Rocuronium Bromide Injection

Dosage Forms And Strengths

ZEMURON (rocuronium bromide) injection is available as

• 5 mL multiple dose vials containing 50 mg rocuronium bromide injection (10 mg/mL)

ZEMURON (rocuronium bromide) injection is available in the following:

• ZEMURON 5 mL multiple dose vials containing 50 mg rocuronium bromide injection (10 mg/mL)

Box of 10 NDC 0052-0450-15

The packaging of this product contains no natural rubber (latex).

ZEMURON 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 ZEMURON within 60 days. Use opened vials of ZEMURON within 30 days.

Safety And Handling

There is no specific work exposure limit for ZEMURON. In case of eye contact, flush with water for at least 10 minutes. 18

Manufactured by: Organon (Ireland) Ltd., Swords, Co. Dublin, Ireland, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Before receiving rocuronium, tell your doctor if you have myasthenia gravis, cirrhosis or other liver disease, a history of kidney disease, heart disease, a history of "Long QT Syndrome," problems with circulation, or if you have ever had an allergic reaction to another anesthetic medication.

Before you receive rocuronium, tell your doctor if you are pregnant or breast-feeding.

There may be other drugs that can interact with rocuronium, especially seizure medication, certain antibiotics, lithium, procainamide, or magnesium. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors.

It may take you longer to recover from the effects of rocuronium if you have cirrhosis or other liver disease.

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

In U.S. 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.

Adult 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 to 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 to 111) and 67 (38 to 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:

Intubating conditions were assessed in 230 patients in 6 clinical studies where anesthesia was induced with either thiopental (3 to 6 mg/kg) or propofol (1.5 to 2.5 mg/kg) in combination with either fentanyl (2 to 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% to 99.9%]) patients receiving rocuronium bromide and in 108/110 (98% [94% to 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 to 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 (2.5)].

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, rocuronium bromide is not recommended for rapid sequence induction in Cesarean section patients.

Geriatric Patients

Rocuronium bromide was evaluated in 55 geriatric patients (ages 65 to 80 years) in 6 clinical studies. Doses of 0.6 mg/kg provided excellent to good intubating conditions in a median (range) time of 2.3 (1 to 8) minutes. Recovery times from 25% to 75% after these doses were not prolonged in geriatric patients compared to other adult patients [see Dosage and Administration (2.5) and Use in Specific Populations (8.5)].

Pediatric Patients

Rocuronium bromide 0.45, 0.6, or 1 mg/kg was evaluated under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia for intubation in 326 patients in 2 studies. In 1 of these studies maintenance bolus and infusion requirements were evaluated in 137 patients. In all age groups, doses of 0.6 mg/kg provided time to maximum block in about 1 minute. Across all age groups, median (range) time to reappearance of T3 for doses of 0.6 mg/kg was shortest in the children [36.7 (20.1 to 65.9) minutes] and longest in infants [59.8 (32.3 to 87.8) minutes]. For pediatric patients older than 3 months, the time to recovery was shorter after stopping infusion maintenance when compared with bolus maintenance [see Dosage and Administration (2.5) and Use in Specific Populations (8.4)].

Rocuronium bromide 0.6 or 0.8 mg/kg was evaluated for intubation in 75 pediatric patients (n = 28; age 3 to 12 months, n = 47; age 1 to 12 years) in 3 studies using halothane (1% to 5%) and nitrous oxide (60% to 70%) in oxygen. Doses of 0.6 mg/kg provided a median (range) time to maximum block of 1 (0.5 to 3.3) minute(s). This dose provided a median (range) time of clinical relaxation of 41 (24 to 68) minutes in 3-month to 1-year-old infants and 26 (17 to 39) minutes in 1- to 12-year-old pediatric patients [see Dosage and Administration (2.5) and Use in Specific Populations (8.4)].

                                                                                    NDC 55150-226-10
Rocuronium
Bromide
Injection
100 mg per 10 mL
(10 mg / mL)
Rx only
For Intravenous Use Only
WARNING: Paralyzing Agent.
May cause respiratory depression.
Facilities for artificial respiration                                Sterile, Nonpyrogenic
must be immediately available.                    10 x 10 mL Multiple Dose Vials
AUROMEDICS