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Roxee Medication Guide

Milbemycin Oxime, Praziquantel

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Rx required Chewable Tablets Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Jun 21, 2026, 5:14 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Milbemycin Oxime, Praziquantel

Milbemycin Oxime, Praziquantel

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Chewable Tablets Rx required 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Milbemycin Oxime, Praziquantel

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, and Echinococcus granulosus ) and Dipylidium caninum infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older. Species commonly shown: Both, Dog.

Generic name
Milbemycin Oxime, Praziquantel
Brand names
INTERCEPTOR™ PLUS, Interceptor Plus, MILPRO CHEWY
Manufacturer
Multiple FDA labelers
Species
Both, Dog
Dosage forms
Chewable Tablets
Prescription
Prescription required
Completeness
100%
Validation
Needs review
Brand names
INTERCEPTOR™ PLUS Interceptor Plus MILPRO CHEWY
Dosage forms
Chewable Tablets

Indications / Uses

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 , and Echinococcus granulosus ) and Dipylidium caninum infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

Top reported reactions (openFDA): Lack of efficacy (endoparasite) - heartworm, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in Neurological), Lack of efficacy (endoparasite) - hookworm, Lack of efficacy (endoparasite) - tapeworm.

FAQ

Both, Dog

Yes. Roxee shows this as prescription-only.

Chewable Tablets

Related Conditions

Heartworm Disease

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

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 (...

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Hives (1 reports)
  • Grand mal seizure (1 reports)
  • Fracture (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Milbemycin Oxime, Praziquantel; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-066918
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 10 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-066918
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-066918
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Hives (1 reports), Grand mal seizure (1 reports), Fracture (1 reports), Fever (1 reports), Ecchymosis (1 reports)

Body systems represented Signal grouping

Digestive (4), Skin & allergy (4), Neurologic (3), Behavior (1)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Dog (25 reports), Cat (7 reports)

Breed metadata in reports Metadata only

Pointing Dog - Hungarian Short-haired (Vizsla) (1), Pit Bull (1), Shepherd Dog - Australian (1), ['Spaniel - Cocker American', 'Poodle (unspecified)'] (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Milbemycin Oxime, Praziquantel fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Hives, Grand mal seizure, Fracture

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Milbemycin Oxime, Praziquantel brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-066918 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. Medication usage source · fda_animal_drugs · quick facts
  5. FOI · document · documents
  6. FOI · document · documents
  7. SPL · document · documents
  8. Structured Product Label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: April 22, 2026, 10:06 AM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Hives
  • Grand mal seizure
  • Fracture

Most reported reactions:

  • Hives (1 reports)
  • Grand mal seizure (1 reports)
  • Fracture (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
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 …
Form / route / dose
Form: Chewable Tablets
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA labelers
Form: Chewable Tablets
Identifiers:
NADA: 141338 NDC Package: 51311-086-02 NDC Package: 51311-087-02 NDC Package: 51311-088-02 NDC Package: 51311-089-24 NDC Package: 51311-090-24 NDC Package: 51311-091-24 NDC Package: 58198-5440-1 NDC Package: 58198-5440-2 NDC Package: 58198-5440-3 NDC Package: 58198-5440-4 NDC Package: 58198-5444-1 NDC Package: 58198-5444-2 NDC Package: 58198-5444-3 NDC Package: 58198-5444-4 NDC Package: 58198-5446-1 NDC Package: 58198-5446-2 NDC Package: 58198-5446-3 NDC Package: 58198-5446-4 NDC Package: 58198-5448-1
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
21
Matching reports
1
Active filters
2
Selected filters
Reaction: Lack of efficacy (endoparasite) - roundworm NOS Clear Body system: Digestive Clear
Reset
Drill into common report signals
Lack of efficacy (endoparasite) - heartworm (8) Lack of efficacy (endoparasite) - roundworm NOS (4) Vomiting (4) Diarrhoea (3) Effectiveness (17) Other (10) Digestive (5) Skin & allergy (3)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-069774

Received 2025-11-25 · MSK · MSK

Non-serious
Species
Dog
Breed
Dachshund - Miniature
Size / weight
10-24 lb (6.07 Kilogram)
Age
4-7 years (5.25 Year)
Sex
Male Neutered
Region
USA
Reactions
Haemorrhagic gastroenteritisLack of efficacy (endoparasite) - roundworm NOSDiarrhoeaEar infection NOSHypochloraemiaSneezingVomiting
Body systems
OtherEffectivenessDigestive
Outcomes
Ongoing

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
10
Species represented
2
Grouped by Body System
Digestive (4) · Vomiting, Drooling, Diarrhea Skin & allergy (4) · Injection site swelling, Hives, Hair loss Neurologic (3) · Unsteady walking (ataxia), Head tilt - neurological disorder, Grand mal seizure Behavior (1) · Behavioral disorder (unspecified) Other (20) · Hypochloraemia, Horizontal nystagmus, Hiding
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Skin & allergy 1 Dog 1
Neurologic 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1

Species coverage: Dog (25) Cat (7)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Digestive Cat Non-serious - 1
Neurologic Dog Non-serious - 1
Skin & allergy Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Skin & allergy Dog Serious - 1
Other Cat Non-serious - 1
Neurologic Dog Non-serious - 1
Other Dog Non-serious - 1
Skin & allergy Dog Non-serious - 1
Other Dog Non-serious - 1
Neurologic Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Skin & allergy Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Digestive Cat Non-serious - 1
Other Cat Serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Serious - 1
Digestive Dog Non-serious - 1
Behavior Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

INTERCEPTOR™ PLUS SPL · SPL Interceptor Plus SPL SPL · Structured Product Label MILPRO CHEWY SPL SPL · Structured Product Label

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

3

FOI

2

INTERCEPTOR™ PLUS

SPL · SPL

Open original
FDA Structured Product Label

INTERCEPTOR™ PLUS

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
141-338
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog
Composition / specifications
Each chewable tablet contains:
2.3 mg milbemycin oxime/22.8 mg praziquantel
5.75 mg milbemycin oxime/57 mg praziquantel
11.5 mg milbemycin oxime/114 mg praziquantel
23 mg milbemycin oxime/228 mg praziquantel

Dogs (2 lbs or greater and 6 weeks or older)

Indication

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, and 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
Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Interceptor Plus SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Interceptor Plus. Use the source link for the full official labeling record.

MILPRO CHEWY SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for MILPRO CHEWY. Use the source link for the full official labeling record.

FOI Summary sN 141-338 Approved June 21, 2017.pdf

FOI · FOI

Open original

UCM318617.pdf

FOI · FOI

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Interceptor Plus MILPRO CHEWY
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: RX
Form/route: Chewable Tablets • Oral
Applications: NADA 141-338
NDC: Packages 51311-086-02 51311-087-02 51311-088-02 51311-089-24 51311-090-24 51311-091-24 • Products 51311 58198
Documents: 2 (FOI: 2) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 43 • Cat 0 • View
Case summaries: 21 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Explore
Related conditions: Heartworm Disease
Linked using: Fda_Label (0.95)
Diagnosis Codes
ICD10_CM: B74.8
Other filariases

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Hives (1) Grand mal seizure (1) Fracture (1) Fever (1) Ecchymosis (1) Dysphoria (1) Dilated pupils (1) Dermal thickening (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
NADA: 141338 NDC Package: 51311-086-02 NDC Package: 51311-087-02 NDC Package: 51311-088-02 NDC Package: 51311-089-24 NDC Package: 51311-090-24 NDC Package: 51311-091-24 NDC Package: 58198-5440-1 NDC Package: 58198-5440-2 NDC Package: 58198-5440-3 NDC Package: 58198-5440-4 NDC Package: 58198-5444-1 NDC Package: 58198-5444-2 NDC Package: 58198-5444-3 NDC Package: 58198-5444-4 NDC Package: 58198-5446-1 NDC Package: 58198-5446-2 NDC Package: 58198-5446-3 NDC Package: 58198-5446-4 NDC Package: 58198-5448-1 NDC Package: 58198-5448-2 NDC Package: 58198-5448-3 NDC Package: 58198-5448-4 NDC Product: 51311
Package NDC Product NDC Form / Route Status
51311-086-02 51311 -
51311-087-02 51311 -
51311-088-02 51311 -
51311-089-24 51311 -
51311-090-24 51311 -
51311-091-24 51311 -
58198-5440-1 58198 -
58198-5440-2 58198 -
58198-5440-3 58198 -
58198-5440-4 58198 -
58198-5444-1 58198 -
58198-5444-2 58198 -
58198-5444-3 58198 -
58198-5444-4 58198 -
58198-5446-1 58198 -
58198-5446-2 58198 -
58198-5446-3 58198 -
58198-5446-4 58198 -
58198-5448-1 58198 -
58198-5448-2 58198 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Interceptor Plus SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • MILPRO CHEWY SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • UCM318617.pdf • FOI summary • Official • Jan. 10, 2018
    FDA FOI summary for application 141338
  • FOI Summary sN 141-338 Approved June 21, 2017.pdf • FOI summary • Official • Jan. 10, 2018
    FDA FOI summary for application 141338

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 118 Clinical 6 Manufacturer 0 Marketing 0
Current Field Facts
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (endoparasite) - heartworm, Vomiting, Diarrhoea, Lethargy (see also Central nervous system depression in Neu… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Official, 2026-04-22)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-22)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-22)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-21)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-20)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-13)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-12)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-12)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-11)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-11)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-10)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-09)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-08)
  • indications: For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina)… (Official, 2026-06-07)
Recent Revisions
  • side_effects updated 2026-04-22 10:06 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-22 10:06 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-22 10:06 by etl_backfill • Backfilled from existing medication fields
  • monitoring updated 2026-04-21 10:07 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-21 10:07 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-21 10:07 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-21 10:07 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-21 10:07 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-21 10:07 by curated_loader • Official FDA application reference for Senvelgo.
  • monitoring updated 2026-04-20 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-20 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-20 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-20 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-20 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.
  • approval_reference updated 2026-04-20 10:08 by curated_loader • Official FDA application reference for Senvelgo.
  • monitoring updated 2026-04-19 10:08 by curated_loader • Clinical monitoring context for feline diabetes management.
  • usage updated 2026-04-19 10:08 by curated_loader • Usage statement from FDA warning letter and approved-product context.
  • drug_profile_type updated 2026-04-19 10:08 by curated_loader • FDA source confirms Senvelgo as a branded approved product.
  • manufacturer_name updated 2026-04-19 10:08 by curated_loader • FDA warning letter identifies the approved sponsor/manufacturer.
  • brand_names updated 2026-04-19 10:08 by curated_loader • FDA warning letter references Senvelgo as the approved animal drug.

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
INTERCEPTOR™ PLUS
RX
Milbemycin Oxime Praziquantel
Chewable Tablets • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-338 Approved Jan 10, 2018

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog
Composition / specifications
Each chewable tablet contains:
2.3 mg milbemycin oxime/22.8 mg praziquantel
5.75 mg milbemycin oxime/57 mg praziquantel
11.5 mg milbemycin oxime/114 mg praziquantel
23 mg milbemycin oxime/228 mg praziquantel
Dogs (2 lbs or greater and 6 weeks or older)
Indication

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, and 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
Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Usage

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 , and Echinococcus granulosus ) and Dipylidium caninum infections in dogs and puppies two pounds of body weight or greater and six weeks of age and older.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Vomiting (1) • Cat Drooling (1) • Cat Diarrhea (1) • Dog Bloody diarrhoea (1) • Dog

Showing top 5 for Digestive.

Skin & allergy
Injection site swelling (1) • Dog Hives (1) • Dog Hair loss (1) • Dog Facial swelling (possible allergy) (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Dog Head tilt - neurological disorder (1) • Dog Grand mal seizure (1) • Cat

Showing top 5 for Neurologic.

Behavior
Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Other
Hypochloraemia (1) • Dog Horizontal nystagmus (1) • Dog Hiding (1) • Cat Head shake - ear disorder (1) • Dog Haemorrhagic gastroenteritis (1) • Dog
Show more (15)
Fracture (1) • Dog Fever (1) • Cat Facial paralysis (1) • Dog Ecchymosis (1) • Dog Ear infection NOS (1) • Dog Dysphoria (1) • Cat Dilated pupils (1) • Cat Dermal thickening (1) • Dog Crust (1) • Dog Cough, hacking (1) • Dog Cough (1) • Dog Constipation (1) • Dog Conjunctivitis (1) • Dog Bacterial skin infection NOS (1) • Dog Abnormal menace reflex test (1) • Dog

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Pointing Dog - Hungarian Short-haired (Vizsla), Male, 8 year, 24.49 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Vomiting, Stiffness limb, Not eating • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-075240
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 24.490 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Vomiting Stiffness limb Not eating
Outcomes: Recovered/Normal

Dog, Pit Bull, Male, 8 year, 30.391 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal • Reactions: Lack of efficacy (endoparasite) - whipworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075063
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 30.391 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 dose per animal
Reactions Reported:
Lack of efficacy (endoparasite) - whipworm
Outcomes: Outcome Unknown

Dog, Shepherd Dog - Australian, Male, 5 year, 38.102 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 dose per animal • Reactions: Lack of efficacy (endoparasite) - whipworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075059
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 38.102 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 dose per animal
Reactions Reported:
Lack of efficacy (endoparasite) - whipworm
Outcomes: Outcome Unknown

Dog, ['Spaniel - Cocker American', 'Poodle (unspecified)'], Male, 7.3 year, 9.29 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - roundworm NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-075045
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.30 Year
  • Weight: 9.290 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - roundworm NOS
Outcomes: Outcome Unknown

Dog, ['Poodle - Miniature', 'Retriever - Golden'], Male, 3 year, 16.7 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (endoparasite) - tapeworm • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074819
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 16.700 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Lack of efficacy (endoparasite) - tapeworm
Outcomes: Outcome Unknown

Dog, Cattle Dog (unspecified), Male, 3 year, 20.412 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Lack of efficacy (endoparasite) - roundworm NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074808
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 20.412 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Lack of efficacy (endoparasite) - roundworm NOS
Outcomes: Outcome Unknown

Dog, Dachshund - Miniature, Male, 3 year, 5.89 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Diarrhea, Vomiting, Unwell • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-074909
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 5.890 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Diarrhea Vomiting Unwell
Outcomes: Recovered/Normal

Dog, Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog), Male, 4.8 year • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal, Frequency: 1 per month • Reactions: Limping, Swelling NOS, Limb non-weight bearing, Constipation, Lack of efficacy (endoparasite) - heartworm… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-074820
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 4.80 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
  • Frequency: 1 per month
Reactions Reported:
Limping Swelling NOS Limb non-weight bearing Constipation Lack of efficacy (endoparasite) - heartworm Pain NOS Pica NOS Localised pain NOS
Outcomes: Outcome Unknown

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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