Today's Veterinary Practice

SEP-OCT 2018

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PEER REVIEWED 22 SEPTEMBER/OCTOBER 2018 Credelio ™ (lotilaner) Chewable Tablets For oral use in dogs Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Before using Credelio, please consult the product insert, a summary of which follows: Indications: CREDELIO kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick) and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. Dosage and Administration: CREDELIO is given orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg). See product insert for complete dosing and administration information. Contraindications: There are no known contraindications for the use of CREDELIO. Warnings: Not for human use. Keep this and all drugs out of the reach of children. Precautions: The safe use of CREDELIO in breeding, pregnant or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures (see Adverse Reactions). Adverse Reactions: In a well-controlled U.S. field study, which included 284 dogs (198 dogs treated with CREDELIO and 86 dogs treated with an oral active control), there were no serious adverse reactions. Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence of 1% or greater are presented in the following table. Dogs with Adverse Reactions in the Field Study Adverse CREDELIO Group: Active Control Group: Reaction (AR) Number (and Percent) Number (and Percent) of Dogs with the AR of Dogs with the AR (n=198) (n=86) Weight Loss 3 (1.5%) 2 (2.3%) Elevated Blood Urea Nitrogen (BUN) 2 (1.0%)* 0 (0.0%) Polyuria 2 (1.0%)* 0 (0.0%) Diarrhea 2 (1.0%) 2 (2.3%) *Two geriatric dogs developed mildly elevated BUN (34 to 54 mg/dL; reference range: 6 to 31 mg/dL) during the study. One of these dogs also developed polyuria and a mildly elevated potassium (6.5 mEq/L; reference range: 3.6 to 5.5 mEq/L) and phosphorous (6.4 mg/dL; reference range: 2.5 to 6.0 mg/dL). The other dog also developed a mildly elevated creatinine (1.7 to 2.0 mg/dL; reference range: 0.5 to 1.6 mg/dL) and weight loss. In addition, one dog experienced intermittent head tremors within 1.5 hours of administration of vaccines, an ear cleaning performed by the owner, and its first dose of CREDELIO. The head tremors resolved within 24 hours without treatment. The owner elected to withdraw the dog from the study. In an Australian field study, one dog with a history of seizures experienced seizure activity (tremors and glazed eyes) six days after receiving CREDELIO. The dog recovered without treatment and completed the study. In the U.S. field study, two dogs with a history of seizures received CREDELIO and experienced no seizures throughout the study. In three well-controlled European field studies and one U.S. laboratory study, seven dogs experienced episodes of vomiting and four dogs experienced episodes of diarrhea between 6 hours and 3 days after receiving CREDELIO. To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco US, Inc. at 1-888-545-5973. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or Effectiveness: In well-controlled European laboratory studies, CREDELIO began to kill fleas four hours after administration or infestation, with greater than 99% of fleas killed within eight hours after administration or infestation for 35 days. In a well-controlled U.S. laboratory study, CREDELIO demonstrated 100% effectiveness against adult fleas 12 hours after administration or infestation for 35 days. In a 90-day well-controlled U.S. field study conducted in households with existing flea infestations of varying severity, the effectiveness of CREDELIO against fleas on Days 30, 60 and 90 compared to baseline was 99.5%,100% and 100%, respectively. Dogs with signs of flea allergy dermatitis showed improvement in erythema, papules, scaling, alopecia, dermatitis/ pyodermatitis and pruritus as a direct result of eliminating fleas. In well-controlled laboratory studies, CREDELIO demonstrated > 97% effectiveness against Amblyomma americanum, Dermacentor variabilis, Ixodes scapularis and Rhipicephalus sanguineus ticks 48 hours after administration or infestation for 30 days. In a well-controlled European laboratory study, CREDELIO started killing Ixodes ricinus ticks within four hours after administration. Storage Information: Store at 15-25°C (59 -77°F), excursions permitted between 5 to 40°C (41 to 104°F). How Supplied: CREDELIO is available in five chewable tablet sizes for use in dogs: 56.25, 112.5, 225, 450, and 900 mg lotilaner. Each chewable tablet size is available in color-coded packages of 1 or 6 chewable tablets. NADA #141-494, Approved by the FDA Manufactured for: Elanco US Inc Greenfield, IN 46140 USA Credelio, Elanco and the diagonal bar logo are trademarks of Eli Lilly and Company or its affiliates. PA209456X_BrS1 P2a have been demonstrated by increasing the threshold for epinephrine- induced arrhythmias in dogs. 23 Use of acepromazine in combination with other sedatives/anesthetics to facilitate echocardiography in healthy cats has been evaluated; effects were limited to mild decreases in blood pressure (when administered with an opioid) or increases in heart rate (when administered with an opioid and ketamine). 24 Acepromazine use in cats with suspected or confirmed heart disease should be avoided if safer alternatives are available. Alpha-2 Agonists Dexmedetomidine is a highly selective alpha-2 adrenoceptor agonist that produces excellent centrally mediated sedation and dose- dependent analgesia. However, it also causes profound cardiovascular depression. 25 Alpha-2 adrenoceptor agonists produce a biphasic cardiovascular response. Initially, alpha-1 and alpha-2 adrenoceptor- mediated vasoconstriction causes increased systemic vascular resistance and blood pressure, resulting in a baroreceptor reflex mediated decrease in heart rate. Subsequently, the bradycardia persists and blood pressure decreases because of reduced sympathetic outflow and circulating catecholamines and an impaired stress response (reduced cortisol secretion). 26 Use of this class of drugs should generally be avoided in animals with cardiovascular disease; however, in one study, when administered intramuscularly, medetomidine had the desirable effects of reducing heart rate and eliminating left ventricular outflow tract obstruction in cats with hypertrophic obstructive cardiomyopathy. 27 Gabapentin Gabapentin is an antiepileptic drug that consists of a GABA molecule covalently bound to a lipophilic cyclohexane ring. It produces antihyperalgesic effects on neuropathic pain in people and certain neuropathic pain conditions in dogs and cats. The exact mechanism of action for the analgesic and mild sedative effects are unknown, but gabapentin does bind the α2δ-1 subunit of N-type voltage-gated calcium channels, which are densely populated in the dorsal horn of the spinal cord and interfere with sodium entry through presynaptic N-methyl-D-aspartate (NMDA) receptor channels. A supraspinal effect also may contribute to the analgesic and sedative effects. Ketamine is an NMDA receptor antagonist. It is thought to produce anesthesia by overstimulating selective sites in the central nervous system (CNS) and inducing a cataleptic state.

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