Propofol: Product Information

PROPOFOL- propofol injection, emulsion
Butler Animal Health Supply, LLC dba Covetrus North America

For Animals Only

Covetrus

Propofol injectable emulsion

Anesthetic Injection

Each mL contains 10 mg propofol

Approved by FDA under NADA #141-070

Emulsion for intravenous in dogs and cats.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

Propofol injectable emulsion 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 178.28. Propofol is very slightly soluble in water and is therefore formulated as a white, oil-in-water emulsion. Each mL contains propofol (10 mg), soybean oil (100 mg), glycerol (22.5 mg), egg yolk phospholipid (12 mg) and sodium metabisulfite (0.25 mg), with sodium hydroxide to adjust the pH. The propofol emulsion is isotonic and has a pH of 4.5-6.6.

INDICATIONS

Propofol injectable emulsion is an anesthetic injection for use in dogs and cats as follows:

1. As a single injection to provide general anesthesia for short procedures.

2. For induction and maintenance of general anesthesia using incremental doses to effect.

3. For induction of general anesthesia where maintenance is provided by inhalant anesthetics.

Induction of general anesthesia will usually be observed within 30 to 60 seconds after the end of administration (administration should take 60 to 90 seconds). The doses for induction and maintenance vary depending upon species and preanesthetics. The duration of anesthesia varies depending upon species, dose, and preanesthetics.

In dogs, the duration of anesthesia following the recommended induction dose (5.5 to 7.0 mg/kg without premedication) is generally 5 to 7 minutes. The duration of anesthesia after maintenance doses varies from 2 to 6 minutes following 1.1 mg/kg to 6 to 10 minutes following 3.3 mg/kg. Full standing recovery is generally observed within 10 to 20 minutes after the end of anesthesia, regardless of the duration of anesthesia. Recovery may be delayed in sighthounds or if preanesthetics are administered.

In cats, the duration of anesthesia following the recommended induction dose (8.0 to 13.2 mg/kg without premedication) is generally 5 to 12 minutes. The duration of anesthesia after maintenance doses varies from 5 to 7 minutes following 1.1 mg/kg to 12 to 18 minutes following 4.4 mg/kg. Full standing recovery is generally observed within 30 to 45 minutes after the end of anesthesia, regardless of the duration of anesthesia. Recovery may be delayed if preanesthetics are administered.

DOSAGE AND ADMINISTRATION

Shake the vial thoroughly before opening. Propofol injectable emulsion injection contains no antimicrobial preservatives. Strict aseptic techniques must always be maintained during handling since the vehicle is capable of supporting 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.

Propofol injectable emulsion injection should be prepared for use just prior to initiation of each individual anesthetic procedure. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. The entire contents of the vial should be drawn into sterile syringes immediately after vials are opened. Administration should commence promptly and be completed within 6 hours after the vials are opened. Any unused product should be discarded within 6 hours. Administer by intravenous injection only.

The emulsion should not be mixed with other therapeutic agents or injected into containers of infusion fluids prior to administration.

INDUCTION OF GENERAL ANESTHESIA

For induction, propofol injectable emulsion injection should be titrated against the response of the patient over approximately 60 to 90 seconds or until clinical signs show the onset of anesthesia.

If propofol injectable emulsion injection is injected too slowly (greater than 90 seconds), an inadequate plane of anesthesia can occur. If this occurs, an additional low dose (1.1 mg/kg) of propofol may be administered to facilitate intubation or the transition to inhalant maintenance anesthesia.

The average induction dose ranges and dosage rates for healthy dogs given propofol alone, or when propofol is preceded by a premedicant, are indicated in the following table (the Table is for guidance only; in practice, the dose should be based upon patient response):

Induction Dosage Guidelines for Dogs

Preanesthetic

Propofol Induction Dose

Propofol Rate of Administration

mg/kg

mg/lb

Seconds

mg/kg/min

mL/kg/min

None

5.5-7.0

2.5-3.2

60-90

3.7-7.0

0.37-0.70

Acepromazine

4.0-4.4

1.8-2.0

60-90

2.7-4.4

0.27-0.44

Xylazine

2.2-3.3

1.0-1.5

60-90

1.5-3.3

0.15-0.33

Oxymorphone

2.2-3.3

1.0-1.5

60-90

1.5-3.3

0.15-0.33

Medetomidine

2.2-2.8

1.0-1.3

60-90

1.5-2.8

0.15-0.28

The required dose of tranquilizers, sedatives, or analgesics administered as preanesthetic medications (listed below) may be lower than the label directions for their use as a single medication1.

Acepromazine

0.03-0.1

mg/kg

IM, SC, IV

Xylazine

0.25-0.5

mg/kg

IV

Xylazine

0.5-1.0

mg/kg

IM, SC

Oxymorphone

0.1-0.2

mg/kg

IM, SC, IV

Medetomidine

5.0-10.0

µg/kg

IM

The use of the drugs listed above as preanesthetics for dogs markedly reduces propofol requirements. As with other sedative hypnotic agents, the amount of phenothiazine, opioid, and/or alpha2 -agonist premedication will influence the response of the patient to an induction dose of propofol injectable emulsion injection. The induction dose will also be influenced by the interval between the administration of premedication and induction, and by the rate of administration of propofol.

The average induction dose ranges and dosage rates for healthy cats given propofol alone, or when propofol is preceded by a premedicant, are indicated in the following table (the Table is for guidance only; in practice, the dose should be based upon patient response):

Induction Dosage Guidelines for Cats

Preanesthetic

Propofol Induction Dose

Propofol Rate of Administration

mg/kg

mg/lb

Seconds

mg/kg/min

mL/kg/min

None

8.0-13.2

3.6-6.0

60-90

5.3-13.2

0.53-1.32

Acepromazine

8.0-13.2

3.6-6.0

60-90

5.3-13.2

0.53-1.32

Butorphanol

8.0-13.2

3.6-6.0

60-90

5.3-13.2

0.53-1.32

Oxymorphone

8.0-13.2

3.6-6.0

60-90

5.3-13.2

0.53-1.32

Xylazine

7.0-12.0

3.2-5.5

60-90

4.7-12.0

0.47-1.20

The required dosage of tranquilizers, sedatives, or analgesics administered as preanesthetic medications (listed below) may be lower than the label directions for their use as a single medication1,8,9.

Acepromazine

0.03-0.1

mg/kg

IM, SC, IV

Butorphanol

0.1-0.4

mg/kg

IM, SC

Oxymorphone

0.1-0.4

mg/kg

IM, SC, IV

Xylazine

0.25-0.5

mg/kg

IV

Xylazine

0.5-1.0

mg/kg

IM, SC

The use of the drugs listed above as preanesthetics for cats may reduce propofol requirements. As with other sedative hypnotic agents, the amount of phenothiazine, opioid and/or alpha2 -agonist premedication will influence the response of the patient to an induction dose of propofol injectable emulsion injection. The induction dose will also be influenced by the interval between the administration of premedication and induction, and by the rate of administration of propofol.

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