Regulatory product record
VITRECTO
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
- VITRECTO
- DIN
- 02491729
- DPD drug code
- 98174
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- TOPICAL
- Pharmaceutical form(s)
- SOLUTION
- Ingredients
- FLURALANER (112.5 MG), MOXIDECTIN (5.6 MG)
- Species (DPD record)
- CATS
- Company
- INTERVET CANADA CORP (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 98174
- 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.
Indications3
Heartworm prevention (6-/12-month injectable ProHeart; monthly topical Advantage Multi); extra-label generalized demodicosis (0.2–0.4 mg/kg PO q24h)
DogExtra-label (EXTRA_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Heartworm prevention (6-/12-month injectable ProHeart; monthly topical Advantage Multi); extra-label generalized demodicosis (0.2–0.4 mg/kg PO q24h) — Authorized (label forms); demodex extra-label
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Heartworm prevention + fleas + parasites via topical combo
CatOn-label (ON_LABEL)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Heartworm prevention + fleas + parasites via topical combo — Authorized (Advantage Multi/Advocate cat)
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Cochliomyia hominivorax Rhipicephalus microplus Exzolt Cattle-CA1 is indicated for the prevention and treatment of infestations caused by New World screwworm () larvae (myiasis) and treatment and control of cattle fever tick () in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age. Not for use in bulls intended for breeding 1 year of age and older, dairy calves, and veal calves.
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 regimens6
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 effects404
Oral daily (demodex doses): vomiting, ataxia, lethargy, inappetence — Dose-limiting
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Neurotoxicity (tremors, coma) — MDR1-mutant dogs at high doses (ivermectin-rule applies); low-body-fat patients more prone
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Injection-site/procedure reactions (ProHeart) — Label-era safety history — why availability has fluctuated
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
In a well-controlled U.S. field study, 225 dogs were administered two doses of BRAVECTO QUANTUM at a 1-year interval and 96 dogs were administered an oral active control every 12 weeks for a total of 6 doses. Over the 455-day study period, all observations of potential adverse reactions were recorded. One dog treated in the BRAVECTO QUANTUM group had a hypersensitivity reaction which included hives, facial edema, vomiting, and heavy breathing within the first 12 hours following the initial treatment. The dog was treated with oral antihistamines and recovered within 24 hours of treatment. No additional hypersensitivity reactions were observed in subsequent dosing 12 months later when premedicated with diphenhydramine. In well-controlled foreign laboratory effectiveness studies, after administration of BRAVECTO QUANTUM, two dogs exhibited slight mucosal hyperemia the day following administration that resolved the following day, one dog exhibited transient erythema 10 minutes post-injection that resolved within 1 hour, and one dog had a nonpainful swollen upper eyelid observed 24 hours post treatment. In a large European field study, pain on injection of BRAVECTO QUANTUM was reported in 5 dogs. Percentage of Dogs with Adverse Reactions in the Field Study Adverse Reaction (AR) BRAVECTO QUANTUM(n = 225 dogs) Active Control(n = 96 dogs) Lethargy 4.9% 3.1% Decreased appetite 4.4% 4.2% Vomiting 4.0% 0% Diarrhea 2.7% 3.1% Alanine aminotransferase (ALT); Alkaline phosphatase (ALP) Liver enzymes (serum ALT or ALP) greater than twice the upper reference range 2.7% 2.1% Pruritus 1.8% 2.1% Mild injection site reactions, described as a lump, bump or knot, occurred in three BRAVECTO QUANTUM treated dogs and were all observed within 3 days of the injection. All injection site reactions were self-limiting and resolved following 1, 4, and 27 days after the initial observation. Injection site lumps or swelling 1.3% 0% Two dogs treated with BRAVECTO QUANTUM experienced seizures during the study. One dog with a history of at least one seizure within three months prior to the start of the study, reported 6 seizures in 9 months starting 23 days after the initial dose. Although anticonvulsant medications were not started, no additional seizures were observed during the study following the second dose administered 12 months after the initial dose. A second dog reported 8 seizures starting 57 days after the initial dose. The dog was removed from the study on Day 84 and managed with anticonvulsant medications. Seizures 0.9% 0%
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
- Vomiting19,858 reports
- Vomiting14,339 reports
- Lack of efficacy (ectoparasite) - flea13,545 reports
- Lack of efficacy (endoparasite) - heartworm10,751 reports
- Diarrhoea5,688 reports
- Lack of efficacy (endoparasite) - hookworm5,573 reports
- Emesis (multiple)5,521 reports
- Lethargy (see also Central nervous system depression in 'Neurological')5,212 reports
- Anaphylaxis5,034 reports
- Lethargy (see also Central nervous system depression in 'Neurological')4,881 reports
- Lack of efficacy (ectoparasite) - tick NOS4,826 reports
- Diarrhoea4,374 reports
Cat
- Lack of efficacy (ectoparasite) - flea3,556 reports
- Application site hair loss2,465 reports
- Lack of efficacy (ectoparasite) - flea1,643 reports
- Hypersalivation1,490 reports
- Lethargy (see also Central nervous system depression in 'Neurological')1,234 reports
- Lethargy (see also Central nervous system depression in 'Neurological')1,233 reports
- Application site alopecia1,181 reports
- Behavioural disorder NOS1,103 reports
- Drug administered at inappropriate site1,030 reports
- Pruritus839 reports
- Emesis (multiple)819 reports
- Vomiting811 reports
Monitoring1
Clinical: HW test annually + before restarts; demodex courses: neuro signs + skin scrapes q2–4 wk; weight for injectable dosing
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications2
Hypersensitivity; HW-positive dogs (test before starting prevention — reactions to microfilariae + risk)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
There are no known contraindications for the use of the product.
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
Precautions12
>2-month dosing gap → retest before resuming; MDR1 status at demodicosis doses; cachectic/neonatal animals
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Prevention-safe vs treatment-risk split: the monthly microgram doses are MDR1-safe across genotypes (Mealey) — the DAILY demodicosis doses re-open the ivermectin-sensitivity question; know which regime you're dispensing.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
ProHeart's 6-month injection = the compliance solution for forgetful owners, with a regulatory-history asterisk (2004 recall, label changes).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Advantage Multi pairing: moxidectin (HW + parasites) + imidacloprid (fleas) in one spot-on — the combination-product era of parasiticide dispensing.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Interactions3
Other avermectins — Don't stack macrocyclic lactones
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Imidacloprid (combo product) — Deliberate pairing
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Spinosad — High-dose-ivermectin-like interaction caution (class)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics4
Mechanism — Avermectin: glutamate-gated chloride channels → parasite paralysis (class mechanism shared with ivermectin)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
MDR1 safety — HW-prevention doses (oral 3 µg/kg-class, topical 2.5 mg/kg) safe for ALL ABCB1 genotypes (Mealey) — but daily demodex doses carry ivermectin-like mutation risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Duration — Lipophilic depot (injectable = months)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Clinical Pharmacology:
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
Label statements per product; reproduction studies generally reassuring at preventive doses.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 864–866 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references21
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.
- Pharmacokinetics, Absolute Bioavailability, and Nonlinear Topical Absorption of a Fluralaner-Moxidectin Spot-On Formulation in Cats.
Study summary not available in the imported record. Open the original citation to review the study.
- Efficacy of a single oral administration of a formulation of fluralaner, moxidectin and pyrantel (BRAVECTO® TriUNO) in dogs for the treatment and prevention of angiostrongylosis.
Study summary not available in the imported record. Open the original citation to review the study.
- Effect of fluralaner administration to domestic dogs on the bloodmeal profile of Triatoma infestans in a cluster-randomized trial in the Argentine Chaco.
Study summary not available in the imported record. Open the original citation to review the study.
- Overcoming doramectin failure: field efficacy of pour-on 5% fluralaner and an experimental 1% oral formulation for the prevention of Cochliomyia hominivorax-associated umbilical myiasis in newborn calves.
Study summary not available in the imported record. Open the original citation to review the study.
- Determination and stereoselective pharmacokinetics of fluralaner enantiomers in broiler chickens by liquid chromatography-tandem mass spectrometry.
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.