Drontal Plus Datasheet

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. For a non-technical article, please click the link in the blue bar above.
 

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Introduction

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/products/animalhealth.html
Incorporating the data sheets for the following products:
Drontal Plus Flavour Tablets
Drontal Plus XL Tablets

Presentation

Drontal Plus Flavour Tablet is a pale brown to brown flavoured round tablet cross scored on one side containing 50 mg praziquantel, 144 mg pyrantel embonate and 150 mg febantel.
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.

Uses

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).

Dosage and administration

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 body weight;
1 Drontal Plus XL Flavour Tablet per 35 kg body weight.
The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after treatment.
Dosage Guide: Puppies and small dogs
3–5 kg body weight = ½ Drontal Plus Flavour Tablet
6–10 kg body weight = 1 Drontal Plus Flavour Tablet
Dosage Guide: Medium dogs
11–15 kg body weight = 1½ Drontal Plus Flavour Tablet
16–20 kg body weight = 2 Drontal Plus Flavour Tablet
21–25 kg body weight = 2½ Drontal Plus Flavour Tablet
26–30 kg body weight = 3 Drontal Plus Flavour Tablet
Dosage Guide: Large dogs Dogs of 35 kg bodyweight1 Drontal Plus XL Flavour Tablet
Dogs of > 35 kg body weight 1 Drontal Plus XL Flavour Tablet plus the appropriate quantity of Drontal Plus Flavour Tablets equivalent to 1 tablet per 10 kg body weight.
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.

Pharmaceutical precautions

Do not store above 25°C.
Protect from light.
Do not use after the expiry date.
Any part used tablets should be discarded.
Any unused or waste material should be disposed of in accordance with local requirements.

Legal category

NFA-VPS

Packaging Quantities

Drontal Plus Flavour Tablets:	Cardboard carton containing polyethylene-coated aluminium foil blisters with 2, 8, 24, and 104 tablets.
Drontal Plus XL Flavour Tablets:	Cardboard carton containing polyethylene-coated aluminium foil blisters of 2, 8 and 48 tablets.

Further information

The product contains anthelmintics active against roundworms and tapeworms. The product contains three active substances: Febantel, Pyrantel embonate (pamoate) and Praziquantel.
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 00010/4115
Drontal® Plus XL Flavour Tablets	Vm 00010/4153