ROCURONIUM BROMIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Rocuronium bromide (UNII: I65MW4OFHZ) (ROCURONIUM - UNII:WRE554RFEZ)

Available from:

Sanovel Ilac San. Ve Tic.A.S.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see Warnings and Precautions (5.2)] . 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 re

Product summary:

Rocuronium bromide injection is available in the following: 50 mg/5 mL (10 mg/mL) NDC 71479-005-05 multidose vials of 5 mL in box of 10 100 mg/10 mL (10 mg/mL) NDC 71479-004-10 multidose vials of 10 mL in boxes of 10 The packaging of this product contains no natural rubber (latex). Rocuronium bromide should be stored in a refrigerator, 2-8°C (36-46°F). DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use rocuronium bromide within 60 days. Use opened vials of rocuronium bromide within 30 days. Safety and Handling There is no specific work exposure limit for rocuronium bromide. In case of eye contact, flush with water for at least 10 minutes.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROCURONIUM BROMIDE- ROCURONIUM BROMIDE INJECTION, SOLUTION
SANOVEL ILAC SAN. VE TIC.A.S.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROCURONIUM BROMIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROCURONIUM BROMIDE.
ROCURONIUM BROMIDE INJECTION SOLUTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1994
RECENT MAJOR CHANGES
Dosage and Administration
Important Dosing and Administration Information (2.1)
07/2018
Warnings and Precautions
Risk of Death due to Medication Errors (5.3)
07/2018
INDICATIONS AND USAGE
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. (1)
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 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)
DOSAGE FORMS AND STRENGTHS
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
Hypersensitivit