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PRECEDEX (dexmedetomidine hydrochloride injection)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
PRECEDEX Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Intensive Care Unit Sedation
PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Administration Instructions
- •
- PRECEDEX dosing should be individualized and titrated to desired clinical response.
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- ...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
PRECEDEX (dexmedetomidine hydrochloride) injection is a clear and colorless solution, to be used after dilution. It is available as:
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- 200 mcg/2 mL (100 mcg/mL) single-dose...
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Warnings and Precautions
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...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Anesthetics, Sedatives, Hypnotics, Opioids
Co-administration of PRECEDEX with anesthetics, sedatives, hypnotics, and opioids is likely to lead...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Drug Abuse and Dependence
...
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
PRECEDEX (dexmedetomidine hydrochloride) is not a controlled substance.
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Overdosage
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...
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Description
11 DESCRIPTION
PRECEDEX (dexmedetomidine hydrochloride) injection (100 mcg/mL) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. PRECEDEX (dexmedetomidine hydrochloride) in 0.9% Sodium...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
PRECEDEX is a relatively selective centrally acting alpha2-adrenergic agonist with sedative...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
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.
...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]...
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Medication Guide
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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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.