PropoFlo: Product Information

PROPOFLO- propofol injection, emulsion
Zoetis Inc.

For Animal Use Only

PropoFloTM
(propofol injectable emulsion) Intravenous Anesthetic Injection for Use in Dogs.

Fliptop vial. Each mL contains 10 mg propofol.
Shake Well Before Use.

CAUTION

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

PropoFlo™ Injection is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration. Propofol is chemically described as 2, 6-diisopropylphenol and has a molecular weight of 178.27. Propofol is very slightly soluble in water and is therefore formulated as a white, oil-in-water emulsion. In addition to the active component, propofol, the formulation also contains soybean oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12 mg/mL), and oleic acid (0.6 mg/mL) with sodium hydroxide to adjust the pH. The propofol emulsion is isotonic and has a pH of 6.0-9.0.

CLINICAL PHARMACOLOGY

Propofol injection is an intravenous sedative hypnotic agent for use in the induction and maintenance of anesthesia. Intravenous injection of propofol in the dog is followed by extensive metabolism of propofol in the liver to inactive conjugates which are excreted in the urine. Elimination from the central compartment occurs rapidly, with an initial elimination phase of less than 10 minutes1.

Induction of anesthesia will usually be observed within 75-120 seconds after the beginning of propofol administration. The duration of anesthesia following the recommended induction doses averages 6.7 minutes in premedicated and unpremedicated animals.

Recommended maintenance doses for anesthesia in unpremedicated animals, animals premedicated with acepromazine, and animals premedicated with a combination of agents results in anesthesia lasting an average of 3.68, 3.80 and 5.43 minutes, respectively, after each maintenance dose.

Recovery from propofol is rapid; full standing recovery is generally observed within 20 minutes. The use of certain premedicant combinations (e.g., acepromazine/oxymorphone) may result in prolonged recovery. Recovery may be delayed in Sighthounds.

Propofol has been used in association with atropine, glycopyrrolate, acepromazine, xylazine, oxymorphone, halothane and isoflurane. No pharmacological incompatibility has been observed.

INDICATIONS

Propofol is an intravenous anesthetic injection for use in dogs as follows:
1. For induction of anesthesia.
2. For maintenance of general anesthesia for up to 20 minutes. 3. For induction of general anesthesia where maintenance is provided by inhalant anesthetics.

DOSAGE AND ADMINISTRATION

Shake the vial thoroughly before opening.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Propofol is a white stable emulsion; do not use if there is evidence of separation of the phases. Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised. Slight creaming, which should disappear after shaking, may be visible upon prolonged standing. Do not use if particulate matter and discoloration are present.

Propofol contains no antimicrobial preservatives. Strict aseptic techniques must always be maintained during handling since the vehicle is capable of supporting the rapid growth of microorganisms. Failure to follow aseptic handling procedures may result in microbial contamination causing fever, infection/sepsis, and/or other life-threatening illness. Do not use if contamination is suspected.

Once propofol has been opened, vial contents should be drawn into sterile syringes; each syringe should be prepared for single patient use only.

Unused product should be discarded within 6 hours.

The emulsion should not be mixed with other therapeutic agents prior to administration. Administer by intravenous injection only.

INDUCTION OF GENERAL ANESTHESIA

For induction, propofol injection should be titrated against the response of the patient over 30-60 seconds or until clinical signs show the onset of anesthesia. Rapid injection of propofol (≤ 5 seconds) may be associated with an increased incidence of apnea2.

The average propofol induction dose rates for healthy dogs given propofol alone, or when propofol is preceded by a premedicant, are indicated in the table below. This table is for guidance only. The dose and rate should be based upon patient response.

Induction Dosage Guidelines

Preanesthetic

Propofol Induction

Propofol Rate of Administration

Dose

mg/kg

Seconds

mg/kg/min

mL/kg/min

None

5.5

40 — 60

5.5 — 8.3

0.55 — 0.83

Acepromazine

3.7

30 — 50

4.4 — 7.4

0.44 — 0.74

Acepromazine / Oxymorphone

2.6

30 — 50

3.1 — 5.2

0.31 — 0.52

Propofol doses and rates for the above premedicants were based upon the following average dosages. These doses may be lower than the label directions for their use as a single medication3,4.

Dose (mg/kg)

Routes

Acepromazine

0.060

IM, SC, IV

Oxymorphone

0.090

IM, SC, IV

Xylazine

0.33

IM, SC

The use of these drugs as preanesthetics markedly reduces propofol requirements. As with other sedative hypnotic agents, the amount of opioid and/or α-2 agonist premedication will influence the response of the patient to an induction dose of propofol.

In the presence of premedication, the dose of propofol may be reduced with increasing age of the animal. The dose of propofol should always be titrated against the response of the patient.

During induction, additional low doses of propofol, similar to those used for maintenance with propofol, may be administered to facilitate intubation or the transition to inhalant maintenance anesthesia.

.

MAINTENANCE OF GENERAL ANESTHESIA

A. Intermittent Propofol Injections: Anesthesia can be maintained by administering propofol in intermittent IV injections. Clinical response will be determined by the amount and the frequency of maintenance injections. The following table is provided for guidance:

Maintenance Dosage Guidelines

Preanesthetic

Propofol Maintenance Dose

Rate of Administration

mg/kg

Seconds

mg/kg/min

mL/kg/min

None

2.2

10 — 30 4.4 — 13.2 .044 — 1.32

Acepromazine

1.6

10 — 30

3.2 — 9.6

0.32 — 0.96

Acepromazine / Oxymorphone

1.8

10 — 30

3.6 — 10.8

0.36 — 1.08

Repeated maintenance doses of propofol do not result in increased recovery times or dosing intervals, indicating that the anesthetic effects of propofol are not cumulative.

B. Maintenance by Inhalant Anesthetics: Due to the rapid metabolism of propofol, additional low doses of propofol, similar to those used for maintenance with propofol, may be required to complete the transition to inhalant maintenance anesthesia.

Clinical trials using propofol have shown that it may be necessary to use a higher initial concentration of the inhalant anesthetic halothane than is usually required following induction using barbiturate anesthetics, due to rapid recovery from propofol5.

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