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Date: Monday, February 26, 2024 7:49

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.250
Credelio chewable tablets for dogs (GB)
Species: Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs
Active ingredient: Lotilaner
Product:Credelio chewable tablets for dogs
Product index: Credelio chewable tablets for dogs
Incorporating:Credelio 56 mg chewable tablets for dogs (1.3–2.5 kg)
Credelio 112 mg chewable tablets for dogs (>2.5–5.5 kg)
Credelio 225 mg chewable tablets for dogs (>5.5–11 kg)
Credelio 450 mg chewable tablets for dogs (>11–22 kg)
Credelio 900 mg chewable tablets for dogs (>22–45 kg)
Qualitative and quantitative composition
Active substance:
Credelio chewable tablets
lotilaner (mg)
for dogs (1.3-2.5 kg)
for dogs (>2.5-5.5 kg)
for dogs (>5.5-11 kg)
for dogs (>11-22 kg)
for dogs (>22-45 kg)
For a full list of excipients, see Pharmaceutical particulars section.
Pharmaceutical form
Chewable tablet.
White to beige round chewable tablets with brownish spots.
Clinical particulars
Target species
Indications for use, specifying the target species
For the treatment of flea and tick infestations in dogs.
This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
For the treatment of demodicosis (caused by Demodex canis)
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Parasites need to start feeding on the host to become exposed to lotilaner; therefore the risk of the transmission of parasite borne diseases cannot be completely excluded.aused by Demodex canis)
Special precautions for use
Special precautions for use in animals
All safety and efficacy data have been acquired from dogs and puppies 8 weeks of age and older and 1.3 kg of body weight and greater. Use of this veterinary medicinal product in puppies younger than 8 weeks of age or less than 1.3 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after handling the product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
iii) Other precautions
Not applicable
Adverse reactions (frequency and seriousness)
Target species: Dogs
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Diarrhoea1,2, Vomiting1,2
Anorexia1,2, Lethargy2
Ataxia3, Convulsion3, Tremor3
1 Mild and transient
2 Typically resolve without treatment
3 Transient in most cases
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for the respective contact details.
Use during pregnancy, lactation or lay
Laboratory studies in rats have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females. The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established. Use only according to the benefit-risk assessment of the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
None known. During clinical testing, no interactions between Credelio chewable tablets and routinely used veterinary medicinal products were observed.
Amounts to be administered and administration route
For oral use.
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 20 to 43 mg lotilaner/kg bodyweight.
Strength and number of tablets to be administered
Bodyweight of dog (kg)
Credelio 56 mg
Credelio 112 mg
Credelio 225 mg
Credelio 450 mg
Credelio 900 mg
Appropriate combination of tablets
Use an appropriate combination of available strengths to achieve the recommended dose of 20-43 mg/kg.
Credelio is a palatable chewable flavoured tablet. Administer the chewable tablet(s) monthly with or after food.
For the treatment of demodicosis (caused by Demodex canis)
Monthly administration of the product for two consecutive months is efficacious and leads to a marked improvement of clinical signs. Treatment should be continued until two negative skin scrapings are obtained one month apart. Severe cases may require prolonged monthly treatments. As demodicosis is a multi factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions were observed following oral administration to puppies aged 8–9 weeks and weighing 1.3–3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: ectoparasiticides for systemic use, isoxazolines.
ATCvet code: QP53BE04
Pharmacodynamic properties
Lotilaner, a pure enantiomer from the isoxazoline class is active against fleas (Ctenocephalides felis and Ctenocephalides canis) the tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus as well as Demodex canis mites.
Lotilaner is a potent inhibitor of gamma–aminobutyric acid (GABA)-gated chloride channels, resulting in rapid death of ticks and fleas. In in vitro studies, the activity of lotilaner against some arthropod species was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).
For fleas, the onset of efficacy is within 4 hours of attachment for one month after product administration. Fleas on the animal prior to administration are killed within 6 hours.
For ticks, the onset of efficacy is within 48 hours of attachment for one month after product administration. Existing I. ricinus ticks on the animal prior to administration are killed within 8 hours.
The veterinary medicinal product kills existing and newly emerged fleas on dogs before they can lay eggs. Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the dog has access.
Pharmacokinetic particulars
Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached within 4 hours. Lotilaner is approximately 10 times more bioavailable when administered with food. The terminal half-life is approximately 4 weeks (harmonic mean). This long terminal half-life provides effective blood concentrations for the entire duration of the inter- dosing interval.
The major route of elimination is biliary excretion and renal excretion is the minor route of elimination (less than 10% of the dose). Lotilaner is metabolized to a small extent into more hydrophilic compounds which are observed in faeces and urine.
Pharmaceutical particulars
List of excipients
Cellulose, powdered
Lactose monohydrate
Silicified microcrystalline cellulose
Meat dry flavour
Povidone K30
Sodium laurilsulfate
Silica, colloidal anhydrous
Magnesium stearate
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
The tablets are packaged in aluminium/aluminium blisters packaged into an outer cardboard box. Each tablet strength is available in pack sizes of 1, 3 or 6 tablets.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Marketing Authorisation Number
Credelio 56 mg chewable tablets for dogs (1.3–2.5 kg)
UK (Great Britain): Vm 52127/5009
Credelio 112 mg chewable tablets for dogs (>2.5–5.5 kg)
UK (Great Britain): Vm 52127/5004
Credelio 225 mg chewable tablets for dogs (>5.5–11 kg)
UK (Great Britain): Vm 52127/5006
Credelio 450 mg chewable tablets for dogs (>11–22 kg)
UK (Great Britain): Vm 52127/5007
Credelio 900 mg chewable tablets for dogs (>22–45 kg)
UK (Great Britain): Vm 52127/5010
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 25/04/2017
Date of revision of the text
September 2023
Any other information
Legal category
Legal category: POM-V
GTIN description:Credelio 56mg, 3 tab
GTIN description:Credelio 56mg, 6 tab
GTIN description:Credelio 112mg, 3 tab
GTIN description:Credelio 112mg, 6 tab
GTIN description:Credelio 225mg, 3 tab
GTIN description:Credelio 225mg, 6 tab
GTIN description:Credelio 450mg, 3 tab
GTIN description:Credelio 450mg, 6 tab