Lotilaner

Indications

CREDELIO 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 4.4 pounds or greater. CREDELIO is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

Dosage and Administration

CREDELIO is given orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg). Dosage Schedule: Body Weight Lotilaner Per Chewable Tablet (mg) Chewable Tablets Administered 4.4 to 6.0 lbs 56.25 One 6.1 to 12.0 lbs 112.5 One 12.1 to 25.0 lbs 225 One 25.1 to 50.0 lbs 450 One 50.1 to 100.0 lbs 900 One Over 100.0 lbs Administer the appropriate combination of chewable tablets CREDELIO must be administered with food (see

Contraindications

There are no known contraindications for the use of CREDELIO.

Warnings

Not for human use. Keep this and all drugs out of the reach of children. Keep CREDELIO in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions

Lotilaner is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. The safe use of CREDELIO in breeding, pregnant or lactating dogs has not been evaluated.

Adverse Reactions

In a well-controlled U.S. field study, which included 284 dogs (198 dogs treated with CREDELIO and 86 dogs treated with an oral active control), there were no serious adverse reactions. Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence of 1% or greater are presented in the following table. Dogs with Adverse Reactions in the Field Study *Two geriatric dogs developed mildly elevated BUN (34 to 54 mg/dL; reference range: 6 to 31 mg/dL) during the study. One of these dogs also developed polyuria and a mildly elevated potassium (6.5 mEq/L; reference range: 3.6 to 5.5 mEq/L) and phosphorous (6.4 mg/dL; reference range: 2.5 to 6.0 mg/dL). The other dog also developed a mildly elevated creatinine (1.7 to 2.0 mg/dL; reference range: 0.5 to 1.6 mg/dL) and weight loss. Adverse Reaction (AR) CREDELIO Group: Number (and Percent) of Dogs with the AR (n=198) Active Control Group: Number (and Percent) of Dogs with the AR (n=86) Weight Loss 3 (1.5%) 2 (2.3%) Elevated Blood Urea Nitrogen (BUN) 2 (1.0%)* 0 (0.0%) Polyuria 2 (1.0%)* 0 (0.0%) Diarrhea 2 (1.0%) 2 (2.3%) In addition, one dog experienced intermittent head tremors within 1.5 hours of administration of vaccines, an ear cleaning performed by the owner, and its first dose of CREDELIO. 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 CREDELIO. The dog recovered without treatment and completed the study. In the U.S. field study, two dogs with a history of seizures received CREDELIO and experienced no seizures throughout the study. In three well-controlled European field studies and one U.S. laboratory study, seven dogs experienced episodes of vomiting and four dogs experienced episodes of diarrhea between 6 hours and 3 days after receiving CREDELIO. Post-Approval Experience (2023): The following adverse events are based on post-approval adverse drug experience reporting for CREDELIO. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events reported in dogs are listed in decreasing order of reporting frequency: Vomiting, diarrhea (with and without blood), lethargy, anorexia, seizure, pruritus, ataxia, urinary-related signs (polyuria, polydipsia, urinary incontinence, and inappropriate urination), and muscle tremor.

Description

CREDELIO (lotilaner) is a beef-flavored, chewable tablet for oral administration to dogs and puppies according to their weight. Each chewable tablet is formulated to provide a minimum lotilaner dosage of 9 mg/lb (20 mg/kg). Lotilaner has the chemical composition of 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.

Storage

Store at 15-25°C (59 -77°F), excursions permitted between 5 to 40°C (41 to 104°F).

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• Credelio™ CAT (lotilaner), Elanco US Inc.. Set id 365b701f-e9a8-458f-90ff-33ca1fb947ca.

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 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.