rocuronium bromide 10 mg/mL
rocuronium bromide · INJECTION, SOLUTION · Hospira, Inc.
Rocuronium bromide is a prescription injection used during surgery and medical procedures to relax muscles and assist with mechanical ventilation. It works by blocking nerve signals to muscles, allowing doctors to maintain control of breathing during anesthesia.
Key Facts
- Brand Name
- rocuronium bromide
- Generic Name
- rocuronium bromide
- NDC Code (Product)
0409-7037- Manufacturer
- Hospira, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA205656
- Marketing Start
- 07/17/2023
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Pharmedium Services, LLC
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Denver Solutions, LLC DBA Leiters Health
Lack of Assurance of Sterility: Leaking/damaged syringes.
New England Life Care, Inc. dba Advanced Compounding Solutions
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Cantrell Drug Company
Lack of Sterility Assurance.
Piramal Critical Care, Inc.
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
PharMEDium Services, LLC
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Mckesson Medical-Surgical Inc. Corporate Office
cGMP Deviations: Products were stored outside the drug label specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 injection is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. ( 1 )
Dosage & Administration
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 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 ) 2.1 Important 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 experience…
Contraindications
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 )
Drug Interactions
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 ) 7.1 Antibiotics 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. 7.2 Anticonvulsants 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 chro…
Adverse Reactions
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 Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical studies in the U.S. (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the U.S. clinical studies provide the basis for calculation of adverse reaction rates. The following adverse reactions…
Frequently Asked Questions
What is rocuronium bromide used for?
Rocuronium bromide is a prescription injection used during surgery and medical procedures to relax muscles and assist with mechanical ventilation. It works by blocking nerve signals to muscles, allowing doctors to maintain control of breathing during anesthesia.
Is rocuronium bromide a controlled substance?
rocuronium bromide is not classified as a controlled substance by the DEA.
What is the generic name for rocuronium bromide?
The generic name for rocuronium bromide is rocuronium bromide. There are 9 other brand versions of rocuronium bromide.
What is the NDC code for rocuronium bromide 10 mg/mL?
The NDC (National Drug Code) for rocuronium bromide 10 mg/mL is 0409-7037, listed by Hospira, Inc..
Other rocuronium bromide Dosages
Other Rocuronium Brands
See all →- Rocuronium Bromide10 mg/mL72572-650
- ROCURONIUM BROMIDE10 mg/mL51662-1355
- ROCURONIUM BROMIDE10 mg/mL65145-131
- Rocuronium10 mg/mL81565-204
- Rocuronium Bromide10 mg/mL84549-141
- Rocuronium Bromide10 mg/mL0143-9250
- Rocuronium Bromide50 mg/5mL43066-007
- ROCURONIUM BROMIDE10 mg/mL51662-1640
- Rocuronium Bromide50 mg/5mL0264-5711
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)