Dexmedetomidine 200 ug/2mL
Dexmedetomidine · INJECTION, SOLUTION · ProPharma Distribution
Dexmedetomidine is a injection, solution containing dexmedetomidine at 200 ug/2mL, taken intravenous. Manufactured by ProPharma Distribution.
Key Facts
- Brand Name
- Dexmedetomidine
- Generic Name
- Dexmedetomidine
- NDC Code (Product)
84549-230- Manufacturer
- ProPharma Distribution
- Strength
- 200 ug/2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA202126
- Marketing Start
- 01/19/2021
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
CMC Enterprise Pharmacy
Lack of sterility assurance.
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.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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 Injection and Dexmedetomidine in 5% Dextrose 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 Injection and Dexmedetomidine in 5% Dextrose 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 Injection and Dexmedetomidine in 5% Dextrose Injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection should be administered by continuous infusion not to exceed 24 hours. 1.2 Procedural Sedation Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Individualize and titrate dosing to desired clinical effect. (2.1) • Administration duration should not exceed 24 hours. (2.1) • Administer intravenously using a controlled infusion device. (2.1) • Dexmedetomidine Injection must be diluted prior to administration. (2.1) • Dexmedetomidine Injection in 5% Dextrose 200 mcg/50 mL and 400 mcg/100 mL single-dose bags, do not require dilution prior to administration. (2.1) • To be administered only by health care providers skilled in management of patients in the intensive care or operating room setting. (2.1) • Continuously monitor blood pressure, heart rate, and oxygen levels during administration and as clinically appropriate after discontinuation. (2.1) • It is not necessary to discontinue Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection prior to extubation. • 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 cli…
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 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 WG Critical Care at 1-866-562-4708 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 information is…
Frequently Asked Questions
What is Dexmedetomidine used for?
Dexmedetomidine contains Dexmedetomidine. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Dexmedetomidine a controlled substance?
Dexmedetomidine is not classified as a controlled substance by the DEA.
What is the generic name for Dexmedetomidine?
The generic name for Dexmedetomidine is Dexmedetomidine. There are 11 other brand versions of Dexmedetomidine.
What is the NDC code for Dexmedetomidine 200 ug/2mL?
The NDC (National Drug Code) for Dexmedetomidine 200 ug/2mL is 84549-230, listed by ProPharma Distribution.
Other Dexmedetomidine Dosages
Other Dexmedetomidine Brands
See all →- IGALMI120 ug/181092-1120
- Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride4 ug/mL25021-615
- Dexmedetomidine Hydrochloride4 ug/mL0143-9198
- Dexmedetomidine Hydrochloride4 ug/mL0143-9525
- DEXMEDETOMIDINE HYDROCHLORIDE4 ug/mL43598-975
- Dexmedetomidine Hydrochloride4 ug/mL55150-296
- Dexmedetomidine Hydrochloride4 ug/mL68083-238
- Dexmedetomidine Hydrochloride4 ug/mL68083-239
- Dexmedetomidine Hydrochloride4 ug/mL68083-657
- Dexmedetomidine Hydrochloride in Sodium Chloride4 ug/mL68094-147
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)