Credelio for Dogs 12.1-25 lbs (5.5-11 kg)

Description

Credelio for Dogs 12.1-25 lbs (5.5-11 kg) is a beef-flavored chewable tablet manufactured by Elanco that delivers monthly systemic ectoparasite control through isoxazoline-class inhibition of insect and acarine neuromuscular function. Each tablet in this variant contains 225 mg of lotilaner, calibrated to meet the minimum labeled dosage of 9 mg/lb (20 mg/kg) across the full weight band.

Recommended for

Dogs weighing 12.1 to 25.0 lbs (5.5 to 11 kg), 8 weeks of age and older.

Indication/Coverage

For dogs suffering from, or at risk from, flea and tick infestations, Credelio 12.1–25.0 lbs addresses the following parasitic conditions:

• Treatment of flea infestation: Kills adult Ctenocephalides felis (cat flea) on the dog’s body following systemic absorption, reducing the active flea burden on the animal.
• Prevention of flea infestation: Eliminates fleas before egg deposition, disrupting the reproductive cycle and preventing re-establishment of household infestation for 30 days from the start of treatment.
• Treatment and control of lone star tick: Targets Amblyomma americanum at greater than 97% effectiveness, measured at 48 hours post-administration or infestation across the 30-day dosing period.
• Treatment and control of American dog tick: Targets Dermacentor variabilis at greater than 97% effectiveness at 48 hours in controlled laboratory studies conducted in the U.S. and Europe.
• Treatment and control of black-legged tick: Targets Ixodes scapularis, the primary vector of Borrelia burgdorferi in the U.S., with killing activity initiating within four hours based on European laboratory data for 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 full monthly interval.
• Treatment and control of longhorned tick: Targets Haemaphysalis longicornis, an invasive tick species with an established and expanding presence across the eastern 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 pathogen transmission occurs, supported by two controlled laboratory studies.

Key Benefits

• Cleared from 8 weeks: Dogs within this weight range qualify for Credelio from 8 weeks of age, making it applicable to medium-breed puppies during the early-life period when ectoparasite exposure first becomes clinically relevant.
• Simultaneous flea and tick control: One monthly tablet addresses flea infestations and five tick species within a single dosing interval, covering the principal ectoparasite species present across the U.S.
• GABA-channel inhibition: Lotilaner blocks GABA-gated chloride channels in insects and acarines, triggering uncontrolled neuromuscular activity that kills parasites upon feeding without requiring prior contact with the treated skin surface.
• Rapid flea elimination: In European laboratory studies, flea kill commenced within four hours of administration, with greater than 99% of fleas dead within eight hours. U.S. laboratory data confirmed 100% adult flea effectiveness at 12 hours.
• Full-month duration: A single 225 mg tablet sustains efficacy against fleas and all five labeled tick species for 30 days, with field study data from a 90-day U.S. trial recording 99.5%, 100%, and 100% flea effectiveness at days 30, 60, and 90 respectively.
• Pre-oviposition flea kill: Credelio eliminated fleas before egg laying in controlled laboratory conditions, preventing emergence of a new flea generation and reducing household environmental contamination for 30 days after treatment initiation.
• Oral format efficacy: For dogs that resist spot-on applications, 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, with a further 13.6% consuming it when offered with food.
• Vector-borne disease prevention: By eliminating Ixodes scapularis ticks before attachment can facilitate transmission, Credelio reduces the risk of Borrelia burgdorferi infection in dogs living in or traveling through Lyme-endemic regions.

Caution

Hazards to Humans

Credelio is for animal use only and must not be ingested by humans. Keep out of reach of children and prevent unsupervised handling. Wash hands thoroughly after each administration. Store all tablets away from food, beverages, and kitchen preparation areas 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 12.1 lbs for this variant. Do not administer to dogs falling below this threshold. Prior veterinary assessment is advisable for debilitated, aged, pregnant, or nursing animals, as the safety of lotilaner in breeding, pregnant, or lactating dogs has not been formally evaluated. Individual sensitivity reactions are possible in any dog regardless of prior treatment history. 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 for any concurrent medication outside this group.

Possible Side Effects:

Monitor your dog after each monthly administration of Credelio, with particular attention in the 24 hours following the first dose. Lotilaner belongs to the isoxazoline class, which carries an FDA-recognized precaution for neurologic adverse reactions in dogs.

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

• Gastrointestinal reactions: Vomiting, diarrhea (with and without blood), and anorexia appear 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 observation period.
• Neurologic reactions: Seizures, muscle tremor, and ataxia are documented in post-approval data. The isoxazoline class precaution applies to all dogs, including animals with no prior seizure history. One dog with a documented seizure disorder in an Australian field study experienced tremors and glazed eyes six days after administration; the dog 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 period. Associated findings included elevated creatinine, potassium, and phosphorous in one animal, and polyuria in the other.
• Urinary signs: Polyuria, polydipsia, urinary incontinence, and inappropriate urination have been reported in post-approval adverse event data.
• Systemic signs: Lethargy and pruritus appear in post-approval surveillance reports.
• Weight changes: Weight loss was recorded in 1.5% of Credelio-treated dogs in the U.S. field study, against 2.3% in the active control group.

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