Propofol: Product Information (Page 2 of 3)

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, the rate of administration, and the frequency of maintenance injections. The following Tables are provided for guidance:

Maintenance Dosage Guidelines for Dogs

Preanesthetic

Propofol Maintenance Dose

Propofol Rate of Administration

mg/kg

mg/lb

Seconds

mg/kg/min

mL/kg/min

None

1.1-3.3

0.5-1.5

30-60

1.1-3.3

0.11-0.33

Acepromazine

1.1

0.5

30-60

1.1-2.2

0.11-0.22

Xylazine

1.1

0.5

30-60

1.1-2.2

0.11-0.22

Oxymorphone

1.1

0.5

30-60

1.1-2.2

0.11-0.22

Medetomidine

1.1

0.5

30-60

1.1-2.2

0.11-0.22

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

Maintenance Dosage Guidelines for Cats

Preanesthetic

Propofol Maintenance Dose

Propofol Rate of Administration

mg/kg

mg/lb

Seconds

mg/kg/min

mL/kg/min

None

1.1-4.4

0.5-2.0

30-60

1.1-4.4

0.11-0.44

Acepromazine

1.1-4.4

0.5-2.0

30-60

1.1-4.4

0.11-0.44

Butorphanol

1.1-4.4

0.5-2.0

30-60

1.1-4.4

0.11-0.44

Oxymorphone

1.1-4.4

0.5-2.0

30-60

1.1-4.4

0.11-0.44

Xylazine

1.1-2.2

0.5-1.0

30-60

1.1-2.2

0.11-0.22

Acepromazine/Butorphanol

1.1-3.3

0.5-1.5

30-60

1.1-3.3

0.11-0.33

Acepromazine/Oxymorphone

1.1-3.3

0.5-1.5

30-60

1.1-3.3

0.11-0.33

Repeated maintenance doses of propofol may result in slightly increased recovery times, indicating that the anesthetic effects of propofol may be cumulative in cats.

B. Maintenance by Inhalant Anesthetics: Clinical trials using propofol have shown that it may be necessary to use a higher initial concentration of the inhalant anesthetic than is usually required following induction using barbiturate anesthetics, due to rapid recovery from propofol injectable emulsion injection.

OVERDOSAGE

Rapid administration or accidental overdosage of propofol injectable emulsion injection may cause neurologic and cardiopulmonary depression. Respiratory arrest (apnea) may be observed. In cases of respiratory depression, stop drug administration, establish a patent airway, and initiate assisted or controlled ventilation with oxygen. Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other techniques as appropriate for the observed abnormality.

In feline safety studies using healthy cats and elevated doses of propofol, unexplained decreases in albumin, globulin, and total protein values were noted. Increases in bile acids and triglycerides were also noted and were probably due to the lipid content of the drug formulation. These transient changes were not clinically significant in healthy cats.

CONTRAINDICATIONS

Propofol injectable emulsion injection is contraindicated in dogs and cats with a known hypersensitivity to propofol or its components, or when general anesthesia or sedation are contraindicated.

WARNINGS

Induction of anesthesia with propofol injectable emulsion injection is frequently associated with apnea and respiratory depression. Hypotension and oxygen desaturation can occur also, especially following rapid bolus administration. Apnea is observed less frequently following maintenance doses of propofol injectable emulsion injection when given as the sole maintenance agent, or when a maintenance dose is administered during inhalant anesthesia.

When using propofol injectable emulsion injection, patients should be continuously monitored and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available. The clinical use of propofol without available supplemental oxygen and artificial ventilation has not been adequately evaluated and is not recommended.

PRECAUTIONS

1.
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.
2.
When using propofol injectable emulsion injection, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available. The clinical use of propofol without available supplemental oxygen and artificial ventilation has not been adequately evaluated and is not recommended.
3.
Anesthesia effects: Careful monitoring of the patient is necessary when using propofol injectable emulsion injection as a maintenance anesthetic due to the possibility of rapid arousal. Apnea may occur following maintenance doses of propofol injectable emulsion injection.
Following induction, additional propofol injectable emulsion injection at the lower maintenance dose may be needed to complete the transition to inhalant maintenance anesthesia due to rapid recovery from propofol. Doses administered during the transition to inhalant anesthesia or during inhalant maintenance anesthesia may result in apnea.
4.
Physiological effects: During induction of anesthesia, mild hypotension and increased heart rate may occur when propofol injectable emulsion injection is used alone.
5.
Premedicants: Premedicants may increase the anesthetic or sedative effect of propofol injectable emulsion injection and result in more pronounced changes in systolic, diastolic and mean arterial blood pressures. The use of ketamine (an approved compound for restraint in cats) is not recommended as a preanesthetic prior to propofol due to an increased number of patients experiencing apnea.
6.
Breeding animals: Adequate data concerning the safe use of propofol injectable emulsion injection in pregnant, lactating, and breeding dogs and cats have not been obtained. Propofol crosses the placenta, and as with other general anesthetic agents, the administration of propofol may be associated with neonatal depression.
7.
Puppies and Kittens: The use of propofol has not been evaluated in puppies or kittens.
8.
Compromised or debilitated dogs and cats: Doses may need adjustment for geriatric or debilitated patients. The administration of propofol injectable emulsion injection to patients with renal failure and/or hepatic failure has not been evaluated. As with other anesthetic agents, caution should be exercised in dogs or cats with cardiac, respiratory, renal or hepatic impairment, or in hypovolemic or debilitated dogs and cats.
9.
Sighthounds: Propofol injectable emulsion injection induction followed by inhalant anesthetic agents produced satisfactory anesthesia and recovery times in sighthounds. Propofol alone in 6 greyhounds and 7 non-greyhounds showed satisfactory, but longer recovery times in the greyhounds (averages of 47 and 18 minutes, respectively).2 In a propofol pharmacokinetics study, greyhounds had higher propofol levels in plasma, a lower volume of distribution, slower total body clearance rates, and longer recovery times than did mixed-breed dogs. The elimination half-life was similar in both groups.3
10.
Arrhythmogenicity: In one study in dogs, propofol increased myocardial sensitivity to the development of epinephrine-induced ventricular arrhythmias in a manner similar to other anesthetics.4
11.
Consecutive day treatment: Heinz bodies increased dramatically in cats following repeat administration of propofol on consecutive days and were associated with decreases in RBC count and hematocrit. Large numbers of Heinz bodies can lead to hemolytic anemia.5,6 In one study in cats, treatment with propofol once a day for 3 days led to a marked increase in Heinz bodies. Treatment for 5 or more consecutive days resulted in generalized malaise and/or facial edema; clinical signs of illness resolved within 24 to 48 hours after cessation of propofol.
12.
Concurrent medication: No significant adverse interactions with commonly used drugs have been observed.
13.
Perivascular administration: Perivascular administration does not produce local tissue reaction.
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