Drugplain

PRECEDEX 100 ug/mL

DEXMEDETOMIDINE HYDROCHLORIDE · INJECTION, SOLUTION, CONCENTRATE · Henry Schein, Inc.

No Recall HistoryCurrently in Shortage
Plain English

PRECEDEX is a injection, solution, concentrate containing dexmedetomidine hydrochloride at 100 ug/mL, taken intravenous. Manufactured by Henry Schein, Inc..

Key Facts

Brand Name
PRECEDEX
Generic Name
DEXMEDETOMIDINE HYDROCHLORIDE
NDC Code (Product)
0404-9938
Manufacturer
Henry Schein, Inc.
Strength
100 ug/mL
Dosage Form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Marketing Status
Application #
NDA021038
Marketing Start
01/13/2022

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PRECEDEX is a alpha 2 -adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. ( 1.1 ) • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. ( 1.2 ) • Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours. PRECEDEX has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue PRECEDEX prior to extubation. 1.2 Procedural Sedation PRECEDEX is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. PRECEDEX is indicated for sedation of non-intubated pediatr…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Individualize and titrate PRECEDEX dosing to desired clinical effect. ( 2.1 ) • Administer PRECEDEX using a controlled infusion device. ( 2.1 ) • The 80 mcg/20 mL single-dose vial, and 200 mcg/50 mL, 400 mcg/100 mL, and 1,000 mcg/250 mL single-dose bottles do not require further dilution prior to administration. ( 2.4 ) • For Adult Intensive Care Unit Sedation : Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion of 0.2 to 0.7 mcg/kg/ hour . ( 2.2 ) • For Adult Procedural Sedation : Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion initiated at 0.6 mcg/kg/ hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/ hour . ( 2.2 ) • For Sedation of Pediatric Patients During Non-invasive Procedures : Patients 1 month to less than 2 years old initiate at 1.5 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/ hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 to 1.5 mcg/kg/ hour ; patients 2 to less than 18 years old initiate at 2.0 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/ hour and titrated…

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of PRECEDEX or the concomitant medication may be required. ( 7.1 ) 7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of PRECEDEX with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects. Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. No pharmacokinetic interactions between PRECEDEX and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with PRECEDEX, a reduction in dosage of PRECEDEX or the concomitant anesthetic, sedative, hypnotic or opioid may be required. 7.2 Neuromuscular Blockers In one study of 10 healthy adult volunteers, administration of PRECEDEX for 45 minutes at a plasma concentration of one ng/mL resulted in no clinically meaningful increases in the magnitude of neuromuscular blockade associated with rocuronium administration.

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2) ] • Transient hypertension [see Warnings and Precautions (5.3) ] • The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth. ( 6.1 ) • The most common adverse reactions (incidence >5%) in pediatric patients aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension. ( 6.1 ) • Adverse reactions in adults, associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common treatment-emergent adverse reactions, occurring in greater than 2% of ad…

Frequently Asked Questions

What is PRECEDEX used for?

PRECEDEX contains DEXMEDETOMIDINE HYDROCHLORIDE. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.

Is PRECEDEX a controlled substance?

PRECEDEX is not classified as a controlled substance by the DEA.

What is the generic name for PRECEDEX?

The generic name for PRECEDEX is DEXMEDETOMIDINE HYDROCHLORIDE. There are 12 other brand versions of DEXMEDETOMIDINE HYDROCHLORIDE.

What is the NDC code for PRECEDEX 100 ug/mL?

The NDC (National Drug Code) for PRECEDEX 100 ug/mL is 0404-9938, listed by Henry Schein, Inc..

Product NDC

0404-9938

Package NDC

0404-9938-02

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