Target species: Cats and dogs
Indications for use, specifying the target species
Treatment of flea infestations (C. felis).
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
Do not use Capstar 11.4 mg tablets on animals less than 4 weeks old or weighing less than 1 kg as these groups of animals were not studied.
Do not use Capstar 57 mg tablets on dogs weighing less than 11 kg.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Special precautions for the protection of the environment.
Adverse reactions (frequency and seriousness)
Cats and Dogs
(<1 animal / 10,000 animals treated, including isolated reports)
Excessive chewing, licking and/or grooming1, Hyperactivity, Vocalisation1,
Neurological signs (e.g., muscle tremor, ataxia, convulsion)1
2 For the first hour following administration; presumably caused by flea response to the veterinary medicinal product
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.
Use during pregnancy, lactation or lay
Can be used during pregnancy.
Can be used during lactation.
Laboratory studies in rats and rabbits have produced no evidence of teratogenic or foetotoxic effects and the safety of the product was demonstrated in pregnant and lactating cats and dogs.
Interaction with other medicinal products and other forms of interaction
None known. No adverse drug reactions were seen in clinical studies when nitenpyram was administered with other veterinary medicinal products including commonly used flea products, anthelmintics, vaccines or antibiotics.
Amounts to be administered and administration route
The minimum effective recommended dose is 1 mg/kg, with the following recommendations:
One Capstar 11.4 mg tablet should be given to cats and small dogs weighing 1 kg to 11.0 kg when a flea infestation is detected.
One Capstar 57 mg tablet should be given to dogs weighing 11.1 kg to 57.0 kg and two tablets for dogs weighing over 57 kg when a flea infestation is detected.
The frequency of treatment depends on the degree of infestation. In the case of a severe flea infestation, it may be necessary to treat the animals every day or every other day, until the flea infestation is controlled. Treatment may be resumed if fleas reappear. No more than one treatment should be given per day.
Tablets should be given orally, with or without food. In order to improve palatability, tablets can be disguised in a small quantity of food immediately prior to administration.
The veterinary medicinal product does not have persistent activity. To prevent re-infestation, a suitable treatment to control immature stages of the flea life cycle is recommended. The veterinary surgeon should establish an appropriate treatment regime.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Nitenpyram is well-tolerated by the target species. Overdoses up to 50 mg/kg in cats and up to 70 mg/kg in dogs were asymptomatic.
Side-effects such as salivation, vomiting, soft stools, seizures, or decreased activity are observed at higher dosages and their seriousness increases as dosages increase. Symptoms disappear quickly and recovery is complete by 24 hours after overdosing because of the rapid elimination of nitenpyram. During 6 months of daily dosing in cats and dogs no clinically significant treatment-related side effects were observed.