ALFAXAN MULTIDOSE IDX: Product Information (Page 2 of 4)

FERRETS

MARSUPIALS

MINOR SPECIES UNGULATES

DRUG INTERACTIONS

No specific preanesthetic is either indicated or contraindicated with ALFAXAN MULTIDOSE IDX. 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 IDX is compatible with benzodiazepines, opioids, alpha₂ ‑agonists, and phenothiazines as commonly used in surgical practice.

CONTRAINDICATIONS

ALFAXAN MULTIDOSE IDX is contraindicated in animals with a known sensitivity to ALFAXAN MULTIDOSE IDX or its components, or when general anesthesia and/or sedation are contraindicated. Do not use in any minor species animal that may become eligible for consumption by humans or food‑producing animals.

WARNINGS

Animal Safety: 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 IDX 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 IDX 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.
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 1-888-963-8471.
Note to physician: This product contains an injectable anesthetic.

DRUG ABUSE AND DEPENDENCE

Controlled substance: ALFAXAN MULTIDOSE IDX 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 inducephysical 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.

PRECAUTIONS

Analgesia during anesthesia: ALFAXAN MULTIDOSE IDX is not an analgesic and appropriate analgesia should be provided to the patient for painful procedures.
Rapid arousal: Careful monitoring of the patient is necessary due to possibility of rapid arousal.
Apnea: Apnea may occur following IV administration of an induction dose, maintenance dose or a dose administered during transition to inhalant maintenance anesthesia of ALFAXAN MULTIDOSE IDX, 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 in the appropriate species.
Blood Pressure: ALFAXAN MULTIDOSE IDX can exacerbate the myocardial depressive and vasodilatory effects of inhalant anesthetics resulting in hypotension. Preanesthetics can potentiate the effect of ALFAXAN MULTIDOSE IDX resulting in more pronounced changes in blood pressure. Transient hypertension has also been observed with ALFAXAN MULTIDOSE IDX administration, possibly due to elevated sympathetic activity in the patient. It is prudent to monitor blood pressure whenever possible.
Body temperature: Steps should be taken to maintain the normal physiological temperature of the patient during anesthesia. Supplemental heat, appropriate for the species, should be provided to maintain acceptable core body temperature until full recovery.
Breeding animals: Alfaxalone crosses the placenta, and as with other general anesthetic agents, the administration of ALFAXAN MULTIDOSE IDX may be associated with neonatal depression.
Compromised or debilitated animals: Caution should be used in animals with cardiac, respiratory, renal or hepatic impairment, or in hypovolemic or debilitated animals and geriatric animals.

ADVERSE REACTIONS

Specific adverse reactions described in the referenced literature are listed in the Dosage and Administration section of the product insert.

CONTACT INFORMATION

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.

OVERDOSE

Rapid administration, accidental overdose, or relative overdose due to inadequate dose sparing of ALFAXAN MULTIDOSE IDX in the presence of preanesthetics may cause 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 pure oxygen. Cardiovascular depression should be treated with plasma expanders, pressor agents, antiarrhythmic agents or other techniques as appropriate for the observed abnormality.

STORAGE INFORMATION

Store at controlled room temperature 20°C — 25°C (68° to 77°F) with excursions between 15° and 30°C (59° and 86°F). ALFAXAN MULTIDOSE IDX contains preservatives. The product can be used for 56 days after broaching the vial. Any unused ALFAXAN MULTIDOSE IDX remaining after 56 days should be discarded.

HOW SUPPLIED

ALFAXAN MULTIDOSE IDX is supplied in 10 mL and 20 mL multiple-dose vials containing 10 mg alfaxalone per mL.