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PRECEDEX (dexmedetomidine hydrochloride injection)
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PRECEDEX Quick Finder
1 INDICATIONS AND USAGE
1.1 Intensive Care Unit Sedation
Precedex is indicated for sedation of initially intubated and mechanically ventilated patients during...
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Guidelines
- Precedex dosing should be individualized and titrated to desired clinical response.
- Precedex is not...
3 DOSAGE FORMS AND STRENGTHS
Precedex Injection is clear and colorless and is available as follows.
Precedex Injection
...5 WARNINGS AND PRECAUTIONS
5.1 Drug Administration
Precedex should be administered only by persons skilled in the management of patients in the intensive care or...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypotension, bradycardia and sinus arrest [see Warnings and...
7 DRUG INTERACTIONS
7.1 Anesthetics, Sedatives, Hypnotics, Opioids
Co-administration of Precedex with anesthetics, sedatives, hypnotics, and opioids is likely to lead...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
There are no adequate and well-controlled...
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Precedex (dexmedetomidine hydrochloride) is not a controlled substance.
10 OVERDOSAGE
The tolerability of Precedex was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved...
11 DESCRIPTION
Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Precedex is a relatively selective alpha2-adrenergic agonist with sedative properties....
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
14 CLINICAL STUDIES
The safety and efficacy of Precedex has been evaluated in four randomized, double-blind, placebo-controlled multicenter clinical trials in 1,185 adult patients.
...16 HOW SUPPLIED/STORAGE AND HANDLING
Precedex Injection
Precedex (dexmedetomidine hydrochloride) injection 200 mcg/2 mL (100 mcg/mL) is...
17 PATIENT COUNSELING INFORMATION
Precedex is indicated for short-term intravenous sedation. Dosage must be individualized and titrated to the desired clinical effect. Blood pressure, heart rate and oxygen levels will be...
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