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Rocuronium Bromide 50 mg/5mL Injection — NDC 00264-5711-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rocuronium Bromide 50 mg/5mL Injection — NDC 0264-5711-10 (Billing 00264-5711-10)

by B. Braun Medical Inc. · 30 BOX in 1 CASE / 10 SYRINGE in 1 BOX / 5 mL in 1 SYRINGE

This is a package of Rocuronium Bromide 50 mg/5mL Injection from B. Braun Medical Inc., marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 00264-5711-10
🏷️ FDA NDC (as labeled) 0264-5711-10 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 20, 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 0264-5711-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0264 labeler · 5711 product · 10 package
Package marketed since
May 21, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0264571110 6
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0264-5711-10
Product NDC 0264-5711
11-digit billing NDC 00264571110
NCPDP billing unit ML — per mL (volume)
RxCUI 2740933
UNII I65MW4OFHZ
Application # NDA219108
SPL Set ID a54a79f7-5207-43d8-a139-7d57557caa50
Established class (EPC) Nondepolarizing Neuromuscular Blocker
Physiologic effect Neuromuscular Nondepolarizing Blockade
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-21
Route INTRAVENOUS
Dosage form INJECTION
Substance ROCURONIUM BROMIDE
Quick answers
  • RxCUI (RxNorm): 2740933
Why two NDCs? The FDA registers this code as 0264-5711-10 — 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 → 00264-5711-10. 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 Nondepolarizing Neuromuscular Blocker class.

Pharmacologic class Nondepolarizing Neuromuscular Blocker
Drug family (ATC) Other quaternary ammonium compounds
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

📗 Our plain-language guide HelloPharmacist
  • It relaxes your muscles during general anesthesia. That helps the team place a breathing tube and keeps you still during surgery or while you are on a ventilator. You will also be...
  • Only through an IV by trained anesthesia staff in a hospital or surgical setting. You won't take it yourself. They adjust the dose for you and use a nerve stimulator to track how i...
  • Most people notice little. Temporary changes in blood pressure are the most common effect. Less often, people have a fast heartbeat, nausea, vomiting, rash, itching or hiccups. You...
  • Tell them about any past allergic reaction to a muscle relaxant. Also mention myasthenia gravis, liver disease, heart or lung blood vessel problems, and any medicines you take, suc...
📖 Read our full Rocuronium guide →

Supplement & herbal interactions

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

Pricing

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

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00264-5711-10 You're viewing this Main listing 30 BOX in 1 CASE / 10 SYRINGE in 1 BOX / 5 mL in 1 SYRINGE 2026-05-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rocuronium Bromide 50 mg/5mL 70756-0669-10 Lifestar 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 50 mg/5mL 43066-0007-10 Baxter 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 50 mg/5mL 43547-0530-10 Solco 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 50 mg/5mL 55150-0225-05 Eugia 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 50 mg/5mLthis 00264-5711-10 B. 10 syringes — — FDA listed —
Rocuronium Bromide 50 mg/5mL 71872-7262-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 50 mg/5mL 82449-0001-02 STERISCIENCE 10 vials — AP FDA listed —
Rocuronium Bromide 50 mg/5mL 42677-0309-10 Shandong 10 vials — AP FDA listed —
Rocuronium Bromide 50 mg/5mL 51662-1546-01 HF 5 ml — AP FDA listed —
Rocuronium Bromide 50 mg/5mL 43066-0507-05 Baxter 1 syringe — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2025
First FDA approval
Oct 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 24, 2025 RLD RS ⏳ ~12.8 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 11998605 — drug product
2025 2027 2029 2031 2033 2035 2037 2039
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 (1)
PatentTypeUse codeExpires
US 11998605 ↗ Drug product — Jul 22, 2039
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.

🧪 Avoiding an ingredient? See Rocuronium inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII WQ29KQ9POT
    Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.

4 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

LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA219108 (NDA)
Labeler code00264
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio95 products on file

More NDCs from B. Braun Medical Inc. labeler code 00264

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 71 words ▾

1 INDICATIONS AND USAGE ROCURONIUM BROMIDE INJECTION is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. ROCURONIUM BROMIDE INJECTION is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION To be administered only by experienced clinicians or adequately trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents ( 2.1 ) ROCURONIUM BROMIDE INJECTION is for intravenous use only Individualize the dose for each patient ( 2.1 ) Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery ( 2.1 ) Store ROCURONIUM BROMIDE INJECTION in a manner that minimizes the possibility of selecting the wrong product ( 2.1 ) Tracheal intubation: Recommended initial dose is 0.6 mg/kg ( 2.2 ) Rapid sequence intubation: 0.6 mg/kg to 1.2 mg/kg ( 2.3 ) Maintenance doses: Guided by response to prior dose, not administered until recovery is evident ( 2.4 ) Continuous infusion: Initial rate of 10 mcg/kg/min to 12 mcg/kg/min.

Start only after early evidence of spontaneous recovery from an intubating dose ( 2.5 )

2.1Important Dosing and Administration Information ROCURONIUM BROMIDE INJECTION is for intravenous use only. This drug should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics and complications of neuromuscular blocking agents. Doses of ROCURONIUM BROMIDE INJECTION should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.

The dosage information which follows is derived from studies based upon units of drug per unit of body weight. It is intended to serve as an initial guide to clinicians familiar with other neuromuscular blocking agents to acquire experience with rocuronium bromide. In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [see Dosage and Administration (2.6) , Warnings and Precautions ( 5.10 , 5.13 ), Drug Interactions ( 7.2 , 7.3 , 7.4 , 7.5 , 7.6 , 7.8 , 7.10 ), Use in Specific Populations ( 8.6 )] .

Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store ROCURONIUM BROMIDE INJECTION in prefilled syringe within its sealed unit box in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions (5.3) ] .

2.2Dose for Tracheal Intubation The recommended initial dose of rocuronium bromide, regardless of anesthetic technique, is 0.6 mg/kg. Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1 (0.4 to 6) minute(s) and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 3 minutes.

This dose may be expected to provide 31 (15 to 85) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. Under halothane, isoflurane, and enflurane anesthesia, some extension of the period of clinical relaxation should be expected [see Drug Interactions (7.3) ] . A lower dose of rocuronium bromide (0.45 mg/kg) may be used.

Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1.3 (0.8 to 6.2) minute(s) and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 4 minutes. This dose may be expected to provide 22 (12 to 31) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia.

Patients receiving this low dose of 0.45 mg/kg who achieve less than 90% block (about 16% of these patients) may have a more rapid time to 25% recovery, 12 to 15 minutes. A large bolus dose of 0.9 mg/kg or 1.2 mg/kg can be administered under opioid/nitrous oxide/oxygen anesthesia without adverse effects to the cardiovascular system [see Cli… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 50 mg/5 mL (10 mg/mL) rocuronium bromide as a clear, colorless to yellowish solution in single-dose luer-lock prefilled glass syringes. Injection: 50 mg/5 mL (10 mg/mL) rocuronium bromide ( 3 )

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see Warnings and Precautions (5.2) ] . Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Appropriate Administration and Monitoring: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available ( 5.1 ) Anaphylaxis: Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents ( 5.2 ) Risk of Death due to Medication Errors: Accidental administration can cause death ( 5.3 ) Need for Adequate Anesthesia: Must be accompanied by adequate anesthesia or sedation ( 5.4 ) Residual Paralysis: Consider using a reversal agent in cases where residual paralysis is more likely to occur ( 5.5 )

5.1Appropriate Administration and Monitoring Rocuronium bromide should be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are familiar with the drug’s actions and the possible complications of its use. The drug should not be administered unless facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. It is recommended that clinicians administering neuromuscular blocking agents such as rocuronium bromide employ a peripheral nerve stimulator to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.

5.2Anaphylaxis Severe anaphylactic reactions to neuromuscular blocking agents, including rocuronium bromide, have been reported. These reactions have, in some cases (including cases with rocuronium bromide) been life threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken.

Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents, since cross-reactivity between neuromuscular blocking agents, both depolarizing and nondepolarizing, has been reported.

5.3Risk of Death due to Medication Errors Administration of ROCURONIUM BROMIDE INJECTION results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated.

5.4Need for Adequate Anesthesia Rocuronium bromide has no known effect on consciousness, pain threshold, or cerebration. Therefore, its administration must be accompanied by adequate anesthesia or sedation.

5.5Residual Paralysis In order to prevent complications resulting from residual paralysis, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Geriatric patients (65 years or older) may be at increased risk for residual neuromuscular block. Other factors which could cause residual paralysis after extubation in the post-operative phase (such as drug interactions or patient condition) should also be considered.

If not used as part of standard clinical practice the use of a reversal agent should be considered, especially in those cases where residual paralysis is more likely to occur.

5.6Long-Term Use in an Intensive Care Unit Rocuronium bromide has not been studied for long-term use in the intensive care unit (ICU). As with other nondepolarizing neuromuscular blocking drugs, apparent tolerance to rocuronium bromide may develop during chronic administration in the ICU. While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor.

It is strongly recommended that neuromuscular transmission be monitored continuously during administration and recovery with the help of a nerve stimulator. Additional doses o… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension. The following adverse reactions are described, or described in greater detail, in other sections: Anaphylaxis [see Warnings and Precautions (5.2) ] Residual paralysis [see Warnings and Precautions (5.5) ] Myopathy [see Warnings and Precautions (5.6) ] Increased pulmonary vascular resistance [see Warnings and Precautions (5.12) ] Most common adverse reactions (2%) are transient hypotension and hypertension To report SUSPECTED ADVERSE REACTIONS, contact B.Braun Medical Inc at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction 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. Clinical studies in the U.S. (n=1137) and Europe (n=1394) totaled 2531 patients.

The patients exposed in the U.S. clinical studies provide the basis for calculation of adverse reaction rates. The following adverse reactions were reported in patients administered rocuronium bromide (all events judged by investigators during the clinical trials to have a possible causal relationship): Adverse reactions in greater than 1% of patients: None Adverse reactions in less than 1% of patients (probably related or relationship unknown): Cardiovascular: arrhythmia, abnormal electrocardiogram, tachycardia Digestive: nausea, vomiting Respiratory: asthma (bronchospasm, wheezing, or rhonchi), hiccup Skin and Appendages: rash, injection site edema, pruritus In the European studies of another ROCURONIUM BROMIDE INJECTION product, the most commonly reported reactions were transient hypotension (2%) and hypertension (2%); these are in greater frequency than the U.S. studies (0.1% and 0.1%).

Changes in heart rate and blood pressure were defined differently from in the U.S. studies in which changes in cardiovascular parameters were not considered as adverse events unless judged by the investigator as unexpected, clinically significant, or thought to be histamine related. In a clinical study in patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft, hypertension and tachycardia were reported in some patients, but these occurrences were less frequent in patients receiving beta or calcium channel-blocking drugs.

In some patients, rocuronium bromide was associated with transient increases (30% or greater) in pulmonary vascular resistance. In another clinical study of patients undergoing abdominal aortic surgery, transient increases (30% or greater) in pulmonary vascular resistance were observed in about 24% of patients receiving rocuronium bromide 0.6 or 0.9 mg/kg. In pediatric patient studies worldwide (n=704), tachycardia occurred at an incidence of 5.3% (n=37) and it was judged by the investigator as related in 10 cases (1.4%).

6.2Post-Marketing Experience The following adverse reactions have been identified during post-approval use of ROCURONIUM BROMIDE INJECTION. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders In clinical practice, there have been reports of severe allergic reactions (anaphylactic and anaphylactoid reactions and shock) with rocuronium bromide, including some that have been life-threatening and fatal [see Warnings and Precautions (5.2) ] .

General disorders and administration site conditions There have been reports of malignant hyperthermia with the use of ROCURONIUM BROMIDE INJECTION [see Warnings and Precautions (5.7) ] .

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Succinylcholine: Use before succinylcholine has not been studied ( 7.11 ) Nondepolarizing muscle relaxants: Interactions have been observed ( 7.7 ) Enhanced rocuronium bromide activity possible: Inhalation anesthetics ( 7.3 ), certain antibiotics ( 7.1 ), quinidine ( 7.10 ), magnesium ( 7.6 ), lithium ( 7.4 ), local anesthetics ( 7.5 ), procainamide ( 7.8 ) Reduced rocuronium bromide activity possible: Anticonvulsants ( 7.2 )

7.1Antibiotics Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as rocuronium bromide include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). If these antibiotics are used in conjunction with rocuronium bromide, prolongation of neuromuscular block may occur.

7.2Anticonvulsants In 2 of 4 patients receiving chronic anticonvulsant therapy, apparent resistance to the effects of rocuronium bromide was observed in the form of diminished magnitude of neuromuscular block or shortened clinical duration. As with other nondepolarizing neuromuscular blocking drugs, if rocuronium bromide is administered to patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, shorter durations of neuromuscular block may occur, and infusion rates may be higher due to the development of resistance to nondepolarizing muscle relaxants.

While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor [see Warnings and Precautions (5.10) ] .

7.3Inhalation Anesthetics Use of inhalation anesthetics (enflurane > isoflurane > halothane) has been shown to enhance the activity of other neuromuscular blocking agents. Isoflurane and enflurane may also prolong the duration of action of initial and maintenance doses of rocuronium bromide and decrease the average infusion requirement of rocuronium bromide by 40% compared to opioid/nitrous oxide/oxygen anesthesia. No definite interaction between rocuronium bromide and halothane has been demonstrated.

In one study, use of enflurane in 10 patients resulted in a 20% increase in mean clinical duration of the initial intubating dose, and a 37% increase in the duration of subsequent maintenance doses, when compared in the same study to 10 patients under opioid/nitrous oxide/oxygen anesthesia. The clinical duration of initial doses of rocuronium bromide of 0.57 to 0.85 mg/kg under enflurane or isoflurane anesthesia, as used clinically, was increased by 11% and 23%, respectively. The duration of maintenance doses was affected to a greater extent, increasing by 30% to 50% under either enflurane or isoflurane anesthesia.

Potentiation by these agents is also observed with respect to the infusion rates of rocuronium bromide required to maintain approximately 95% neuromuscular block. Under isoflurane and enflurane anesthesia, the infusion rates are decreased by approximately 40% compared to opioid/nitrous oxide/oxygen anesthesia. The median spontaneous recovery time (from 25% to 75% of control T 1 ) is not affected by halothane but is prolonged by enflurane (15% longer) and isoflurane (62% longer).

Reversal-induced recovery of rocuronium bromide neuromuscular block is minimally affected by anesthetic technique [see Dosage and Administration (2.6) and Warnings and Precautions (5.10) ] .

7.4Lithium Carbonate Lithium has been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions (5.10) ] .

7.5Local Anesthetics Local anesthetics have been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions (5.10) ] .

7.6Magnesium Magnesium salts administered for the management of pre-eclampsia or eclampsia of pregnancy may enhance neuromuscular blockade [see Warnings and Precautions (5.10) ] .

7.7Nondep… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Not recommended for rapid sequence induction in patients undergoing Cesarean section. ( 8.1 , 14.1 ) Pediatric Use: Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients ( 8.4 )

8.1Pregnancy Risk Summary Available data from controlled trials, case series, and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ) . Based on data from umbilical cord blood sampling, rocuronium bromide is transferred across the placenta [see Clinical Studies (14.1) ] .

In animal reproduction studies, there was no evidence of teratogenicity when rocuronium bromide was administered intravenously to pregnant, conscious, nonventilated rats and rabbits at 15%-30% and 25%, respectively, the human intubation dose of 0.6-1.2 mg/kg during the period of organogenesis (see Data ) . The 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 to 4% and 15 to 20%, respectively. Clinical Considerations Labor or Delivery Magnesium sulfate used in the management of pre-eclampsia or eclampsia in pregnancy may enhance neuromuscular blockade [see Warnings and Precautions (5.10) ] . The use of another ROCURONIUM BROMIDE INJECTION product in Cesarean section has been studied in a limited number of patients.

Adverse events in this study included low APGAR scores in neonates at 5 minutes and poor intubation conditions in some pregnant women who received rocuronium bromide [see Clinical Studies (14.1) ] . Therefore, ROCURONIUM BROMIDE INJECTION is not recommended for rapid sequence induction in Cesarean section patients. Data Animal Data Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats.

Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously three times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m 2 ) from Day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from Day 6 to 18 of pregnancy. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug.

Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia.

8.2Lactation Risk Summary There are no available data on the presence of rocuronium bromide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ROCURONIUM BROMIDE INJECTION and any potential adverse effects on the breastfed infant from ROCURONIUM BROMIDE INJECTION or from the underlying maternal condition.

8.4Pediatric Use The use of another ROCURONIUM BROMIDE INJECTION product has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. Of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. One of the 19 infant… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from controlled trials, case series, and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ) . Based on data from umbilical cord blood sampling, rocuronium bromide is transferred across the placenta [see Clinical Studies (14.1) ] .

In animal reproduction studies, there was no evidence of teratogenicity when rocuronium bromide was administered intravenously to pregnant, conscious, nonventilated rats and rabbits at 15%-30% and 25%, respectively, the human intubation dose of 0.6-1.2 mg/kg during the period of organogenesis (see Data ) . The 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 to 4% and 15 to 20%, respectively. Clinical Considerations Labor or Delivery Magnesium sulfate used in the management of pre-eclampsia or eclampsia in pregnancy may enhance neuromuscular blockade [see Warnings and Precautions (5.10) ] . The use of another ROCURONIUM BROMIDE INJECTION product in Cesarean section has been studied in a limited number of patients.

Adverse events in this study included low APGAR scores in neonates at 5 minutes and poor intubation conditions in some pregnant women who received rocuronium bromide [see Clinical Studies (14.1) ] . Therefore, ROCURONIUM BROMIDE INJECTION is not recommended for rapid sequence induction in Cesarean section patients. Data Animal Data Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats.

Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously three times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m 2 ) from Day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from Day 6 to 18 of pregnancy. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug.

Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The use of another ROCURONIUM BROMIDE INJECTION product has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. Of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. One of the 19 infants anesthetized with halothane and fentanyl who received atropine for induction experienced this magnitude of change [see Dosage and Administration (2.6) and Clinical Studies (14.3) ] .

Another ROCURONIUM BROMIDE INJECTION product was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. Onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the QTc interval.

The data also suggest that rocuronium bromide may increase heart rate. However, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. Additionally, when examining plasma levels of rocuronium bromide in correlation to QTc interval prolongation, no relationship was observed [see Dosage and Administration (2.6) , Warnings and Precautions (5.9) , Clinical Studies (14.3) ] .

ROCURONIUM BROMIDE INJECTION is not recommended for rapid sequence intubation in pediatric patients. Recommendations for use in pediatric patients are discussed in other sections [see Dosage and Administration (2.6) , Clinical Pharmacology (12.2) ] .

🧓 Geriatric Use 104 words ▾

8.5Geriatric Use Another ROCURONIUM BROMIDE INJECTION product was administered to 140 geriatric patients (65 years or greater) in U.S. clinical trials and 128 geriatric patients in European clinical trials. The observed pharmacokinetic profile for geriatric patients (n=20) was similar to that for other adult surgical patients [see Clinical Pharmacology (12.3) ] . Onset time and duration of action were slightly longer for geriatric patients (n=43) in clinical trials.

Clinical experiences and recommendations for use in geriatric patients are discussed in other sections [see Dosage and Administration (2.6) , Warnings and Precautions (5.5) , Clinical Pharmacology (12.2) , and Clinical Studies (14.2) ] .

🆘 Overdosage 174 words ▾

10 OVERDOSAGE Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway, controlled ventilation, and adequate sedation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent in conjunction with an appropriate anticholinergic agent.

Reversal of Neuromuscular Blockade Anticholinesterase agents should not be administered prior to the demonstration of some spontaneous recovery from neuromuscular blockade. The use of a nerve stimulator to document recovery is recommended. Patients should be evaluated for adequate clinical evidence of neuromuscular recovery, e.g., 5-second head lift, adequate phonation, ventilation, and upper airway patency.

Ventilation must be supported while patients exhibit any signs of muscle weakness. Recovery may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain drugs which enhance neuromuscular blockade or separately cause respiratory depression. Under such circumstances the management is the same as that of prolonged neuromuscular blockade.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium.

12.2Pharmacodynamics The ED 95 (dose required to produce 95% suppression of the first [T 1 ] mechanomyographic [MMG] response of the adductor pollicis muscle [thumb] to indirect supramaximal train-of-four stimulation of the ulnar nerve) during opioid/nitrous oxide/oxygen anesthesia is approximately 0.3 mg/kg. Patient variability around the ED 95 dose suggests that 50% of patients will exhibit T 1 depression of 91% to 97%. Table 5 presents intubating conditions in patients with intubation initiated at 60 to 70 seconds.

Table 5. Percent of Excellent or Good Intubating Conditions and Median (Range) Time to Completion of Intubation in Patients with Intubation Initiated at 60 to 70 Seconds Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Percent of Patients with Excellent or Good Intubating Conditions Time to Completion of Intubation (min) Adults Excludes patients undergoing Cesarean section. 18 to 64 yrs 0.45 (n=43) 0.6 (n=51) 86% 96% 1.6 (1.0-7.0) 1.6 (1.0-3.2) Infants Pediatric patients were under halothane anesthesia.

3 mo to 1 yr 0.6 (n=18) Pediatric † 1 to 12 yrs 0.6 (n=12) 100% 100% 1.0 (1.0-1.5) 1.0 (0.5-2.3) Excellent intubating conditions = jaw relaxed, vocal cords apart and immobile, no diaphragmatic movement. Good intubating conditions = same as excellent but with some diaphragmatic movement. Table 6 presents the time to onset and clinical duration for the initial dose of ROCURONIUM BROMIDE INJECTION under opioid/nitrous oxide/oxygen anesthesia in adults and geriatric patients, and under halothane anesthesia in pediatric patients.

Table 6. Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose during Opioid/Nitrous Oxide/Oxygen Anesthesia (Adults) and Halothane Anesthesia (Pediatric Patients) Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Time to ≥80% Block (min) Time to Maximum Block (min) Clinical Duration (min) Adults 18 to 64 yrs 0.45 (n=50) 0.6 (n=142) 0.9 (n=20) 1.2 (n=18) 1.3 (0.8-6.2) 1.0 (0.4-6.0) 1.1 (0.3-3.8) 0.7 (0.4-1.7) 3.0 (1.3-8.2) 1.8 (0.6-13.0) 1.4 (0.8-6.2) 1.0 (0.6-4.7) 22 (12-31) 31 (15-85) 58 (27-111) 67 (38-160) Geriatric ≥65 yrs 0.6 (n=31) 0.9 (n=5) 1.2 (n=7) 2.3 (1.0-8.3) 2.0 (1.0-3.0) 1.0 (0.8-3.5) 3.7 (1.3-11.3) 2.5 (1.2-5.0) 1.3 (1.2-4.7) 46 (22-73) 62 (49-75) 94 (64-138) Infants 3 mo to 1 yr 0.6 (n=17) 0.8 (n=9) – – 0.8 (0.3-3.0) 0.7 (0.5-0.8) 41 (24-68) 40 (27-70) Pediatric 1 to 12 yrs 0.6 (n=27) 0.8 (n=18) 0.8 (0.4-2.0) – 1.0 (0.5-3.3) 0.5 (0.3-1.0) 26 (17-39) 30 (17-56) n = the number of patients who had time to maximum block recorded.

Clinical duration = time until return to 25% of control T 1 . Patients receiving doses of 0.45 mg/kg who achieved less than 90% block (16% of these patients) had about 12 to 15 minutes to 25% recovery. Table 7 presents the time to onset and clinical duration for the initial dose of ROCURONIUM BROMIDE INJECTION under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia in pediatric patients.

Table 7. Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Sevoflurane (induction) and Isoflurane/Nitrous Oxide (maintenance) Anesthesia (Pediatric Patients) Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Time to Maximum Block (min) Time to Reappearance T 3 (min) Neonates birth to <28 days 0.45 (n=5) 0.6 (n=10) 1 (n=6) 1.1 (0.6-2.2) 1.0 (0.2-2.1) 0.6 (0.3-1.8) 40.3 (32.5-62.6) 49.7 (16.6-119.0) 114.4 (92.6-136.3) Infants 28 days to ≤3 mo 0.45 (n=9) 0.6 (n=11) 1 (n=5) 0.5 (0.4-1.3) 0.4 (0.2-0.8) 0.3 (0.2-0.7) 49.1 (13.5-79.9) 59.8 (32.3-87.8) 103.3 (90.8-155.4) Toddlers >3 mo to ≤2 yr… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 47 words ▾

12.1Mechanism of Action Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium.

📦 How Supplied / Storage and Handling 86 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ROCURONIUM BROMIDE INJECTION 50 mg/5 mL (10 mg/mL), a clear, colorless to yellowish solution in single-dose luer-lock prefilled glass syringes is available in the following presentation: Unit of Sale Concentration (per total volume) REF NDC 0264-5711-10 Box of 10 5 mL Single-Dose Luer Lock Prefilled Syringe 50 mg/5 mL (10 mg/mL) PFS5711 Store at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. DO NOT FREEZE.

Discard unused portion.

📋 Description 150 words ▾

11 DESCRIPTION ROCURONIUM BROMIDE INJECTION is a nondepolarizing neuromuscular blocking agent. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The molecular formula is C 32 H 53 BrN 2 O 4 and its molecular weight is 609.70 g/mol.

The structural formula is: Rocuronium bromide is an almost white to pale yellow, hygroscopic powder. It is soluble in water and dichloromethane, slightly soluble in ethanol and methanol. It has a partition coefficient of 0.5 at 20°C.

ROCURONIUM BROMIDE INJECTION is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellowish in single-dose luer-lock prefilled glass syringes, for intravenous use only. Each mL contains 10 mg rocuronium bromide (equivalent to 8.7 mg of rocuronium) and the following inactive ingredients: 25 mg of gluconolactone, 5 mg sodium acetate trihydrate, 5 mg sodium citrate dihydrate in water for injection. The formulation has a pH of 3.8 – 4.2.

Structural formula

💬 Information for Patients 86 words ▾

17 PATIENT COUNSELING INFORMATION Obtain information about your patient’s medical history, current medications, any history of hypersensitivity to rocuronium bromide or other neuromuscular blocking agents. If applicable, inform your patients that certain medical conditions and medications might influence how ROCURONIUM BROMIDE INJECTION works. In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including ROCURONIUM BROMIDE INJECTION, have been reported.

Since allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Adult and Geriatric Patients In an effort to maximize the information gathered in the in vivo pharmacokinetic studies, the data from the studies was used to develop population estimates of the parameters for the subpopulations represented (e.g., geriatric, pediatric, renal and hepatic impairment). These population-based estimates and a measure of the estimate variability are contained in the following section. Following intravenous administration of rocuronium bromide, plasma levels of rocuronium follow a three-compartment open model.

The rapid distribution half-life is 1 to 2 minutes, and the slower distribution half-life is 14 to 18 minutes. Rocuronium is approximately 30% bound to human plasma proteins. In geriatric and other adult surgical patients undergoing either opioid/nitrous oxide/oxygen or inhalational anesthesia, the observed pharmacokinetic profile was essentially unchanged [see Dosage and Administration (2.6) ] .

Table 8. Mean (SD) Pharmacokinetic Parameters in Adults (n=22; ages 27 to 58 yrs) and Geriatric (n=20; 65 yrs or greater) During Opioid/Nitrous Oxide/Oxygen Anesthesia PK Parameters Adults (Ages 27 to 58 yrs) Geriatrics (≥65 yrs) Clearance (L/kg/hr) 0.25 (0.08) 0.21 (0.06) Volume of Distribution at Steady State (L/kg) 0.25 (0.04) 0.22 (0.03) t 1/2 β Elimination (hr) 1.4 (0.4) 1.5 (0.4) In general, studies with normal adult subjects did not reveal any differences in the pharmacokinetics of rocuronium due to gender. Studies of distribution, metabolism, and excretion in cats and dogs indicate that rocuronium is eliminated primarily by the liver.

The rocuronium analog 17-desacetyl-rocuronium, a metabolite, has been rarely observed in the plasma or urine of humans administered single doses of 0.5 to 1 mg/kg with or without a subsequent infusion (for up to 12 hr) of rocuronium. In the cat, 17-desacetyl-rocuronium has approximately one-twentieth the neuromuscular blocking potency of rocuronium. The effects of renal failure and hepatic disease on the pharmacokinetics and pharmacodynamics of rocuronium in humans are consistent with these findings.

In general, patients undergoing cadaver kidney transplant have a small reduction in clearance which is offset pharmacokinetically by a corresponding increase in volume, such that the net effect is an unchanged plasma half-life. Patients with demonstrated liver cirrhosis have a marked increase in their volume of distribution resulting in a plasma half-life approximately twice that of patients with normal hepatic function. Table 9 shows the pharmacokinetic parameters in subjects with either impaired renal or hepatic function.

Table 9. Mean (SD) Pharmacokinetic Parameters in Adults with Normal Renal and Hepatic Function (n=10, ages 23 to 65), Renal Transplant Patients (n=10, ages 21 to 45) and Hepatic Dysfunction Patients (n=9, ages 31 to 67) During Isoflurane Anesthesia PK Parameters Normal Renal and Hepatic Function Renal Transplant Patients Hepatic Dysfunction Patients Clearance (L/kg/hr) 0.16 (0.05) Differences in the calculated t 1/2 β and Cl between this study and the study in young adults vs. geriatrics (≥65 years) is related to the different sample populations and anesthetic techniques.

0.13(0.04) 0.13 (0.06) Volume of Distribution at Steady State (L/kg) 0.26 (0.03) 0.34 (0.11) 0.53 (0.14) t 1/2 β Elimination (hr) 2.4 (0.8) 2.4 (1.1) 4.3 (2.6) The net result of these findings is that subjects with renal failure have clinical durations that are similar to but somewhat more variable than the duration that one would expect in subjects with normal renal function. Hepatically impaired patients, due to the large increase in volume, may demonstrate clinical durations approaching 1.5 times that of subjects with normal hepatic function.

In both populations the clinician should individualize the dose to the needs of the patient [see Dosage and Administration (2.6)] . Tissue redistribution accounts for most (about 80%) of the initial amount of rocuroniu… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics The ED 95 (dose required to produce 95% suppression of the first [T 1 ] mechanomyographic [MMG] response of the adductor pollicis muscle [thumb] to indirect supramaximal train-of-four stimulation of the ulnar nerve) during opioid/nitrous oxide/oxygen anesthesia is approximately 0.3 mg/kg. Patient variability around the ED 95 dose suggests that 50% of patients will exhibit T 1 depression of 91% to 97%. Table 5 presents intubating conditions in patients with intubation initiated at 60 to 70 seconds.

Table 5. Percent of Excellent or Good Intubating Conditions and Median (Range) Time to Completion of Intubation in Patients with Intubation Initiated at 60 to 70 Seconds Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Percent of Patients with Excellent or Good Intubating Conditions Time to Completion of Intubation (min) Adults Excludes patients undergoing Cesarean section. 18 to 64 yrs 0.45 (n=43) 0.6 (n=51) 86% 96% 1.6 (1.0-7.0) 1.6 (1.0-3.2) Infants Pediatric patients were under halothane anesthesia.

3 mo to 1 yr 0.6 (n=18) Pediatric † 1 to 12 yrs 0.6 (n=12) 100% 100% 1.0 (1.0-1.5) 1.0 (0.5-2.3) Excellent intubating conditions = jaw relaxed, vocal cords apart and immobile, no diaphragmatic movement. Good intubating conditions = same as excellent but with some diaphragmatic movement. Table 6 presents the time to onset and clinical duration for the initial dose of ROCURONIUM BROMIDE INJECTION under opioid/nitrous oxide/oxygen anesthesia in adults and geriatric patients, and under halothane anesthesia in pediatric patients.

Table 6. Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose during Opioid/Nitrous Oxide/Oxygen Anesthesia (Adults) and Halothane Anesthesia (Pediatric Patients) Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Time to ≥80% Block (min) Time to Maximum Block (min) Clinical Duration (min) Adults 18 to 64 yrs 0.45 (n=50) 0.6 (n=142) 0.9 (n=20) 1.2 (n=18) 1.3 (0.8-6.2) 1.0 (0.4-6.0) 1.1 (0.3-3.8) 0.7 (0.4-1.7) 3.0 (1.3-8.2) 1.8 (0.6-13.0) 1.4 (0.8-6.2) 1.0 (0.6-4.7) 22 (12-31) 31 (15-85) 58 (27-111) 67 (38-160) Geriatric ≥65 yrs 0.6 (n=31) 0.9 (n=5) 1.2 (n=7) 2.3 (1.0-8.3) 2.0 (1.0-3.0) 1.0 (0.8-3.5) 3.7 (1.3-11.3) 2.5 (1.2-5.0) 1.3 (1.2-4.7) 46 (22-73) 62 (49-75) 94 (64-138) Infants 3 mo to 1 yr 0.6 (n=17) 0.8 (n=9) – – 0.8 (0.3-3.0) 0.7 (0.5-0.8) 41 (24-68) 40 (27-70) Pediatric 1 to 12 yrs 0.6 (n=27) 0.8 (n=18) 0.8 (0.4-2.0) – 1.0 (0.5-3.3) 0.5 (0.3-1.0) 26 (17-39) 30 (17-56) n = the number of patients who had time to maximum block recorded.

Clinical duration = time until return to 25% of control T 1 . Patients receiving doses of 0.45 mg/kg who achieved less than 90% block (16% of these patients) had about 12 to 15 minutes to 25% recovery. Table 7 presents the time to onset and clinical duration for the initial dose of ROCURONIUM BROMIDE INJECTION under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia in pediatric patients.

Table 7. Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Sevoflurane (induction) and Isoflurane/Nitrous Oxide (maintenance) Anesthesia (Pediatric Patients) Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Time to Maximum Block (min) Time to Reappearance T 3 (min) Neonates birth to <28 days 0.45 (n=5) 0.6 (n=10) 1 (n=6) 1.1 (0.6-2.2) 1.0 (0.2-2.1) 0.6 (0.3-1.8) 40.3 (32.5-62.6) 49.7 (16.6-119.0) 114.4 (92.6-136.3) Infants 28 days to ≤3 mo 0.45 (n=9) 0.6 (n=11) 1 (n=5) 0.5 (0.4-1.3) 0.4 (0.2-0.8) 0.3 (0.2-0.7) 49.1 (13.5-79.9) 59.8 (32.3-87.8) 103.3 (90.8-155.4) Toddlers >3 mo to ≤2 yrs 0.45 (n=17) 0.6 (n=29) 1 (n=15) 0.8 (0.3-1.9) 0.6 (0.2-1.6) 0.5 (0.2-1.5) 39.2 (16.9-59.4) 44.2 (18.9-68.8) 72.0 (36.2-128.2) Children >2 yrs to ≤11 yrs 0.45 (n=14) 0.6 (n=37) 1 (n=16) 0.9 (0.4-1.9) 0.8 (0.3-1.7) 0.7 (0.4-1.2) 21.5 (17.5-38.0) 36.7 (20.1-65.9) 53.1 (31.2-89.9) Adolescents >11 to ≤17 yrs 0.45 (n=18) 0.6 (n=31) 1 (n=14) 1.0 (0.5-1.7) 0.9 (0.2-2.1) 0.7… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The effectiveness of ROCURONIUM BROMIDE INJECTION has been established based on adequate and well-controlled studies of another formulation of ROCURONIUM BROMIDE INJECTION. Below is a display of the efficacy results of the adequate and well-controlled studies of the other formulation of ROCURONIUM BROMIDE INJECTION. In U.S. clinical studies, a total of 1137 patients received ROCURONIUM BROMIDE INJECTION, including 176 pediatric, 140 geriatric, 55 obstetric, and 766 other adults.

Most patients (90%) were ASA physical status I or II, about 9% were ASA III, and 10 patients (undergoing coronary artery bypass grafting or valvular surgery) were ASA IV. In European clinical studies, a total of 1394 patients received ROCURONIUM BROMIDE INJECTION, including 52 pediatric, 128 geriatric (65 years or greater) and 1214 other adults.

14.1Adult Patients Intubation using doses of rocuronium bromide 0.6 to 0.85 mg/kg was evaluated in 203 adults in 11 clinical studies. Excellent to good intubating conditions were generally achieved within 2 minutes and maximum block occurred within 3 minutes in most patients. Doses within this range provide clinical relaxation for a median (range) time of 33 (14 to 85) minutes under opioid/nitrous oxide/oxygen anesthesia.

Larger doses (0.9 and 1.2 mg/kg) were evaluated in 2 studies with 19 and 16 patients under opioid/nitrous oxide/oxygen anesthesia and provided 58 (27 to 111) and 67 (38 to 160) minutes of clinical relaxation, respectively. Cardiovascular Disease In 1 clinical study, 10 patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft received an initial dose of 0.6 mg/kg rocuronium bromide. Neuromuscular block was maintained during surgery with bolus maintenance doses of 0.3 mg/kg.

Following induction, continuous 8 mcg/kg/min infusion of rocuronium bromide produced relaxation sufficient to support mechanical ventilation for 6 to 12 hours in the surgical intensive care unit (SICU) while the patients were recovering from surgery. Rapid Sequence Intubation Intubation was assessed in patients in 6 clinical studies where anesthesia was induced with either thiopental (3 to 6 mg/kg) or propofol (1.5 to 2.5 mg/kg) in combination with either fentanyl (2 to 5 mcg/kg) or alfentanil (1 mg). Most of the patients also received a premedication such as midazolam or temazepam.

Most patients had intubation attempted within 60 to 90 seconds of administration of rocuronium bromide 0.6 mg/kg or succinylcholine 1 to 1.5 mg/kg. Excellent or good intubating conditions were achieved in 119/120 (99% [95% confidence interval 95% to 99.9%]) patients receiving rocuronium bromide and in 108/110 (98% [94% to 99.8%]) patients receiving succinylcholine. The duration of action of rocuronium bromide 0.6 mg/kg is longer than succinylcholine and at this dose is approximately equivalent to the duration of other intermediate-acting neuromuscular blocking drugs.

Obese Patients Rocuronium bromide was dosed according to actual body weight (ABW) in most clinical studies. The administration of rocuronium bromide in the 47 of 330 (14%) patients who were at least 30% or more above their ideal body weight (IBW) was not associated with clinically significant differences in the onset, duration, recovery, or reversal of rocuronium bromide-induced neuromuscular block. In 1 clinical study in obese patients, rocuronium bromide 0.6 mg/kg was dosed according to ABW (n=12) or IBW (n=11).

Obese patients dosed according to IBW had a longer time to maximum block, a shorter median (range) clinical duration of 25 (14 to 29) minutes, and did not achieve intubating conditions comparable to those dosed based on ABW. These results support the recommendation that obese patients be dosed based on actual body weight [see Dosage and Administration (2.6) ] . Obstetric Patients Rocuronium bromide 0.6 mg/kg was administered with thiopental, 3 to 4 mg/kg (n=13) or 4 to 6 mg/kg (n=42), for rapid sequence inducti… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 50 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals have not been performed with rocuronium bromide to evaluate carcinogenic potential or impairment of fertility. Mutagenicity studies (Ames test, analysis of chromosomal aberrations in mammalian cells, and micronucleus test) conducted with rocuronium bromide did not suggest mutagenic potential.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 47 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals have not been performed with rocuronium bromide to evaluate carcinogenic potential or impairment of fertility. Mutagenicity studies (Ames test, analysis of chromosomal aberrations in mammalian cells, and micronucleus test) conducted with rocuronium bromide did not suggest mutagenic potential.

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - SYRINGE REF PFS5711 NDC 0264-5711-01 Rocuronium Bromide Injection 50 mg/5 mL (10 mg/mL) Rx Only For intravenous use only. WARNING: Paralyzing Agent. May Cause Respiratory Arrest. Facilities for artificial respiration must be immediately available. Single-Dose. Dosage: See Prescribing Information. DO NOT FREEZE. Discard unused portion. 4015/1025 12632596 LD-872-1 Lot: Exp: PFS5711 Syringe Label

PRINCIPAL DISPLAY PANEL - SINGLE BOX OPEN HERE NDC 0264-5711-01 REF PFS5711 Rx Only Rocuronium Bromide Injection 50 mg/5 mL (10 mg/mL) For Intravenous Use Only Sterile Solution WARNING: Paralyzing Agent Single-Dose Luer Lock Prefilled Syringe. Discard unused portion. Sterile, non pyrogenic.

Each mL contains: Rocuronium bromide 10 mg (equivalent to 8.7 mg of rocuronium) and the following inactive ingredients: gluconolactone 25 mg, sodium acetate 5 mg, and sodium citrate 5 mg in water for injection. Dosage: see Prescribing Information. Storage: Store at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

DO NOT FREEZE. WARNING: Paralyzing Agent. May Cause Respiratory Arrest.

Facilities for artificial respiration must be immediately available. Distributed by: B. Braun Medical Inc.

Prepared in Canada. API from Spain. 4015/1025 12632597 LD-873-1 LOT: EXP: PFS5711 Single Carton

PRINCIPAL DISPLAY PANEL - 10 COUNT BOX NDC 0264-5711-10 REF PFS5711 Rx Only Rocuronium Bromide Injection 50 mg/5 mL (10 mg/mL) WARNING: Paralyzing Agent For Intravenous Use Only Sterile Solution 10 × 5 mL Single-Dose Luer Lock Prefilled Syringes Discard unused portion Sterile, non-pyrogenic. Each mL contains: Rocuronium bromide 10 mg (equivalent to 8.7 mg of rocuronium) and the following inactive ingredients: gluconolactone 25 mg, sodium acetate 5 mg, and sodium citrate 5 mg in water for injection. Dosage: see Prescribing Information.

Storage: Store at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. DO NOT FREEZE. WARNING: Paralyzing Agent.

May Cause Respiratory Arrest. Facilities for artificial respiration must be immediately available. Manufactured by: Sterinova Inc.

3005 Av. José-Maria-Rosell, Saint-Hyacinthe, QC J2S 0J9, Canada Distributed by: B. Braun Medical Inc.

Bethlehem, PA 18018-3524 USA 1-800-227-2862 Prepared in Canada. API from Spain. 4015/12632598/1025 LD-874-1 Lot: EXP: PFS5711 10 Count Carton

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

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← 00264-5600-52 · B. 00264-5802-00 · B. →
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