Home › NDC Lookup › Ingredients › Dexmedetomidine Hydrochloride › 42023-0187-10

Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution

by Par Health USA, LLC · 10 VIAL in 1 CARTON (42023-187-10) / 100 mL in 1 VIAL

NDC 42023-0187-10

🏷️ FDA NDC (as labeled) 42023-187-10 billing pads the product segment with a zero

Rx only Generic On market Non-controlled ⚠ On shortage

🗂️ Data synced 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 Dr. Brian Staiger, PharmD

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 (Other). Unavailable Shortage details →

⚠️

Other active recalls for Dexmedetomidine Hydrochloride (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0810-2026

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 42023-187-10

Product NDC 42023-187

11-digit billing NDC 42023018710

NCPDP billing unit ML — per mL (volume)

RxCUI 309710, 1718906, 1718909

UNII 1018WH7F9I

Application # ANDA208266

SPL Set ID 1ee59985-4c1d-48f7-b8f9-5584c2d55e08

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 2020-12-04

Route INTRAVENOUS

Dosage form INJECTION, SOLUTION

Substance DEXMEDETOMIDINE HYDROCHLORIDE

GPI-14 60206030202040

GPI class Dexmedetomidine HCl in NaCl

GCN Seq No 070877

GCN 34539

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 DEXMEDETOMIDIN 400MCG/100ML-NS

FDB brand name Dexmedetomidine-0.9% Nacl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 42023-187-10 — 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 → 42023-0187-10. 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.

🏭 Manufacturer & labeler

LabelerPar Health USA, LLC

Application holderPH HEALTH LTD

FDA applicationANDA208266 (ANDA)

Labeler code42023

First marketedDec 2020

Product typeHuman Prescription Drug

Portfolio210 products on file

🔎 All NDCs from Par Health USA, LLC

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.

🩺 Clinical

Label name DEXMEDETOMIDIN 400MCG/100ML-NS Ingredient Dexmedetomidine In 0.9 % Nacl

📖 What it is MedlinePlus · NLM

Dexmedetomidine is used to provide short-term sedation (you are relaxed, sleepy or in some cases asleep) for surgical procedures or during mechanical ventilation. Dexmedetomidine is in a class of medications called alpha2 receptor agonists. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Dexmedetomidine is used to keep patients calm and comfortable when they need a breathing machine or are going through a stressful procedure in a hospital setting. It helps reduce a...
Why is my loved one getting dexmedetomidine in the ICU?
Yes — low blood pressure and a slow heart rate are the most common serious risks with this medication. Your care team knows this and will continuously monitor your heart rate, bloo...
Can dexmedetomidine cause my heart rate or blood pressure to drop dangerously low?

📖 Read our full Dexmedetomidine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

9 mg / 1 mL UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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 system	Per mL	Per 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Dexmedetomidine Hydrochloride 4 ug/mL 00143-9525-10	Hikma	10 pouches	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 400 ug/100mL 00338-9557-12	Baxter	100 ml	—	AP	FDA listed	—
Precedex 4 ug/mL 00409-0155-02	Hospira,	10 bottles	—	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 00409-1660-10	Hospira,	10 bottles	—	AP	FDA listed	—
Precedex 4 ug/mL 00409-7853-24	Hospira,	24 pouches	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 4 ug/mL 00781-3495-95	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 25021-0617-82	Sagent	100 ml	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mLthis 42023-0187-10	Par	10 vials	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride 400 ug/100mL 43066-0557-12	Baxter	100 ml	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 400 ug/100mL 43066-0565-12	Baxter	100 ml	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 43598-0975-58	Dr.Reddy's	10 vials	—	AP	FDA listed	—
Dexmedetomidine in Dextrose 4 ug/mL 44567-0603-24	WG	100 ml	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 52536-0126-08	Wilshire	8 bottles	—	—	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 55150-0297-10	Eugia	10 pouches	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 63323-0671-00	Fresenius	10 bottles	—	AP	Discontinued	—
Dexmedetomidine Hydrochloride 4 ug/mL 66794-0235-41	Piramal	10 vials	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 400 ug/100mL 67457-0925-10	Mylan	10 bottles	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0239-10	Gland	10 vials	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0657-10	Gland	10 pouches	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride in Sodium Chloride 4 ug/mL 68094-0247-10	Precision	10 bottles	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 70121-1389-07	Amneal	10 bottles	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 70121-1712-03	Amneal	12 pouches	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 71225-0126-04	Slayback	10 vials	—	—	Discontinued	—
Dexmedetomidine Hydrochloride 4 ug/mL 72572-0128-08	CIVICA,	8 bottles	—	—	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	—
Precedex 4 ug/mL 00409-3301-10	Hospira,	10 vials	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 72572-0127-10	CIVICA,	10 bottles	—	—	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 43598-0976-58	Dr.Reddy's	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 00409-4596-20	Hospira,	20 bottles	—	AP	FDA listed	—
Precedex 4 ug/mL 00409-7838-24	Hospira,	24 pouches	—	AP	FDA listed	—
Precedex 4 ug/mL 00409-7875-12	Hospira,	12 pouches	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 00143-9198-10	Hikma	250 ml	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 66794-0234-44	Piramal	20 vials	—	AP	FDA listed	—
Precedex 4 ug/mL 00409-1434-01	Hospira,	1 bottle	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 00143-9526-10	Hikma	10 pouches	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 42023-0186-20	Par	20 vials	—	AP	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 52536-0125-10	Wilshire	10 bottles	—	—	FDA listed	—
Dexmedetomidine Hydrochloride 4 ug/mL 68083-0238-20	Gland	20 vials	—	AP	FDA listed	—
Precedex 4 ug/mL 00409-1454-20	Hospira,	20 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

🏛️

2020

On the market since

Dec 2020

📍

2026

Currently FDA-listed

6 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
42023-0187-10 You're viewing this	10 VIAL in 1 CARTON (42023-187-10) / 100 mL in 1 VIAL	2020-12-04	Active

🧭 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	✓ Available
Inactive ingredients (structured)	✓ 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	✓ Available
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 FDA registers it as 42023-187-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 42023-0187-10, written without dashes as 42023018710. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 42023-0187-10, the first segment (42023) is the labeler code FDA assigned to Par Health USA, LLC; the middle segment (0187) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Par Health USA, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Par Health USA, LLC 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 194 words ▾

1 INDICATIONS AND USAGE Dexmedetomidine hydrochloride 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 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 injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine hydrochloride 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 injection prior to extubation.

1.2Procedural Sedation Dexmedetomidine hydrochloride 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™ (dexmedetomidine hydrochloride) injection and PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

⏱️ Dosage and Administration ~3 min read ▾

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/2 mL (100 mcg/mL) vial contents in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) prior to administration.

( 2.4 ) The 200 mcg/50 mL and 400 mcg/100 mL single-dose vials 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 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.

2.2Recommended 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 )].

Pediatric use information is approved for Hospira Inc.’s PRECEDEX™ (dexmedetomidine hydrochloride) injection and PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusi…

💊 Dosage Forms and Strengths 154 words ▾

3 DOSAGE FORMS AND STRENGTHS Dexmedetomidine Injection, USP 200 mcg/2 mL (100 mcg/mL) in a single-dose glass vial. To be used after dilution. ( 3 ) Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg/mL) in a single-dose glass vial.

Ready to use. ( 3 ) Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4 mcg/mL) in a single-dose glass vial. Ready to use.

( 3 ) Dexmedetomidine Hydrochloride Injection is clear and colorless and is available as follows: Dexmedetomidine Injection, USP Dexmedetomidine Injection, 200 mcg dexmedetomidine/2 mL (100 mcg/mL) in a single-dose glass vial. To be used after dilution. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 mcg dexmedetomidine/50 mL (4 mcg/mL) in a single-dose glass vial.

Ready to use. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg dexmedetomidine/100 mL (4 mcg/mL) in a single-dose glass vial. Ready to use.

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Monitoring : Continuously monitor patients while receiving dexmedetomidine hydrochloride 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 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, patients should be continuously monitored while receiving dexmedetomidine hydrochloride.

5.2Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine hydrochloride 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 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, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because dexmedetomidine hydrochloride 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 to patients with advanced heart block and/or severe ventricular dysfunction.

Because dexmedetomidine hydrochloride 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 an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with dexmedetomidine hydrochloride.

5.3Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of dexmedetomidine hydrochloride. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.

5.4Arousability Some patients receiving dexmedetomidine hydrochloride have been observed to be arousa…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 ) For medical advice about adverse reactions contact your medical professional.

To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 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 )]

6.1Clinical 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 for sedation in the Intensive Care Unit setting in which 1,007 adult patients received dexmedetomidine.

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 (N = 1007) (%) Randomized Dexmedetomidine (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 group and 10 subjects in the randomized dexmedetomidine group had exposure for greater than 24 hours.

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of dexmedetomidine for sedation in the surgical intensive care unit setting in which 387 adult patients received dexmedetomidine 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 Dexmedetomidine (N = 387) Placebo (N = 379) Hypotension 28% 13% Hypertension 16% 18% Nausea 11% 9% Bradycardia 7% 3% Fever 5% 4% Vomiting 4% 6% Atrial Fibrillation 4% 3% Hypoxia 4% 4% Tachycardia 3% 5% Hemorrhage 3% 4% Anemia 3% 2% Dry Mouth 3% 1% Rigors 2% 3% Agitation 2% 3% Hyperpyrexia 2% 3% Pain 2% 2% Hyperglycemia 2% 2…

🔄 Drug Interactions 153 words ▾

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 )

7.1Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine hydrochloride 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 and isoflurane, propofol, alfentanil and midazolam have been demonstrated.

However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine hydrochloride injection, a reduction in dosage of dexmedetomidine hydrochloride 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 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 ) Pediatric use information is approved for Hospira Inc.’s PRECEDEX™ (dexmedetomidine hydrochloride) injection and PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection.

However, due to Hospira Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

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 admin…

🤰 Pregnancy ~3 min read ▾

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 repro…

🧒 Pediatric Use 133 words ▾

8.4Pediatric Use Sedation for Non-Invasive Procedures The safety and effectiveness of dexmedetomidine hydrochloride have not been established in pediatric patients less than 1 month of age. Pediatric use information is approved for Hospira Inc.’s PRECEDEX™ (dexmedetomidine hydrochloride) injection and PRECEDEX™ (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

ICU Sedation The safety and efficacy of dexmedetomidine hydrochloride 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 for these patient populations.

🧓 Geriatric Use 184 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 [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) ]. P r o ce dural 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-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 180 words ▾

10 OVERDOSAGE The tolerability of dexmedetomidine hydrochloride 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 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 (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 is a relatively selective centrally acting 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 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 10 shows the main pharmacokinetic parameters when dexmedetomidine hydrochloride 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 maintenance doses of 0.2 to 1.4 mcg/kg/hr for >24 hours were similar to the pharmacokinetic (PK) parameters after dexmedetomidine hydrochloride 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 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…

🧬 Mechanism of Action 60 words ▾

📦 How Supplied / Storage and Handling 156 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING D exmedetomidine Injection, USP NDC 42023-146-25: 200 mcg/2 mL (100 mcg/mL) is clear and colorless, and available in 2 mL clear glass vials supplied in packages of twenty-five. The strength is based on the dexmedetomidine base. Vials are intended for single-dose only.

Discard unused portion. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection NDC 42023-186-20: 200 mcg/50 mL (4 mcg/mL) is clear and colorless, and available in 50 mL clear glass vials supplied in packages of twenty. NDC 42023-187-10: 400 mcg/100 mL (4 mcg/mL) is clear and colorless, and available in 100 mL clear glass vials supplied in packages of ten.

The strength is based on the dexmedetomidine base. Vials are intended for single-dose only. Discard unused portion.

Vial stoppers do not contain natural rubber latex. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature.) Do not use if product is discolored or if precipitate matter is present.

📦 Storage and Handling 26 words ▾

Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature.) Do not use if product is discolored or if precipitate matter is present.

📋 Description ~1 min read ▾

11 DESCRIPTION Dexmedetomidine Injection, USP is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-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 Injection, USP is intended to be used after dilution.

It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride (equivalent to 100 mcg or 0.1 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers.

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 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg sodium chloride in water for injection.

The solution is preservative-free and contains no additives or chemical stabilizers. Chemical Structure

💬 Information for Patients 136 words ▾

17 PATIENT COUNSELING INFORMATION Dexmedetomidine hydrochloride 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 and as clinically appropriate after discontinuation.

When dexmedetomidine hydrochloride 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 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 to monitor breastfed neonates for irritability [see Use in Specific Populations ( 8.2 )].

Glossary — plain-language definitions of medical terms used in this label:

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

sedative: A substance with a calming effect that can also cause drowsiness.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

atelectasis: A partial or complete collapse of a lung or part of a lung, so its air sacs cannot fill with air.

atrial fibrillation: An irregular, often fast heart rhythm coming from the heart's upper chambers, which can raise the risk of blood clots.

atrioventricular block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

bolus: A single dose given all at once, often as a quick push into a vein.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crosses the placenta: When a substance passes from a pregnant mother's blood, through the placenta, and into the developing baby.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

displacement: When one medicine knocks another off the blood proteins it was riding on, briefly raising the free, active amount of the second medicine.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypocalcemia: A lower-than-normal level of calcium, a mineral, in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

hypoxia: A condition in which the body's tissues do not get enough oxygen.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

linear pharmacokinetics: When blood levels of a medicine rise in direct proportion to the size of the dose.

loading dose: A larger dose given at the start to quickly build the medicine up to an effective level in the body.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

oxygen saturation: A measurement, shown as a percentage, of how much oxygen the red blood cells are carrying.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pleural effusion: A buildup of fluid in the space between the lungs and the chest wall.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

pyrexia: A raised body temperature; a fever.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

respiratory failure: A serious condition in which the lungs cannot get enough oxygen into the blood or remove enough carbon dioxide.

sedation: A calm, sleepy, slowed-down state caused by a medicine that relaxes the brain and body.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tachyphylaxis: A rapid drop in a medicine's effect after repeated doses given close together, so it quickly stops working as well.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

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

← 42023-0186-20 · Par 42023-0188-10 · Par →

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.

Dexmedetomidine Hydrochloride 4 ug/mL Injection, Solution

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