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PRECEDEX (dexmedetomidine hydrochloride injection)

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PRECEDEX Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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3 DOSAGE FORMS AND STRENGTHS

Precedex Injection is clear and colorless and is available as follows.

Precedex Injection

...
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4 CONTRAINDICATIONS

None.

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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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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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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Precedex (dexmedetomidine hydrochloride) is not a controlled substance.

...
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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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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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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Precedex is a relatively selective alpha2-adrenergic agonist with sedative properties....

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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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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16 HOW SUPPLIED/STORAGE AND HANDLING

Precedex Injection

Precedex (dexmedetomidine hydrochloride) injection 200 mcg/2 mL (100 mcg/mL) is...

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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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Distributed by Hospira, Inc. Lake Forest, IL 60045

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