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Side Effects & Adverse Reactions
WARNINGS:
When anesthetized using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.
Rapid bolus administration or anesthetic overdose may cause cardiorespiratory depression, including hypotension, apnea, hypoxia, or death. Arrhythmias may occur secondary to apnea and hypoxia. In cases of anesthetic overdose, stop ALFAXAN administration and administer treatment as indicated by the patient’s clinical signs. Cardiovascular depression should be treated with plasma expanders, pressor agents, anti-arrhythmic agents or other techniques as appropriate for the treatment of the clinical signs.
HUMAN WARNINGS:
Not for human use. Keep out of the reach of children.
Exercise caution to avoid accidental self-injection. Overdose is likely to cause cardiorespiratory depression (such as hypotension, bradycardia and/or apnea). Remove the individual from the source of exposure and seek medical attention. Respiratory depression should be treated by artificial ventilation and oxygen.
Avoid contact of this product with skin, eyes, and clothes. In case of contact, eyes and skin should be liberally flushed with water for 15 minutes. Consult a physician if irritation persists. In the case of accidental human ingestion, seek medical advice immediately and show the package insert or the label to the physician.
The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for this product call 1-844-ALFAXAN
Note to physician: This product contains an injectable neurosteroid anesthetic.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS
ALFAXAN is indicated for the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in cats and dogs.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
ALFAXAN (alfaxalone) is a neuroactive steroid molecule with properties of a general anesthetic. Alfaxalone is chemically described as 3-α-hydroxy-5-α-pregnane-11, 20-dione, and has a molecular weight 332.5. The primary mechanism for the anesthetic action of alfaxalone is modulation of neuronal cell membrane chloride ion transport, induced by binding of alfaxalone to GABAA (gamma-aminobutyric acid) cell surface receptors.
Sources
Alfaxan Manufacturers
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Jurox Pty. Limited
Alfaxan | Jurox Pty. Limited
DOSAGE AND ADMINISTRATION
Administer by intravenous injection only. For induction, administer ALFAXAN over approximately 60 seconds or until clinical signs show the onset of anesthesia, titrating administration against the response of the patient. Rapid administration of ALFAXAN may be associated with an increased incidence of cardiorespiratory depression or apnea. Apnea can occur following induction or after the administration of maintenance boluses of ALFAXAN. The use of preanesthetics may reduce the ALFAXAN induction dose. The choice and the amount of phenothiazine, alpha2-adrenoreceptor agonist, benzodiazepine or opioid will influence the response of the patient to an induction dose of ALFAXAN.
When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.ALFAXAN does not contain an antimicrobial preservative. Do not use if contamination is suspected. Strict aseptic techniques must be maintained because the vehicle is capable of supporting the rapid growth of microorganisms. Failure to follow aseptic handling procedures may result in microbial contamination which may cause fever, infection/sepsis, and/or other life-threatening illness.
Once ALFAXAN 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. ALFAXAN should not be mixed with other therapeutic agents prior to administration.
Induction of general anesthesia in cats: Induction dose guidelines are based on data from the field study (see EFFECTIVENESS) and range between 2.2 - 9.7 mg/kg for cats that did not receive a preanesthetic, and between 1.0 - 10.8 mg/kg for cats that received a preanesthetic. The ALFAXAN induction dose in the field study was reduced by 10 - 43%, depending on the combination of preanesthetics (dose sparing effect). Dose sparing of ALFAXAN will depend on the potency, dose, and time of administration of the various preanesthetics that are used prior to induction. To avoid anesthetic overdose, titrate the administration of ALFAXAN against the response of the patient.
Anesthesia is usually observed within 60 seconds after the start of injection, and permits intubation within 1 - 2 minutes, irrespective of preanesthetic. The duration of anesthesia from a single induction dose ranges between 15 - 30 minutes in the unpreanesthetized cat. If a preanesthetic is used, anesthetic duration may be longer, depending on the class and dose of preanesthetic. Individual anesthesia times vary.
Examples from the field study of average induction doses (and ranges) for cats that received various preanesthetics are presented as dosing guidelines in the table. The table is for guidance only. The actual induction dose should be based on patient response.
ALFAXAN Induction Dose Guidelines: CATS Preanesthetic Average ALFAXAN induction dose (and range) in mg/kg Number of cats No preanesthetic 4.0 (2.2-9.7) 33 Opioid + phenothiazine 3.2 (1.1-10.8) 96 Benzodiazepine + phenothiazine 3.6 (1.5-7.1) 23 Benzodiazepine + opioid + phenothiazine 2.3 (1.2-5.0) 26 Alpha2-adrenergic agonist with/without phenothiazine 3.6 (1.1-5.0) 15 Alpha2-adrenergic agonist + phenothiazine with/without benzodiazepine or opioid 2.9 (1.0-3.9) 11Additional doses of ALFAXAN similar to those used for maintenance (1.1 - 1.5 mg/kg) may be administered to facilitate intubation.
Maintenance of general anesthesia in cats: Following induction of anesthesia with ALFAXAN and intubation, anesthesia may be maintained using intermittent ALFAXAN intravenous boluses or an inhalant anesthetic agent. A maintenance bolus containing 1.1 - 1.3 mg/kg provides an additional 7 - 8 minutes of anesthesia in preanesthetized cats. A dose of 1.4 - 1.5 mg/kg provides an additional 3 - 5 minutes anesthesia in unpreanesthetized cats. Clinical response may vary, and is determined by the dose, rate of administration, and frequency of maintenance injections.
ALFAXAN maintenance dose sparing is greater in cats that receive a preanesthetic. Examples from the field study of maintenance doses for preanesthetized and unpreanesthetized cats are presented as guidelines in the table. Maintenance dose and frequency should be based on the response of the individual patient.
ALFAXAN Maintenance Dose Guidelines: CATS Dose and Duration Preanesthetized Cats Unpreanesthetized Cats Maintenance anesthesia doses 1.1 - 1.3 mg/kg 1.4 - 1.5 mg/kg Mean duration of anesthesia 7-8 minutes 3 - 5 minutesIn the field study, recovery times (extubation to head lift) following ALFAXAN maintenance anesthesia averaged 15 minutes in cats that did not receive a preanesthetic, and 17 minutes in preanesthetized cats.
Inhalant anesthetic maintenance of general anesthesia in cats: Additional low doses of ALFAXAN, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.
Induction of general anesthesia in dogs: Induction dose guidelines are based on data from the field study (see EFFECTIVENESS) and range between 1.5 - 4.5 mg/kg for dogs that did not receive a preanesthetic, and between 0.2 - 3.5 mg/kg for dogs that received a preanesthetic. The ALFAXAN induction dose in the field study was reduced by 23 - 50% depending on the combination of preanesthetics (dose sparing effect). Dose sparing of ALFAXAN will depend on the potency, dose, and time of administration of the various preanesthetics that are used prior to induction. To avoid anesthetic overdose, titrate the administration of ALFAXAN against the response of the patient. In the field study, the use of a preanesthetic appeared to decrease the occurrence of apnea following ALFAXAN induction in dogs.
In dogs, ALFAXAN usually produces recumbence within 60 seconds after the start of injection, and permits intubation within 1 - 2 minutes, irrespective of preanesthetic. The duration of anesthesia from a single induction dose is approximately 5 - 10 minutes in the unpreanesthetized dog. If a preanesthetic is used, anesthetic duration may be longer, depending on the class and dose of preanesthetic. Individual anesthesia times vary.
Examples from the field study of average induction doses (and ranges) for dogs that received various preanesthetics are presented as dosing guidelines in the table. The table is for guidance only. The actual induction dose should be based on patient response.
ALFAXAN Induction Dose Guidelines: DOGS Preanesthetic Average ALFAXAN induction dose (and range) in mg/kg Number of dogs No preanesthetic 2.2 (1.5 - 4.5) 17 Benzodiazepine + opioid + acepromazine 1.7 (0.9 - 3.5) 39 Opioid + acepromazine 1.6 (0.6 - 3.5) 80 Alpha2-agonist 1.1 (0.21 - 2.00) 9Additional doses of ALFAXAN similar to those used for maintenance (1.2 - 2.2 mg/kg) may be administered to facilitate intubation.
Maintenance of general anesthesia in dogs: Following induction of anesthesia with ALFAXAN and intubation, anesthesia may be maintained using intermittent ALFAXAN intravenous boluses or an inhalant anesthetic agent. A maintenance bolus containing 1.2 - 1.4 mg/kg provides an additional 6 - 8 minutes anesthesia in preanesthetized dogs. A dose of 1.5 - 2.2 mg/kg provides an additional 6 - 8 minutes of anesthesia in unpreanesthetized dogs. Clinical response may vary, and is determined by the dose, rate of administration, and frequency of maintenance injections.
ALFAXAN (alfaxalone) maintenance dose sparing is greater in dogs that receive a preanesthetic. Examples from the field study of maintenance doses for preanesthetized and unpreanesthetized dogs are presented as guidelines in the table. Maintenance dose and frequency should be based on the response of the individual patient.
ALFAXAN Maintenance Dose Guidelines: DOGS Dose and Duration Preanesthetized Dogs Unpreanesthetized Dogs Maintenance anesthesia doses 1.2 - 1.4 mg/kg 1.5 - 2.2 mg/kg Mean duration of anesthesia 6 - 8 minutes 6 - 8 minutesIn the field study, recovery times (extubation to head lift) following ALFAXAN maintenance anesthesia averaged 22 minutes in dogs that did not receive a preanesthetic, and 15 minutes in preanesthetized dogs.
Inhalant anesthetic maintenance of general anesthesia in dogs: Additional low doses of ALFAXAN, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.
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