Droncit Spot-On 20 mg Solution Species: Cats Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats, Tapeworm products Active ingredient: Praziquantel Product:Droncit® Spot-on 20 mg Solution Product index: Droncit Spot-on 20 mg Solution Presentation A clear, colourless to slightly reddish solution for spot-on use containing 20 mg praziquantel per 0.5 ml tube with 0.5 mg butylated hydroxytoluene. Uses For the treatment of tapeworms of cats. The product is effective against mature and immature forms of Dipylidium caninum and Taenia species. The product is also effective against Echinococcus multilocularis. Dosage and administration The minimum dose rate is 8 mg/kg bodyweight, which equates to 1 tube per 2.5 kg bodyweight. Bodyweight (kg) Number of tubes Quantity of Praziquantel (mg) mg/kg Bodyweight 1-2.5 1 20 8-20 >2.5-5 2 40 8-16 >5 3 60 maximum 12 Method of administration Remove one tube from the package. Hold the tube in an upright position, twist and pull off cap. Use reversed cap to twist and remove seal from tube. See Figure 1. Description: h-560 Figure 1: Opening a tube Part the hair on the cat’s neck at the base of the skull until the skin is visible. See Figure 2. Description: h-564 Figure 2: Administration Place the tip of the tube on the skin and squeeze firmly several times to empty the contents directly onto the skin. Application at the base of the skull will minimise the opportunity for the cat to lick the product. To minimise the possibility of run-off after application of more than one pipette, it is advised that the applications should be performed slowly to allow absorption and that it may be advisable to allow the contents of the previous pipette to be absorbed before applying another. Tapeworm infestation is certain to re-occur unless control of the intermediate hosts such as fleas, mice, etc, is undertaken. Flea control: Flea infestations can be controlled by the regular use of effective flea control remedies. Control of mice: If cats roam and hunt, contact with, and consumption of, mice and subsequent re-infestation with Taenia taeniaeformis is impossible to prevent. It is recommended to re-apply Droncit Spot-On when signs of tapeworm infestation re-appear or at monthly intervals. Use During Pregnancy and Lactation There are no contra-indications against use during pregnancy and lactation. Contra-indications, warnings, etc Do not use on cats weighing less than 1 kg body weight. Do not allow recently treated animals to groom each other. Care should be taken to avoid the contents of the tube coming into contact with the eyes or mouth of the recipient animal. For external use only. Occasionally a transient local reaction such as scurf or mild exudation may be observed at the application site following treatment. The product is bitter tasting and salivation may occasionally occur if the cat licks the application site immediately after treatment. This is not a sign of intoxication and disappears after a short time without treatment. No incompatibility has been observed between this product at the recommended dose and a range of common veterinary treatments. Overdosing can lead to slight skin reactions which disappear without treatment within a few days. Withdrawal period(s) Not applicable as the product is not indicated for the treatment of food producing animals. User safety This product can be irritant to the skin and eyes. Care should be taken to prevent contact of the solution with the skin, eyes or mouth. If contact with the skin occurs, wash off any skin contamination with soap and water immediately. If accidental contact occurs with the eyes, flush the affected eyes thoroughly with clean fresh water. In the event of skin or eye contact, seek medical advice if irritation persists and show the Doctor this package. Do not stroke or groom animals until area of application is dry (typically around 1 hour after application). Wash hands thoroughly after use. Do not eat, drink or smoke during application. Store away from food, drink or animal feeding stuffs. Environmental safety Any unused product or waste material should be disposed of in accordance with national requirements. Pharmaceutical precautions Store away from food, drink and animal feeding stuffs. Do not use after expiry date. Shelf-life of the product as packaged for sale: 30 months. The solvent in Droncit Spot-on may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials. Legal category Legal category: AVM-GSL Packaging quantities Blister pack, containing 4 unit dose white opaque polypropylene tubes, with an integral nozzle and rupturable membrane and white polypropylene caps, each containing 0.5 ml solution per tube (20 mg praziquantel). Marketing Authorisation Holder (if different from distributor) Marketing Authorisation Holder Vetoquinol UK Ltd., Steadings Barn, Pury Hill Business Park, Towcester. NN12 7LS Further information Praziquantel, the active ingredient of Droncit Spot-on is a pyrazinoisoquinoline derivative used widely as an anthelmintic for both human and veterinary medicine. The chemical name for this substance is 2-cyclohexyl-carbonyl[1,2,3,6,7,11b] hexahydro-4H-pyrazino-[2,1-a]isoquinolin-4-one¹. ATCVet Code: QP52AA01. Praziquantel is effective against all stages of development of intestinal tapeworms. The substance is very rapidly absorbed and distributed throughout the parasite. Both in vivo and in vitro studies have shown that praziquantel causes severe damage to the parasite integument, resulting in contraction and paralysis. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolisation of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, particularly calcium. Praziquantel is absorbed very rapidly and almost completely in the stomach and small intestine. Studies of the behaviour following oral administration have been conducted in rats, dogs, monkeys, sheep and humans. Depending on species, maximum serum levels are reached within 0.3 to 2 hours. The chemical is evenly distributed to all organs. The elimination half-lives of 14C-praziquantel and its metabolites are between 2 and 3 hours in rats, dogs, monkeys and sheep. Praziquantel is rapidly metabolised in the liver in both humans and animals with the 4-hydroxycyclohexyl derivative as the main metabolite. Praziquantel is completely eliminated from the body within 48 hours; irreversible binding to body constituents has not been observed. Elimination is in the form of metabolites with virtually no parent compound excreted. Between 40% and 71% of the substance is eliminated in the urine and 13%-30% in the faeces.