vial. Ready to use. Precedex Injection, 200 mcg dexmedetomidine/50 mL (4 mcg/mL) in a glass bottle. Ready to use. Precedex Injection, 400 mcg dexmedetomidine/100 mL (4 mcg/mL) in a glass bottle. Ready to use. Precedex Injection, 1,000 mcg dexmedetomidine/250 mL (4 mcg/mL) in a glass bottle. Ready to use. |
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Precedex InjectionPrecedex (dexmedetomidine hydrochloride) injection 200 mcg/2 mL (100 mcg/mL) is clear and colorless, and available in 2 mL clear glass vials. The strength is based on the dexmedetomidine base. Vials are intended for single-dose only. Discard unused portion.
Precedex in 0.9% Sodium Chloride InjectionPrecedex (dexmedetomidine hydrochloride in 0.9% Sodium Chloride) injection is clear and colorless, and available as 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) in 20 mL clear glass vials, 50 mL, 100 mL, 250 mL clear glass bottles, respectively. The strength is based on the dexmedetomidine base. Containers are intended for single-dose only. Discard unused portion.
Distributed by: Hospira, Inc., Lake Forest, IL 60045 |
| Drug | Countries | |
|---|---|---|
| PRECEDEX | Brazil, Canada, Ecuador, Hong Kong, Japan, Mexico, New Zealand, Singapore, United States, South Africa |
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