Get your patient on Propofolvet Multidose (Propofol Injectable Emulsion)

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Propofolvet Multidose prescribing information

Indications & Usage

INDICATIONS:

PropofolVet Multidose is an anesthetic injection for use in dogs as follows:
For induction of anesthesia.
For maintenance of general anesthesia by intermittent bolus injections for short procedures.
For induction of general anesthesia where maintenance is provided by inhalant anesthetics.

Dosage & Administration

DOSAGE AND ADMINISTRATION:

Administer by intravenous injection only. Shake the vial thoroughly before opening. 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. Strict aseptic techniques must always be maintained during handling. 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 a vial is opened, the contents begin a 28-day shelf life. The opened vial should be labeled with “Date Opened” and “Use By” in the space provided. To avoid microbial overgrowth, the contents must be used within 28 days (4 weeks) of the date opened. The opened vial should be placed in a covered container, held at room temperature and used within the allotted 28 day timeframe. Refrigeration is not recommended. Any unused propofol remaining at the end of 28 days should be discarded. The emulsion should not be mixed with other therapeutic agents prior to administration. No specific preanesthetic is either indicated or contraindicated with propofol. The necessity for, choice of, as well as any necessary reduction of dose for the preanesthetic, is left to the discretion of the veterinarian. The dose of propofol is not affected by anticholinergic premedication.

Contraindications

CONTRAINDICATIONS:

PropofolVet Multidose is contraindicated in dogs with a known hypersensitivity to propofol or its components, or when general anesthesia or sedation are contraindicated.

Adverse Reactions

ADVERSE REACTIONS:

The primary side effect of propofol is respiratory depression as evidenced by tachypnea and apnea. Other less frequent adverse reactions include:
Respiratory: labored breathing
Cardiovascular: hypotension, hypertension, bradycardia, tachycardia, membrane cyanosis, arrhythmias
Musculoskeletal: fasciculations, tenseness, paddling, movements
Central Nervous System: excitation, opisthotonos, seizures, excessive depression
Gastrointestinal: emesis, retching, salivation.

Description

DESCRIPTION:

PropofolVet Multidose is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol in a multidose vial for intravenous administration. Each mL contains 10 mg propofol. 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), benzyl alcohol (20 mg/mL), oleic acid (0.6 mg/mL), and egg lecithin (12 mg/mL), with sodium hydroxide to adjust the pH. The PropofolVet Multidose emulsion is isotonic and has a pH of 6.0 to 8.5.

Pharmacology

CLINICAL PHARMACOLOGY:

PropofolVet Multidose (propofol injectable emulsion) 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 minutes. Induction of anesthesia will usually be observed within 65 to 120 seconds after the beginning of propofol administration. The duration of anesthesia following the recommended induction doses averages 5.5 to 6.5 minutes in preanesthetized and unpreanesthetized animals. The duration of anesthesia following recommended maintenance doses in unpreanesthetized dogs averages 8.5 minutes. In preanesthetized dogs (phenothiazine/opioid or benzodiazepine/opioid), maintenance anesthesia averages 5.0 to 5.4 minutes after each maintenance dose. Recovery from propofol is rapid; full standing recovery is generally observed within 20 minutes. The use of certain premedicants may result in prolonged recovery. Recovery may be delayed in Sighthounds. Propofol has been used in association with anticholinergics, phenothiazines, alpha 2 -agonists, opioids, and benzodiazepines, as well as inhalant anesthetics. No pharmacological incompatibility has been observed.

Clinical Studies

ANIMAL SAFETY:

Unpreserved propofol injectable emulsion safety study: Two propofol groups received total doses of either 11.6 (lower dose) or 29.7 mg/kg (higher dose) during each anesthetic episode. In group 1, anesthesia was induced with 6.5 mg/kg and maintained with 3 bolus injections of 1.7 mg/kg propofol. Group 2 dogs received 19.5 mg/kg propofol for induction and 6 bolus injections of 1.7 mg/kg propofol for maintenance. A third group of dogs was injected with saline (controls) at a volume equal to that administered to the higher dose dogs. Each group included a total of 8 Beagles (4 males: 4 females). Dogs were anesthetized 6 times over 11 days (every other day).

Recovery times were much longer in higher dose group dogs, except for the first episode of anesthesia in which there was a small difference between the doses. The time to recovery increased after the first anesthetic episode. Average daily heart rate tended to increase over time in dogs that received propofol, but was within the normal range for Beagles.

During anesthesia in the lower propofol dose group, transient increases in respiratory rate occurred 1 minute after induction and declined to baseline within 5 minutes. Respiratory rate declined initially in response to the higher propofol dose, then returned to or above baseline within 10 minutes. Heart rate increased after induction in both dose groups and gradually returned to baseline. Transient, clinically acceptable increases in systolic and mean blood pressure and decreases in diastolic blood pressure (higher dose only), occurred immediately (by 1 minute) after propofol administration in both groups.

The duration of apnea averaged 28 and 70 seconds after induction doses of 6.5 and 19.5 mg/kg, respectively, and did not increase with repeated episodes of propofol anesthesia. All animals which became apneic resumed breathing spontaneously; at no time in the study was oxygen supplementation or assisted ventilation administered.

Tachypnea, another adverse reaction, was transient and clinically manageable; its incidence was similar among the lower and higher dose groups. Muscle fasciculations were observed during maintenance with intermittent bolus injections and were considered to be related to a light plane of anesthesia. Changes in mucous membrane color were consistent with mild respiratory depression and subsequent vasodilation. Mucous membrane color was normal in all dogs within 5 minutes of induction.

Hematology and clinical chemistry findings were not attributed to the administration of propofol.

Preanesthetics: Propofol is compatible with benzodiazepines, opioids, alpha 2 -agonists, and phenothiazines as commonly used for preanesthesia in surgical practice.

Inhalant Anesthetics: Propofol is compatible with commonly used inhalant anesthetics.

How Supplied/Storage & Handling

HOW SUPPLIED:

PropofolVet Multidose is supplied in cartons of five-20 mL (200 mg per vial) vials, or one-50 mL (500 mg per vial) vial containing 10 mg propofol per mL.

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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