HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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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 patients during...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Guidelines
- Precedex dosing should be individualized and titrated to desired clinical response.
- Precedex is not...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Precedex Injection is clear and colorless and is available as follows.
Precedex Injection
...
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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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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypotension, bradycardia and sinus arrest [see
6.1 Clinical Trials...
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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
Pregnancy Category C
There are no adequate and well-controlled...
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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 is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Precedex is a relatively selective alpha2-adrenergic agonist with sedative properties....
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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
Precedex Injection
Precedex (dexmedetomidine hydrochloride) injection 200 mcg/2 mL (100 mcg/mL) is...
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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 the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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 https://vaers.hhs.gov or call (800) 822-7967.