Rocuronium Bromide (Page 9 of 9)

Rapid Sequence Intubation

Intubation was assessed in 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 (2.6)].

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.

14.2 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 ( 2.6) and Use in Specific Populations (8.5)].

14.3 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 T 3 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 ( 2.6) 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 ( 2.6) and Use in Specific Populations (8.4)].

16 HOW SUPPLIED/STORAGE AND HANDLING

Rocuronium bromide injection is available in the following:

50 mg/5 mL (10 mg/mL)

NDC 0781-3220-95 multiple-dose vials of 5 mL in boxes of 10

100 mg/10 mL (10 mg/mL)

NDC 0781-3220-92 multiple-dose vials of 10 mL in boxes of 10

Rocuronium bromide should be stored in a refrigerator, 2° to 8°C (36° to 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 injection. In case of eye contact, flush with water for at least 10 minutes.

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, inform your patients that certain medical conditions and medications might influence how rocuronium bromide injection works.

In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including rocuronium bromide injection, have been reported. Since allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents.

Distributed by

Sandoz Inc., Princeton, NJ 08540

Revised: March 2019

46238554

5 mL Label

NDC 0781-3220-95 10 X 5 mL Multiple-Dose Vials

Rocuronium Bromide Injection

50mg/5mL

(10 mg/mL) Rx Only

WARNING: Paralyzing Agent

For Intravenous Use Only

Rx only

SANDOZ – A Novartis Division

carton-5ml
(click image for full-size original)

10 mL Label

NDC 0781-3220-92 10 X 10 mL Multiple-Dose Vials

Rocuronium Bromide Injection

100mg/10mL

(10 mg/mL) Rx Only

WARNING: Paralyzing Agent

For Intravenous Use Only

Rx only

SANDOZ – A Novartis Division

carton-10ml
(click image for full-size original)
ROCURONIUM BROMIDE
rocuronium bromide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-3220
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROCURONIUM BROMIDE (ROCURONIUM) ROCURONIUM BROMIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETIC ACID
SODIUM ACETATE
SODIUM CHLORIDE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-3220-92 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (0781-3220-70)
1 NDC:0781-3220-70 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0781-3220-92)
2 NDC:0781-3220-95 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (0781-3220-75)
2 NDC:0781-3220-75 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0781-3220-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079195 12/05/2008
Labeler — Sandoz Inc (005387188)
Establishment
Name Address ID/FEI Operations
Delpharm Boucherville Canada Inc. 242254227 analysis (0781-3220), label (0781-3220), manufacture (0781-3220), pack (0781-3220), sterilize (0781-3220)

Revised: 10/2022 Sandoz Inc

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