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PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Injection, Solution, Concentrate — NDC 00404-9938-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Injection, Solution, Concentrate — NDC 0404-9938-02 (Billing 00404-9938-02)

by Henry Schein, Inc. · 1 VIAL in 1 BAG / 2 mL in 1 VIAL

This is a package of PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL Injection, Solution, Concentrate from Henry Schein, Inc., marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.

NDC 00404-9938-02
🏷️ FDA NDC (as labeled) 0404-9938-02 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 0404-9938-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0404 labeler · 9938 product · 02 package
Package marketed since
Jan 13, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0404993802 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0404-9938-02
Product NDC 0404-9938
11-digit billing NDC 00404993802
RxCUI 284397, 309710
UNII 1018WH7F9I
Application # NDA021038
SPL Set ID 9eb336de-5fa5-4b46-b40b-a7ca5a0864bd
Established class (EPC) Central alpha-2 Adrenergic Agonist
Mechanism of action Adrenergic alpha2-Agonists
Physiologic effect General Anesthesia
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-13
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance DEXMEDETOMIDINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 284397
Why two NDCs? The FDA registers this code as 0404-9938-02 — a 4-4-2 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 labeler segment → 00404-9938-02. 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

📖 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 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 mLPer 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
00404-9938-02 You're viewing this Main listing 1 VIAL in 1 BAG / 2 mL in 1 VIAL 2022-01-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dexmedetomidine HCl 100 ug/mL 00143-9532-25 Hikma 25 vials — AP FDA listed —
Precedex 100 ug/mLthis 00404-9938-02 Henry 1 vial — AP FDA listed —
Precedex 100 ug/mL 00409-1638-02 Hospira, 25 vials — AP FDA listed —
Dexmedetomidine 100 ug/mL 16729-0239-93 Accord 25 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 36000-0262-05 Baxter 5 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 42023-0146-25 Par 25 vials — AP FDA listed —
Dexmedetomidine 100 ug/mL 55150-0209-02 Eugia 25 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 57664-0596-50 Sun 25 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 63323-0421-02 Fresenius 25 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 65219-0642-02 Fresenius 25 vials — AP FDA listed —
Dexmedetomidine 200 ug/2mL 66794-0230-42 Piramal 25 vials — AP FDA listed —
Dexmedetomidine 200 ug/2mL 66794-0233-42 Piramal 25 vials — AP FDA listed —
Dexmedetomidine 100 ug/mL 67457-0251-02 Mylan 25 vials — AP FDA listed —
Dexmedetomidine 100 ug/mL 68083-0527-25 Gland 25 vials — AP FDA listed —
Dexmedetomidine 100 ug/mL 71288-0505-03 Meitheal 25 vials — AP FDA listed —
Dexmedetomidine hydrochloride 100 ug/mL 71872-7030-01 Medical 1 vial — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 71872-7031-01 Medical 1 vial — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 71872-7122-01 Medical 1 vial — AP FDA listed —
Dexmedetomidine HCl 100 ug/mL 71872-7218-01 Medical 1 vial — AP FDA listed —
Dexmedetomidine 200 ug/2mL 71872-7323-01 Medical 1 vial — AP FDA listed —
Dexmedetomidine 100 ug/mL 83634-0600-02 Avenacy 25 vials — AP FDA listed —
Dexmedetomidine 200 ug/2mL 84549-0230-42 ProPharma 2 ml — AP FDA listed —
Dexmedetomidine 100 ug/mL 84549-0505-03 ProPharma 2 ml — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 70069-0759-04 Somerset 4 vials — AP FDA listed —
Dexmedetomidine Hydrochloride 100 ug/mL 70069-0758-04 Somerset 4 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
First FDA approval
Jan 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 31, 2020 AP TE-rated RLD RS ⏳ ~5.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8455527 — method of use (U-421)
US 8455527 — method of use (U-421)
US 8455527 — method of use (U-421)
US 9616049 — drug product
US 8242158 — drug product
US 10016396 — drug product
US 9616049 — drug product
US 8338470 — drug product
US 8242158 — drug product
US 8338470 — drug product
US 8648106 — drug product
US 8648106 — drug product
US 10016396 — drug product
US 9320712 — drug product
US 8338470 — drug product
US 8242158 — drug product
US 9320712 — drug product
US 9320712 — drug product
US 9616049 — drug product
US 8648106 — drug product
US 8455527*PED — drug product
US 8242158*PED — drug product
US 8338470*PED — drug product
US 8455527*PED — drug product
US 8242158*PED — drug product
US 8338470*PED — drug product
US 8648106*PED — drug product
US 8648106*PED — drug product
US 8648106*PED — drug product
US 8242158*PED — drug product
US 8455527*PED — drug product
US 8338470*PED — drug product
US 9320712*PED — drug product
US 9320712*PED — drug product
US 9320712*PED — drug product
US 9616049*PED — drug product
US 9616049*PED — drug product
US 9616049*PED — drug product
2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (38)
PatentTypeUse codeExpires
US 8455527 ↗ Method of use U-421 Jan 4, 2032
US 8455527 ↗ Method of use U-421 Jan 4, 2032
US 8455527 ↗ Method of use U-421 Jan 4, 2032
US 9616049 ↗ Drug product — Jan 4, 2032
US 8242158 ↗ Drug product — Jan 4, 2032
US 10016396 ↗ Drug product — Jan 4, 2032
US 9616049 ↗ Drug product — Jan 4, 2032
US 8338470 ↗ Drug product — Jan 4, 2032
US 8242158 ↗ Drug product — Jan 4, 2032
US 8338470 ↗ Drug product — Jan 4, 2032
US 8648106 ↗ Drug product — Jan 4, 2032
US 8648106 ↗ Drug product — Jan 4, 2032
US 10016396 ↗ Drug product — Jan 4, 2032
US 9320712 ↗ Drug product — Jan 4, 2032
US 8338470 ↗ Drug product — Jan 4, 2032
US 8242158 ↗ Drug product — Jan 4, 2032
US 9320712 ↗ Drug product — Jan 4, 2032
US 9320712 ↗ Drug product — Jan 4, 2032
US 9616049 ↗ Drug product — Jan 4, 2032
US 8648106 ↗ Drug product — Jan 4, 2032
US 8455527*PED ↗ Drug product — Jul 4, 2032
US 8242158*PED ↗ Drug product — Jul 4, 2032
US 8338470*PED ↗ Drug product — Jul 4, 2032
US 8455527*PED ↗ Drug product — Jul 4, 2032
US 8242158*PED ↗ Drug product — Jul 4, 2032
US 8338470*PED ↗ Drug product — Jul 4, 2032
US 8648106*PED ↗ Drug product — Jul 4, 2032
US 8648106*PED ↗ Drug product — Jul 4, 2032
US 8648106*PED ↗ Drug product — Jul 4, 2032
US 8242158*PED ↗ Drug product — Jul 4, 2032
US 8455527*PED ↗ Drug product — Jul 4, 2032
US 8338470*PED ↗ Drug product — Jul 4, 2032
US 9320712*PED ↗ Drug product — Jul 4, 2032
US 9320712*PED ↗ Drug product — Jul 4, 2032
US 9320712*PED ↗ Drug product — Jul 4, 2032
US 9616049*PED ↗ Drug product — Jul 4, 2032
US 9616049*PED ↗ Drug product — Jul 4, 2032
US 9616049*PED ↗ Drug product — Jul 4, 2032
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

💡 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.

Manufacturer & labeler

LabelerHenry Schein, Inc.
Application holderHOSPIRA INC
FDA applicationNDA021038 (NDA)
Labeler code00404
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio172 products on file

More NDCs from Henry Schein, Inc. labeler code 00404

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 180 words ▾

1 INDICATIONS AND USAGE

1.1Intensive Care Unit Sedation PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours. PRECEDEX has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation.

It is not necessary to discontinue PRECEDEX prior to extubation.

1.2Procedural Sedation PRECEDEX is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. PRECEDEX is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. PRECEDEX is a alpha 2 -adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.

Administer Precedex by continuous infusion not to exceed 24 hours. (1.1) Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.2) Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures.

(1.2)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION

2.1Administration Instructions PRECEDEX dosing should be individualized and titrated to desired clinical response. PRECEDEX is not indicated for infusions lasting longer than 24 hours. PRECEDEX 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 mcg/kg/ hour 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 mcg/kg/ hour 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)]. Table 2: Recommended Dosage in Pediatric Patients Initiation of Sedation During Non‑invasive Procedures For pediatric patients: •1 month to less than 2 years: a loading infusion of 1.5 mcg/kg over 10 minutes. •2 to less than 18 years: a loading infusion of 2 mcg/kg over 10 minutes. Consider a reduction in dosage if clinically indicated.

Maintenance of Sedation During Non-invasive Procedures For pediatric patients: •1 month to less than 18 years: the maintenance infusion is generally initiated at 1.5 mcg/kg/ hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 mcg/kg/ hour to 1.5 mcg/kg/ hour . As clinically warranted, titrate the maintenance dose to individual patient clinical response.

2.3Dosage Adjustment Due to possible pharmacodynamic interactions, a reduction in dosage of PRECEDEX or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [see Drug Interactions (7.1)]. Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients [see Warnings and Precautions (5.9), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.4Preparation of Solution Strict aseptic technique must always be maintained during handling of PRECEDEX. Parenteral drug products should be inspected visu… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 205 words ▾

3 DOSAGE FORMS AND STRENGTHS PRECEDEX Presentations Requiring Dilution: PRECEDEX (dexmedetomidine hydrochloride) injection is a clear and colorless solution, to be used after dilution. It is available as: •200 mcg/2 mL (100 mcg/mL) single-dose vial. PRECEDEX Presentations that are Ready To Use: PRECEDEX (dexmedetomidine hydrochloride) in 0.9% sodium chloride injection is a clear and colorless solution, ready to use.

It is available as: •PRECEDEX 80 mcg/20 mL (4 mcg/mL) single-dose vial. •PRECEDEX 200 mcg/50 mL (4 mcg/mL) single-dose glass bottle. •PRECEDEX 400 mcg/100 mL (4 mcg/mL) single-dose glass bottle. •PRECEDEX 1,000 mcg/250 mL (4 mcg/mL) single-dose glass bottle. •PRECEDEX 200 mcg/50 mL (4 mcg/mL) single-dose flexible container. •PRECEDEX 400 mcg/100 mL (4 mcg/mL) single-dose flexible container. •PRECEDEX 1,000 mcg/250 mL (4 mcg/mL) single-dose flexible container. Precedex Injection, 200 mcg/2 mL (100 mcg/mL) in a glass vial.

To be used after dilution. (3) Precedex in 0.9% Sodium Chloride Injection 80 mcg/20 mL (4 mcg/mL) in a 20 mL glass vial. Ready to use.

(3) Precedex in 0.9% Sodium Chloride Injection 200 mcg/50 mL (4 mcg/mL) in a 50 mL glass bottle. Ready to use. (3) Precedex in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) in a 100 mL glass bottle.

Ready to use. (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None None. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS

5.1Drug Administration PRECEDEX 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 PRECEDEX, patients should be continuously monitored while receiving PRECEDEX.

5.2Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with PRECEDEX 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 PRECEDEX infusion. Some of these cases have resulted in fatalities.

If medical intervention is required, treatment may include decreasing or stopping the infusion of PRECEDEX, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because PRECEDEX 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 PRECEDEX-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering PRECEDEX to patients with advanced heart block and/or severe ventricular dysfunction.

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

5.3Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of PRECEDEX. 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 PRECEDEX have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.

5.5Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) PRECEDEX adult subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) PRECEDEX adult subjects experienced at least 1 event 24 to 48 hours after end of study drug. The most common events were nausea, vomiting, and agitation [see Adverse Reactions (6.1)]. In adult subjects, tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%.

Procedural Sedation In adult subjects, withdrawal symptoms were not seen after discontinuation of short‑term infusions of PRECEDEX (<6 hours). In pediatric patients, mild transient withdrawal symptoms of emergence delirium or agitation were seen after discontinuation of short‑term infusions of PRECEDEX (<2 hours) [see Adverse Reactions (6.1)].

5.6Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose‑related increase in adverse reactions [see Adverse Reactions (6.1)].

5.7Hyperthermia or Pyrexia PRECEDEX may induce hyperthermia or pyrexia, which may be resistant to traditional cooling methods, such as administration of cooled intravenous fluids and a… [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)]

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Most common treatment-emergent adverse reactions, occurring in greater than 2% of 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 PRECEDEX for sedation in the Intensive Care Unit setting in which 1,007 adult patients received PRECEDEX.

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 Precedex (N = 1007) (%) Randomized Precedex (N = 798) (%) Placebo (N = 400) (%) Propofol (N = 188) (%) *26 subjects in the all PRECEDEX group and 10 subjects in the randomized PRECEDEX group had exposure for greater than 24 hours. 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% Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of PRECEDEX for sedation in the surgical intensive care unit setting in which 387 adult patients received PRECEDEX 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% Acidosis 2% 2% Pleural Effusion 2% 1% Oliguria 2% <1% Thirst 2% <1% In a controlled clinical trial, PRECEDEX was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients.

Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 5. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by mainten… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 141 words ▾

7 DRUG INTERACTIONS

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

However, due to possible pharmacodynamic interactions, when co-administered with PRECEDEX, a reduction in dosage of PRECEDEX or the concomitant anesthetic, sedative, hypnotic or opioid may be required.

7.2Neuromuscular Blockers In one study of 10 healthy adult volunteers, administration of PRECEDEX 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. Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of Precedex or the concomitant medication may be required. (7.1)

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS SECTION 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 mother's clinical need for PRECEDEX and any potential adverse effects on the breastfed infant from PRECEDEX or from the underlying condition. Data In two published clinical s… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 178 words ▾

10 OVERDOSAGE The tolerability of PRECEDEX was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 mcg/kg/hr 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 PRECEDEX 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 PRECEDEX (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 Precedex is a relatively selective alpha2-adrenergic agonist with sedative properties. Alpha2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10-300 mcg/kg). Both alpha1 and alpha2 activity is observed following slow intravenous infusion of high doses (1000 mcg/kg) or with rapid intravenous administration.

12.2Pharmacodynamics In a study in healthy volunteers (N = 10), respiratory rate and oxygen saturation remained within normal limits and there was no evidence of respiratory depression when Precedex was administered by intravenous infusion at doses within the recommended dose range (0.20.7 mcg/kg/hr).

12.3Pharmacokinetics Following intravenous administration, dexmedetomidine exhibits the following pharmacokinetic parameters: a rapid distribution phase with a distribution half-life (t1/2) of approximately 6 minutes; a terminal elimination half-life (t1/2) of approximately 2 hours; and steady-state volume of distribution (Vss) 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 mcg/kg/hr 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 PRECEDEX 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 8: Mean ± SD Pharmacokinetic Parameters Abbreviations: 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. 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 ±

0.20The 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 PRECEDEX maintenance doses of 0.2 mcg/kg/hr to 1.4 mcg/kg/hr for >24 hours were similar to the pharmacokinetic (PK) parameters after PRECEDEX 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 TElimination Metabolism Dexmedetomidine undergoes almost complete biotransformation with very little unchanged dexmedetomidine excreted in urine and feces. Biotransformation involves both direct glucuronidation as well as cytochrome P450 mediated metabolism.

The major metabolic pathways of dexmedetomidine are: direct N-glucuronidation to inactive metabolites; aliphatic hydroxylation (mediated primarily by CYP2A6 with a minor role of CYP1A2, CYP2E1, CYP2D6 and CYP2C19) of dexmedetomidine to generate 3-hydroxy-dexmedetomidine, the glucuronide of 3-hydroxy-dexmedetomidine, and 3-carboxy-dexmedetomidine; and N-methylation of dexmedetomidine to generate 3-hydroxy N-methyl-dexmedetomidine, 3-carboxy N-methyl-dexmedetomidine, and dexmedetomidine-N-methyl O-glucuronide. Excretion The terminal elimination half-life (t1/2) of dexmedetomidine is ap… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 153 words ▾

HOW SUPPLIED/STORAGE AND HANDLING Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Do not use if product is discolored or if precipitate matter is present. PRECEDEX (dexmedetomidine hydrochloride) injection 200 mcg/2 mL (100 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base.

Discard unused portion. PRECEDEX (dexmedetomidine hydrochloride in 0.9% Sodium Chloride) injection (4 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base.

Discard unused portion. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-1638-02 Tray of 25 single-dose clear glass vials NDC 0404-9938-02 1 2 mL single-dose clear glass vial in a bag (Vial bears NDC 0409-1638-32) 200 mcg/2 mL (100 mcg/mL) Image8.jpg Image9.jpg

📋 Description ~1 min read ▾

11 Description PRECEDEX (dexmedetomidine hydrochloride) injection (100 mcg/mL) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. PRECEDEX (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection (4 mcg/mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. PRECEDEX 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 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S).

Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C 13 H 16 N •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. PRECEDEX Injection 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.

PRECEDEX 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) and 9 mg sodium chloride in water for injection.

The solution is preservative-free and contains no additives or chemical stabilizers. Formula1.jpg

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and efficacy of PRECEDEX 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 PRECEDEX 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 PRECEDEX 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. In the first study, 175 adult patients were randomized to receive placebo and 178 to receive PRECEDEX by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 mcg/kg/hr 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 PRECEDEX (see Table 13). A second prospective primary analysis assessed the sedative effects of PRECEDEX 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 PRECEDEX group maintained a Ramsay sedation score of ≥3 without receiving any midazolam rescue compared to the placebo group (see Table 13).

A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the PRECEDEX and placebo groups. On average, PRECEDEX-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 PRECEDEX patients received no morphine sulfate for pain versus 19% (33 of 175 patients) in the placebo group.

In a second study, 198 adult patients were randomized to receive placebo and 203 to receive PRECEDEX by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 mcg/kg/hr and 0.7 mcg/kg/hr) following an initial loading infusion of one mcg/kg intravenous over 10 minutes. The study drug infusion was adjusted to maintain a Ramsay sedation score of ≥3. Patients were allowed to receive "rescue" propofol as needed to augment the study drug infusion.

In addition, morphine sulfate was administered as needed for pain. The primary outcome measure for this study was the total amount of rescue medication (propofol) needed to maintain sedation as specified while intubated. Adult patients randomized to placebo received significantly more propofol than adult patients randomized to PRECEDEX (see Table 14).

A significantly greater percentage of adult patients in the PRECEDEX group compared to the placebo group maintained a Ramsay sedation score of ≥3 without receiving any propofol rescue (see Table 14). A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the PRECEDEX and placebo groups. On average, PRECEDEX-treated patients received less morphine sulfate for pain than placebo-treated patients (0.43 versus 0.89 mg/h).

In addition, 41% (83 of 203 patients) of PRECEDEX patients received no morphine sulfate for pain versus 15% (30 of 198 patient… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 67 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance PRECEDEX (dexmedetomidine hydrochloride) is not a controlled substance.

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

🧪 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.

📄 Recent Major Changes 11 words ▾

RECENT MAJOR CHANGES Dosage and Administration, Preparation of Solution (2.4) 10/2024

📄 Package Label / Principal Display Panel 4 words ▾

Sample Package Label Label1.jpg

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PRECEDEX (this brand).

Top reported reactions

Bradycardia249
Hypotension176
Cardiac Arrest168
Pyrexia115
Pneumonia99
Respiratory Failure86
Drug Interaction85

Reporter sex

0 reports

Serious outcomes

Life-threatening627
Death457
Disabling68
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 270 80
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

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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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Henry Schein, 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.
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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.