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rocuronium bromide injection

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rocuronium bromide injection Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing and Administration Information

Rocuronium bromide injection is for intravenous use only. ...

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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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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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5 WARNINGS AND PRECAUTIONS

 

5.1 Appropriate Administration and Monitoring

Rocuronium bromide should be administered in carefully adjusted...

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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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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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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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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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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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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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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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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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16 HOW SUPPLIED/STORAGE AND HANDLING

Rocuronium bromide is available in the following:

...
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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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