Regulatory product record
ALFAXAN MULTIDOSE
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- ALFAXAN MULTIDOSE
- DIN
- 02468670
- DPD drug code
- 95714
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- INTRAVENOUS
- Pharmaceutical form(s)
- SOLUTION
- Ingredients
- ALFAXALONE (10 MG)
- Species (DPD record)
- DOGS, CATS
- Company
- ZOETIS CANADA INC (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 95714
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications5
Induction and/or maintenance of general anesthesia; deep sedation (IM, cats)
DogCatOn-label (ON_LABEL)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Induction and/or maintenance of general anesthesia; deep sedation (IM, cats) — Authorized
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Induction and/or maintenance of general anesthesia; deep sedation (IM, cats) — Authorized
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
ALFAXAN MULTIDOSE IDX is indicated as a sedative and anesthetic in multiple minor species*. More specifically, ALFAXAN MULTIDOSE IDX is indicated for the following: Use only when there is reasonable certainty that the treated animal will not be consumed by humans or food‑producing animals. * The term “minor species” means animals other than humans that are not major species. “Major species” means cattle, horses, swine, chickens, turkeys, dogs and cats. As used on this label, a “food‑producing minor species” is considered to be a minor species of which some members are bred, cultured, farmed, ranched, hunted, caught, trapped or otherwise harvested for the purpose of having the animals or edible products of the animals commercially distributed for consumption by humans or food‑producing animals in the United States. For sedation and anesthesia in captive reptiles, excluding any food‑producing species For sedation and anesthesia in captive amphibians, excluding any food‑producing species For sedation and anesthesia in ornamental fish, including species used in research such as the zebrafish For sedation and anesthesia in captive species and pet birds in the orders Psittaciformes, Passeriformes, and Columbiformes, excluding any food‑producing species For sedation and anesthesia in non‑human primates For sedation and anesthesia in captive rodents For sedation and anesthesia in captive mustelids For sedation and anesthesia in captive marsupials For induction of anesthesia and immobilization in captive minor species ungulates, excluding any food‑producing species**
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
• For sedation and anesthesia in captive reptiles, excluding any food-producing species• For sedation and anesthesia in captive amphibians, excluding any food-producing species• For sedation and anesthesia in ornamental fish, including species used in research such as the zebra fish• For sedation and anesthesia in captive species and pet birds in the orders Psittaciformes, Passeriformes, and Columbiformes, excluding any food-producing species• For sedation and anesthesia in non-human primates• For sedation and anesthesia in captive rodents• For sedation and anesthesia in captive mustelids• For sedation and anesthesia in captive marsupials• For induction of anesthesia and immobilization in captive minor species ungulates, excluding any food-producing speciesUse only when there is reasonable certainty that the treated animal will not be consumed by humans or food-producing animals.* The term “minor species” means animals other than humans that are not major species. “Major species” means cattle, horses, swine, chickens, turkeys, dogs and cats.** As used on this label, a “food-producing minor species” is considered to be a minor species of which some members are bred, cultured, farmed, ranched, hunted, caught, trapped or otherwise harvested for the purpose of having the animals or edible products of the animals commercially distributed for consumption by humans or food-producing animals in the United States.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
ALFAXAN MULTIDOSE 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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens9
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects208
Post-induction apnea — 44% of dogs, 19% of cats in clinical trials
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Respiratory/CNS depression, hypotension — Dose-related
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pain/discomfort if given IM — Notable — avoid IM/SC for induction
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Rough/excited recovery — More likely with benzodiazepine-only premed
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Specific adverse reactions described in the referenced literature are listed in the Dosage and Administration section of the product insert. To report adverse reactions or to obtain a copy of the SDS for this product call 1‑844‑253‑2926. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1‑888‑FDA‑VETS or online at http://www.fda.gov/reportanimalae.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Death65 reports
- Tachycardia42 reports
- Cardiac arrest41 reports
- Lack of efficacy - NOS40 reports
- Vomiting39 reports
- Seizure NOS38 reports
- Vocalisation37 reports
- Bradycardia36 reports
- Paddling35 reports
- Diarrhoea34 reports
- Apnoea29 reports
- Cyanosis25 reports
Cat
- Not eating53 reports
- Death52 reports
- Behavioural disorder NOS36 reports
- Bradycardia32 reports
- Anorexia29 reports
- Dilated pupils28 reports
- Hypotension27 reports
- Lack of efficacy - NOS27 reports
- Recovery prolonged27 reports
- Death by euthanasia26 reports
- Hiding26 reports
- Hyperactivity26 reports
Monitoring1
Depth/character of anesthesia, blood pressure, heart rate, body temperature, respiratory rate — watch closely for apnea after induction
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications4
Do not combine with other injectable general anesthetics in the same protocol (per label)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
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.
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions10
Hepatic dysfunction (lower dose/extend interval); safety not established <12 weeks age; must have ET intubation/O2/ventilation capability available
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Negligible analgesic effect — always pair with a separate analgesic plan.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
IM/SC routes are inappropriate for induction/maintenance — IV only for anesthetic effect; the cat IM "deep sedation" dose is a distinct, separate use case, not equivalent to IV induction.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
High apnea incidence in dogs specifically — always have ET intubation and ventilatory support ready before administering.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
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 1‑844‑253‑2926. Note to physician: This product contains an injectable anesthetic.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Interactions6
Other CNS depressants — Additive depression — dose-adjust
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Medetomidine and/or butorphanol premed — Significantly reduces induction dose requirement
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Propofol, thiopental — Label states do not use together with alfaxalone
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
2 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, alpha‑agonists, and phenothiazines as commonly used in surgical practice.
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 34073-7 (DRUG INTERACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34073-7 (DRUG INTERACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
2 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, alpha-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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34073-7 (DRUG INTERACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics6
Volume of distribution — ~2.5 L/kg (dog); ~2 L/kg (cat)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — ~27 min (dog, clinical dose); 45–77 min (cat, dose-dependent)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Hepatic Phase I (CYP450) + Phase II conjugation
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Hepatic/fecal + renal
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
ALFAXAN MULTIDOSE is a reformulation of previously approved, single-use ALFAXAN (NADA 141-342) which contained no antimicrobial preservative. The bioequivalence of ALFAXAN (unpreserved) and ALFAXAN MULTIDOSE following administration of 5 mg/kg IV was demonstrated in a two sequence, two period crossover study in 24 cats (see EFFECTIVENESS). The bioequivalence of ALFAXAN (unpreserved) and ALFAXAN MULTIDOSE following administration of 3 mg/kg IV was demonstrated in a two sequence, two period crossover study in 24 dogs (see EFFECTIVENESS).
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Not established. No deleterious gestational effects seen in mice/rat/rabbit studies. Effects on fertility not evaluated.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 48–50; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 17–18 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references19
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Need for Pharmacologic Targets and Therapeutics for Postoperative Respiratory Depression and Pulmonary Complications in Veterinary Medicine.
Study summary not available in the imported record. Open the original citation to review the study.
- Atropine and glycopyrrolate significantly raise the heart rate of Sonoran Desert toads (Incilius alvarius).
Study summary not available in the imported record. Open the original citation to review the study.
- Intravenous lidocaine administered in the dorsal occipital sinus was ineffective for euthanasia of Asian box turtles (Cuora spp).
Study summary not available in the imported record. Open the original citation to review the study.
- High-flow nasal oxygen therapy reduces work of breathing without altering systemic oxygen delivery or consumption in healthy, anesthetized, spontaneously breathing dogs.
Study summary not available in the imported record. Open the original citation to review the study.
- The effect of maropitant on sedation, propofol requirements, and cardiovascular function at induction of anesthesia in healthy cats.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.