Credelio for Dogs 4.4 – 6.0 lbs (1.3-2.5 kg)

Description

Credelio for Dogs 4.4 – 6.0 lbs (1.3-2.5 kg) is a beef-flavored chewable tablet manufactured by Elanco that delivers monthly flea and tick control through systemic isoxazoline activity. Each tablet contains 56.25 mg of lotilaner, formulated to meet the minimum labeled dosage of 9 mg/lb (20 mg/kg) across this weight band.

Recommended for

Dogs weighing 4.4 to 6.0 lbs (1.3 to 2.5 kg), 8 weeks of age and older.

Indication/Coverage

For dogs suffering from, or at risk from, flea and tick infestations, Credelio 4.4–6.0 lbs addresses the following parasitic conditions:

• Treatment of flea infestation: Kills adult Ctenocephalides felis (cat flea) on the dog’s body, reducing flea burden on the animal and within the household environment.
• Prevention of flea infestation: Eliminates fleas before they can deposit eggs, interrupting the reproductive cycle for 30 days following the start of treatment.
• Treatment and control of lone star tick: Targets Amblyomma americanum with greater than 97% effectiveness at 48 hours post-administration or infestation.
• Treatment and control of American dog tick: Targets Dermacentor variabilis, demonstrated at greater than 97% effectiveness in controlled laboratory studies.
• Treatment and control of black-legged tick: Targets Ixodes scapularis, the primary vector of Lyme disease in the U.S., with onset of activity 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.
• Treatment and control of longhorned tick: Targets Haemaphysalis longicornis, an invasive tick species of increasing geographic range in the U.S.
• Prevention of Lyme disease transmission: Credelio is indicated for the prevention of Borrelia burgdorferi infections as a direct consequence of killing Ixodes scapularis vector ticks before transmission can occur.

Key Benefits

• Eligible from 8 weeks: Dogs in this weight range qualify from 8 weeks of age, making Credelio one of the earliest-start flea and tick treatments available for small-breed puppies.
• Dual parasite class: A single monthly dose addresses both flea infestations and five tick species simultaneously, covering the major ectoparasite threats present across the contiguous U.S.
• Systemic isoxazoline action: Lotilaner inhibits GABA-gated chloride channels in insects and acarines, producing uncontrolled neuromuscular activity that kills fleas and ticks upon feeding rather than requiring direct contact with the treated coat surface.
• Flea kill within 4 hours: In European laboratory studies, Credelio began eliminating fleas within four hours of administration or infestation. Greater than 99% of fleas were killed within eight hours.
• Full-month protection per dose: A single 56.25 mg tablet maintains efficacy against fleas and listed tick species for 30 days, with no requirement for supplemental treatment during the dosing interval.
• Egg-laying prevention: Credelio eliminated fleas before oviposition in controlled laboratory conditions, preventing the establishment of a new flea generation in the household environment for 30 days following treatment initiation.
• Oral chewable format: For small dogs that resist topical applications, the beef-flavored tablet can be offered by hand, in a bowl, or concealed in food. In the U.S. field study, 80.4% of dogs accepted the tablet voluntarily when offered by hand or in an empty bowl.
• Lyme disease prevention: By killing Ixodes scapularis ticks, Credelio reduces the risk of Borrelia burgdorferi transmission in endemic regions, a benefit supported by two separate controlled laboratory studies.

Caution

Hazards to Humans

Credelio is for animal use only and should be kept out of reach of children. Do not allow children to handle tablets unsupervised. Wash hands thoroughly after administering the dose. Store all tablets away from food, food-preparation areas, and kitchen surfaces.

Hazards to Domestic Animals

Credelio is approved for oral use in dogs and puppies 8 weeks of age and older, weighing at least 4.4 lbs. Do not administer to dogs below this weight threshold. Consult a veterinarian before use in dogs that are debilitated, aged, pregnant, or nursing, as the safety of Credelio in breeding, pregnant, or lactating dogs has not been formally evaluated. As with all medications, individual sensitivity reactions are possible. No drug interactions were observed in field studies where Credelio was used alongside vaccines, anthelmintics, antibiotics, steroids, NSAIDs, anesthetics, and antihistamines. Seek veterinary guidance if concurrent medications fall outside these categories.

Possible Side Effects

Monitor your dog after each monthly administration of Credelio, particularly following the first dose. Lotilaner belongs to the isoxazoline class, which has been associated with neurologic adverse reactions in dogs.

Adverse events reported in clinical studies and post-approval surveillance, listed in decreasing frequency of reporting, include the following:

• Gastrointestinal reactions: Vomiting, diarrhea (with and without blood), and anorexia were reported post-approval. In a controlled U.S. field study at the labeled dose, diarrhea occurred in 1.0% of treated dogs.
• Neurologic reactions: Seizures, muscle tremor, and ataxia appear in post-approval adverse event reports. Seizures have been documented in dogs receiving isoxazoline-class drugs, including dogs with no prior seizure history. One dog in an Australian field study with a pre-existing seizure history 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 90-day study period. Associated findings included elevated creatinine, potassium, and phosphorous in one case, and polyuria in the other.
• Urinary signs: Polyuria, polydipsia, urinary incontinence, and inappropriate urination have been reported post-approval.
• Systemic signs: Lethargy and pruritus appear in post-approval adverse event 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 should be assessed by a veterinarian before initiating Credelio or any isoxazoline-class treatment. If adverse signs occur following administration, contact your veterinarian.