Milbemycin oxime and praziquantel

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This page reprints a manufacturer label. Everything below in quotation marks is copied from INTERCEPTOR™, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for INTERCEPTOR™ by Elanco US Inc, a milbemycin oxime and praziquantel product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.

The label

Product: INTERCEPTOR™. Manufacturer: Elanco US Inc. FDA Structured Product Label set id 86b367e3-64e5-4c44-9961-6caea5d12e75. Label effective 2026-07-27. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

INTERCEPTOR PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis ; and for the treatment and control of adult roundworm ( Toxocara canis, Toxascaris leonina ), adult hookworm ( Ancylostoma caninum ), adult whipworm ( Trichuris vulpis ), and adult tapeworm ( Taenia pisiformis, Echinococcus multilocularis, Echinococcus granulosus, and Dipylidium caninum ) infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

Dosage and Administration

INTERCEPTOR PLUS should be administered orally, once every month, at the minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime, and 2.28 mg/lb (5 mg/kg) praziquantel. For heartworm prevention, give once monthly for at least 6 months after exposure to mosquitoes (see

Contraindications

There are no known contraindications to the use of INTERCEPTOR PLUS.

Warnings

Not for use in humans. Keep this and all drugs out of the reach of children.

Precautions

Treatment with fewer than 6 monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention (see

Adverse Reactions

The following adverse reactions have been reported in dogs after administration of milbemycin oxime or praziquantel: vomiting, diarrhea, depression/lethargy, ataxia, anorexia, convulsions, weakness, and salivation.

Description

INTERCEPTOR PLUS is available in four strengths in color-coded packages for oral administration to dogs and puppies according to their weight. Each chewable flavored tablet is formulated to provide a minimum of 0.23 mg/pound (0.5 mg/kg) of milbemycin oxime and 2.28 mg/pound (5 mg/kg) of praziquantel. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A 4 (C 32 H 45 NO 7 , MW 555.71) and 20% A 3 (C 31 H 43 NO 7 , MW 541.68). Milbemycin oxime is classified as a macrocyclic anthelmintic. Praziquantel is an isoquinolone anthelmintic with the chemical name 2-(Cyclohexylcarbonyl)-1,2,3,6,7,-11b-hexahydro-4H-pyrazino [2,1-a]isoquinolin-4-one.

Storage

Store at room temperature, between 59° and 77°F (15-25°C).

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming milbemycin oxime and praziquantel as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 34,124 reports

Reactions most often coded in dogs, 34,124 reports
VeDDRA reaction termReports
Lack of efficacy (endoparasite) - heartworm8,267
Vomiting6,900
INEFFECTIVE, HOOKS2,759
Diarrhoea2,680
Lack of efficacy (endoparasite) - hookworm2,405
Lethargy (see also Central nervous system depression in 'Neurological')1,951
Other abnormal test result NOS1,709
Lack of efficacy (roundworm)1,245
Lack of efficacy (endoparasite) - roundworm NOS1,244
Seizure NOS907
Not eating833
Behavioural disorder NOS779
Lack of efficacy (endoparasite) - tapeworm713
Lethargy (see also Central nervous system depression in Neurological)583
Weight gain581

Outcome as recorded by the reporter: Outcome Unknown 21,034; Recovered/Normal 8,022; Ongoing 3,988; Died 612; Euthanized 376; Recovered with Sequela 101.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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