Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Drontal Plus Flavour Tablets
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Email: animal.health@bayer.com
Website: www.bayer.co.uk/animalhealth
Drontal Plus Flavour Tablets are pale brown to brown flavoured round tablet cross scored on one side containing 50 mg praziquantel, 144 mg pyrantel embonate and 150 mg febantel as active constituents and 116.5 mg Artificial beef flavour irradiated.
Drontal Plus XL Flavour Tablet is a pale brown to brown oval shaped divisible tablet scored on both sides containing 175 mg praziquantel, 504 mg pyrantel embonate and 525 mg febantel as active constituents and 408.0 mg Artificial beef flavour irradiated.
For the control of the following gastrointestinal roundworms and tapeworms of dogs and puppies.
Ascarids
Toxocara canis, Toxascaris leonina (adult and late immature forms).
Hookworms
Uncinaria stenocephala, Ancylostoma caninum (adults).
Whipworms
Trichuris vulpis (adults).
Tapeworms
Echinococcus species, Taenia species, Dipylidium caninum (adults and immature forms).
For oral administration only.
The recommended dose rates are: 15 mg/kg body weight febantel, 14.4 mg/kg pyrantel and 5 mg/kg praziquantel.
1 Drontal Plus Flavour Tablet per 10 kg (22 lbs) body weight.
1 Drontal Plus XL Flavour Tablet per 35 kg body weight.
Dosage Guide:
Drontal Plus Flavour Tablets
Puppies and small dogs
3–5 kg body weight = ½ tablet
6–10 kg body weight = 1 tablet
Dosage Guide: Medium dogs
11–15 kg body weight = 1½ tablets
16–20 kg body weight = 2 tablets
21–25 kg body weight = 2½ tablets
26–30 kg body weight = 3 tablets
Dosage Guide: Large dogs
31-35 kg body weight = 3 ½ tablets
36-40 kg body weight = 4 tablets
Dosage Guide:
Drontal Plus XL Flavour Tablets
17.5 kg body weight = ½ tablet
>17.5 - 35 kg body weight = 1 tablet
>35 - 52.5 kg body weight = 1 ½ tablets
>52.5 - 70 kg body weight = 2 tablets
Drontal Plus Flavour Tablets should be used to achieve accurate dosing in dogs weighing less than 17.5 kg. The dose is equivalent to 1 tablet per 10 kg.
The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after treatment.
For routine treatment a single dose is recommended.
Puppies should be treated at 2 weeks of age and every 2 weeks until 12 weeks of age. Thereafter they should be treated at 3 month intervals. It is advisable to treat the bitch at the same time as the puppies. Not for use in dogs weighing less than 3 kg.
For the control of Toxocara, nursing bitches should be dosed 2 weeks after giving birth and every two weeks until weaning.
For routine control adult dogs should be treated every 3 months. For routine treatment a single dose is recommended. In the event of heavy roundworm infestation a repeat dose should be given after 14 days.
Use During Pregnancy and Lactation
Consult a veterinary surgeon before treating pregnant animals for roundworms.
The product may be used during lactation.
Do not exceed recommended dose when treating pregnant bitches.
Contra-indications, warnings, etc
Do not use simultaneously with piperazine compounds.
The product is well tolerated in dogs. In safety studies doses of 5 x or greater gave rise to occasional vomiting.
User safety
In the interests of good hygiene, persons administering the tablets directly to the dog, or by adding them to the dog's food, should wash their hands afterwards.
Environmental safety
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Do not store above 25°C.
Do not use after the expiry date.
Any part used tablets should be discarded.
Drontal Plus Flavour Tablets: Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
Drontal Plus XL Flavour Tablets: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
NFA-VPS
Drontal Plus Flavour Tablets: | Carton containing polyethylene-coated aluminium foil blisters with 2, 8, 24, or 104 tablets. |
Drontal Plus XL Flavour Tablets: | Carton containing a PCTFE/PVC- aluminium foil strip of 2, 8 or 48 tablets. |
Pharmacotherapeutic group: Antheilminitics, tetrahydropyrimidine. ATC VetCode: QP52AF30.
The product contains three active substances active against roundworms and tapeworms: 1. Febantel, a probenzimidazole, 2. Pyrantel embonate (pamoate) a tetrahydropyrimidine derivative, 3. Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative.
Praziquantel is a partially hydrogenated pyrazino-isoquinoline derivative used widely as an anthelmintic for both human and veterinary use.
In this fixed combination pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs. In particular the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis. This combination shows synergistic activity in the case of hookworms and febantel is effective against T.vulpis.
The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp, Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against all adult and immature forms of these parasites.
Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.
Within the mammalian system febantel undergoes ring closure forming fenbendazole and oxfendazole. It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerization. Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth. Glucose uptake in particular is affected, leading to a depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2-3 days later.
Praziquantel is very rapidly absorbed through the parasite’s surface and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites. There is an almost instantaneous titanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.
Benzimidazoles possess a wide safety margin. Pyrantel is not absorbed systemically to any extent. Praziquantel also has a wide safety margin, beyond five-times overdose.
Since it contains praziquantel, the product is effective against Echinococcus multilocularis, which does not occur in the UK but is becoming more common in some European countries. As a precautionary measure to prevent establishment of E. multilocularis in the UK and Ireland, it is recommended that all dogs entering the country travelling either under the PETS scheme (UK only) or going into quarantine (UK & Ireland) be treated with praziquantel.
Fleas serve as intermediate hosts for one common type of tapeworm - Dipylidium caninum. Tapeworm infestation is certain to re-occur unless control of intermediate hosts such as fleas, mice etc. is undertaken.
Marketing authorisation number
Drontal® Plus Flavour Tablets | Vm 00010/4158 |
Drontal® Plus XL Flavour Tablets | Vm 00010/4153 |