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Rocuronium Bromide 10 mg/mL Injection — NDC 72572-0650-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rocuronium Bromide 10 mg/mL Injection — NDC 72572-650-10 (Billing 72572-0650-10)

by Civica, Inc. · 10 VIAL in 1 CARTON / 5 mL in 1 VIAL

This is a package of Rocuronium Bromide 10 mg/mL Injection from Civica, Inc., marketed since Dec 2020 and currently FDA-listed; retail pharmacies pay about $0.3942 per mL (NADAC). It is this product's only package size.

NDC 72572-0650-10
🏷️ FDA NDC (as labeled) 72572-650-10 billing pads the product 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) 72572-650-10
Product NDC 72572-650
11-digit billing NDC 72572065010
NCPDP billing unit ML — per mL (volume)
RxCUI 1234995
UNII I65MW4OFHZ
Application # ANDA204679
SPL Set ID 8ea475c7-d35e-47f4-8955-0df5ccd35b79
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 2020-12-16
Route INTRAVENOUS
Dosage form INJECTION
Substance ROCURONIUM BROMIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 74200047102020
GPI class Rocuronium Bromide
GCN Seq No 021727
GCN 37201
HICL code 008963
Ingredient (HICL) Rocuronium Bromide
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S7
Therapeutic class — intermediate (HIC2) Affect Primarily Skeletal Muscle
HIC3 code S7A
Therapeutic class — specific (HIC3) Neuromuscular Blocking Agents
AHFS code 12:20.20.00
AHFS class Neuromuscular Blocking Agents
FDB label name ROCURONIUM 50 MG/5 ML VIAL
FDB brand name Rocuronium Bromide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 021727
  • GCN: 37201
  • GPI-14 (Medi-Span): 74200047102020
  • HICL (First Databank): 008963
  • AHFS class code: 12:20.20.00
  • RxCUI (RxNorm): 1234995
Why two NDCs? The FDA registers this code as 72572-650-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72572-0650-10. 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

Label name ROCURONIUM 50 MG/5 ML VIAL Ingredient Rocuronium Bromide
📗 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 $0.394 $19.71 / 50 ml
Medicaid paysCMS SDUD · 12 mo $2.65 $132.61 / 50 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Mar 2026 Apr 2026 $0.394 $0.394
Flat over the last 2 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72572-0650-10 You're viewing this Main listing 10 VIAL in 1 CARTON / 5 mL in 1 VIAL 2020-12-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rocuronium Bromide 10 mg/mL 00143-9250-10 Hikma 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 00409-9558-49 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 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 10 mg/mL 63323-0426-05 Fresenius 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 65219-0065-05 Fresenius 10 vials $0.394 AP Availability likely —
Rocuronium 50 mg/5mL 66794-0228-41 Piramal 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 10 mg/mL 67457-0228-05 Mylan 10 vials $0.394 AP Availability likely —
Rocuronium Bromide 50 mg/5mL 70756-0669-10 Lifestar 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/mLthis 72572-0650-10 Civica, 10 vials $0.394 AP Availability likely —
Rocuronium 10 mg/mL 81565-0204-02 Phlow 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 65219-0695-05 Fresenius 10 vials $0.394 — Availability likely —
Rocuronium Bromide 10 mg/mL 00143-9251-10 Hikma 10 vials — 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 00781-3220-92 Sandoz 10 vials — AP FDA listed —
Rocuronium Bromide 50 mg/5mL 42677-0309-10 Shandong 10 vials — AP FDA listed —
Rocuronium Bromide 100 mg/10mL 42677-0310-10 Shandong 10 vials — AP FDA listed —
Rocuronium Bromide 100 mg/10mL 43066-0013-10 Baxter 10 vials — AP FDA listed —
Rocuronium Bromide 100 mg/10mL 43547-0531-10 Solco 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1354-01 HF 5 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1355-01 HF 10 ml — AP FDA listed —
Rocuronium Bromide 100 mg/10mL 51662-1545-01 HF 10 ml — AP FDA listed —
Rocuronium Bromide 50 mg/5mL 51662-1546-01 HF 5 ml — AP FDA listed —
Rocuronium Bromide 10 mg/mL 51662-1640-01 HF 5 ml — AP FDA listed —
Rocuronium Bromide 100 mg/10mL 55150-0226-10 Eugia 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 65145-0131-10 Caplin 10 vials — AP FDA listed —
Rocuronium 100 mg/10mL 66794-0229-41 Piramal 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 68083-0364-10 Gland 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 68083-0365-10 Gland 10 vials — AP FDA listed —
Rocuronium Bromide 100 mg/10mL 70756-0670-10 Lifestar 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 50 mg/5mL 71872-7262-01 Medical 1 vial — AP FDA listed —
rocuronium bromide 10 mg/mL 71872-7309-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7317-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7344-01 Medical 1 vial — AP FDA listed —
Rocuronium 100 mg/10mL 71872-7349-01 Medical 1 vial — AP FDA listed —
Rocuronium Bromide 10 mg/mL 71872-7372-01 Medical 1 vial — AP FDA listed —
Rocuronium 50 mg/5mL 72162-2263-02 Bryant 10 vials — AP FDA listed —
Rocuronium Bromide 10 mg/mL 72572-0651-10 Civica, 10 vials — AP FDA listed —
Rocuronium Bromide 50 mg/5mL 82449-0001-02 STERISCIENCE 10 vials — 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 10 mg/mL 65219-0697-10 Fresenius 10 vials — — FDA listed —
Rocuronium Bromide 10 mg/mL 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 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

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

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

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 2 mg / 1 mL 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.
  • 3.3 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

5 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

LabelerCivica, Inc.
Application holderWEST WARD PHARMACEUTICAL CORP
FDA applicationANDA204679 (ANDA)
Labeler code72572
First marketedDec 2020
Product typeHuman Prescription Drug
Portfolio95 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 74 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. Rocuronium Bromide 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 ) 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 with the cap and ferrule intact and 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 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 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 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 ), and Use in Specific Populations ( 8.6 )] .

Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store Rocuronium Bromide Injection with the cap and ferrule intact and 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 (0.4–6) 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 (15–85) 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 (0.8–6.2) 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 (12–31) 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 )] .

2.3Rapid Sequence Intubati… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 69 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) 5 mL multiple dose vials containing 50 mg Rocuronium Bromide Injection (10 mg/mL). ( 3 ) 10 mL multiple dose vials containing 100 mg Rocuronium Bromide Injection (10 mg/mL). ( 3 )

⛔ Contraindications 44 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 non depolarizing, 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; this progression 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 the critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the dose is clearly 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… [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.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 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 US (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the US 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 US studies (0.1% and 0.1%).

Changes in heart rate and blood pressure were defined differently from in the US 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 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 )] . Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 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 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 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 toxemia of pregnancy may enhance neuromuscular blockade [see Warnings and Precautions ( 5.10 )] .

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

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Labor and Delivery: Not recommended for rapid sequence induction in patients undergoing Cesarean section. ( 8.2 ) 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 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%–30% of human intubation dose of 0.6–1.2 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 ( 14.1 )] . 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 ( 2.6 ) and Clinical Studies ( 14.3 )] .

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 ( 2.6 ), Warnings and Precautions ( 5.9 ), and Clinical Studies ( 14.3 )] .

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 ( 2.6 ) and Clinical Pharmacology ( 12.2 )] .

8.5Geriatric Use Rocuronium Bromide was administered to 140 geriatric patients (65 years or greater) in US 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 oth… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 181 words ▾

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%–30% of human intubation dose of 0.6–1.2 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.

🧒 Pediatric Use ~1 min read ▾

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 ( 2.6 ) and Clinical Studies ( 14.3 )] .

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 ( 2.6 ), Warnings and Precautions ( 5.9 ), and Clinical Studies ( 14.3 )] .

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 ( 2.6 ) and Clinical Pharmacology ( 12.2 )] .

🧓 Geriatric Use 106 words ▾

8.5Geriatric Use Rocuronium Bromide was administered to 140 geriatric patients (65 years or greater) in US 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 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 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) 86% 1.6 (1.0-7.0) 0.6 (n=51) 96% 1.6 (1.0-3.2) Infants 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. 3 mo to 1 yr 0.6 (n=18) 100% 1.0 (1.0-1.5) Pediatric 1 to 12 yrs 0.6 (n=12) 100% 1.0 (0.5-2.3) 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) 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) 1.3 (0.8-6.2) 3.0 (1.3-8.2) 22 (12-31) 0.6 (n=142) 1.0 (0.4-6.0) 1.8 (0.6-13.0) 31 (15-85) 0.9 (n=20) 1.1 (0.3-3.8) 1.4 (0.8-6.2) 58 (27-111) 1.2 (n=18) 0.7 (0.4-1.7) 1.0 (0.6-4.7) 67 (38-160) Geriatric ≥65 yrs 0.6 (n=31) 2.3 (1.0-8.3) 3.7 (1.3-11.3) 46 (22-73) 0.9 (n=5) 2.0 (1.0-3.0) 2.5 (1.2-5.0) 62 (49-75) 1.2 (n=7) 1.0 (0.8-3.5) 1.3 (1.2-4.7) 94 (64-138) Infants 3 mo to 1 yr 0.6 (n=17) - 0.8 (0.3-3.0) 41 (24-68) 0.8 (n=9) - 0.7 (0.5-0.8) 40 (27-70) Pediatric 1 to 12 yrs 0.6 (n=27) 0.8 (0.4-2.0) 1.0 (0.5-3.3) 26 (17-39) 0.8 (n=18) - 0.5 (0.3-1.0) 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 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) 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) 1.1 (0.6-2.2) 40 (32.5-62.6) 0.6 (n=10) 1.0 (0.2-2.1) 49.7 (16.6-119.0) 1 (n=6) 0.6 (0.3-1.8) 114.4 (92.6-136.3) Infants 28 days to ≤3 mo 0.45 (n=9) 0.5 (0.4-1.3) 49.1 (13.5-79.9) 0.6 (n=11) 0.4 (0.2-0.8) 59.8 (32.3-87.8) 1 (n=5) 0.3 (0.2-0.7) 103.3 (90.8-155.4) Toddlers >3 mo to ≤2 yrs 0.45 (n=17) 0… [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 163 words ▾

16 HOW SUPPLIED / STORAGE AND HANDLING Rocuronium Bromide Injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Rocuronium Bromide Injection is available in the following: Rocuronium Bromide Injection 5 mL multiple dose vials containing 50 mg Rocuronium Bromide Injection (10 mg/mL) Box of 10 NDC 72572-650-10 Rocuronium Bromide Injection 10 mL multiple dose vials containing 100 mg Rocuronium Bromide Injection (10 mg/mL) Box of 10 NDC 72572-651-10 The container closure of this drug product does not contain natural rubber latex.

Rocuronium Bromide Injection should be stored in a refrigerator, 2º to 8ºC (36º to 46ºF). DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25ºC/77ºF), use Rocuronium Bromide Injection within 60 days.

Use opened vials of Rocuronium Bromide Injection within 30 days. Safety and Handling There is no specific work exposure limit for Rocuronium Bromide Injection. In case of eye contact, flush with water for at least 10 minutes.

📋 Description 123 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 C 32 H 53 BrN 2 O 4 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. rocuronium bromide chemical structure

💬 Information for Patients 117 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 works. In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including Rocuronium Bromide, 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. Distributed by: Civica, Inc. Lehi, Utah 84048 Manufactured by: Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, Portugal Revised: July 2025 PIN562-CIV/3

🧬 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 7: 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) Clear (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 8 shows the pharmacokinetic parameters in subjects with either impaired renal or hepatic function.

Table 8: 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 Heparic 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 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 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) 86% 1.6 (1.0-7.0) 0.6 (n=51) 96% 1.6 (1.0-3.2) Infants 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. 3 mo to 1 yr 0.6 (n=18) 100% 1.0 (1.0-1.5) Pediatric 1 to 12 yrs 0.6 (n=12) 100% 1.0 (0.5-2.3) 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) 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) 1.3 (0.8-6.2) 3.0 (1.3-8.2) 22 (12-31) 0.6 (n=142) 1.0 (0.4-6.0) 1.8 (0.6-13.0) 31 (15-85) 0.9 (n=20) 1.1 (0.3-3.8) 1.4 (0.8-6.2) 58 (27-111) 1.2 (n=18) 0.7 (0.4-1.7) 1.0 (0.6-4.7) 67 (38-160) Geriatric ≥65 yrs 0.6 (n=31) 2.3 (1.0-8.3) 3.7 (1.3-11.3) 46 (22-73) 0.9 (n=5) 2.0 (1.0-3.0) 2.5 (1.2-5.0) 62 (49-75) 1.2 (n=7) 1.0 (0.8-3.5) 1.3 (1.2-4.7) 94 (64-138) Infants 3 mo to 1 yr 0.6 (n=17) - 0.8 (0.3-3.0) 41 (24-68) 0.8 (n=9) - 0.7 (0.5-0.8) 40 (27-70) Pediatric 1 to 12 yrs 0.6 (n=27) 0.8 (0.4-2.0) 1.0 (0.5-3.3) 26 (17-39) 0.8 (n=18) - 0.5 (0.3-1.0) 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 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) 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) 1.1 (0.6-2.2) 40 (32.5-62.6) 0.6 (n=10) 1.0 (0.2-2.1) 49.7 (16.6-119.0) 1 (n=6) 0.6 (0.3-1.8) 114.4 (92.6-136.3) Infants 28 days to ≤3 mo 0.45 (n=9) 0.5 (0.4-1.3) 49.1 (13.5-79.9) 0.6 (n=11) 0.4 (0.2-0.8) 59.8 (32.3-87.8) 1 (n=5) 0.3 (0.2-0.7) 103.3 (90.8-155.4) Toddlers >3 mo to ≤2 yrs 0.45 (n=17) 0.8 (0.3-1.9) 39.2 (16.9-59.4) 0.6 (n=29) 0.6 (0.2-1.6) 44.2 (18.9-68.8) 1 (n=16) 0.5 (0.2-1.5) 72.0 (36.2-128.2) Children >2 yrs to ≤11 yrs 0.45 (n=14) 0.9 (0.4-1.9) 21.5 (17.5-38.0) 0.6 (n=37) 0.8 (0.3-1.7) 36.7 (20.1-65.9) 1 (n=16) 0.7 (0.4-1.2) 53.1 (31.2-89.9) Adolescents >11 to ≤17 yrs 0.45 (n=18) 1.0 (0.5-1.7) 37.5 (18.3-65.7) 0.6 (n=31) 0.9 (0.2-2.1) 41.4 (16.3… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES In US clinical studies, a total of 1137 patients received Rocuronium Bromide, 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, 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 (14–85) 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 (27–111) and 67 (38–160) 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 (3–6 mg/kg) or propofol (1.5–2.5 mg/kg) in combination with either fentanyl (2–5 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%–99.9%]) patients receiving Rocuronium Bromide and in 108/110 (98% [94%–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 (14–29) 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 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 seconds after drug injection.

Therefore, Rocuro… [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.

📄 Recent Major Changes 26 words ▾

Dosage and Administration Important Dosing and Administration Information ( 2.1 ) 11/2018 Warnings and Precautions Risk of Death due to Medication Errors ( 5.3 ) 11/2018

📄 Package Label / Principal Display Panel 176 words ▾

PRINCIPAL DISPLAY PANEL NDC 72572- 650 -01 Rx Only Rocuronium Bromide Injection 50 mg/5 mL (10 mg/mL) WARNING: Paralyzing Agent For Intravenous Use ONLY 5 mL Multiple Dose Vial NDC 72572- 650 -01 Rx Only Rocuronium Bromide Injection 50 mg per 5 mL (10 mg/mL) For Intravenous use ONLY PARALYZING AGENT Peel off & apply to syringe NDC 72572- 650 -10 Rx Only Rocuronium Bromide Injection 50 mg/5 mL (10 mg/mL) WARNING: Paralyzing Agent For Intravenous Use ONLY 10 x 5 mL Multiple Dose Vial LBL peel CTN

PRINCIPAL DISPLAY PANEL NDC 72572- 651 -01 Rx Only Rocuronium Bromide Injection 100 mg/10 mL (10 mg/mL) WARNING: Paralyzing Agent For Intravenous Use ONLY 10 mL Multiple Dose Vial NDC 72572- 651 -01 Rx Only Rocuronium Bromide Injection 100 mg per 10 mL (10 mg/mL) For Intravenous use ONLY PARALYZING AGENT Peel off & apply to syringe NDC 72572- 651 -10 Rx Only Rocuronium Bromide Injection 100 mg/10 mL (10 mg/mL) WARNING: Paralyzing Agent For Intravenous Use ONLY 10 x 10 mL Multiple Dose Vial LBL peel CTN

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q3 2025 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
38
Units reimbursed last 4 qtrs
53
Gross reimbursed last 4 qtrs
$140.56
Avg / prescription
$3.70
Avg / unit
$2.6521
Latest quarter Q3 2025
18Rx
Medicaid pays / mL
$2.6521
gross reimbursed
vs
NADAC / mL
$0.3942
acquisition cost
=
Spread
+$2.2579
+573% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 38 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 53 units · 6.8 per 100k residents ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.86.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 North Dakota 6.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 72572-0612-10 · Civica, 72572-0651-10 · Civica, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.