INDICATIONS
DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic
agent that can be used for both induction and/or maintenance
of anesthesia as proof of a balanced anesthetic technique
for inpatient and outpatient surgery in adults and in
children 3 years of age or older.
DIPRIVAN Injectable Emulsion, when administered intravenously
as directed, can be used to initiate and maintain monitored
anesthesia care (MAC) sedation during diagnostic procedures
in adults. DIPRIVAN Injectable Emulsion may also be used
for MAC sedation in conjunction with local/regional anesthesia
in patients undergoing surgical procedures. (See PRECAUTIONS)
DIPRIVAN Injectable Emulsion should only be administered
to intubated, mechanically ventilated adult patients in
the Intensive Care Unit (ICU) to provide continuous sedation
and control of stress responses. In this setting, DIPRIVAN
Injectable Emulsion should be administered only by persons
skilled in the medical management of critically ill patients
and trained in cardiovascular resuscitation and airway
management.
DIPRIVAN Injectable Emulsion is not recommended for obstetrics,
including cesarean section deliveries. DIPRIVAN Injectable
Emulsion crosses the placenta, and as with other general
anesthetic agents, the administration of DIPRIVAN Injectable
Emulsion may be associated with neonatal depression. (See
PRECAUTIONS)
DIPRIVAN Injectable Emulsion is not recommended for use
in nursing mothers because DIPRIVAN Injectable Emulsion
has been reported to be excreted in human milk, and the
effects of oral absorption of small amounts of propofol
are not known. (See PRECAUTIONS)
DIPRIVAN Injectable Emulsion is not recommended for anesthesia
in children below the age of 3 years because safety and
effectiveness have not been established. DIPRIVAN Injectable
Emulsion is not recommended for MAC sedation in children
because safety and effectiveness have not been established.
DIPRIVAN Injectable Emulsion is not recommended for pediatric
ICU sedation because safety and effectiveness have not
been established.
DOSAGE AND ADMINISTRATION
Dosage and rate of administration should be individualized
and titrated to the desired effect, according to clinically
relevant factors including preinduction and concomitant
medications, age, ASA physical classification, and level
of debilitation of the patient.
The following is abbreviated dosage and administration
information which is only intended as a general guide
in the use of DIPRIVAN Injectable Emulsion. Prior to administering
DIPRIVAN Injectable Emulsion, it is imperative that the
physician review and be completely familiar with the specific
dosage and administration information detailed in the
CLINICAL PHARMACOLOGY - Individualization of Dosage section.
In the elderly, debilitated, or ASA III/IV patients,
rapid bolus doses should not be the method of administration.
(See WARNINGS.)
Intensive Care Unit Sedation
STRICT ASEPTIC TECHNIQUE MUST ALWAYS BE MAINTAINED
DURING HANDLING. DIPRIVAN INJECTABLE EMULSION IS A SINGLE-USE
PARENTERAL PRODUCT WHICH CONTAINS 0.005% DISODIUM EDETATE
TO R.T.(R.) THE R.T. OF GROWTH OF MICROORGANISMS IN THE
EVENT OF ACCIDENTAL EXTRINSIC CONTAMINATION. HOWEVER,
DIPRIVAN INJECTABLE EMULSION CAN STILL SUPPORT THE GROWTH
OF MICROORGANISMS AS IT IS NOT AN ANTIMICROBIALLY PRESERVED
PRODUCT UNDER USP STANDARDS. ACCORDINGLY, STRICT ASEPTIC
TECHNIQUE MUST STILL BE ADHERED TO. DO NOT USE IF CONTAMINATION
IS SUSPECTED.
DIPRIVAN Injectable Emulsion should be individualized
according to the patient's condition and response, blood
lipid profile, and vital signs. (See PRECAUTIONS - ICU
sedation) For intubated, mechanically ventilated adult
patients, Intensive Care Unit (ICU) sedation should be
initiated slowly with a continuous infusion in order to
titrate to desired clinical effect and minimize hypotension.
When indicated, initiation of sedation should begin at
5 µg/kg/min (0.3 mg/kg/h). The infusion rate should
be increased by increments of 5 to 10 µg/kg/min
(0.3 to 0.6 mg/kg/h) until the desired level of sedation
is achieved. A minimum period of 5 minutes between adjustments
should be allowed for onset of peak drug effect. Most
adult patients require maintenance rates of 5 to 50 µg/kg/min
(0.3 to 3 mg/kg/h) or higher. Dosages of DIPRIVAN Injectable
Emulsion should be reduced in patients who have received
large dosages of narcotics. Conversely, the DIPRIVAN Injectable
Emulsion dosage requirement may be reduced by adequate
management of pain with analgesic agents. As with other
sedative medications, there is interpatient variability
in dosage requirements, and these requirements may change
with time. (See DOSAGE GUIDE) EVALUATION OF LEVEL OF SEDATION
AND ASSESSMENT OF CNS FUNCTION SHOULD BE CARRIED OUT DAILY
THROUGHOUT MAINTENANCE TO DETERMINE THE MINIMUM DOSE OF
DIPRIVAN INJECTABLE EMULSION REQUIRED FOR SEDATION (See
CLINICAL TRIALS, ICU Sedation). Bolus administration of
10 or 20 mg should only be used to rapidly increase depth
of sedation in patients where hypotension is not likely
to occur. Patients with compromised myocardial function,
intravascular volume depletion, or abnormally low vascular
tone (eg, sepsis) may be more susceptible to hypotension.
(See PRECAUTIONS)
EDTA is a strong chelator of trace metals – including
zinc. Calcium disodium edetate has been used in gram quantities
to treat heavy metal toxicity. When used in this manner,
it is possible that as much as 10 mg of elemental zinc
can be lost per day via this mechanism. Although with
DIPRIVAN Injectable Emulsion there are no reports of decreased
zinc levels or zinc deficiency-related adverse events,
DIPRIVAN Injectable Emulsion should not be infused for
longer than 5 days without providing a drug holiday to
safely replace estimated or measured urine zinc losses.
At high doses (2-3 grams per day), EDTA has been reported,
on rare occasions, to be toxic to the renal tubules. Studies
to-date, in patients with normal or impaired renal function
have not shown any alteration in renal function with DIPRIVAN
Injectable Emulsion containing 0.005% disodium edetate.
In patients at risk for renal impairment, urinalysis and
urine sediment should be checked before initiation of
sedation and then be monitored on alternate days during
sedation.
SUMMARY OF DOSAGE GUIDELINES - Dosages and rates of administration
in the following table should be individualized and titrated
to clinical response. Safety and dosage requirements in
pediatric patients have only been established for induction
and maintenance of anesthesia. For complete dosage information,
see CLINICAL PHARMACOLOGY - Individualization of Dosage.
HOW SUPPLIED
DIPRIVAN Injectable Emulsion is available in ready to
use 20 mL ampules, 50 mL infusion vials, 100 mL infusion
vials, and 50 mL prefilled syringes containing 10 mg/mL
of propofol.
20 mL ampules (NDC 0310-0300-20)
50 mL infusion vials (NDC 0310-0300-50)
100 mL infusion vials (NDC 0310-0300-11)
50 mL prefilled syringes (NDC 0310-300-54)
Propofol undergoes oxidative degradation in the presence
of oxygen, and is therefore packaged under nitrogen to
eliminate this degradation path.
Store between 4°-22°C (40°-72°F). Do
not freeze. Shake well before use.
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