For intravenous administration

Maintenance of General Anesthesia:  Intermittent 

Bolus 

Healthy Adults Less Than 55 Years of Age: 

Increments of 20 to 50 mg as needed. 

Initiation of MAC Sedation:  

Healthy Adults Less Than 55 Years of Age: 

Slow infusion or slow injection techniques are recommended to avoid apnea 

or hypotension.  Most patients require an infusion of 100 to 150 mcg/kg/min 

(6 to 9 mg/kg/h) for 3 to 5 minutes or a slow injection of 0.5 mg/kg over 3 

to 5 minutes followed immediately by a maintenance infusion. 

Elderly, Debilitated, Neurosurgical, or ASA-PS III or IV Patients: 

Most patients require dosages similar to healthy adults. 

Rapid boluses are to be avoided (see WARNINGS). 

45 

Reference ID: 3520825 

Maintenance of MAC Sedation:  

Healthy Adults Less Than 55 Years of Age: 

A variable rate infusion technique is preferable over an intermittent bolus  

technique.  Most patients require an infusion of 25 to 75 mcg/kg/min 

(1.5 to 4.5 mg/kg/h) or incremental bolus doses of 10 mg or 20 mg. 

In Elderly, Debilitated, Neurosurgical, or ASA-PS III or IV Patients: 

Most patients require 80% of the usual adult dose.  A rapid (single or 

repeated) bolus dose should not be used (see WARNINGS). 

Initiation and Maintenance of ICU Sedation in Intubated, Mechanically Ventilated 

Adult Patients - Because of the residual effects of previous anesthetic or 

sedative agents, in most patients the initial infusion should be 5 mcg/kg/min 

(0.3 mg/kg/h) for at least 5 minutes.  Subsequent increments of 5 to 10 

mcg/kg/min (0.3 to 0.6 mg/kg/h) over 5 to 10 minutes may be used until 

desired clinical effect is achieved.  Maintenance rates of 5 to 50 mcg/kg/min 

(0.3 to 3 mg/kg/h) or higher may be required.  Administration should not 

exceed 4 mg/kg/hour unless the benefits outweigh the risks (see 

WARNINGS). 

Evaluation of clinical effect and assessment of CNS function should be 

carried out daily throughout maintenance to determine the minimum 

dose of DIPRIVAN Injectable Emulsion required for sedation. 

The tubing and any unused DIPRIVAN Injectable Emulsion drug product 

should be discarded after 12 hours because DIPRIVAN Injectable 

Emulsion contains no preservatives and is capable of supporting growth 

of microorganisms (see WARNINGS and DOSAGE AND 

ADMINISTRATION). 

Administration with Lidocaine 

If lidocaine is to be administered to minimize pain on injection of DIPRIVAN Injectable 

Emulsion, it is recommended that it be administered prior to DIPRIVAN Injectable Emulsion 

administration or that it be added to DIPRIVAN Injectable Emulsion immediately before 

administration and in quantities not exceeding 20 mg lidocaine/200 mg DIPRIVAN. 

Compatibility and Stability 

DIPRIVAN Injectable Emulsion should not be mixed with other therapeutic agents prior to 

administration. 

46  

Reference ID: 3520825 

1 

Dilution Prior to Administration 

2 

DIPRIVAN Injectable Emulsion is provided as a ready-to-use formulation.  However, should 

3 

dilution be necessary, it should only be diluted with 5% Dextrose Injection, USP, and it 

4 

should not be diluted to a concentration less than 2 mg/mL because it is an emulsion.  In 

5 

diluted form it has been shown to be more stable when in contact with glass than with plastic 

6 

(95% potency after 2 hours of running infusion in plastic).    

7 

Administration with Other Fluids 

8 

Compatibility of DIPRIVAN Injectable Emulsion with the coadministration of 

9 

blood/serum/plasma has not been established (see WARNINGS).  When administered using 

10 

a y-type infusion set, DIPRIVAN Injectable Emulsion has been shown to be compatible with 

11 

the following intravenous fluids. 

12 

- 5% Dextrose Injection, USP 

13 

- Lactated Ringers Injection, USP 

14 

- Lactated Ringers and 5% Dextrose Injection 

15 

- 5% Dextrose and 0.45% Sodium Chloride Injection, USP 

16 

- 5% Dextrose and 0.2% Sodium Chloride Injection, USP 

17 

Handling Procedures 

18 

General 

19 

Parenteral drug products should be inspected visually for particulate matter and 

20 

discoloration prior to administration whenever solution and container permit. 

21 

Clinical experience with the use of in-line filters and DIPRIVAN Injectable 

22 

Emulsion during anesthesia or ICU/MAC sedation is limited.  DIPRIVAN Injectable 

23 

Emulsion should only be administered through a filter with a pore size of 5 micron or 

47  

Reference ID: 3520825 

1 

greater unless it has been demonstrated that the filter does not restrict the flow of 

2 

DIPRIVAN Injectable Emulsion and/or cause the breakdown of the emulsion.  Filters should 

3 

be used with caution and where clinically appropriate.  Continuous monitoring is necessary 

4 

due to the potential for restricted flow and/or breakdown of the emulsion. 

5 

Do not use if there is evidence of separation of the phases of the emulsion. 

6 

Rare cases of self-administration of DIPRIVAN Injectable Emulsion by health care 

7 

professionals have been reported, including some fatalities (see DRUG ABUSE AND 

8 

DEPENDENCE). 

9 

Strict aseptic technique must always be maintained during handling.  

10 

DIPRIVAN Injectable Emulsion is a single access parenteral product (single patient 

11 

infusion vial) which contains 0.005% disodium edetate to inhibit the rate of growth of 

12 

microorganisms, up to 12 hours, in the event of accidental extrinsic contamination.  

13 

However, DIPRIVAN Injectable Emulsion can still support the growth of 

14 

microorganisms as it is not an antimicrobially preserved product under USP 

15 

standards.  Do not use if contamination is suspected.  Discard unused drug product as 

16 

directed within the required time limits. There have been reports in which failure to 

17 

use aseptic technique when handling DIPRIVAN Injectable Emulsion was associated 

18 

with microbial contamination of the product and with fever, infection/sepsis, other 

19 

life-threatening illness, and/or death. 

20 

There have been reports, in the literature and other public sources, of the 

21 

transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) 

22 

from unsafe injection practices, and use of propofol vials intended for single use on 

48  

Reference ID: 3520825 

1 

multiple persons.  DIPRIVAN Injectable Emulsion vials are never to be accessed more 

2 

than once or used on more than one person. 

3 

Diprivan, with EDTA inhibits microbial growth for up to 12 hours, as demonstrated 

4 

by test data for representative USP microorganisms. 

5 

Guidelines for Aseptic Technique for General Anesthesia/MAC Sedation 

6 

DIPRIVAN Injectable Emulsion must be prepared for use just prior to initiation of each 

7 

individual anesthetic/sedative procedure.  The vial rubber stopper should be disinfected 

8 

using 70% isopropyl alcohol.  DIPRIVAN Injectable Emulsion should be drawn into a 

9 

sterile syringe immediately after a vial is opened.  When withdrawing DIPRIVAN Injectable 

10 

Emulsion from vials, a sterile vent spike should be used.  The syringe should be labelled 

11 

with appropriate information including the date and time the vial was opened. 

12 

Administration should commence promptly and be completed within 12 hours after the vial 

13 

has been opened. 

14 

DIPRIVAN Injectable Emulsion must be prepared for single-patient use only.  Any 

15 

unused DIPRIVAN Injectable Emulsion drug product, reservoirs, dedicated administration 

16 

tubing and/or solutions containing DIPRIVAN Injectable Emulsion must be discarded at the 

17 

end of the anesthetic procedure or at 12 hours, whichever occurs sooner.  The IV line should 

18 

be flushed every 12 hours and at the end of the anesthetic procedure to remove residual 

19 

DIPRIVAN Injectable Emulsion. 

20 

Guidelines for Aseptic Technique for ICU Sedation 

21 

DIPRIVAN Injectable Emulsion must be prepared for single-patient use only.  Strict aseptic 

22 

techniques must be followed.  The vial rubber stopper should be disinfected using 70% 

23 

isopropyl alcohol.  A sterile vent spike and sterile tubing must be used for administration of 

49  

Reference ID: 3520825 

1 

DIPRIVAN Injectable Emulsion.  As with other lipid emulsions, the number of IV line 

2 

manipulations should be minimized.  Administration should commence promptly and must 

3 

be completed within 12 hours after the vial has been spiked.  The tubing and any unused 

4 

DIPRIVAN Injectable Emulsion drug product must be discarded after 12 hours. 

5 

If DIPRIVAN Injectable Emulsion is transferred to a syringe prior to administration, 

6 

it should be drawn into a sterile syringe immediately after a vial is opened.  When 

7 

withdrawing DIPRIVAN Injectable Emulsion from a vial, a sterile vent spike should be 

8 

used.  The syringe should be labelled with appropriate information including the date and 

9 

time the vial was opened. Administration should commence promptly and be completed 

10 

within 12 hours after the vial has been opened.  DIPRIVAN Injectable Emulsion should be 

11 

discarded and administration lines changed after 12 hours. 

12 

HOW SUPPLIED: 

13 

DIPRIVAN Injectable Emulsion, USP is available as follows: 

Product 

NDC 

No. 

No. 

Strength 

260910 

63323-269-10 

1% (10 mg/mL 

propofol) 

10 mL ready-to-use single-patient 

infusion vial in packages of ten. 

260929 

63323-269-29 

1% (10 mg/mL 

propofol) 

20 mL ready-to-use single-patient 

infusion vial in packages of ten. 

260950 

63323-269-50 

1% (10 mg/mL 

propofol) 

50 mL ready-to-use single-patient 

infusion vial in packages of twenty. 

260965 

63323-269-65 

1% (10 mg/mL 

propofol) 

100 mL ready-to-use single-patient 

infusion vial in packages of ten. 

14 

Propofol undergoes oxidative degradation, in the presence of oxygen, and is therefore 

15 

packaged under nitrogen to eliminate this degradation path. 

16 

Store between 4° to 25°C (40° to 77°F).  Do not freeze.  Shake well before use.   

 

50

Reference ID: 3520825 

1 

All trademarks are the property of Fresenius Ka

2 

3 

Manufactured for: 

4 

5 

Fresenius Kabi USA, LLC 

6 

Lake Zurich, IL 60047 

7 

8 

Made in Austria 

9 

451094F 

10 

Revised: February 2014 

bi USA, LLC. 

51  

Reference ID: 3520825