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Rocuronium bromide (NDC 0409-9558-05 and 0409-9558-10) (rocuronium bromide)
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Rocuronium bromide (NDC 0409-9558-05 and 0409-9558-10) Quick Finder
Highlights
Indications and 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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing and Administration Information
Rocuronium bromide injection is for intravenous use only. ...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Rocuronium bromide is available as
- •
- 5 mL multiple dose vials containing 50 mg rocuronium bromide injection (10 mg/mL)
- •
- 10 mL multiple dose vials containing...
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Contraindications
4 CONTRAINDICATIONS
Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Appropriate Administration and Monitoring
Rocuronium bromide should be administered in carefully adjusted...
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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...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Antibiotics
Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as rocuronium bromide include certain...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits...
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Overdosage
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...
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Description
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-[...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies in animals have not been performed with rocuronium bromide to evaluate...
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Clinical Studies
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...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Rocuronium bromide is available in the following:
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Medication Guide
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,...
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