Credelio for Dogs 50.1-100 lbs (22-45 kg)

Description

Credelio for Dogs 50.1-100 lbs (22-45 kg) is a beef-flavored chewable tablet manufactured by Elanco that delivers monthly systemic flea and tick control through isoxazoline-class inhibition of parasite neuromuscular activity. Each tablet in this variant contains 900 mg of lotilaner, meeting the minimum labeled dosage of 9 mg/lb (20 mg/kg) across the full weight band.

Recommended for

Dogs weighing 50.1 to 100.0 lbs (22 to 45 kg), 8 weeks of age and older.

Indication/Coverage

For dogs suffering from, or at risk from, flea and tick infestations, Credelio 50.1–100.0 lbs addresses the following parasitic conditions:

• Treatment of flea infestation: Kills adult Ctenocephalides felis (cat flea) present on the dog following systemic absorption, reducing the active flea burden on the animal within hours of ingestion.
• Prevention of flea infestation: Eliminates fleas before oviposition occurs, disrupting the reproductive cycle and preventing household flea re-establishment for 30 days from the start of treatment.
• Treatment and control of lone star tick: Targets Amblyomma americanum at greater than 97% effectiveness recorded at 48 hours post-administration or infestation, sustained across the full 30-day dosing interval.
• Treatment and control of American dog tick: Targets Dermacentor variabilis at greater than 97% effectiveness at 48 hours in controlled U.S. and European laboratory studies.
• Treatment and control of black-legged tick: Targets Ixodes scapularis, the principal Borrelia burgdorferi vector in the U.S., with onset of kill activity demonstrated within four hours in European laboratory studies using the related species Ixodes ricinus.
• Treatment and control of brown dog tick: Targets Rhipicephalus sanguineus at greater than 97% effectiveness at 48 hours post-administration or infestation for the complete monthly interval.
• Treatment and control of longhorned tick: Targets Haemaphysalis longicornis, an invasive tick species with a documented and expanding distribution across the eastern and southeastern U.S.
• Prevention of Lyme disease: Indicated for the prevention of Borrelia burgdorferi infections as a direct result of eliminating Ixodes scapularis vector ticks before transmission can occur, a claim supported by two separate controlled laboratory studies.

Key Benefits

• Approved from 8 weeks: Large and giant-breed dogs in this weight range are eligible for Credelio from 8 weeks of age, covering the early growth period when ectoparasite exposure begins.
• Comprehensive ectoparasite coverage: One monthly tablet addresses flea infestations and five tick species concurrently, covering the primary ectoparasite threats present across all major U.S. geographic regions.
• Systemic kill mechanism: Lotilaner inhibits GABA-gated chloride channels in insects and acarines, producing uncontrolled neuromuscular activity that kills parasites upon feeding without requiring surface contact with the treated coat.
• Rapid flea elimination: European laboratory data recorded flea kill commencing within four hours of administration, with greater than 99% of fleas eliminated within eight hours. U.S. laboratory studies confirmed 100% adult flea effectiveness at 12 hours.
• Sustained monthly protection: A single 900 mg tablet maintains efficacy against fleas and all five listed tick species for 30 days. In a 90-day U.S. field study, flea effectiveness against existing household infestations was 99.5%, 100%, and 100% at days 30, 60, and 90 respectively.
• Egg-laying prevention: In controlled laboratory conditions, Credelio eliminated fleas before egg deposition, blocking the emergence of a subsequent flea generation and reducing environmental contamination for 30 days following treatment initiation.
• High voluntary acceptance: For large dogs that are difficult to apply spot-on treatments to, the beef-flavored tablet is voluntarily consumed by the majority of animals. In the U.S. field study, 80.4% of dogs accepted the tablet by hand or from an empty bowl, and a further 13.6% consumed it when offered with food.
• Lyme disease prevention: By eliminating Ixodes scapularis ticks before attachment facilitates pathogen transfer, Credelio reduces Borrelia burgdorferi transmission risk in dogs living in or traveling through Lyme-endemic areas.

Caution

Hazards to Humans

Credelio is for animal use only and must not be ingested by humans. Keep tablets out of reach of children and prevent unsupervised handling. Wash hands thoroughly after administering each dose. Store all tablets away from food, beverages, and food-preparation surfaces throughout the treatment course.

Hazards to Domestic Animals

Credelio is approved for oral use in dogs and puppies 8 weeks of age and older, with a minimum body weight of 50.1 lbs for this tablet size. Do not administer to dogs below this threshold. Veterinary consultation is advisable before use in debilitated, aged, pregnant, or nursing animals, as Elanco has not formally evaluated lotilaner safety in breeding, pregnant, or lactating dogs. Individual sensitivity reactions, while uncommon, may occur in any dog. In the U.S. field study, no adverse interactions were observed when Credelio was co-administered with vaccines, anthelmintics, antibiotics, steroids, NSAIDs, anesthetics, or antihistamines; seek veterinary guidance before combining Credelio with any medication outside that group.

Possible Side Effects:

Monitor your dog after each monthly administration of Credelio, with particular vigilance in the 24 hours following the first dose. Lotilaner is an isoxazoline-class drug, and the FDA has issued a class-level precaution for neurologic adverse reactions associated with this group.

The adverse events below derive from controlled field studies and post-approval surveillance reporting, listed in decreasing order of frequency:

• Gastrointestinal reactions: Vomiting, diarrhea (with and without blood), and anorexia appear in post-approval adverse drug experience data. In the controlled U.S. field study, diarrhea was recorded in 1.0% of Credelio-treated dogs across the 90-day observation period.
• Neurologic reactions: Seizures, muscle tremor, and ataxia are documented in post-approval reports. The isoxazoline precaution applies to all dogs, including those without a prior seizure history. One dog with a pre-existing seizure disorder in an Australian field study developed tremors and glazed eyes six days after administration and recovered without treatment.
• Renal and metabolic signs: Two geriatric dogs in the U.S. field study developed mildly elevated blood urea nitrogen during the study. One animal showed concurrent elevations in creatinine, potassium, and phosphorous; the other developed polyuria.
• Urinary signs: Polyuria, polydipsia, urinary incontinence, and inappropriate urination have been reported in post-approval adverse event submissions.
• Systemic signs: Lethargy and pruritus are noted in post-approval surveillance data.
• Weight changes: Weight loss occurred in 1.5% of Credelio-treated dogs in the U.S. field study, compared with 2.3% in the active control group.

Dogs with a history of seizures or neurological disorders require veterinary assessment before Credelio or any isoxazoline-class treatment is started. If adverse signs develop following administration, contact your veterinarian.