Regulatory product record
NEXGARD SPECTRA
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
- NEXGARD SPECTRA
- DIN
- 02473364
- DPD drug code
- 96276
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- TABLET (CHEWABLE)
- Ingredients
- AFOXOLANER (9.4 MG), MILBEMYCIN OXIME (1.9 MG)
- Species (DPD record)
- DOGS
- Company
- BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC. (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 96276
- 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, hookworm/roundworm/whipworm control (FDA-approved); demodicosis, scabies, cheyletiellosis (higher doses)
DogExtra-label (EXTRA_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Heartworm prevention, hookworm/roundworm/whipworm control (FDA-approved); demodicosis, scabies, cheyletiellosis (higher doses) — Labeled (prevention); extra-label at higher doses
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Heartworm prevention, adult hookworm/roundworm control
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Indications table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Heartworm prevention, adult hookworm/roundworm control — Labeled
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Indications table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Otodectes cynotis MILBEMITE OTIC Solution is indicated for treatment of ear mite () infestations in cats and kittens four weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.
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 regimens4
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 effects405
Generally well tolerated at labeled dose — —
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — 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. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
CNS toxicity (ataxia, depression, tremors, mydriasis) at high doses — Dose-dependent, esp. ABCB1-mutant breeds (1–2.2 mg/kg range)
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Vomiting, diarrhea (Demodex-dose treatment) — Uncommon
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
No adverse reactions caused by MILBEMITE OTIC Solution have been reported in controlled effectiveness studies in adult cats and kittens (4 weeks of age).
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
- Emesis42,902 reports
- Vomiting38,995 reports
- Lethargy (see also Central nervous system depression in 'Neurological')21,869 reports
- Vomiting15,966 reports
- Lack of efficacy (endoparasite) - heartworm14,074 reports
- Lack of efficacy - NOS13,033 reports
- Diarrhoea10,790 reports
- INEFFECTIVE, HEARTWORM LARVAE9,080 reports
- Lack of efficacy (ectoparasite) - flea7,647 reports
- Lack of efficacy (endoparasite) - hookworm7,561 reports
- Diarrhoea6,119 reports
- Seizure NOS5,760 reports
Cat
- Lethargy (see also Central nervous system depression in 'Neurological')123 reports
- Vomiting116 reports
- Accidental exposure106 reports
- Lack of efficacy (ectoparasite) - ear mite76 reports
- Emesis53 reports
- Ataxia37 reports
- Behavioural disorder NOS33 reports
- INEFFECTIVE, EAR MITES28 reports
- Diarrhoea23 reports
- Not eating21 reports
- Lack of efficacy - NOS16 reports
- Anorexia14 reports
Monitoring1
Heartworm status check before initiating; skin scrapings to confirm parasitological cure when used for demodicosis (may take 4 months clinical, 8 months parasitological)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications1
Manufacturer: not for puppies <4 weeks/<2 lbs or kittens <6 weeks/<1.5 lbs
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Precautions6
Test for pre-existing heartworm infection before starting — dogs with high microfilaria burden can develop a transient shock-like syndrome; genetic ABCB1 testing recommended before high-dose therapy in susceptible breeds
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Considered a safer alternative to ivermectin in ABCB1-mutant breeds when used at labeled heartworm-prevention doses, but genetic testing is still prudent before high-dose (demodicosis) therapy.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Demodicosis treatment is a significant financial commitment given the extended treatment duration at above-label doses — set owner expectations on cost and duration upfront.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Sentinel combination product also provides flea egg development inhibition via lufenuron — worth clarifying with clients which product (Interceptor vs. Sentinel) they actually have.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Not for human use. Keep this and all drugs out of the reach of children.
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
Interactions2
P-glycoprotein inhibitors (azole antifungals, cyclosporine, diltiazem, erythromycin/clarithromycin, quinidine, spironolactone, amiodarone, tamoxifen, verapamil, carvedilol) — ↑ CNS penetration risk, especially in ABCB1-mutant dogs
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Benzodiazepines — Potentiated effects
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics2
Duration of effect — Effective ≥45 days post D. immitis larval infection at labeled dose
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Not fully characterized (Plumb's: no specific data located)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Studies at 3× labeled dose in pregnant dogs showed no adverse effects to bitch or offspring. Excreted in milk — no adverse effects noted in nursing puppies at standard doses. Safety in breeding/pregnant/lactating queens/toms not established.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 838–841; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 531–533 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references32
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.
- Efficacy of afoxolaner (NexGard®) for the treatment of myiasis caused by the zoonotic tumbu fly, Cordylobia anthropophaga, in domestic dogs under field conditions.
Study summary not available in the imported record. Open the original citation to review the study.
- Comparative speed of kill of induced Ixodes scapularis infestations following treatment of dogs with endectocides containing either sarolaner (Simparica Trio™), afoxolaner (NexGard(®) PLUS), or lotilaner (Credelio Quattro™).
Study summary not available in the imported record. Open the original citation to review the study.
- Patterns of antiparasitic usage in Golden Retriever breed of dogs: A 9-year cohort study.
Study summary not available in the imported record. Open the original citation to review the study.
- Saving a species, one mite at a time: efficacy of afoxolaner (NexGard®) against Macronyssidae mites in the critically endangered Aeolian wall lizard (Podarcis raffonei).
Study summary not available in the imported record. Open the original citation to review the study.
- Comparative efficacy of six monthly doses of Simparica Trio(®) (sarolaner, moxidectin, and pyrantel chewable tablets) versus NexGard(®) Plus (afoxolaner, moxidectin, and pyrantel chewable tablets) against a macrocyclic lactone-resistant Dirofilaria immitis isolate in dogs.
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.