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DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection — NDC 72572-127-10 (Billing 72572-0127-10)

by CIVICA, INC. · 10 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE

This is a package of DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL Injection from CIVICA, INC., marketed since Aug 2021 and currently FDA-listed. It is this product's only package size.

NDC 72572-0127-10
🏷️ FDA NDC (as labeled) 72572-127-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Active FDA shortage. Dexmedetomidine Hydrochloride Injection is currently reported in shortage by the FDA. Available Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72572-127-10
Product NDC 72572-127
11-digit billing NDC 72572012710
NCPDP billing unit ML — per mL (volume)
RxCUI 1718906, 1718909
UNII 1018WH7F9I
Application # ANDA212791
SPL Set ID 1faf1ac8-ff9b-4ed9-b562-06dab971173a
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
Physiologic effect General Anesthesia
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-08-23
Route INTRAVENOUS
Dosage form INJECTION
Substance DEXMEDETOMIDINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 60206030202020
GPI class Dexmedetomidine HCl in NaCl
GCN Seq No 070876
GCN 34538
HICL code 040230
Ingredient (HICL) Dexmedetomidine In 0.9 % Nacl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 28:24.92.00
AHFS class Anxiolytics,Sedatives,And Hypnotics,Misc
FDB label name DEXMEDETOMIDINE 200MCG/50ML-NS
FDB brand name Dexmedetomidine-0.9% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 070876
  • GCN: 34538
  • GPI-14 (Medi-Span): 60206030202020
  • HICL (First Databank): 040230
  • AHFS class code: 28:24.92.00
  • RxCUI (RxNorm): 1718906
Why two NDCs? The FDA registers this code as 72572-127-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72572-0127-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Other hypnotics and sedatives
How it works Adrenergic alpha2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DEXMEDETOMIDINE 200MCG/50ML-NS Ingredient Dexmedetomidine In 0.9 % Nacl
📗 Our plain-language guide HelloPharmacist
  • Dexmedetomidine is a sedative used in hospital settings. If you're receiving the IV form, it's being used to keep you calm and comfortable — either while you're on a breathing mach...
  • Why am I getting dexmedetomidine — what is it actually used for?
  • Dexmedetomidine causes sedation, but it's different from general anesthesia. Some patients can actually be roused — meaning if someone calls your name or stimulates you, you may op...
  • Will I be completely unconscious, or will I be able to wake up?
📖 Read our full Dexmedetomidine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72572-0127-10 You're viewing this Main listing 10 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE 2021-08-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dexmedetomidine Hydrochloride 4 ug/mL 00143-9526-10 Hikma 10 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 200 ug/50mL 00338-9555-24 Baxter 50 ml — AP FDA listed —
Precedex 4 ug/mL 00409-1454-20 Hospira, 20 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-1660-10 Hospira, 10 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-4596-20 Hospira, 20 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-7838-24 Hospira, 24 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 4 ug/mL 00781-3494-95 Sandoz 10 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride 4 ug/mL 25021-0615-50 Sagent 10 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 42023-0186-20 Par 20 vials — AP FDA listed —
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 200 ug/50mL 43066-0555-24 Baxter 50 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 200 ug/50mL 43066-0561-24 Baxter 50 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 43598-0976-58 Dr.Reddy's 10 vials — AP FDA listed —
Dexmedetomidine in Dextrose 4 ug/mL 44567-0602-24 WG 50 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 52536-0125-10 Wilshire 10 bottles — — FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 55150-0296-10 Eugia 10 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 63323-0671-00 Fresenius 10 bottles — AP Discontinued —
Dexmedetomidine Hydrochloride 4 ug/mL 66794-0234-44 Piramal 20 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 200 ug/50mL 67457-0924-50 Mylan 20 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0238-20 Gland 20 vials — AP FDA listed —
Dexmedetomidine Hydrochloride in Sodium Chloride 4 ug/mL 68094-0147-20 Precision 20 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 70121-1388-08 Amneal 20 bottles — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 70121-1711-09 Amneal 24 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 71225-0126-04 Slayback 10 vials — — Discontinued —
Dexmedetomidine Hydrochloride 4 ug/mLthis 72572-0127-10 CIVICA, 10 bottles — — FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0239-10 Gland 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 72572-0128-08 CIVICA, 8 bottles — — FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 00143-9525-10 Hikma 10 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 43598-0975-58 Dr.Reddy's 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 66794-0235-41 Piramal 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 70121-1389-07 Amneal 10 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-0155-02 Hospira, 10 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-3301-10 Hospira, 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride in Sodium Chloride 4 ug/mL 68094-0047-10 Precision 10 vials — AP FDA listed —
Precedex 4 ug/mL 00409-1174-10 Hospira, 10 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-1596-01 Hospira, 1 bottle — AP FDA listed —
Precedex 4 ug/mL 00409-7875-12 Hospira, 12 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 25021-0617-82 Sagent 100 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 00143-9198-10 Hikma 250 ml — AP FDA listed —
Precedex 4 ug/mL 00409-7853-24 Hospira, 24 pouches — AP FDA listed —
Precedex 4 ug/mL 00409-1434-01 Hospira, 1 bottle — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 42023-0187-10 Par 10 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0657-10 Gland 10 pouches — AP FDA listed —
Dexmedetomidine Hydrochloride 4 ug/mL 52536-0126-08 Wilshire 8 bottles — — FDA listed —
Dexmedetomidine Hydrochloride in Sodium Chloride 4 ug/mL 68094-0247-10 Precision 10 bottles — AP FDA listed —
Precedex 4 ug/mL 00409-2815-01 Hospira, 1 bottle — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Aug 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCIVICA, INC.
Application holderWILSHIRE PHARMACEUTICALS INC
FDA applicationANDA212791 (ANDA)
Labeler code72572
First marketedAug 2021
Product typeHuman Prescription Drug
Portfolio95 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 183 words ▾

1 INDICATIONS & 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)

1.1Intensive 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.

1.2Procedural Sedation Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & 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 200 mcg/50mL and 400 mcg/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 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)

2.1Administration 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 injection is not indicated for infusions lasting longer than 24 hours. • Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered using a controlled infusion device.

2.2Recommended Dosage Table 1: Recommended Dosage in Adult Patients INDICATION DOSAGE AND ADMINISTRATION Initiation of Intensive Care Unit Sedation For adult patients : a loading infusion of one mcg/kg over 10 minutes . For adult patients being converted from alternate sedative therapy : a loading dose may not be required. For patients over 65 years of age : Consider a dose reduction [ see Use in Specific Populations (8.5) ].

For adult patients with impaired hepatic function : Consider a dose reduction [ see Use in Specific Populations (8.6), Clinical Pharmacology (12.3) ]. Maintenance of Intensive Care Unit Sedation For adult patients : a maintenance infusion of 0.2 to 0.7 mcg/kg/ hour . The rate of the maintenance infusion should be adjusted to achieve the desired level of sedation.

For patients over 65 years of age : Consider a dose reduction [ see Use in Specific Populations (8.5) ] . For adult patients with impaired hepatic function : Consider a dose reduction [ see Use in Specific Populations (8.6), Clinical Pharmacology (12.3) ]. Initiation of Procedural Sedation For adult patients : a loading infusion of one mcg/kg over 10 minutes .

For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable. For awake fiberoptic intubation in adult patients : a loading infusion of one mcg/kg over 10 minutes . For patients over 65 years of age : a loading infusion of 0.5 mcg/kg over 10 minutes [ see Use in Specific Populations (8.5) ] .

For adult patients with impaired hepatic function : Consider a dose reduction [ see Use in Specific Populations (8.6), Clinical Pharmacology (12.3) ]. Maintenance of Procedural Sedation For adult patients : the maintenance infusion is generally 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 . Adjust the rate of the maintenance infusion to achieve the targeted level of sedation.

For awake fiberoptic intubation in adult patients : a maintenance infusion of 0.7 mcg/kg/ hour is recommended until the endotracheal tube is secured. For patients over 65 years of age : Consider a dose reduction [ see Use in Specific Populations (8.5) ] . For adult patients with impaired hepatic function : Consider a dose reduction [ see Use in Specific Populations (8.6), Clinical Pharmacology (12.3) ].

2.3Dosage Adjustment Due to possible pharmacodynamic interactions, a reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [ see Drug Intera… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 78 words ▾

3 DOSAGE FORMS & STRENGTHS Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is clear colorless solution, ready to use. It is available as: Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg/mL) single-dose glass bottle. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4 mcg/mL) single-dose glass bottle.

Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection 200 mcg/50 mL and 400 mcg/100 mL (4 mcg/mL) in a single-dose glass bottles. Ready to use. (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None None. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Monitoring : Continuously monitor patients while receiving Dexmedetomidine hydrochloride in 0.9% sodium chloride injection. (5.1) • Bradycardia and Sinus Arrest : Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration. (5.2) • Hypotension and Bradycardia : May necessitate medical intervention.

May be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly. Use with caution in patients with advanced heart block or severe ventricular dysfunction. (5.2) • Co-administration with Other Vasodilators or Negative Chronotropic Agents : Use with caution due to additive pharmacodynamic effects.

(5.2) • Transient Hypertension : Observed primarily during the loading dose. Consider reduction in loading infusion rate. (5.3) • Arousability : Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy.

(5.4) • Tolerance and Tachyphylaxis : Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events. (5.6)

5.1Drug Administration Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of dexmedetomidine hydrochloride in 0.9% sodium chloride injection, patients should be continuously monitored while receiving dexmedetomidine hydrochloride in 0.9% sodium chloride injection.

5.2Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine hydrochloride in 0.9% sodium chloride injection administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration. Reports of hypotension and bradycardia have been associated with dexmedetomidine hydrochloride in 0.9% sodium chloride injection infusion. Some of these cases have resulted in fatalities.

If medical intervention is required, treatment may include decreasing or stopping the infusion of dexmedetomidine hydrochloride in 0.9% sodium chloride injection, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because dexmedetomidine hydrochloride in 0.9% sodium chloride injection has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone.

In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of dexmedetomidine hydrochloride ­induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering dexmedetomidine hydrochloride in 0.9% sodium chloride injection to patients with advanced heart block and/or severe ventricular dysfunction.

Because dexmedetomidine hydrochloride in 0.9% sodium chloride injection decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients. In clinical trials where other vasodilators or negative chronotropic agents were co-administered with dexmedetomidine hydrochloride in 0.9% sodium chloride injection an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with dexmedetomidine hydrochloride in 0.9% sodium chloride injection.

5.3Transient Hypertension Transient hypertension has bee… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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 Wilshire Pharmaceuticals, Inc. at 1-877-495-6856, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 derived from the continuous infusion trials of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for sedation in the Intensive Care Unit setting in which 1,007 adult patients received dexmedetomidine hydrochloride in 0.9% sodium chloride injection.

The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 3.

The most frequent adverse reactions were hypotension, bradycardia and dry mouth [ see Warnings and Precautions (5.2) ]. Table 3: Adverse Reactions with an Incidence >2%—Adult Intensive Care Unit Sedation Population <24 hours* Adverse Event All Dexmedetomidine Hydrochloride in 0.9% sodium chloride Injection (N = 1007) (%) Randomized Dexmedetomidine Hydrochloride in 0.9% sodium chloride Injection (N = 798) (%) Placebo (N = 400) (%) Propofol (N = 188) (%) Hypotension 25% 24% 12% 13% Hypertension 12% 13% 19% 4% Nausea 9% 9% 9% 11% Bradycardia 5% 5% 3% 0 Atrial Fibrillation 4% 5% 3% 7% Pyrexia 4% 4% 4% 4% Dry Mouth 4% 3% 1% 1% Vomiting 3% 3% 5% 3% Hypovolemia 3% 3% 2% 5% Atelectasis 3% 3% 3% 6% Pleural Effusion 2% 2% 1% 6% Agitation 2% 2% 3% 1% Tachycardia 2% 2% 4% 1% Anemia 2% 2% 2% 2% Hyperthermia 2% 2% 3% 0 Chills 2% 2% 3% 2% Hyperglycemia 2% 2% 2% 3% Hypoxia 2% 2% 2% 3% Post-procedural Hemorrhage 2% 2% 3% 4% Pulmonary Edema 1% 1% 1% 3% Hypocalcemia 1% 1% 0 2% Acidosis 1% 1% 1% 2% Urine Output Decreased 1% 1% 0 2% Sinus Tachycardia 1% 1% 1% 2% Ventricular Tachycardia <1% 1% 1% 5% Wheezing <1% 1% 0 2% Edema Peripheral <1% 0 1% 2% * 26 subjects in the all dexmedetomidine hydrochloride in 0.9% sodium chloride injection group and 10 subjects in the randomized dexmedetomidine hydrochloride in 0.9% sodium chloride injection group had exposure for greater than 24 hours.

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for sedation in the surgical intensive care unit setting in which 387 adult patients received dexmedetomidine hydrochloride in 0.9% sodium chloride injection for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 4).

Table 4: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Adult Patients in the Randomized Placebo-Controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event Randomized… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 177 words ▾

7 DRUG INTERACTIONS Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant medication may be required. (7.1)

7.1Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine hydrochloride in 0.9% sodium chloride 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 hydrochloride in 0.9% sodium chloride injection and isoflurane, propofol, alfentanil and midazolam have been demonstrated.

However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine hydrochloride in 0.9% sodium chloride injection, a reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant anesthetic, sedative, hypnotic or opioid may be required.

7.2Neuromuscular Blockers In one study of 10 healthy adult volunteers, administration of dexmedetomidine hydrochloride in 0.9% sodium chloride 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.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Geriatric Patients: Dose reduction should be considered. (2.2, 2.3, 5.2, 8.5) • Hepatic Impairment: Dose reduction should be considered. (2.2, 2.3, 5.8, 8.6)

8.1Pregnancy Risk Summary Available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant Apgar scores.

Available data indicate that dexmedetomidine crosses the placenta. In animal reproduction studies, fetal toxicity that lower fetal viability and reduced live fetuses occurred with subcutaneous administration of dexmedetomidine to pregnant rats during organogenesis at doses 1.8 times the maximum recommended human dose (MRHD) of 17.8 mcg/kg/day. Developmental toxicity (low pup weights and adult offspring weights, decreased F1 grip strength, increased early implantation loss and decreased viability of second-generation offspring) occurred when pregnant rats were subcutaneously administered dexmedetomidine at doses less than the clinical dose from late pregnancy through lactation and weaning ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Increased post-implantation losses and reduced live fetuses in the presence of maternal toxicity (i.e. decreased body weight) were noted in a rat embryo-fetal development study in which pregnant dams were administered subcutaneous doses of dexmedetomidine 200 mcg/kg/day (equivalent to 1.8 times the intravenous MRHD of 17.8 mcg/kg/day based on body surface area [BSA]) during the period of organogenesis (Gestation Day [GD] 6 to 15). No malformations were reported. No malformations or embryo-fetal toxicity were noted in a rabbit embryo-fetal development study in which pregnant does were administered dexmedetomidine intravenously at doses of up to 96 mcg/kg/day (approximately half the human exposure at the MRHD based on AUC) during the period of organogenesis (GD 6 to 18).

Reduced pup and adult offspring birth weights, and grip strength were reported in a rat developmental toxicology study in which pregnant females were administered dexmedetomidine subcutaneously at doses of 8 mcg/kg/day (0.07 times the MRHD based on BSA) during late pregnancy through lactation and weaning (GD 16 to postnatal day [PND] 25). Decreased viability of second generation offspring and an increase in early implantation loss along with delayed motor development occurred in the 32 mcg/kg/day group (equivalent to less than the clinical dose based on BSA) when first generation offspring were allowed to mate.

This study limited dosing to hard palate closure (GD 15 to 18) through weaning instead of dosing from implantation (GD 6 to 7) to weaning (PND 21). In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously.

8.2Lactation Risk Summary Available published literature reports the presence of dexmedetomidine in human milk following intravenous administration ( see Data ). There is no information regarding the effects of dexmedetomidine on the breastfed infant or the effects on milk production. Advise women to monitor the breastfed infant for irritability.

The developmental and health benefits of breastfeeding should be considered along with the mothe… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant Apgar scores.

Available data indicate that dexmedetomidine crosses the placenta. In animal reproduction studies, fetal toxicity that lower fetal viability and reduced live fetuses occurred with subcutaneous administration of dexmedetomidine to pregnant rats during organogenesis at doses 1.8 times the maximum recommended human dose (MRHD) of 17.8 mcg/kg/day. Developmental toxicity (low pup weights and adult offspring weights, decreased F1 grip strength, increased early implantation loss and decreased viability of second-generation offspring) occurred when pregnant rats were subcutaneously administered dexmedetomidine at doses less than the clinical dose from late pregnancy through lactation and weaning ( see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Increased post-implantation losses and reduced live fetuses in the presence of maternal toxicity (i.e. decreased body weight) were noted in a rat embryo-fetal development study in which pregnant dams were administered subcutaneous doses of dexmedetomidine 200 mcg/kg/day (equivalent to 1.8 times the intravenous MRHD of 17.8 mcg/kg/day based on body surface area [BSA]) during the period of organogenesis (Gestation Day [GD] 6 to 15). No malformations were reported. No malformations or embryo-fetal toxicity were noted in a rabbit embryo-fetal development study in which pregnant does were administered dexmedetomidine intravenously at doses of up to 96 mcg/kg/day (approximately half the human exposure at the MRHD based on AUC) during the period of organogenesis (GD 6 to 18).

Reduced pup and adult offspring birth weights, and grip strength were reported in a rat developmental toxicology study in which pregnant females were administered dexmedetomidine subcutaneously at doses of 8 mcg/kg/day (0.07 times the MRHD based on BSA) during late pregnancy through lactation and weaning (GD 16 to postnatal day [PND] 25). Decreased viability of second generation offspring and an increase in early implantation loss along with delayed motor development occurred in the 32 mcg/kg/day group (equivalent to less than the clinical dose based on BSA) when first generation offspring were allowed to mate.

This study limited dosing to hard palate closure (GD 15 to 18) through weaning instead of dosing from implantation (GD 6 to 7) to weaning (PND 21). In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously.

🧒 Pediatric Use 111 words ▾

8.4Pediatric Use Sedation for Non-Invasive Procedures The safety and effectiveness of dexmedetomidine hydrochloride in 0.9% sodium chloride injection have not been established in pediatric patients less than 1 month of age. ICU Sedation The safety and efficacy of dexmedetomidine hydrochloride in 0.9% sodium chloride injection have not been established in pediatric patients for ICU sedation. One assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for ICU sedation.

These studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for these patient populations.

🧓 Geriatric Use 188 words ▾

8.5Geriatric Use Intensive Care Unit Sedation A total of 729 patients in the clinical studies were 65 years of age and over. A total of 200 patients were 75 years of age and over. In patients greater than 65 years of age, a higher incidence of bradycardia and hypotension was observed following administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection [ see Warnings and Precautions (5.2) ].

Therefore, a dose reduction may be considered in patients over 65 years of age [ see Dosage and Administration (2.2, 2.3), Clinical Pharmacology (12.3) ]. Procedural Sedation A total of 131 patients in the clinical studies were 65 years of age and over. A total of 47 patients were 75 years of age and over.

Hypotension occurred in a higher incidence in dexmedetomidine hydrochloride in 0.9% sodium chloride injection-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). A reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age.

🆘 Overdosage 196 words ▾

10 OVERDOSAGE The tolerability of dexmedetomidine hydrochloride in 0.9% sodium chloride injection was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block.

No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute. Five adult patients received an overdose of dexmedetomidine hydrochloride in 0.9% sodium chloride injection in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr.

Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted dexmedetomidine hydrochloride in 0.9% sodium chloride injection (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha 2 -adrenergic agonist with sedative properties. Alpha 2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10-300 mcg/kg). Both alpha 1 and alpha 2 activity is observed following slow intravenous infusion of high doses (≥1,000 mcg/kg) or with rapid intravenous administration.

12.2Pharmacodynamics In a study in healthy adult volunteers (N = 10), respiratory rate and oxygen saturation remained within normal limits and there was no evidence of respiratory depression when dexmedetomidine hydrochloride in 0.9% sodium chloride injection was administered by intravenous infusion at doses within the recommended dose range (0.2–0.7 mcg/kg/hr).

12.3Pharmacokinetics Following intravenous administration to adults, dexmedetomidine exhibits the following pharmacokinetic parameters: a rapid distribution phase with a distribution half-life (t 1/2 ) of approximately 6 minutes; a terminal elimination half-life (t 1/2 ) of approximately 2 hours; and steady-state volume of distribution (V ss ) of approximately 118 liters. Clearance is estimated to be approximately 39 L/h. The mean body weight associated with this clearance estimate was 72 kg.

Dexmedetomidine exhibits linear pharmacokinetics in the dosage range of 0.2 to 0.7 mcg/kg/hr when administered to adults by intravenous infusion for up to 24 hours. Table 8 shows the main pharmacokinetic parameters when dexmedetomidine hydrochloride in 0.9% sodium chloride injection was infused (after appropriate loading doses) at maintenance infusion rates of 0.17 mcg/kg/hr (target plasma concentration of 0.3 ng/mL) for 12 and 24 hours, 0.33 mcg/kg/hr (target plasma concentration of 0.6 ng/mL) for 24 hours, and 0.70 mcg/kg/hr (target plasma concentration of 1.25 ng/mL) for 24 hours.

Table 10: Mean ± SD Pharmacokinetic Parameters in Adults Parameter Loading Infusion (min)/Total Infusion Duration (hrs) 10 min/12 hrs 10 min/24 hrs 10 min/24 hrs 35 min/24 hrs Dexmedetomidine Target Plasma Concentration (ng/mL) and Dose (mcg/kg/hr) 0.3/0.17 0.3/0.17 0.6/0.33 1.25/0.70 t 1/2 *, hour 1.78 ± 0.30 2.22 ± 0.59 2.23 ± 0.21 2.50 ±

0.61CL, liter/hour 46.3 ± 8.3 43.1 ± 6.5 35.3 ± 6.8 36.5 ±

7.5V ss , liter 88.7 ± 22.9 102.4 ± 20.3 93.6 ± 17.0 99.6 ±

17.8Avg C ss # , ng/mL 0.27 ± 0.05 0.27 ± 0.05 0.67 ± 0.10 1.37 ±

0.20Abbreviations: t 1/2 = half-life, CL = clearance, V ss = steady-state volume of distribution * Presented as harmonic mean and pseudo standard deviation. # Mean C ss = Average steady-state concentration of dexmedetomidine. The mean C ss was calculated based on post-dose sampling from 2.5 to 9 hours samples for 12 hour infusion and post-dose sampling from 2.5 to 18 hours for 24 hour infusions. The loading doses for each of the above indicated groups were 0.5, 0.5, 1 and 2.2 mcg/kg, respectively.

Dexmedetomidine pharmacokinetic parameters in adults after dexmedetomidine hydrochloride in 0.9% sodium chloride injection maintenance doses of 0.2 to 1.4 mcg/kg/hr for >24 hours were similar to the pharmacokinetic (PK) parameters after dexmedetomidine hydrochloride in 0.9% sodium chloride injection maintenance dosing for < 24 hours in other studies. The values for clearance (CL), volume of distribution (V), and t 1/2 were

39.4L/hr, 152 L, and 2.67 hours, respectively. Distribution The steady-state volume of distribution (V ss ) of dexmedetomidine was approximately 118 liters. Dexmedetomidine protein binding was assessed in the plasma of normal healthy male and female subjects.

The average protein binding was 94% and was constant across the different plasma concentrations tested. Protein binding was similar in males and females. The fraction of dexmedetomidine hydrochloride in 0.9% sodium chloride injection that was bound to plasma proteins was significantly decreased in subjects with hepatic impairment compared to healthy s… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 63 words ▾

12.1Mechanism of Action Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha 2 -adrenergic agonist with sedative properties. Alpha 2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10-300 mcg/kg). Both alpha 1 and alpha 2 activity is observed following slow intravenous infusion of high doses (≥1,000 mcg/kg) or with rapid intravenous administration.

📦 How Supplied / Storage and Handling 108 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Do not use if product is discolored or if precipitate matter is present. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride injection is a clear colorless solution.

The strength is based on the dexmedetomidine base. Discard unused portion. Unit of Sale Concentration NDC 72572-127-01 Single-dose clear glass bottle 200 mcg/50 mL (4 mcg/mL) NDC 72572-127-10 Carton of 10 single-dose clear glass bottles 200 mcg/50 mL (4 mcg/mL) NDC 72572-128-01 Single-dose clear glass bottle 400 mcg/100 mL (4 mcg/mL) NDC 72572-128-08 Carton of 8 single-dose clear glass bottles 400 mcg/100 mL (4 mcg/mL)

📋 Description 177 words ▾

11 DESCRIPTION Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist.

Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C 13 H 16 N 2 • HCl and the structural formula is: Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1.

Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 8.0.

Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine), 1 mg of L-Methionine and 9 mg sodium chloride in water for injection. The solution is preservative-free. dexmed-structure

💬 Information for Patients 172 words ▾

17 PATIENT COUNSELING INFORMATION Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for short-term intravenous sedation. Dosage must be individualized and titrated to the desired clinical effect. Blood pressure, heart rate and oxygen levels will be monitored both continuously during the infusion of dexmedetomidine hydrochloride in 0.9% sodium chloride injection and as clinically appropriate after discontinuation. • When dexmedetomidine hydrochloride in 0.9% sodium chloride injection is infused for more than 6 hours, patients should be informed to report nervousness, agitation, and headaches that may occur for up to 48 hours. • Additionally, patients should be informed to report symptoms that may occur within 48 hours after the administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness. • Advise breastfeeding mothers who were exposed to dexmedetomidine hydrochloride in 0.9% sodium chloride injection to monitor breastfed neonates for irritability [ see Use in Specific Populations (8.2) ].

Distributed by: Civica, Inc. Lehi, Utah 84043. Revised: 8/2024

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Following intravenous administration to adults, dexmedetomidine exhibits the following pharmacokinetic parameters: a rapid distribution phase with a distribution half-life (t 1/2 ) of approximately 6 minutes; a terminal elimination half-life (t 1/2 ) of approximately 2 hours; and steady-state volume of distribution (V ss ) of approximately 118 liters. Clearance is estimated to be approximately 39 L/h. The mean body weight associated with this clearance estimate was 72 kg.

Dexmedetomidine exhibits linear pharmacokinetics in the dosage range of 0.2 to 0.7 mcg/kg/hr when administered to adults by intravenous infusion for up to 24 hours. Table 8 shows the main pharmacokinetic parameters when dexmedetomidine hydrochloride in 0.9% sodium chloride injection was infused (after appropriate loading doses) at maintenance infusion rates of 0.17 mcg/kg/hr (target plasma concentration of 0.3 ng/mL) for 12 and 24 hours, 0.33 mcg/kg/hr (target plasma concentration of 0.6 ng/mL) for 24 hours, and 0.70 mcg/kg/hr (target plasma concentration of 1.25 ng/mL) for 24 hours.

Table 10: Mean ± SD Pharmacokinetic Parameters in Adults Parameter Loading Infusion (min)/Total Infusion Duration (hrs) 10 min/12 hrs 10 min/24 hrs 10 min/24 hrs 35 min/24 hrs Dexmedetomidine Target Plasma Concentration (ng/mL) and Dose (mcg/kg/hr) 0.3/0.17 0.3/0.17 0.6/0.33 1.25/0.70 t 1/2 *, hour 1.78 ± 0.30 2.22 ± 0.59 2.23 ± 0.21 2.50 ±

0.61CL, liter/hour 46.3 ± 8.3 43.1 ± 6.5 35.3 ± 6.8 36.5 ±

7.5V ss , liter 88.7 ± 22.9 102.4 ± 20.3 93.6 ± 17.0 99.6 ±

17.8Avg C ss # , ng/mL 0.27 ± 0.05 0.27 ± 0.05 0.67 ± 0.10 1.37 ±

0.20Abbreviations: t 1/2 = half-life, CL = clearance, V ss = steady-state volume of distribution * Presented as harmonic mean and pseudo standard deviation. # Mean C ss = Average steady-state concentration of dexmedetomidine. The mean C ss was calculated based on post-dose sampling from 2.5 to 9 hours samples for 12 hour infusion and post-dose sampling from 2.5 to 18 hours for 24 hour infusions. The loading doses for each of the above indicated groups were 0.5, 0.5, 1 and 2.2 mcg/kg, respectively.

Dexmedetomidine pharmacokinetic parameters in adults after dexmedetomidine hydrochloride in 0.9% sodium chloride injection maintenance doses of 0.2 to 1.4 mcg/kg/hr for >24 hours were similar to the pharmacokinetic (PK) parameters after dexmedetomidine hydrochloride in 0.9% sodium chloride injection maintenance dosing for < 24 hours in other studies. The values for clearance (CL), volume of distribution (V), and t 1/2 were

39.4L/hr, 152 L, and 2.67 hours, respectively. Distribution The steady-state volume of distribution (V ss ) of dexmedetomidine was approximately 118 liters. Dexmedetomidine protein binding was assessed in the plasma of normal healthy male and female subjects.

The average protein binding was 94% and was constant across the different plasma concentrations tested. Protein binding was similar in males and females. The fraction of dexmedetomidine hydrochloride in 0.9% sodium chloride injection that was bound to plasma proteins was significantly decreased in subjects with hepatic impairment compared to healthy subjects.

The potential for protein binding displacement of dexmedetomidine by fentanyl, ketorolac, theophylline, digoxin and lidocaine was explored in vitro, and negligible changes in the plasma protein binding of dexmedetomidine hydrochloride in 0.9% sodium chloride injection were observed. The potential for protein binding displacement of phenytoin, warfarin, ibuprofen, propranolol, theophylline and digoxin by dexmedetomidine hydrochloride in 0.9% sodium chloride injection was explored in vitro and none of these compounds appeared to be significantly displaced by dexmedetomidine hydrochloride in 0.9% sodium chloride injection.

Elimination Metabolism Dexmedetomidine undergoes almost complete biotransformation with very little unchanged dexmedetomidine excreted in urine and feces. Biotransformation involves both direct glu… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 51 words ▾

12.2Pharmacodynamics In a study in healthy adult volunteers (N = 10), respiratory rate and oxygen saturation remained within normal limits and there was no evidence of respiratory depression when dexmedetomidine hydrochloride in 0.9% sodium chloride injection was administered by intravenous infusion at doses within the recommended dose range (0.2–0.7 mcg/kg/hr).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and efficacy of dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been evaluated in four randomized, double-blind, placebo-controlled multicenter clinical trials in 1,185 adult patients.

14.1Intensive Care Unit Sedation Two randomized, double-blind, parallel-group, placebo-controlled multicenter clinical trials included 754 adult patients being treated in a surgical intensive care unit. All patients were initially intubated and received mechanical ventilation. These trials evaluated the sedative properties of dexmedetomidine hydrochloride in 0.9% sodium chloride injection by comparing the amount of rescue medication (midazolam in one trial and propofol in the second) required to achieve a specified level of sedation (using the standardized Ramsay Sedation Scale) between dexmedetomidine hydrochloride in 0.9% sodium chloride injection and placebo from onset of treatment to extubation or to a total treatment duration of 24 hours.

The Ramsay Level of Sedation Scale is displayed in Table 12. Table 12: Ramsay Level of Sedation Scale Clinical Score Level of Sedation Achieved 6 Asleep, no response 5 Asleep, sluggish response to light glabellar tap or loud auditory stimulus 4 Asleep, but with brisk response to light glabellar tap or loud auditory stimulus 3 Patient responds to commands 2 Patient cooperative, oriented, and tranquil 1 Patient anxious, agitated, or restless In the first study, 175 adult patients were randomized to receive placebo and 178 to receive dexmedetomidine hydrochloride in 0.9% sodium chloride injection by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 and 0.7 mcg/kg/hr) following an initial loading infusion of one mcg/kg intravenous over 10 minutes.

The study drug infusion rate was adjusted to maintain a Ramsay sedation score of ≥3. Patients were allowed to receive “rescue” midazolam as needed to augment the study drug infusion. In addition, morphine sulfate was administered for pain as needed.

The primary outcome measure for this study was the total amount of rescue medication (midazolam) needed to maintain sedation as specified while intubated. Patients randomized to placebo received significantly more midazolam than patients randomized to dexmedetomidine hydrochloride in 0.9% sodium chloride injection (see Table 13). A second prospective primary analysis assessed the sedative effects of dexmedetomidine hydrochloride in 0.9% sodium chloride injection by comparing the percentage of adult patients who achieved a Ramsay sedation score of ≥3 during intubation without the use of additional rescue medication.

A significantly greater percentage of adult patients in the dexmedetomidine hydrochloride in 0.9% sodium chloride injection group maintained a Ramsay sedation score of ≥3 without receiving any midazolam rescue compared to the placebo group (see Table 13). Table 13: Midazolam Use as Rescue Medication During Intubation (ITT) Study One Placebo (N = 175) Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (N = 178) p-value Mean Total Dose (mg) of Midazolam Standard deviation 19 mg 53 mg 5 mg 19 mg 0.0011* Categorized Midazolam Use 0 mg 43 (25%) 108 (61%) <0.001** 0–4 mg 34 (19%) 36 (20%) >4 mg 98 (56%) 34 (19%) ITT (intent-to-treat) population includes all randomized patients. * ANOVA model with treatment center. ** Chi-square.

A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the dexmedetomidine hydrochloride in 0.9% sodium chloride injection and placebo groups. On average, dexmedetomidine hydrochloride in 0.9% sodium chloride injection -treated patients received less morphine sulfate for pain than placebo-treated patients (0.47 versus 0.83 mg/h). In addition, 44% (79 of 178 patients) of dexmedetomidine hydrochloride in 0.9% sodium chloride injection patients received no morphine sulfate for pain versus 19% (33 of 175 patients) in the placebo group.

In a second s… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 92 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (dexmedetomidine hydrochloride) is not a controlled substance.

9.3Dependence The dependence potential of dexmedetomidine hydrochloride in 0.9% sodium chloride injection has not been studied in humans. However, since studies in rodents and primates have demonstrated that dexmedetomidine hydrochloride in 0.9% sodium chloride injection exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine hydrochloride in 0.9% sodium chloride injection may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see Warnings and Precautions (5.5)] .

🔒 Controlled Substance 17 words ▾

9.1Controlled Substance Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (dexmedetomidine hydrochloride) is not a controlled substance.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Animal carcinogenicity studies have not been performed with dexmedetomidine. Mutagenesis Dexmedetomidine was not mutagenic in vitro , in either the bacterial reverse mutation assay ( E. coli and Salmonella typhimurium ) or the mammalian cell forward mutation assay (mouse lymphoma). Dexmedetomidine was clastogenic in the in vitro human lymphocyte chromosome aberration test with, but not without, rat S9 metabolic activation.

In contrast, dexmedetomidine was not clastogenic in the in vitro human lymphocyte chromosome aberration test with or without human S9 metabolic activation. Although dexmedetomidine was clastogenic in an in vivo mouse micronucleus test in NMRI mice, there was no evidence of clastogenicity in CD-1 mice. Impairment of Fertility Fertility in male or female rats was not affected after daily subcutaneous injections of dexmedetomidine at doses up to 54 mcg/kg (less than the maximum recommended human intravenous dose on a mcg/m 2 basis) administered from 10 weeks prior to mating in males, and 3 weeks prior to mating and during mating in females.

13.2Animal Toxicology and/or Pharmacology There were no differences in the adrenocorticotropic hormone (ACTH)-stimulated cortisol response in dogs following a single dose of dexmedetomidine compared to saline control. However, after continuous subcutaneous infusions of dexmedetomidine at 3 mcg/kg/hr and 10 mcg/kg/hr for one week in dogs (exposures estimated to be within the clinical range), the ACTH-stimulated cortisol response was diminished by approximately 27% and 40%, respectively, compared to saline-treated control animals indicating a dose-dependent adrenal suppression.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 171 words ▾

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Animal carcinogenicity studies have not been performed with dexmedetomidine. Mutagenesis Dexmedetomidine was not mutagenic in vitro , in either the bacterial reverse mutation assay ( E. coli and Salmonella typhimurium ) or the mammalian cell forward mutation assay (mouse lymphoma). Dexmedetomidine was clastogenic in the in vitro human lymphocyte chromosome aberration test with, but not without, rat S9 metabolic activation.

In contrast, dexmedetomidine was not clastogenic in the in vitro human lymphocyte chromosome aberration test with or without human S9 metabolic activation. Although dexmedetomidine was clastogenic in an in vivo mouse micronucleus test in NMRI mice, there was no evidence of clastogenicity in CD-1 mice. Impairment of Fertility Fertility in male or female rats was not affected after daily subcutaneous injections of dexmedetomidine at doses up to 54 mcg/kg (less than the maximum recommended human intravenous dose on a mcg/m 2 basis) administered from 10 weeks prior to mating in males, and 3 weeks prior to mating and during mating in females.

📄 Package Label / Principal Display Panel 148 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL - 50 mL BOTTLE LABEL NDC 72572-127-01 Single-dose bottle. Discard unused portion. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 200 mcg/50 mL (4 mcg/mL) For Intravenous Infusion Rx Only PRINCIPAL DISPLAY PANEL - 50 mL CARTON LABEL 10 Units x 50 mL NDC 72572-127-10 Single-dose bottle.

Discard unused portion. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 200 mcg/50 mL (4 mcg/mL) For Intravenous Infusion Rx Only PRINCIPAL DISPLAY PANEL - 100 mL BOTTLE LABEL NDC 72572-128-01 Single-dose bottle. Discard unused portion.

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) For Intravenous Infusion Rx Only PRINCIPAL DISPLAY PANEL - 100 mL CARTON LABEL 8 Units x 100 mL NDC 72572-128-08 Single-dose bottle. Discard unused portion. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) For Intravenous Infusion Rx Only dexmed-50ml-container-civica dexmed-50ml-carton-civica dexmed-100ml-container-civica 100ml-label dexmed-100ml-carton-civica 100ml-carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CIVICA, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CIVICA, INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 72572-0122-25 · Civica, 72572-0128-08 · CIVICA, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.