Lotilaner, moxidectin, praziquantel and pyrantel

Indications

Credelio Quattro is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina ), hookworm (fourth stage larvae, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala ), and tapeworm ( Dipylidium caninum , Taenia pisiformis , and Echinococcus granulosus ) infections. Credelio Quattro kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of tick infestations [ Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. Credelio Quattro is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Credelio Quattro-CA1 is indicated for the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax ) larvae (myiasis) in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater.

Dosage and Administration

Credelio Quattro/Credelio Quattro-CA1 is given orally at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt). Credelio Quattro/Credelio Quattro-CA1 must be administered with food (see

Contraindications

There are no known contraindications for the use of Credelio Quattro/Credelio Quattro-CA1.

Warnings

Not for use in humans. Keep this and all drugs out of reach of children. Wash hands after handling. If accidentally ingested, seek medical attention immediately. Keep Credelio Quattro/Credelio Quattro-CA1 in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Adverse Reactions

In a field safety and effectiveness study, Credelio Quattro was administered to dogs for the prevention of heartworm disease. The study included a total of 372 dogs treated once monthly for up to 11 treatments (191 treated with Credelio Quattro and 181 treated with an active control). Over the 330-day study period, all observations of potential adverse reactions were recorded. Adverse reactions seen during the field study are summarized in the table below. Dogs with Adverse Reactions in the Field Study * Four dogs administered Credelio Quattro and five dogs administered the active control had bloody diarrhea. Clinical Sign Credelio Quattro N=191 Number (Percentage) Active Control N=181 Number (Percentage) Diarrhea, with or without blood * 21 (11%) 15 (8.3%) Vomiting 18 (9.4%) 8 (4.4%) Lethargy 12 (6.3%) 1 (0.6%) Anorexia 11 (5.8%) 5 (2.8%) Dermatitis 10 (5.2%) 8 (4.4%) Weight Loss 6 (3.1%) 3 (1.7%) Pruritus (itching) 3 (1.6%) 1 (0.6%) Alopecia (hair loss) 2 (1.0%) 4 (2.2%) Seizure 1 (0.5%) 4 (2.2%) Ataxia 1 (0.5%) 1 (0.6%) Nystagmus 1 (0.5%) 0 (0.0%) Anisocoria 1 (0.5%) 1 (0.6%) One geriatric dog receiving Credelio Quattro experienced two episodes of vomiting, ataxia, and nystagmus, 11 days apart, with the first episode occurring two days after the eighth dose. The dog recovered within 24 hours after the first episode and 1 hour after the second episode and completed the study. One dog receiving Credelio Quattro was observed by the investigator to have anisocoria during scheduled physical examinations one month after the ninth dose and one month after the eleventh dose. In a second U.S. field safety and effectiveness study, Credelio Quattro was administered to 103 dogs with hookworms. Adverse reactions in dogs treated with Credelio Quattro included gastrointestinal signs (diarrhea, emesis) and lethargy. In a U.S. field study, 165 dogs received a combination of lotilaner, moxidectin, and praziquantel, three of the active ingredients at the same doses as in Credelio Quattro, monthly for up to 11 months. Two dogs with no history of seizures experienced seizures during the study. One of the dogs developed cluster seizures and was removed from the study. Ataxia was also observed in one other dog three days after the first dose. In a U.S. field study, one dog administered lotilaner alone, a component of Credelio Quattro, was observed with intermittent head tremors within 1.5 hours of administration of vaccines, an ear cleaning performed by the owner, and its first dose of lotilaner. The head tremors resolved within 24 hours without treatment. The owner elected to withdraw the dog from the study. In an Australian field study, one dog with a history of seizures experienced seizure activity (tremors and glazed eyes) six days after receiving lotilaner alone. The dog recovered without treatment and completed the study. In a U.S. field study, two dogs with a history of seizures received lotilaner alone and experienced no seizures throughout the study.

Description

Credelio Quattro/Credelio Quattro-CA1 (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) are flavored chewable tablets available in five sizes for oral administration to dogs and puppies according to their weight. Each chewable is formulated to provide minimum doses of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt). Lotilaner is a member of the isoxazoline class of parasiticides and the chemical name is 5-[(5S)-4,5-dihydro-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-3-isoxazolyl]-3-methyl-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]- 2-thiophenecarboxamide. Moxidectin is a semisynthetic macrocyclic lactone derived from the actinomycete Streptomycetes cyaneogriseus noncyanogenus . The chemical name for moxidectin is [6R,23E,25S(E)]-5-O- demethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)- 6,28-epoxy-23-(methoxyimino) milbemycin B. 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. Pyrantel is a member of the tetrahydropyrimidine family of compounds. Its chemical name is (E)- 1,4,5,6-tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine 4, 4’ methylenebis [3-hydroxy-2-naphthoate](1:1).

Storage

Store at 15-25°C (59-77°F). Excursions permitted between 5 and 40°C (41 and 104°F). 1 do Vale TL, Costa AR, Miranda LM, Silva GF, Silva NCS, Lima TB, Chaves DP, Sager H, Lasmar PVF, Costa-Junior LM. Efficacy of lotilaner against myiasis caused by Cochliomyia hominivorax (Diptera: Calliphoridae) in naturally infested dogs. Parasit Vectors. 2023;16(1):86. Approved by FDA under NADA # 141-581 Manufactured for: Elanco US Inc, Indianapolis, IN 46221 Credelio Quattro/Credelio Quattro-CA1, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2025 Elanco or its affiliates Revision: December 2025 Elanco TM Principal Display Panel 3.3 - 6 lbs Dogs & Puppies 8 weeks of age and older Credelio Quattro ™ Credelio Quattro ™ -CA1 (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) Fleas Ticks Heartworms Roundworms Hookworms Tapeworms New World Screwworm* *Credelio Quattro-CA1 is conditionally

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 lotilaner and moxidectin and praziquantel and pyrantel 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.