Propofol (Page 9 of 9)
14.2 Neuroanesthesia
Propofol injectable emulsion was studied in patients undergoing craniotomy for supratentorial tumors in two clinical trials. The mean lesion size (anterior/posterior × lateral) was 31 mm × 32 mm in one trial and 55 mm × 42 mm in the other trial respectively. Anesthesia was induced with a median propofol injectable emulsion dose of 1.4 mg/kg (range: 0.9 mg/kg to 6.9 mg/kg) and maintained with a median maintenance propofol injectable emulsion dose of 146 mcg/kg/min (range: 68 mcg/kg/min to 425 mcg/kg/min). The median duration of the propofol injectable emulsion maintenance infusion was 285 minutes (range: 48 minutes to 622 minutes).
Propofol injectable emulsion was administered by infusion in a controlled clinical trial to evaluate its effect on cerebrospinal fluid pressure (CSFP). The mean arterial pressure was maintained relatively constant over 25 minutes with a change from baseline of -4% ± 17% (mean ± SD). The change in CSFP was -46% ± 14%. As CSFP is an indirect measure of intracranial pressure (ICP), propofol injectable emulsion, when given by infusion or slow bolus in combination with hypocarbia, is capable of decreasing ICP independent of changes in arterial pressure.
14.3 Cardiac Anesthesia
Propofol injectable emulsion was evaluated in clinical trials involving patients undergoing coronary artery bypass graft (CABG).
In post-CABG (coronary artery bypass graft) patients, the maintenance rate of propofol administration was usually low (median 11 mcg/kg/min) due to the intraoperative administration of high opioid doses. Patients receiving propofol injectable emulsion required 35% less nitroprusside than midazolam patients. During initiation of sedation in post-CABG patients, a 15% to 20% decrease in blood pressure was seen in the first 60 minutes. It was not possible to determine cardiovascular effects in patients with severely compromised ventricular function.
14.4 Intensive Care Unit (ICU) Sedation in Adult Patients
Propofol injectable emulsion was compared to benzodiazepines and opioids in clinical trials involving ICU patients. Of these, 302 received propofol injectable emulsion and comprise the overall safety database for ICU sedation.
Across all clinical studies, the mean infusion maintenance rate for all propofol injectable emulsion patients was 27 ± 21 mcg/kg/min. The maintenance infusion rates required to maintain adequate sedation ranged from 2.8 mcg/kg/min to 130 mcg/kg/min. The infusion rate was lower in patients over 55 years of age (approximately 20 mcg/kg/min) compared to patients under 55 years of age (approximately 38 mcg/kg/min). Although there are reports of reduced analgesic requirements, most patients received opioids for analgesia during maintenance of ICU sedation. In these studies, morphine or fentanyl was used as needed for analgesia. Some patients also received benzodiazepines and/or neuromuscular blocking agents. During long-term maintenance of sedation, some ICU patients were awakened once or twice every 24 hours for assessment of neurologic or respiratory function.
In Medical and Postsurgical ICU studies comparing propofol injectable emulsion to benzodiazepine infusion or bolus, there were no apparent differences in maintenance of adequate sedation, mean arterial pressure, or laboratory findings. Like the comparators, propofol injectable emulsion reduced blood cortisol during sedation while maintaining responsivity to challenges with adrenocorticotropic hormone (ACTH). Case reports from the published literature generally reflect that propofol injectable emulsion has been used safely in patients with a history of porphyria or malignant hyperthermia.
In hemodynamically stable head trauma patients ranging in age from 19 to 43 years, adequate sedation was maintained with propofol injectable emulsion or morphine. There were no apparent differences in adequacy of sedation, intracranial pressure, cerebral perfusion pressure, or neurologic recovery between the treatment groups. In literature reports of severely head injured patients in Neurosurgical ICUs, propofol injectable emulsion infusion and hyperventilation, both with and without diuretics, controlled intracranial pressure while maintaining cerebral perfusion pressure. In some patients, bolus doses resulted in decreased blood pressure and compromised cerebral perfusion pressure.
Propofol injectable emulsion was found to be effective in status epilepticus which was refractory to the standard anticonvulsant therapies. For these patients, as well as for ARDS/respiratory failure and tetanus patients, sedation maintenance dosages were generally higher than those for other critically ill patient populations.
14.5 Intensive Care Unit (ICU) Sedation in Pediatric Patients
A single, randomized, controlled, clinical trial that evaluated the safety and effectiveness of propofol injectable emulsion versus standard sedative agents (SSA) was conducted on 327 pediatric ICU patients. Patients were randomized to receive either propofol injectable emulsion 2%, (113 patients), propofol injectable emulsion 1%, (109 patients), or an SSA (e.g, lorazepam, chloral hydrate, fentanyl, ketamine, morphine, or phenobarbital). Propofol injectable emulsion therapy was initiated at an infusion rate of 5.5 mg/kg/hr and titrated as needed to maintain sedation at a standardized level. The results of the study showed an increase in the number of deaths in patients treated with propofol injectable emulsion as compared to SSAs. Of the 25 patients who died during the trial or within the 28-day follow up period: 12 (11% were) in the propofol injectable emulsion 2% treatment group, 9 (8% were) in the propofol injectable emulsion 1% treatment group, and 4% were (4%) in the SSA treatment group. The differences in mortality rate between the groups were not statistically significant. Review of the deaths failed to reveal a correlation with underlying disease status or a correlation to the drug or a definitive pattern to the causes of death.
16 HOW SUPPLIED/STORAGE AND HANDLING
Propofol injectable emulsion, USP is available as follows:
| Strength | Package Sizes and NDC No. |
| 200 mg per 20 mL (10 mg/mL) | 20 mL ready-to-use single-dose infusion vial (NDC 16714-528-01) in packages of 10 (NDC 16714-528-10) and in packages of 20 (NDC 16714-528-20) |
| 500 mg per 50 mL (10 mg/mL) | 50 mL ready-to-use single-dose infusion vial (NDC 16714-977-01) in packages of 20 (NDC 16714-977-20) |
| 1,000 mg per 100 mL (10 mg/mL) | 100 mL ready-to-use single-dose infusion vial (NDC 16714-690-01) in packages of 10 (NDC 16714-690-10) |
Store between 4° to 25°C (40° to 77°F). Do not freeze. Shake well before use.
17 PATIENT COUNSELING INFORMATION
17.1 Impaired Mental Alertness
Advise patients that performance of activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery or signing legal documents may be impaired for some time after general anesthesia or sedation.
17.2 Effect of Anesthetic and Sedation Drugs on Early Brain Development
Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs.
All trademarks are the property of their respective owners.
Manufactured for:
Northstar Rx LLC
Memphis, TN 38141.
Manufactured by:
Emcure Pharmaceuticals Ltd.,
Plot No. SM-14, 15 & 16/1, GIDC,
Sanand — II, Charal, Tal — Sanand,
Ahmedabad, Gujarat 382110, India.
Revised: 09 /2023
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Propofol Injectable Emulsion, USP
200 mg/20 mL
(10 mg/mL)
For Intravenous Administration
SHAKE WELL BEFORE USING
10 x 20 mL Vials for Single Patient Use Only
NDC 16714-528 -01
Propofol Injectable Emulsion, USP
200 mg/20 mL
(10 mg/mL)
For Intravenous Administration
SHAKE WELL BEFORE USING
20 mL Vial for Single Patient Use Only
Propofol Injectable Emulsion, USP
500 mg/50 mL
(10 mg/mL)
For Intravenous Administration
SHAKE WELL BEFORE USING
20 x 50 mL Vials for Single Patient Use Only
NDC 16714-977 -01
Propofol Injectable Emulsion, USP
500 mg/50 mL
(10 mg/mL)
For Intravenous Administration
SHAKE WELL BEFORE USING
50 mL Vial for Single Patient Use Only
Propofol Injectable Emulsion, USP
1,000 mg/100 mL
(10 mg/mL)
For Intravenous Administration
SHAKE WELL BEFORE USING
10 x 100 mL Vials for Single Patient Use Only
Propofol Injectable Emulsion, USP
1,000 mg/100 mL
(10 mg/mL)
For Intravenous Administration
SHAKE WELL BEFORE USING
100 mL Vial for Single Patient Use Only
| PROPOFOL propofol injection, emulsion | |||||||||||||||||||||||||
| |||||||||||||||||||||||||
| |||||||||||||||||||||||||
| |||||||||||||||||||||||||
| |||||||||||||||||||||||||
| |||||||||||||||||||||||||
| PROPOFOL propofol injection, emulsion | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| PROPOFOL propofol injection, emulsion | |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| |||||||||||||||||
| Labeler — NorthStar Rx LLC (830546433) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Emcure Pharmaceuticals Limited | 675467924 | ANALYSIS (16714-528), ANALYSIS (16714-977), ANALYSIS (16714-690), MANUFACTURE (16714-528), MANUFACTURE (16714-977), MANUFACTURE (16714-690), PACK (16714-528), PACK (16714-977), PACK (16714-690), LABEL (16714-528), LABEL (16714-977), LABEL (16714-690) | |
Revised: 10/2023 NorthStar Rx LLC
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.