ALFAXAN MULTIDOSE: Product Information (Page 2 of 4)
No specific preanesthetic is either indicated or contraindicated with ALFAXAN MULTIDOSE. The necessity for and choice of preanesthetic is left to the discretion of the veterinarian. Preanesthetic doses may be lower than the label directions for their use as a single medication. ALFAXAN MULTIDOSE is compatible with benzodiazepines, opioids, alpha2 -agonists, and phenothiazines as commonly used in surgical practice.
In the field study, alfaxalone was used safely in cats and dogs that received frequently used veterinary products, including antibiotics, anticholinergics, vaccines, steroids, and dewormers.
ALFAXAN MULTIDOSE is contraindicated in cats and dogs with a known sensitivity to ALFAXAN MULTIDOSE or its components, or when general anesthesia and/or sedation are contraindicated.
Animal safety: When using ALFAXAN MULTIDOSE, 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 MULTIDOSE 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 treatments of the clinical signs.
Human safety: Not for human use. Keep out of the reach of children.
ALFAXAN MULTIDOSE should be managed to prevent the risk of diversion, through such measures as restriction of access and the use of drug accountability procedures appropriate to the clinical setting.
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.
Note to physician: This product contains an injectable anesthetic.
For a copy of the Safety Data Sheet or to report adverse reactions, call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or at www.fda.gov/reportanimalae.
DRUG ABUSE AND DEPENDENCE
Controlled substance: ALFAXAN MULTIDOSE contains alfaxalone a neurosteroid anesthetic and a class IV controlled substance.
Abuse: Alfaxalone is a central nervous system depressant that acts on GABA receptor associated chloride channels, similar to the mechanism of action of Schedule IV sedatives such as benzodiazepines (diazepam and midazolam), barbiturates (phenobarbital and methohexital) and fospropofol. In a drug discrimination behavioral test in rats, the effects of alfaxalone were recognized as similar to those of midazolam. These biochemical and behavioral data suggest that alfaxalone has an abuse potential similar to other Schedule IV sedatives.
Physical dependence: There are no data that assess the ability of alfaxalone to induce physical dependence. However, alfaxalone has a mechanism of action similar to the benzodiazepines and can block the behavioral responses associated with precipitated benzodiazepine withdrawal. Therefore, it is likely that alfaxalone can also produce physical dependence and withdrawal signs similar to that produced by the benzodiazepines.
Psychological dependence: The ability of alfaxalone to produce psychological dependence is unknown because there are no data on the rewarding properties of the drug from animal self-administration studies or from human abuse potential studies.
Rapid arousal: Careful monitoring of the patient is necessary due to possibility of rapid arousal.
Preanesthesia: Benzodiazepines may be used safely prior to ALFAXAN MULTIDOSE in the presence of other preanesthetics (see DRUG INTERACTIONS). However, when a benzodiazepine was used as the sole preanesthetic, excitation occurred in some cats and dogs during ALFAXAN MULTIDOSE anesthesia and recovery.
Apnea: Apnea may occur following administration of an induction dose, a maintenance dose or a dose administered during the transition to inhalant maintenance anesthesia, especially with higher doses and rapid administration. Endotracheal intubation, oxygen supplementation, and intermittent positive pressure ventilation (IPPV) should be administered to treat apnea and associated hypoxemia.
Blood Pressure: The myocardial depressive effects of ALFAXAN MULTIDOSE combined with the vasodilatory effects of inhalant anesthetics can be additive, resulting in hypotension. Preanesthetics may increase the anesthesia effect of ALFAXAN MULTIDOSE and result in more pronounced changes in systolic, diastolic, and mean arterial blood pressures. Transient hypertension may occur, possibly due to elevated sympathetic activity.
Body Temperature: A decrease in body temperature occurs during ALFAXAN MULTIDOSE anesthesia unless an external heat source is provided. Supplemental heat should be provided to maintain acceptable core body temperature until full recovery.
Breeding Animals: ALFAXAN MULTIDOSE has not been evaluated in pregnant, lactating, and breeding cats. Alfaxalone crosses the placenta, and as with other general anesthetic agents, the administration of ALFAXAN MULTIDOSE may be associated with neonatal depression.
Kittens and Puppies: ALFAXAN MULTIDOSE has not been evaluated in cats less than 4 weeks of age or in dogs less than 10 weeks of age.
Compromised or Debilitated Cats and Dogs: The administration of ALFAXAN MULTIDOSE to debilitated patients or patients with renal disease, hepatic disease, or cardiorespiratory disease has not been evaluated. Doses may need adjustment for geriatric or debilitated patients. Caution should be used in cats or dogs with cardiac, respiratory, renal or hepatic impairment, or in hypovolemic or debilitated cats and dogs, and geriatric animals.
Analgesia during anesthesia: Appropriate analgesia should be provided for painful procedures.
|Adverse Reaction||Number of Catsa = 207|
|Hypotension (≤90 mm Hg)||92|
|Tachycardia (≥ 180 bpm)||61|
|Apnea (≥ 30 seconds)||32 (of 202)|
|Hypertension (> 165 mm Hg)||23|
|Bradypnea (RR< 10 breaths/min)||16|
|Apnea (≥ 60 seconds)||12 (of 202)|
|Bradycardia (≤90 beats/min)||10|
|Hypoxia (SpO2 <85%)||4|
|Unacceptable Anesthesia Quality||1|
|a Each cat may have experienced more than one adverse reaction|
Additional adverse reactions for cats included vocalization, paddling, and muscle tremors. One cat that experienced tachycardia and hypoxia during anesthesia was euthanized 3 days later due to carcinoma involving the liver, pancreas and common bile duct. The relationship of the original tachycardia during anesthesia and the carcinoma is unknown.
|Adverse Reaction||Number of Dogsa = 182|
|Bradypnea (RR< 10 breaths/min)||89|
|Apnea (≥ 30 seconds)||55 (of 137)|
|Hypertension (> 165 mm Hg)||54|
|Tachycardia (≥ 180 bpm)||49|
|Apnea (≥ 60 seconds)||34 (of 137)|
|Hypotension (≤70 mm Hg)||32|
|Bradycardia (≤70 beats/min)||24|
|Hypoxia (SpO2 <85%)||4|
|Lack of Effectiveness||3|
|Unacceptable Anesthesia Quality||1|
|a Each dog may have experienced more than one adverse reaction|
Additional adverse reactions for dogs included vocalization, paddling, and muscle tremors.
To report adverse reactions or to obtain a copy of the SDS for this product call 1-888-963-8471.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
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