Credelio® for Dogs

Credelio kills adult fleas and is indicated for the treatment and prevention of flea infestations and treatment and control of tick infestations (lone star tick, American dog tick, black-legged tick, brown dog tick, and longhorned tick) for one month in dogs and puppies 8 weeks and older and 4.4 pounds or greater. Credelio is indicated for the prevention of Lyme disease infections as a direct result of killing black-legged ticks.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the approved product Credelio (lotilaner) for the treatment of infestations caused by NWS (Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies. However, Credelio is not approved for this use.

Credelio is approved for other uses.

For additional information on the EUA, please refer to the Credelio NWS Fact Sheet.

Credelio (lotilaner) is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Credelio (lotilaner) under section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Lotilaner is a member of the isoxazoline class of drugs. This class has been associated with neurologic adverse reactions including tremors, incoordination, and seizures. Seizures have been reported in dogs receiving this class of 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. The most frequently reported adverse reactions are weight loss, elevated blood urea nitrogen, increased urination, and diarrhea. For complete safety information, please see Credelio product label or ask your veterinarian.

*Karadzovska D, Chappell K, Coble S, et al. A randomized, controlled field study to assess the efficacy and safety of lotilaner flavored chewable tablets (Credelio) in eliminating fleas in client-owned dogs in the USA. Parasite Vector. 2017;10(1):528.

Dogs

Lotilaner

Isoxazoline ectoparasiticide

Credelio chewable tablets for dogs are beef flavored.*

Body Weight	Lotilaner (per chewable tablet)
4.4 to 6 lbs	56.25 mg
6.1 to 12 lbs	112.5 mg
12.1 to 25 lbs	225 mg
25.1 to 50 lbs	450 mg
50.1 to 100 lbs	900 mg
Greater than 100 lbs	Administer the appropriate combination of tablets to cover the dog’s full body weight.

Please ensure the selected product and quantity are appropriate for your pet, as recommended by your veterinarian. For current availability, please refer to the product selection above.

Credelio for Dogs should be administered as directed by your veterinarian. Please consult your veterinarian before making any changes or discontinuing the prescribed dosing schedule.

Do not administer more medication than prescribed. If you have questions about your pet’s prescribed dosing schedule (e.g., timing, interval), contact your veterinarian.

Credelio is given orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg).

Credelio must be administered with food.

Treatment with Credelio can begin at any time of the year and can continue year-round without interruption.

Store in a cool, dry place at a controlled room temperature (59-77°F). Excursions permitted between 41 to 104°F. Keep this and all other medications in a secure location out of the reach of children and animals. Tablets should remain sealed in their original packaging and should only be taken out at the time of dosing.

Exposure to extreme temperatures, light, or moisture can affect the integrity and effectiveness of medications. Always store this medication properly (e.g., away from the bathroom, kitchen sink, or other damp places), as outlined on the product label.

The most frequently reported adverse reactions are weight loss, elevated blood urea nitrogen, increased urination, and diarrhea.

Contact your veterinarian immediately if your pet experiences persistent vomiting, complete loss of appetite, or if you notice your pet has a seizure, tremors, extreme weakness, or decreased coordination (e.g., stumbling, difficulty walking).

The information provided above may not encompass all possible side effects. Please notify your veterinarian if your pet experiences any side effects, including those listed above, or if you notice anything unusual.

For oral use in dogs only.

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.

Use with caution in dogs with a history of seizures or neurologic disorders.

Do not administer this medication to animals with a known or suspected allergy/hypersensitivity to it or any of its ingredients. Allergic reactions to medications may occur. Please inform Vetsource and your veterinarian if your pet has any known sensitivities or allergies, especially to medications and supplements.

If your pet displays symptoms of an allergic reaction, discontinue therapy and call your veterinarian immediately or seek emergency veterinary attention. Symptoms may include (but are not limited to): swollen lips, tongue, face, or airways; difficulty breathing; agitation; profuse salivation; and widespread hives or itching.

While there are no documented drug or food interactions with this medication when given at the recommended dosage, potential interactions may still be possible. As with all medications, please consult your veterinarian if you have any questions or concerns prior to use. Contact your veterinarian if your pet experiences any unusual reactions when multiple medications and/or supplements are given together.

Please ensure your veterinarian is aware of all medications, supplements, and over-the-counter (OTC) products that your pet is currently using. Your veterinarian may prescribe multiple medications, even if a potential drug interaction may occur. In these instances, your veterinarian may adjust the dosages or monitor your pet more closely.

If you are concerned that your pet has experienced an adverse reaction to this medication, please contact Elanco at 1-888-545-5973 or Vetsource Pet Owner Care at 877-738-4443.

If you have any reason to suspect accidental ingestion or overdose, call your doctor/veterinarian or the appropriate poison control resource immediately.

The national toll-free Poison Help line, 1-800-222-1222, will connect you to your local poison center in case of emergency. This service is available nationwide and in most U.S. territories.

The ASPCA Animal Poison Control Center is available 24 hours a day, 365 days a year at 888-426-4435.

Pet Poison Helpline also provides a 24/7 animal poison control service at 855-764-7661.

All content, including the images and product description above, is intended for general informational purposes only and should not be considered a substitute for professional veterinary consultation, diagnosis, or treatment.

For additional information about this product and how it fits into your pet's individual treatment plan, please consult your veterinarian.