Imoxat 40 mg + 10 mg Spot-on Solution for Small Dogs
Imidacloprid, Moxidectin
Last verified
Veterinary medicinal product: spot-on solution. Distribution category: POM-V (Veterinary Medicines Regulations 2013, Schedule 3). Active substance: Imidacloprid, Moxidectin.1
- Dispensing
- Prescription only1
POM-V: Prescription Only Medicine - Veterinarian. Supplied only on a prescription written by a veterinary surgeon who has assessed the animal.12
Supplied only on a veterinarian's prescription. As stated in the registration decision.
- Animal species
- Dogs1
- Active substance
- Imidacloprid, Moxidectin
- ATCvet code
- QP54AB523
- Manufacturer
- Marketing authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd
Withdrawal period
No withdrawal period is set for this drug: it is not intended for food-producing animals.3
Summary of product characteristics
Composition
Active substances:
Imoxat for dogs contains 100 mg/ml imidacloprid and 25 mg/ml moxidectin.
Each unit dose (pipette) delivers:
| Unit dose | Imidacloprid | Moxidectin | |
|---|---|---|---|
| Imoxat for small dogs (≤ 4 kg) | 0.4 ml | 40 mg | 10 mg |
Excipients:
Qualitative composition of excipients and other constituents
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Benzyl alcohol -
Butylhydroxytoluene (E321). 1 mg/ml
Propylene carbonate -
Spot-on solution.
Colourless to yellow solution.
Pharmacological properties
4.1 ATCvet code: QP54AB52
4.2 Pharmacodynamics
Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds. Chemically, it is more accurately described as a chloronicotinyl nitroguanidine. Imidacloprid is active against larval flea stages and adult fleas. Flea larvae in the pet’s surroundings are killed after contact with a pet treated with the product. Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea. The ensuing inhibition of cholinergic transmission in insects results in paralysis and death. Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS. Imidacloprid has minimal pharmacological activity in mammals.
Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family. It is a parasiticide which is active against many internal and external parasites. Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis. It is also active against gastrointestinal nematodes. Moxidectin interacts with GABA and glutamate-gated chloride channels. This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state. The result is flaccid paralysis of affected parasites, followed by their death and/or expulsion.
The veterinary medicinal product has a persistent action and protects dogs for 4 weeks after a single application against reinfection with the following parasites: Dirofilaria immitis, Dirofilaria repens, Angiostrongylus vasorum.
4.3 Pharmacokinetics
After topical administration of the veterinary medicinal product, imidacloprid is rapidly distributed over the animal’s skin within one day of application. It can be found on the body surface throughout the treatment interval. Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 4 to 9 days after treatment in dogs. Following absorption from the skin, moxidectin is distributed systemically throughout the body tissues but due to its lipophilicity it is concentrated mainly in the fat. It is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month. The T ½ in dogs is about 28.4 days.
Studies evaluating the pharmacokinetic behaviour of moxidectin after multiple applications have indicated that steady state serum levels are achieved following approximately 4 consecutive monthly treatments in dogs.
Environmental properties
Moxidectin has been classified as persistent, bioaccumulative and toxic in the environment.
See sections 3.5. and 5.5.
Target species
Dogs
Indications
For dogs suffering from, or at risk from, mixed parasitic infections:
- the treatment and prevention of flea infestation (Ctenocephalides felis),
- the treatment of biting lice (Trichodectes canis),
- the treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis),
- the prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis),
- the treatment of circulating microfilariae (Dirofilaria immitis),
- the treatment of cutaneous dirofilariosis (adult stages of Dirofilaria repens)
- the prevention of cutaneous dirofilariosis (L3 larvae of Dirofilaria repens),
- the reduction of circulating microfilariae (Dirofilaria repens),
- the prevention of angiostrongylosis (L4 larvae and immature adults of Angiostrongylus vasorum),
- the treatment of Angiostrongylus vasorum and Crenosoma vulpis,
- the prevention of spirocercosis (Spirocerca lupi),
- the treatment of Eucoleus (syn. Capillaria) boehmi (adults),
- the treatment of the eye worm Thelazia callipaeda (adults),
- the treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Dosage
Dosage schedule:
The recommended minimum doses are 10 mg/kg bodyweight imidacloprid and 2.5 mg/kg bodyweight moxidectin, equivalent to 0.1 ml/kg bodyweight of the veterinary medicinal product.
The treatment schedule should be based on individual veterinary diagnosis and on the local epidemiological situation.
| Weight of dog [kg] | Pipette size to be used | Volume [ml] | Imidacloprid [mg/kg bw] | Moxidectin [mg/kg bw] |
|---|---|---|---|---|
| ≤ 4 kg | Imoxat for small dogs | 0.4 | minimum of 10 | minimum of 2.5 |
Flea treatment and prevention (Ctenocephalides felis) One treatment prevents future flea infestation for 4 weeks. Existing pupae in the environment may emerge for 6 weeks or longer after treatment is initiated, depending upon climatic conditions. Therefore, it may be necessary to combine animal treatment with environmental treatments aimed at breaking the flea life cycle in the surroundings. This can result in a more rapid reduction in the household flea population. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Treatment of biting lice (Trichodectes canis) A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Treatment of ear mite infestation (Otodectes cynotis) A single dose of the veterinary medicinal product should be administered. Loose debris should be gently removed from the external ear canal at each treatment. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment. Do not apply directly to the ear canal.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) A single dose should be administered twice 4 weeks apart.
Treatment of demodicosis (caused by Demodex canis) The administration of a single dose every 4 weeks for 2 to 4 months is efficacious against Demodex canis and leads to a marked improvement of clinical signs particularly in mild to moderate cases. Especially severe cases may require more prolonged and more frequent treatment. To achieve the best possible response in these severe cases, at the discretion of the veterinarian, the veterinary medicinal product can be applied once a week and for a prolonged time. In all cases it is essential that the treatment should be continued until skin scrapings are negative on at least 2 consecutive monthly occasions. Treatment should be stopped in dogs that show no improvement or do not respond in mite count after 2 months treatment. Alternative treatment should be administered. Seek the advice of your veterinarian.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Prevention of heartworm disease (D. immitis) Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms. Therefore prior to treatment with the veterinary medicinal product, the advice provided in section 4.5 should be considered.
For prevention of heartworm disease, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. immitis) are present. The veterinary medicinal product may be administered throughout the year. The first dose may be given after first possible exposure to mosquitoes, but not more than one month after this exposure. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month. When replacing another heartworm preventative product in a heartworm prevention programme, the first treatment with the veterinary medicinal product must be given within 1 month of the last dose of the former medication.
In non-endemic areas there should be no risk of dogs having heartworm. Therefore they can be treated without special precautions.
Prevention of cutaneous dirofilariosis (skinworm) (D. repens) For prevention of cutaneous dirofilariosis, the veterinary medicinal product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit D. repens larvae) are present. The veterinary medicinal product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes. Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes. To establish a treatment routine, it is recommended that the same day or date be used each month.
Treatment of microfilariae (D. immitis) The veterinary medicinal product should be administered monthly for two consecutive months.
Treatment of cutaneous dirofilariosis (skin worm) (adult stages of Dirofilaria repens) The veterinary medicinal product should be administered monthly for six consecutive months.
Reduction of microfilariae (skin worm) (D. repens) The veterinary medicinal product should be administered monthly for four consecutive months.
Treatment and prevention of Angiostrongylus vasorum A single dose should be administered. A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
In endemic areas regular monthly application will prevent angiostrongylosis and patent infection with Angiostrongylus vasorum.
Treatment of Crenosoma vulpis A single dose should be administered.
Prevention of spirocercosis (Spirocerca lupi) The veterinary medicinal product should be administered monthly.
Treatment of Eucoleus (syn. Capillaria) boehmi (adults) The veterinary medicinal product should be administered monthly for two consecutive months. It is advisable to prevent auto-coprophagia between the two treatments in order to prevent possible reinfection.
Treatment of the eye worm Thelazia callipaeda (adults) A single dose of the veterinary medicinal product should be administered.
Roundworm, hookworm and whipworm treatment (Toxocara canis, Ancylostoma caninum, Uncinaria stenocephala, Toxascaris leonina and Trichuris vulpis). In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms. In areas non- endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.
Method of administration Spot-on use.
For external use only.
Remove one pipette from the package. Tap the narrow part of the pipette to ensure the contents are within the main body of the pipette. Snap back the tip of the pipette to enable the contents to be expelled.
For dogs up to 25 kg:
With the dog in a standing position, part the coat between the shoulder blades until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.
For dogs of more than 25 kg:
For easy application the dog should be standing. The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail. At each spot, part the coat until the skin is visible. Wherever possible apply to undamaged skin. Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin. Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’s side.
Contraindications
Do not use in puppies under 7 weeks of age.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Do not use in dogs classified as Class 4 for heartworm disease as the safety of the product has not been evaluated in this animal group.
For cats, the corresponding “Imoxat for cat” product, which contains 100 mg/ml imidacloprid and 10 mg/ml moxidectin, must be used
For ferrets: do not use Imoxat for dogs. Only “Imoxat for small cats and ferrets” (0.4 ml) must be used.
Do not use on canaries.
Adverse reactions
{Dogs}
| Frequency | Adverse events |
|---|---|
| Common (1 to 10 animals / 100 animals treated): | Cough1, Dyspnoea1, Tachypnoea 1, Diarrhoea1, Vomiting1, Inappetence1, Lethargy1 |
| Rare (1 to 10 animals / 10000 animals treated): | Vomiting |
| Very rare (<1 animal / 10000 animals treated, including isolated reports): | Application site greasy fur2, Application site hair loss2, Application site itching2, Application site reddening.2 Behavioural changes (eg. agitation) 3 Hypersalivation 4 Neurological signs (e.g. ataxia, muscle tremor) 5 Pruritus 6 Inappetence 3, Lethargy 3 |
1: These signs are common in heartworm positive dogs with microfilaraemia, and there is a risk of gastrointestinal and severe respiratory signs that may require prompt veterinary treatment.
2: Transient local skin sensitivity reactions, these adverse events have been reported in spontaneous (pharmacovigilance) reports. These signs disappear without further treatment.
3: Transiently noted and related to sensation at application site.
4: may occasionally occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within some minutes without treatment. Correct application will minimise licking of the application sites.
5: Most neurological signs occur transiently.
6: In dogs, transient.
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Warnings
Special precautions for safe use in the target species:
The treatment of animals weighing less than 1 kg should be based on a benefit-risk assessment.
There is limited experience on the use of the veterinary medicinal product in sick and debilitated animals, thus the veterinary medicinal product should only be used based on a risk-benefit assessment for these animals.
Do not apply in the mouth, in the eyes or the ears of the animal.
Care should be taken that the veterinary medicinal product is not ingested by animals and does not come into contact with the eyes or mouth of the recipient and/or other animals.
Consider carefully the correct application method described in section 3.9, especially that the veterinary medicinal product should be applied to the site specified in order to minimise the risk for the animal to lick the veterinary medicinal product.
Do not allow recently treated animals to groom each other. Do not allow treated animals to come into contact with untreated animals until the application site is dry.
In case of accidental oral uptake, symptomatic treatment should be administered. There is no known specific antidote. The use of activated charcoal may be beneficial.
When the veterinary medicinal product is applied in 3 to 4 separate spots (see section 3.9), specific care should be taken to prevent the animal licking the application sites.
This veterinary medicinal product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the veterinary medicinal product as described under section 3.9; in particular, oral uptake by Collie or Old English Sheep dogs and related breeds or crossbreeds should be prevented.
The safety of the veterinary medicinal product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study. Therefore, the use in dogs with obvious or severe symptoms of the disease should be based on a careful benefit risk assessment by the treating veterinarian.
Although experimental overdosage studies have shown that the veterinary medicinal product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis. It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the veterinary medicinal product. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of the veterinary medicinal product has not been evaluated when administered on the same day as an adulticide.
Imidacloprid is toxic for birds, especially canaries.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid contact with skin, eyes or mouth.
Do not eat, drink or smoke during application.
Wash hands thoroughly after use.
After application do not stroke or groom animals until the application site is dry. In case of accidental spillage onto skin, wash off immediately with soap and water. People with a known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the veterinary medicinal product with caution. In very rare cases the veterinary medicinal product may cause skin sensitisation or transient skin reactions (for example numbness, irritation or burning/tingling sensation).
In very rare cases the veterinary medicinal product may cause respiratory irritation in sensitive individuals.
If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.
If skin or eye symptoms persist, or the veterinary medicinal product is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
The veterinary medicinal product should not enter water courses as this may be dangerous for fish and other aquatic organisms: moxidectin is highly toxic to aquatic organisms. Dogs should not be allowed to swim in surface waters for 4 days after treatment.
Other precautions:
The solvent in Imoxat may stain or damage certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species. Therefore, the use of the product is not recommended in animals intended for breeding or during pregnancy and lactation.
Interactions
During treatment with the veterinary medicinal product no other antiparasitic macrocyclic lactone should be administered.
No interactions between the veterinary medicinal product and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
Safety of the veterinary medicinal product when administered on the same day as an adulticide to remove adult heartworms has not been evaluated.
Overdose
Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs. Five times the recommended minimum dose applied at weekly intervals for 17 weeks was investigated in dogs aged over 6 months and tolerated with no evidence of adverse effects or undesirable clinical signs.
The veterinary medicinal product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns. Transient mydriasis, salivation, vomiting and transient rapid respiration were observed.
After accidental oral ingestion or overdose, neurological signs (most of which are transient) such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur in very rare cases.
Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose repeated at monthly intervals without any adverse effects, but the safety of application at weekly intervals has not been investigated in ivermectin-sensitive Collie dogs. When 40 % of the unit dose was given orally, severe neurological signs were observed. Oral administration of 10 % of the recommended dose produced no adverse effects.
Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.
Special warnings
Please refer to section 3.5.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product. However, frequent shampooing or immersion of the animal in water after treatment may reduce the efficacy of the veterinary medicinal product.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Therefore, the use of this veterinary medicinal product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
The use of the veterinary medicinal product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see also sections 3.2 and 3.9).
Efficacy against adult Dirofilaria repens has not been tested under field conditions.
Withdrawal period
Not applicable
Incompatibilities
Not applicable.
Immediate packaging
Pipette: a white pipette composed of a heat-formed shell composed of (polypropylene (PP)/cyclic olefin copolymer (COC)/ethylene vinyl alcohol EVOH)/polypropylene(PP) with a snap-off cap.
Sachet: polyethylene (PET)/aluminium foil/nylon/low density polyethylene (LDPE) Pack size: 0.4 ml per pipette Each cardboard box contains 1 or 3 pipettes in individual foil sachets.
Not all pack sizes may be marketed.
Storage
Store in the original package in order to protect from light and moisture Do not store above 25°C.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Disposal of unused product
Medicines should not be disposed of via wastewater.
The veterinary medicinal product should not enter water courses as imidacloprid and moxidectin may be dangerous for fish and other aquatic organisms.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Additional information
Vm 08749/5030
8 DATE OF FIRST AUTHORISATION
29 March 2022
9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
September 2025
10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product subject to prescription.
Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.
Gavin Hall Approved: 10 December 2025
Registration holder
Chanelle Pharmaceuticals Manufacturing Ltd
Regulations
- Veterinary Medicines Regulations 2013 (SI 2013/2033), Schedule 32