Dexmedetomidine HCl 100 ug/mL
Dexmedetomidine HCl · INJECTION · Medical Purchasing Solutions, LLC
Dexmedetomidine hydrochloride is an injectable medication given intravenously that is used for sedation in hospital and clinical settings. It works by activating certain receptors in the brain to produce calming and pain-relieving effects during medical procedures or in patients on ventilators.
Key Facts
- Brand Name
- Dexmedetomidine HCl
- Generic Name
- Dexmedetomidine HCl
- NDC Code (Product)
71872-7218- Manufacturer
- Medical Purchasing Solutions, LLC
- Strength
- 100 ug/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA205046
- Marketing Start
- 04/26/2017
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Fresenius Kabi USA, LLC
Cross Contamination with other products: trace amounts of lidocaine
Denver Solutions, LLC DBA Leiters Health
Lack of Assurance of Sterility: Leaking/damaged syringes.
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Fresenius Kabi USA, LLC
Cross Contamination with other products: trace amounts of lidocaine
Side 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 injection is a relatively selective alpha 2 -adrenergic agonist indicated for: Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.1) 1.1 Procedural Sedation Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Individualize and titrate dexmedetomidine hydrochloride injection dosing to desired clinical effect. (2.1) Administer dexmedetomidine hydrochloride 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 Procedural Sedation: Generally 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 Dosing Guidelines Dexmedetomidine hydrochloride injection dosing should be individualized and titrated to desired clinical response. Dexmedetomidine hydrochloride injection is not indicated for infusions lasting longer than 24 hours. Dexmedetomidine hydrochloride injection should be administered using a controlled infusion device. 2.2 Dosage Information Table 1: Dosage Information INDICATION DOSAGE AND ADMINISTRATION Initiation of Procedural …
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 hydrochloride 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 hydrochloride and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine hydrochloride, a reduction in dosage of dexmedetomidine hydrochloride 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 hydrochloride for 45 minutes at a plasma concentration of 1 ng/mL resulted in no clinically meaningful increases in the magnitude of neuromuscular blockade associated with rocuronium a…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence greater than 2%) are hypotension, bradycardia, and dry mouth. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies 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 clinical trials of another drug and may not reflect the rates observed in practice. Use of dexmedetomidine hydrochloride has been associated with the following serious adverse reactions: Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2 )] Transient hypertension [see Warnings and Precautions (5.3 )] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in procedural sedation studies include hypotension, bradycardia and dry mouth. Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation [ see Clinical Studies (14.1)] in which 318 adult patients received dexmedetomidine hydrochloride. The me…
Frequently Asked Questions
What is Dexmedetomidine HCl used for?
Dexmedetomidine hydrochloride is an injectable medication given intravenously that is used for sedation in hospital and clinical settings. It works by activating certain receptors in the brain to produce calming and pain-relieving effects during medical procedures or in patients on ventilators.
Is Dexmedetomidine HCl a controlled substance?
Dexmedetomidine HCl is not classified as a controlled substance by the DEA.
What is the generic name for Dexmedetomidine HCl?
The generic name for Dexmedetomidine HCl is Dexmedetomidine HCl. There are no other listed brand versions of Dexmedetomidine HCl.
What is the NDC code for Dexmedetomidine HCl 100 ug/mL?
The NDC (National Drug Code) for Dexmedetomidine HCl 100 ug/mL is 71872-7218, listed by Medical Purchasing Solutions, LLC.
Other Dexmedetomidine HCl Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)