Indications for use, specifying the target species
Treatment of flea infestations (C. felis) on dogs.
Special warnings for each target species
Special precautions for use
Special precautions for use in animals
Do not use on dogs weighing less than 11 kg.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Adverse reactions (frequency and seriousness)
For the first hour after administration, the pet may scratch more than normal. This effect is caused by the fleas reacting to the product. In very rare cases this may present as transient signs of hyperactivity, panting, vocalisation, and excessive grooming/licking.
Transient neurological signs such as muscle tremors, ataxia, and convulsions have also been reported in very rare occasions.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
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 feototoxic 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 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.
CAPSTAR 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.