For Animal Use Only and . No pharmacological incompatibility Induction Dosage Guidelines B. Maintenance by Inhalant : Once propofol has been opened, vial contents should be 10. Concurrent medication: No significant adverse preanesthetic regimens in dogs. JAVMA. 202:1111-1115 has been observed. Preanesthetic Propofol Propofol Rate of Administration Due to the rapid metabolism of propofol, additional low drawn into sterile syringes; each syringe should be prepared interactions with commonly used drugs have been observed. (1993). TM Induction doses of propofol, similar to those used for maintenance for single patient use only. Unused product should be 3. Plumb, D.C. ed. Veterinary Drug Handbook, Second Edition. INDICATIONS: 11. Perivascular administration: Perivascular administration PropoFlo Dose with propofol, may be required to complete the transition to discarded within 6 hours. Iowa State University Press, Ames, IA (1995). Propofol is an intravenous injection for use in does not produce local tissue reaction. (propofol injectable ) mg/kg Seconds mg/kg/min mL/kg/min inhalant maintenance . Clinical trials using propofol 4. Detailed information on the preanesthetic doses used dogs as follows: 2. Anesthesia effects: Careful monitoring of the patient is None 5.5 40 - 60 5.5 - 8.3 0.55 - 0.83 have shown that it may be necessary to use a higher initial CONTRAINDICATIONS: with propofol in clinical studies is available in the Freedom of Intravenous Anesthetic Injection for 1. For induction of anesthesia. necessary when using propofol as a maintenance anesthetic Acepromazine 3.7 30 - 50 4.4 -7.4 0.44 - 0.74 concentration of the inhalant anesthetic halothane than Propofol injection is contraindicated in dogs with a known Information (FOI) Summary or can be obtained from Zoetis 2. For maintenance of general anesthesia for up to due to the possibility of rapid arousal. may occur Use in Dogs. Acepromazine / 2.6 30 - 50 3.1 - 5.2 0.31 - 0.52 is usually required following induction using hypersensitivity to propofol or its components, or when Inc. 20 minutes. following maintenance doses of propofol. Oxymorphone anesthetics, due to rapid recovery from propofol5. general anesthesia or are contraindicated. 5. Muir, W.W., J.A.E. Hubbell, R.T. Skarda, and R.M. Bednarski. Fliptop vial. Each mL contains 10 mg propofol. 3. For induction of general anesthesia where maintenance Following induction, additional propofol may be needed to Handbook of Veterinary Medicine, Second Edition. Mosby- Propofol doses and rates for the above premedicants were HUMAN USER SAFETY: Shake Well Before Use. is provided by inhalant anesthetics. OVERDOSAGE: complete the transition to inhalant maintenance anesthesia Year Book, Inc. (1995). based upon the following average dosages. These doses may Rapid administration or accidental overdosage of propofol due to rapid recovery from propofol. Doses administered Not for human use. Keep out of the reach of children. 6. Kamibayashi, T., Y. Hayashi, K. Sumikawa, A. Yamatodani, CAUTION: DOSAGE AND ADMINISTRATION: be lower than the label directions for their use as a single may cause cardiopulmonary depression. Respiratory arrest during the transition to inhalant anesthesia may result in Rare cases of self-administration have been reported, including K. Kawabata and I. Yoshiya. Enhancement by propofol of Federal (USA) law restricts this drug to use by or on the order Shake the vial thoroughly before opening. 3,4 medication . apnea. fatalities. Propofol should be managed to prevent the risk of of a licensed veterinarian. (apnea) may be observed. In cases of respiratory depression, epinephrine-induced arrhythmias in dogs. Parenteral drug products should be inspected visually for Dose (mg/kg) Routes stop drug administration, establish a patent airway, and Propofol has also been used during inhalant maintenance diversion, through such measures as restriction of access and the 75:1035-1040 (1991). DESCRIPTION: particulate matter and discoloration prior to administration, Acepromazine 0.060 IM, SC, IV initiate assisted or controlled ventilation with pure oxygen. anesthesia to increase anesthetic depth. Propofol used use of drug accountability procedures appropriate to the clinical 7. Laxenaire, M.C., E. Mata-Bermejo, D.A. Moneret-Vautrin PropoFlo™ Injection is a sterile, nonpyrogenic emulsion whenever solution and container permit. Propofol is a white Oxymorphone 0.090 IM, SC, IV Cardiovascular depression should be treated with plasma during inhalant maintenance may result in apnea. setting. and J.L. Gueant. Life-threatening anaphylactoid reactions to containing 10 mg/mL of propofol suitable for intravenous stable emulsion; do not use if there is evidence of separation propofol (Diprivan®). Anesthesiology 77:275-280 (1992). 0.33 IM, SC expanders, pressor agents, antiarrhythmic agents or other 3. Physiological effects: Mild may occur during Exercise caution to avoid accidental self-injection. Overdose administration. Propofol is chemically described as 2, of the phases. Do not use if there is evidence of excessive The use of these drugs as preanesthetics markedly reduces techniques as appropriate for the observed abnormality. propofol anesthesia. is likely to cause cardiorespiratory depression (such as Approved by FDA under NADA # 141-098 6-diisopropylphenol and has a molecular weight of 178.27. creaming or aggregation, if large droplets are visible, or if hypotension, bradycardia and/ or apnea). Remove the Propofol is very slightly soluble in water and is therefore propofol requirements. As with other agents, WARNINGS: 4. Premedicants: Premedicants may increase the anesthesia there are other forms of phase separation indicating that individual from the source of exposure and seek medical formulated as a white, oil-in-water emulsion. In addition the amount of and/or a-2 agonist will Rapid single or repeat bolus administration may cause or sedative effect of propofol and result in more pronounced the stability of the product has been compromised. Slight attention. Respiratory depression should be treated by to the active component, propofol, the formulation also influence the response of the patient to an induction dose of undesirable cardiorespiratory depression including changes in systolic, diastolic and mean arterial blood pressures. creaming, which should disappear after shaking, may be artificial ventilation and oxygen. Distributed by: contains (100 mg/mL), (22.5 mg/mL), egg visible upon prolonged standing. Do not use if particulate propofol. hypotension, apnea and oxygen desaturation. 5. Breeding animals: The use of propofol in pregnant and Zoetis Inc. Hypersensitivity reactions to propofol, including , lecithin (12 mg/mL), and oleic acid (0.6 mg/mL) with sodium matter and discoloration are present. In the presence of premedication, the dose of propofol may breeding dogs has not been evaluated. Propofol crosses the Kalamazoo, MI 49007 When using propofol, dogs should be continuously may occur in some individuals who are also allergic to muscle hydroxide to adjust the pH. The propofol emulsion is isotonic be reduced with increasing age of the animal. The dose of placenta and, as with other general anesthetic agents, the Revised: May 2021 Propofol contains no antimicrobial preservatives. Strict monitored and facilities for the maintenance of a patent 7 and has a pH of 6.0-9.0. relaxants . aseptic techniques must always be maintained during propofol should always be titrated against the response of airway, artificial ventilation, and oxygen supplementation administration of propofol may be associated with neonatal Avoid inhalation and direct contact of this product with skin, CLINICAL PHARMACOLOGY: handling since the vehicle is capable of supporting the patient. must be immediately available. depression. eyes, and clothes. In case of contact, eyes and skin should Propofol injection is an intravenous sedative hypnotic agent the rapid growth of microorganisms. Failure to follow During induction, additional low doses of propofol, similar 6. Neonates: Propofol has not been evaluated in dogs less 339 072 SIDE EFFECTS: be liberally flushed with water for 15 minutes. Consult a for use in the induction and maintenance of anesthesia. aseptic handling procedures may result in microbial to those used for maintenance with propofol, may be than 10 weeks of age. The primary side effect of propofol is respiratory depression physician if irritation persists. Intravenous injection of propofol in the dog is followed by contamination causing fever, infection/sepsis, and/or administered to facilitate intubation or the transition to as evidenced by tachypnea and apnea. Tachypnea and apnea 7. Compromised or debilitated dogs: Doses may need extensive metabolism of propofol in the to inactive other life-threatening illness. Do not use if contamination CONTACT INFORMATION: inhalant maintenance anesthesia. were observed in 43 and 26% of the cases in the , adjustment for geriatric or debilitated patients. The conjugates which are excreted in the . Elimination is suspected. administration of propofol to patients with renal failure and/ To report suspected adverse events, for technical assistance from the central compartment occurs rapidly, with an initial MAINTENANCE OF GENERAL ANESTHESIA: respectively. All cases of apnea resumed normal breathing Once propofol has been opened, vial contents should or hepatic failure has not been evaluated. As with other or to obtain a copy of the Safety Data Sheet (SDS) contact elimination phase of less than 10 minutes1. A. Intermittent Propofol Injections: spontaneously, or responded satisfactorily to oxygen be drawn into sterile syringes; each syringe should be anesthetic agents, caution should be exercised in dogs Zoetis Inc. at 1-888-963-8471. For additional information Anesthesia can be maintained by administering propofol supplementation and/or controlled ventilation. Induction of anesthesia will usually be observed within prepared for single patient use only. with cardiac, respiratory, renal or hepatic impairment, or in about adverse drug experience reporting for animal drugs, in intermittent IV injections. Clinical response will be Other transient side effects are observed infrequently or 75-120 seconds after the beginning of propofol administration. Unused product should be discarded within 6 hours. hypovolemic or debilitated dogs. Geriatric dogs may require contact FDA at 1-888-FDA-VETS or online at www.fda.gov/ The duration of anesthesia following the recommended determined by the amount and the frequency of rarely: Respiratory: labored breathing less propofol for induction of anesthesia (see Dosage and reportanimalae. The emulsion should not be mixed with other therapeutic induction doses averages 6.7 minutes in premedicated and maintenance injections. The following table is provided for Cardiovascular: hypotension, bradycardia, tachycardia, Administration). STORAGE: unpremedicated animals. agents prior to administration. Administer by intravenous guidance: membrane cyanosis, arrhythmias 8. Sighthounds: Propofol induction and maintenance injection only. Musculoskeletal: fasciculations, tenseness, paddling, Propofol undergoes oxidative degradation in the presence of Recommended maintenance doses for anesthesia in Maintenance Dosage Guidelines produced satisfactory anesthesia and recoveries in movements Central Nervous System: excitation, oxygen and is therefore packaged under to eliminate unpremedicated animals, animals premedicated with INDUCTION OF GENERAL ANESTHESIA: Preanesthetic Propofol Rate of Administration sighthounds. In the clinical study, a total of 27 sighthounds this degradation path. Store between 4 – 25°C (40-77°F). Do opisthotonus, , excessive depression acepromazine, and animals premedicated with a combination For induction, propofol injection should be titrated against Maintenance were induced with propofol, 6 of which were maintained not freeze. Protect from light. Shake well before use. Gastrointestinal: emesis, retching, salivation of agents results in anesthesia lasting an average of 3.68, 3.80 the response of the patient over 30-60 seconds or until Dose on propofol. Induction doses were similar in sighthounds HOW SUPPLIED: and 5.43 minutes, respectively, after each maintenance dose. clinical signs show the onset of anesthesia. Rapid injection of mg/kg Seconds mg/kg/min mL/kg/min PRECAUTIONS: compared to other animals, however, recoveries were PropoFlo™ is supplied in cartons of five-20 mL (200 mg per Recovery from propofol is rapid; full standing recovery propofol (≤ 5 seconds) may be associated with an increased None 2.2 10 - 30 4.4 - 13.2 0.44 - 1.32 1. Propofol contains no antimicrobial preservatives. Strict delayed. 2 vial) vials containing 10 mg propofol per mL. is generally observed within 20 minutes. The use of incidence of apnea . Acepromazine 1.6 10 - 30 3.2 - 9.6 0.32 - 0.96 aseptic techniques must always be maintained during 9. Cardiac arrhythmias: In one study, propofol increased certain premedicant combinations (e.g., acepromazine/ The average propofol induction dose rates for healthy dogs Acepromazine / 1.8 10 - 30 3.6 - 10.8 0.36 - 1.08 handling since the vehicle is capable of supporting the rapid myocardial sensitivity to the development of epinephrine- REFERENCES: Oxymorphone oxymorphone) may result in prolonged recovery. Recovery given propofol alone, or when propofol is preceded by a growth of microorganisms. Failure to follow aseptic handling induced ventricular arrhythmias in a manner similar to 1. Detailed information on the and may be delayed in Sighthounds. premedicant, are indicated in the table below. This table is Repeated maintenance doses of propofol do not result in procedures may result in microbial contamination causing other anesthetics6. In the clinical study, transient ventricular metabolism of propofol can be obtained from Zoetis Inc. Propofol has been used in association with , for guidance only. The dose and rate should be based upon increased recovery times or dosing intervals, indicating that fever, infection/sepsis, and/or other life-threatening illness. arrhythmias associated with propofol were observed in 2 of 2. Smith, J.A., J.S. Gaynor, R.M. Bednarski and W.W. Muir. glycopyrrolate, acepromazine, xylazine, oxymorphone, patient response. the anesthetic effects of propofol are not cumulative. Do not use if contamination is suspected. 145 animals induced and maintained on propofol. Adverse effects of administration of propofol with various

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