Drugplain

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride 4 ug/mL

dexmedetomidine hydrochloride · INJECTION, SOLUTION · Sagent Pharmaceuticals

No Recall HistoryCurrently in Shortage
Plain English

Dexmedetomidine hydrochloride is a sedative medication given by injection into a vein, commonly used to help keep patients calm and comfortable during medical procedures or while on a ventilator in intensive care settings. It works by activating certain receptors in the brain and body to produce sedation and pain relief.

Key Facts

Brand Name
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride
Generic Name
dexmedetomidine hydrochloride
NDC Code (Product)
25021-615
Manufacturer
Sagent Pharmaceuticals
Strength
4 ug/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA217308
Marketing Start
02/15/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

bradycardia178 reports
off label use154 reports
cardiac arrest107 reports
hypotension87 reports
product use in unapproved indication80 reports
drug interaction71 reports
product administered to patient of inappropriate age71 reports
pyrexia66 reports
oxygen saturation decreased56 reports
product use issue56 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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 dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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) 1.1 Intensive Care Unit Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. 1.2 Procedural Se…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Individualize and titrate dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing to desired clinical effect. (2.1) Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection using a controlled infusion device. (2.1) The 80 mcg per 20 mL single-dose vial, 200 mcg per 50 mL, and 400 mcg per 100 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 mcg/kg/ hour 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 mcg/kg/ hour to 1 mcg/kg/ hour . (2.2) Alternative Doses: Recommended for patients over 65 years of age and awake fiberoptic intubation patients. (2.2) 2.1 Administration Instructions Dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing should be individualized and titrated to desired clinical response. Dexmedetomidine hydrochloride in 0.9% sodium chloride injec…

Contraindications

4 CONTRAINDICATIONS None. None ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of dexmedetomidine or the concomitant medication may be required. (7.1) 7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine 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 dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine, a reduction in dosage of dexmedetomidine 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 dexmedetomidine 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 most common adverse reactions (incidence greater than 2%) in adults are hypotension, bradycardia, and dry mouth. (6.1) Adverse reactions in adults, associated with infusions greater than 24 hours in duration include ARDS, respiratory failure, and agitation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 )] 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 adult patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction…

Frequently Asked Questions

What is Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride used for?

Dexmedetomidine hydrochloride is a sedative medication given by injection into a vein, commonly used to help keep patients calm and comfortable during medical procedures or while on a ventilator in intensive care settings. It works by activating certain receptors in the brain and body to produce sedation and pain relief.

Is Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride a controlled substance?

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride is not classified as a controlled substance by the DEA.

What is the generic name for Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride?

The generic name for Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride is dexmedetomidine hydrochloride. There are 11 other brand versions of dexmedetomidine hydrochloride.

What is the NDC code for Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride 4 ug/mL?

The NDC (National Drug Code) for Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride 4 ug/mL is 25021-615, listed by Sagent Pharmaceuticals.

Product NDC

25021-615

Package NDC

25021-615-50

Other Dexmedetomidine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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