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Date: Wednesday, May 29, 2024 18:20

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 11.86
Capstar Tablets for Cats and Dogs
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Ectoparasiticides: For dogs, For cats
Active ingredient: Nitenpyram
Product:Capstar® 11.4mg Tablets for Cats and Dogs
Capstar® 57mg Tablets for Large Dogs
Product index: Capstar Tablets for Cats and Dogs
Incorporating:
Qualitative and quantitative composition
One tablet contains:
Capstar 11.4, mg tablets for cats and small dogs:
Active substance: Nitenpyram 11.4 mg .
Capstar 57 mg tablets for large dogs:
Active substance: Nitenpyram 57 mg.
Excipient(s):
For the full list of excipients, see Pharmaceutical particulars section.
Pharmaceutical form
Capstar 11.4, mg tablets for cats and small dogs
White to light yellow, round, biconvex tablets, with bevelled edges, imprinted on one side with “RB”, on the other side with “CG”.
Capstar 57 mg tablets for large dogs
White to light yellow, round, biconvex tablets, with bevelled edges, imprinted on one side with “HIH”, on the other side with “CG”.
Clinical particulars
Target species: Cats and dogs
Indications for use, specifying the target species
Treatment of flea infestations (C. felis).
Contraindications
None
Special warnings for each target species
None.
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
None.
Special precautions for the protection of the environment.
None.
Adverse reactions (frequency and seriousness)
Cats and Dogs
Very rare
(<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
Panting1,
Increased scratching2
1 Transient
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
Pregnancy :
Can be used during pregnancy.
Lactation:
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
Oral Use
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.
Withdrawal period
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: Other ectoparasiticides for systemic use, ATCvet code: QP53BX02.
Pharmacodynamic properties
The active ingredient, nitenpyram belongs to the chemical class of neonicotinoids which bind and inhibit insect specific nicotinic acetylcholine receptors. Nitenpyram interferes with nerve transmission and leads to the death of adult fleas. Nitenpyram does not inhibit acetylcholinesterase.
Effects on fleas (Ctenocephalides felis) may be seen as soon as 15-30 minutes after administration of the product to the host animal. This coincides with the first blood meal taken by fleas after sufficient blood levels are reached. Between 95% and 100% efficacy is observed within the first 6 hours and 100% efficacy is reached within 24 hours with no residual activity.
Pharmacokinetic particular
Nitenpyram is rapidly and to over 90% absorbed from the gastrointestinal tract of cats and dogs. Feeding does not affect absorption in dogs. Feeding slightly delays Tmax in cats without affecting the other pharmacokinetic properties and without affecting efficacy. The maximum blood concentration is reached after 0.5 to 2 hours in both fasted target species and the elimination half-life is about 4 hours in dogs and 8 hours in cats. More than 90% is eliminated in the urine within 1 day in dogs and 2 days in cats, mainly as the unchanged molecule.
Pharmaceutical particulars
List of excipients
Microcristalline cellulose
Maize starch
Lactose monohydrate
Anhydrous silica
Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25 °C
Nature and composition of immediate packaging
Cardboard box with 1 polyamide/aluminium/PVC-aluminium blister. Each blister contains 1 tablet.
Cardboard box with 1 or 10 polyamide/aluminium/PVC-aluminium blisters. Each blister contains 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
Medicines should not be disposed of via wastewater.
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Elanco Europe Ltd
Form 2, Bartley Way
Bartley Wood Business Park
Hook
RG27 9XA
United Kingdom
Marketing Authorisation Number
Capstar 11.4 mg tablets for Cats and Dogs:
UK (Great Britain) Vm 00879/15023
UK (Northern Ireland) Vm 00879/3019
Capstar 57 mg tablets for Large Dogs:
UK (Great Britain) Vm 00879/5024
UK (Northern Ireland) Vm 00879/3023
Significant changes
Date of the first authorisation or date of renewal
03 August 2001
Date of revision of the text
August 2023
Any other information
Legal category
Legal category: AVM-GSL
GTIN
GTIN description:CAPSTAR 11.4MG X 6 GSL
GTIN:05037694016791
GTIN description:CAPSTAR 57MG X 6 GSL
GTIN:05037694016807