Regulatory product record
MILBEMAX
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
- MILBEMAX
- DIN
- 02291940
- DPD drug code
- 77731
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- TABLET
- Ingredients
- MILBEMYCIN OXIME (4 MG), PRAZIQUANTEL (10 MG)
- Species (DPD record)
- CATS
- Company
- ELANCO CANADA LIMITED (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 77731
- 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
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
Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus (and E. multilocularis)
DogOn-label (ON_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus (and E. multilocularis) — FDA-approved (labeled)
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dipylidium caninum, Taenia taeniaeformis
CatOn-label (ON_LABEL)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Dipylidium caninum, Taenia taeniaeformis — FDA-approved (labeled)
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Indications table · Not applicable · On-label (ON_LABEL) · 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 regimens10
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 effects410
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
Uncommon overall (oral use) — <5% (dog), <2% (cat)
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — 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. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Anorexia, vomiting, lethargy, diarrhea (oral) — Uncommon
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · 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
- Vomiting15,638 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 (endoparasite) - heartworm8,774 reports
- Lack of efficacy (ectoparasite) - flea7,647 reports
- Lack of efficacy (endoparasite) - hookworm7,561 reports
- Seizure NOS5,760 reports
Cat
- Hypersalivation1,636 reports
- Vomiting1,595 reports
- Application site alopecia1,497 reports
- Ataxia1,224 reports
- Lethargy (see also Central nervous system depression in 'Neurological')1,052 reports
- Lack of efficacy (endoparasite) - tapeworm906 reports
- Anorexia724 reports
- Behavioural disorder NOS694 reports
- Lethargy (see also Central nervous system depression in Neurological)642 reports
- Diarrhoea541 reports
- Application site hair loss514 reports
- Foaming at the mouth485 reports
Monitoring2
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
Fecal exam to confirm efficacy; reinfection is common with D. caninum given ongoing flea exposure — counsel concurrent flea control
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications2
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
Manufacturer: avoid in puppies <4 weeks or kittens <6 weeks (though praziquantel/febantel combo is approved for all ages); hypersensitivity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Precautions10
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
None major beyond age restriction on monotherapy product
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions3
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
Grapefruit juice — ↑ praziquantel AUC 150–200% in dogs (avoid coadministration if practical)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics5
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
Bioavailability — Rapid, near-complete oral absorption but significant first-pass effect
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Hepatic, CYP3A
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Primarily renal (metabolites)
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations2
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
Considered safe in pregnant dogs/cats and during lactation. Human FDA category B. Papich class A. Excreted in milk (~25% of maternal serum concentration) — unlikely to harm nursing offspring.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 992–994; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 663–664 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references24
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.
- Design, Optimization, Manufacture and Characterization of Milbemycin Oxime Nanoemulsions.
Study summary not available in the imported record. Open the original citation to review the study.
- Pharmacokinetics of Milbemycin Oxime in Pekingese Dogs after Single Oral and Intravenous Administration.
Study summary not available in the imported record. Open the original citation to review the study.
- Effects of Oral Macrocyclic Lactone Heartworm Preventatives on Retinal Function and Chromatic Pupillary Light Reflex in Healthy Companion Dogs.
Study summary not available in the imported record. Open the original citation to review the study.
- Efficacy of a chewable tablet containing sarolaner, moxidectin and pyrantel for the treatment of generalised demodicosis in dogs.
Study summary not available in the imported record. Open the original citation to review the study.
- Cryo-EM structures of Candida albicans Cdr1 reveal azole-substrate recognition and inhibitor blocking mechanisms.
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.