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ROCURONIUM BROMIDE 10 mg/mL Injection, Solution, 10 mL — NDC 51662-1641-1 (Billing 51662-1641-01)

by HF Acquisition Co LLC, DBA HealthFirst · 10 mL in 1 VIAL, MULTI-DOSE

This is a package of 10 mL of ROCURONIUM BROMIDE 10 mg/mL Injection, Solution from HF Acquisition Co LLC, DBA HealthFirst, marketed since Jul 2023 and currently FDA-listed. It is this product's only package size.

NDC 51662-1641-01
🏷️ FDA NDC (as labeled) 51662-1641-1 billing pads the package segment with a zero
Rx only Generic 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 →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1641-1
Product NDC 51662-1641
11-digit billing NDC 51662164101
UNII I65MW4OFHZ
Application # ANDA205656
SPL Set ID 15897860-d6a9-07e5-e063-6394a90aec75
Established class (EPC) Nondepolarizing Neuromuscular Blocker
Physiologic effect Neuromuscular Nondepolarizing Blockade
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-17
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance ROCURONIUM BROMIDE
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 51662-1641-1 — a 5-4-1 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 package segment → 51662-1641-01. 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.

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 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
51662-1641-01 You're viewing this Main listing 10 mL in 1 VIAL, MULTI-DOSE 2023-07-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rocuronium 10 mg/mL 65219-0065-05 Fresenius 10 vials $0.394 AP Availability likely —
rocuronium bromide 10 mg/mL 00409-1403-10 Hospira, 10 vials $0.394 AP Availability likely —
rocuronium bromide 10 mg/mL 00409-3189-10 Hospira, 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 25021-0687-05 Sagent 10 vials $0.394 AP Availability likely —
rocuronium bromide 10 mg/mL 39822-4200-02 XGen 10 vials $0.394 AP Availability likely —
Rocuronium 10 mg/mL 63323-0426-05 Fresenius 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 71288-0700-06 Meitheal 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 71839-0141-10 BE 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 72572-0650-10 Civica, 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 67457-0228-05 Mylan 10 vials $0.394 AP Availability likely —
Rocuronium 10 mg/mL 65219-0442-05 Fresenius 10 vials $0.394 — Availability likely —
Rocuronium 10 mg/mL 81565-0204-02 Phlow 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 00409-9558-49 Hospira, 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 00143-9250-10 Hikma 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 65145-0130-10 Caplin 10 vials $0.394 AP Availability likely —
Rocuronium 10 mg/mL 65219-0695-05 Fresenius 10 vials $0.394 — Availability likely —
Rocuronium Bromide 10 mg/mL 00781-3220-92 Sandoz 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1355-01 HF 10 ml — AP FDA listed —
rocuronium bromide 10 mg/mL 00409-5160-10 Hospira, 10 vials — AP FDA listed —
rocuronium bromide 10 mg/mL 00409-7037-10 Hospira, 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71288-0718-11 Meitheal 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71839-0142-10 BE 10 vials — AP FDA listed —
rocuronium bromide 10 mg/mL 71872-7036-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7207-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1640-01 HF 5 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7317-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 72572-0651-10 Civica, 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 68083-0365-10 Gland 10 vials — AP FDA listed —
rocuronium bromide 10 mg/mL 71872-7309-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1354-01 HF 5 ml — AP FDA listed —
Rocuronium 10 mg/mL 65219-0697-10 Fresenius 10 vials — — FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7344-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 84549-0131-10 ProPharma 10 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 84549-0141-10 ProPharma 5 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7372-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 65145-0131-10 Caplin 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mLthis 51662-1641-01 HF 10 ml — AP FDA listed —
Rocuronium 10 mg/mL 65219-0444-10 Fresenius 10 vials — — FDA listed —
Rocuronium Bromide 10 mg/mL 00143-9251-10 Hikma 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 68083-0364-10 Gland 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 84549-0687-05 ProPharma 5 ml — AP FDA listed —
Rocuronium 10 mg/mL 76045-0221-50 Fresenius 10 syringes — — FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1710-01 HF 10 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1711-01 HF 5 ml — AP FDA listed —
Rocuronium 10 mg/mL 76045-0220-50 Fresenius 10 syringes — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderGLAND PHARMA LTD
FDA applicationANDA205656 (ANDA)
Labeler code51662
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio333 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE Rocuronium bromide injection is indicated for inpatients and outpatients 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

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 ), Warnings and Precautions ( 5 ), Drug Interactions ( 7 ), and Use in Specific Populations ( 8 )].

Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store rocuronium bromide with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions ( 5 ].

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 )]. 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 or 1.2 mg/kg can be administered under opioid/nitrous oxide/oxygen anesthesia without adverse effects to the cardiovascular system [see Clinical Pharmacology ( 12 )].

2.3Rapid Sequence Intubation In appropriately premedicated and adequately anesthetized patients, rocuronium bromide 0.6 to 1.2 mg/kg will provide excellent or good intubating conditions in most patients in less than 2 minutes [see Clinical Studies ( 14 )].

2.4Maintenance Dosing Maintenance doses of 0.1, 0.15, and 0.2 mg/kg rocuronium bromide, administered at 25% recovery of control T1 (defined as 3 twitches of train-of-four), provide a median (range) of 12 (2 to 31), 17 (6 to 50) and 24 (7 to 69) minutes of clinical duration under opioid/nitrous oxide/oxygen anesthesia [see Clinical Pharmacology ( 12 )]. In all cases, dosing should be guided based on the clinical duration following initial dose or prior maintenance dose and not administered until recovery of neuromuscular function is evident.

A clinically insignificant cumulation of effect with repetitive maintenance dosing has been observed [see Clinical Pharmacology ( 12 )].

2.5Use by Continuous Infusion Infusion at an initial rate of 10 to 12 mcg/kg/min of roc… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Rocuronium bromide injection is available as: • 5 mL Multiple Dose Vials containing 50 mg Rocuronium Bromide Injection (10 mg/mL) • 10 mL Multiple Dose Vials containing 100 mg Rocuronium Bromide Injection (10 mg/mL)

⛔ Contraindications 27 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)].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS

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 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 of rocuronium bromideor any other neuromuscular blocking agent should not be given until there is adefinite response (one twitch of the train-of-four) to nerve stimulation. Prolonged paralysis and/or skeletal muscle weakness may be noted during initial attempts to wean from the ventilator patients who have chronically received neuromuscular blocking drugs in the ICU.

Myopathy after long-term administration of other nondepolarizing neuromuscular blocking agents in the ICU alone or in combination with corticosteroid therapy has been reported. Therefore, for patients receiving both neuromuscular blockin… [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 )] • Residual paralysis [see Warnings and Precautions ( 5 )] • Myopathy [see Warnings and Precautions ( 5 )] • Increased pulmonary vascular resistance [see Warnings and Precautions ( 5 )]

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 US (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, 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%).

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of rocuronium bromide. 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 )].

General disorders and administration site conditions: There have been reports of malignant hyperthermia with the use of rocuronium bromide [see Warnings and Precautions ( 5 )].

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS

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 )].

7.3Inhalation Anesthetics Use of inhalation anesthetics has been shown to enhance the activity of other neuromuscular blocking agents (enflurane > isoflurane > halothane). 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 T1) 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 ) and Warnings and Precautions ( 5 )].

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 )].

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 )].

7.6Magnesium Magnesium salts administered for the management of toxemia of pregnancy may enhance neuromuscular blockade [see Warnings and Precautions ( 5 )].

7.7Nondepolarizing Muscle Relaxants There are no controlled studies documenting the use of rocuronium bromide before or after other nondepolarizing muscle relaxants. Interactions have been observed when other nondepolarizing muscle relaxants have been administered in succession.

7.8Procainamide Procainamide has been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions ( 5… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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 3 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/m2) 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. However, there are no adequate and well-controlled studies in pregnant women. Rocuronium bromide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.2Labor and Delivery The use of rocuronium bromide in Cesarean section has been studied in a limited number of patients [see Clinical Studies ( 14 )].Rocuronium bromide is not recommended for rapid sequence induction in Cesarean section patients.

8.4Pediatric Use The use of rocuronium bromide 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 ) and Clinical Studies ( 14 )].

Rocuronium bromide 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 ), Warnings and Precautions ( 5 ), and Clinical Studies ( 14 )].

Rocuronium bromide 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 ) and Clinical Pharmacology ( 12 )].

8.5Geriatric Use Rocuronium bromide 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 )]. 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 ), Warnings and Precautions ( 5 ), Clinical Pharmacology ( 12 ), and Clinical Studies ( 14 )].

8.6Patients with Hepatic Impairment Since rocuronium bromide is primarily excreted by the liver, it should be used with caution in patients with clinically… [Excerpted — this section continues on DailyMed.]

🆘 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 ED95 (dose required to produce 95% suppression of the first [T1] 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 ED95 dose suggests that 50% of patients will exhibit T1 depression of 91% to 97%. Table 4 presents intubating conditions in patients with intubation initiated at 60 to 70 seconds.

Table 4: 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 * Excludes patients undergoing Cesarean section. † Pediatric patients were under halothane anesthesia. 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 5 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 5: Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Opioid/Nitrous Oxide/Oxygen Anesthesia (Adults) and Halothane Anesthesia (Pediatric Patients) n=the number of patients who had time to maximum block recorded. Clinical duration=time until return to 25% of control T1.

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 6 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 6: Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Sevoflurane (induction) and Isoflurane/Nitrous Oxide (maintenance) Anesthesia (Pediatric Patients) n=the number of patients with the highest number of observations for time to maximum block or reappearance T3.

The time to 80% or greater block and clinical duration as a function of dose are presented in Figures 1 and 2. Figure 1: Time to 80% or Greater Block vs. Initial Dose of Rocuronium Bromide by Age Group (Median, 25th and 75th Percentile, and Individual Values) Figure 2: Duration of Clinical Effect vs.

Initial Dose of Rocuronium Bromide by Age Group (Median, 25th and 75th Percentile, and Individual Values) The clinical durations for the first 5 maintenance doses, in patients receiving 5 or more maintenance doses are represented in Figure 3 [see Dosage and Administration ( 2 )]. Figure 3: Duration of Clinical Effect vs. Number of Rocuronium Bromide Maintenance Doses, by Dose Once spontaneous recovery has reached 25% of control T1, the neuromuscular block produced by rocuronium bromide is readily reversed with anticholinesterase agents, e.g., edrophonium or neostigmine.

The median spontaneous recovery from 25% to 75% T1 was 13 minutes in adult patients. When neuromuscular block was reversed in 36 adults at a T1 of 22% to 27%, recovery to a T1 of 89 (50 to 132)% and T4/T1 of 69 (38 to 92)% was achieved within 5 minutes. Only 5 of 320 adults reversed received an additional dose of reversal agent.

The median (range) dose of neostigmine was 0.04 (0.01 to 0.09) mg/kg and the median (range) dose of edrophonium was 0.5 (0.3 to 1.0) mg/kg. In geriatric patients (n=51) reversed with neostigmine, the median… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 7 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING HOW SUPPLIED

📋 Description 113 words ▾

11 DESCRIPTION Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl)pyrrolidinium bromide. The structural formula is: The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70.

The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate.

The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide. Structure

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES 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 )]. 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 induction of anesthesia for Cesarean section.

No neonate had APGAR scores greater than 7 at 5 minutes. The umbilical venous plasma concentrations were 18% of maternal concentrations at delivery. Intubating conditions were poor or inadequate in 5 of 13 women receiving 3 to 4 mg/kg thiopental when intubation was attempted 60… [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.

📄 Package Label / Principal Display Panel 4 words ▾

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