Credelio for Dogs 25.1-50 lbs (11-22 kg)

Description

Credelio for Dogs 25.1-50 lbs (11-22 kg) is a beef-flavored chewable tablet manufactured by Elanco that provides monthly systemic flea and tick control through isoxazoline-class inhibition of parasite neuromuscular function. Each tablet in this variant contains 450 mg of lotilaner, formulated to deliver the minimum labeled dosage of 9 mg/lb (20 mg/kg) across the full weight band.

Recommended for

Dogs weighing 25.1 to 50.0 lbs (11 to 22 kg), 8 weeks of age and older.

Indication/Coverage

For dogs suffering from, or at risk from, flea and tick infestations, Credelio 25.1–50.0 lbs covers the following indications:

• Treatment of flea infestation: Kills adult Ctenocephalides felis (cat flea) present on the dog following systemic absorption of lotilaner, reducing the active flea burden on the animal.
• Prevention of flea infestation: Eliminates fleas prior to egg deposition, breaking the reproductive cycle and preventing the establishment of a new flea generation in the household environment for 30 days from treatment initiation.
• Treatment and control of lone star tick: Targets Amblyomma americanum at greater than 97% effectiveness, recorded at 48 hours post-administration or infestation for the full 30-day dosing period.
• 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 primary Borrelia burgdorferi vector in the U.S., with onset of kill activity documented 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, sustained across the 30-day interval.
• Treatment and control of longhorned tick: Targets Haemaphysalis longicornis, an invasive tick species with an expanding geographic footprint across the eastern and southeastern U.S.
• Prevention of Lyme disease: Indicated for the prevention of Borrelia burgdorferi infections as a direct consequence of eliminating Ixodes scapularis ticks before pathogen transmission can occur, confirmed in two separate controlled laboratory studies.

Key Benefits

• Eligible from 8 weeks: Dogs in this weight range qualify for Credelio from 8 weeks of age, permitting early ectoparasite protection for large-breed puppies entering the weight band during the juvenile growth period.
• Five-species tick coverage: A single monthly dose addresses flea infestations and five distinct tick species, covering the principal ectoparasite threats encountered across the contiguous U.S. in a single oral administration.
• Systemic GABA inhibition: Lotilaner blocks GABA-gated chloride channels in insects and acarines, inducing uncontrolled neuromuscular activity that kills parasites upon feeding without requiring direct contact with the treated coat.
• Flea activity from 4 hours: European laboratory studies recorded flea kill commencing within four hours of administration, with greater than 99% eliminated within eight hours. U.S. laboratory data confirmed 100% effectiveness against adult fleas at 12 hours.
• Sustained 30-day efficacy: A single 450 mg tablet maintains protection against fleas and all five listed tick species for the full monthly dosing interval. In a 90-day U.S. field study, flea effectiveness against existing household infestations reached 99.5%, 100%, and 100% at days 30, 60, and 90 respectively.
• Oviposition interruption: Credelio eliminated fleas before egg laying in controlled laboratory conditions, preventing emergence of a subsequent flea generation and reducing environmental contamination for 30 days following the start of treatment.
• Chewable format acceptance: For dogs that resist topical application, 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 when offered by hand or in an empty bowl; a further 13.6% consumed it when given with food.
• Lyme disease risk reduction: By eliminating Ixodes scapularis ticks before transmission can occur, Credelio reduces Borrelia burgdorferi infection risk in dogs residing in or traveling through Lyme-endemic regions of the U.S.

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 at all times. Wash hands thoroughly after each administration. Store away from food, beverages, and all food-preparation surfaces throughout the treatment period.

Hazards to Domestic Animals

Credelio is approved for oral administration in dogs and puppies 8 weeks of age and older, with a minimum body weight of 25.1 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 safety in breeding, pregnant, or lactating dogs has not been formally evaluated by Elanco. Individual sensitivity reactions are possible in any dog irrespective of prior treatment history. In the U.S. field study, no adverse interactions were identified when Credelio was co-administered with vaccines, anthelmintics, antibiotics, steroids, NSAIDs, anesthetics, or antihistamines; seek veterinary guidance for any concurrent medication not included in that group.

Possible Side Effects:

Monitor your dog after each monthly administration of Credelio, with heightened attention in the first 24 hours following the initial dose. Lotilaner is a member of the isoxazoline class, which carries an FDA-recognized precaution for neurologic adverse reactions across all drugs in this group.

The following adverse events have been identified through controlled field studies and post-approval surveillance, presented in decreasing order of reporting frequency:

• Gastrointestinal reactions: Vomiting, diarrhea (with and without blood), and anorexia are documented in post-approval adverse drug experience reports. In the controlled U.S. field study, diarrhea was recorded in 1.0% of Credelio-treated dogs over the 90-day study period.
• Neurologic reactions: Seizures, muscle tremor, and ataxia appear in post-approval data. The isoxazoline class precaution applies to all dogs, including those with no prior neurologic history. One dog with a documented seizure disorder in an Australian field study experienced 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 observation period. One animal showed concurrent elevations in creatinine, potassium, and phosphorous; the other developed polyuria alongside the BUN finding.
• 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 to 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 medication is initiated. If adverse signs develop after administration, contact your veterinarian.