Dexmedetomidine Hydrochloride 4 ug/mL
Dexmedetomidine Hydrochloride · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.
Dexmedetomidine Hydrochloride is a injection, solution containing dexmedetomidine hydrochloride at 4 ug/mL, taken intravenous. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Dexmedetomidine Hydrochloride
- Generic Name
- Dexmedetomidine Hydrochloride
- NDC Code (Product)
0143-9526- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 4 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA206407
- Marketing Start
- 01/30/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dexmedetomidine hydrochloride 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 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 Injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine Injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine 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 Injection prior to extubation. 1.2 Procedural Sedation Dexmedetomidine Injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Pediatric use information is approved for Hospira Inc.'s PRECEDEX T…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Individualize and titrate dexmedetomidine injection dosing to desired clinical effect. ( 2.1 ) • Administer dexmedetomidine injection using a controlled infusion device. ( 2.1 ) • Dilute the 200 mcg/ 2mL (100 mcg/mL) vial contents in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) 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 ) • Alternative Doses : Recommended for patients over 65 years of age and awake fiberoptic intubation patients. ( 2.2 ) 2.1 Administration Instructions • Dexmedetomidine Injection dosing should be individualized and titrated to desired clinical response. • Dexmedetomidine Injection is not indicated for infusions lasting longer than 24 hours. • Dexmedetomidine Injection should be administered using a controlled infusion device.…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of dexmedetomidine hydrochloride or the concomitant medication may be required. ( 7.1 ) 7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of Dexmedetomidine Injection 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 Injection and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with Dexmedetomidine Injection, a reduction in dosage of Dexmedetomidine Injection 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 Injection 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 ) • 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 Fresenius Kabi USA, LLC at 1-800-551-7176 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 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 used for?
Dexmedetomidine Hydrochloride contains Dexmedetomidine Hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Dexmedetomidine Hydrochloride a controlled substance?
Dexmedetomidine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Dexmedetomidine Hydrochloride?
The generic name for Dexmedetomidine Hydrochloride is Dexmedetomidine Hydrochloride. There are 6 other brand versions of Dexmedetomidine Hydrochloride.
What is the NDC code for Dexmedetomidine Hydrochloride 4 ug/mL?
The NDC (National Drug Code) for Dexmedetomidine Hydrochloride 4 ug/mL is 0143-9526, listed by Hikma Pharmaceuticals USA Inc..