Drontal Wormer

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

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/­animalhealth
Incorporating the data sheets for the following products:
Drontal Cat Tablets
Drontal Cat XL Tablets
 

Presentation

Drontal Cat Tablets are scored coated white to yellowish ellipsoid, biconvex tablets that can be divided into equal halves. Each tablet contains 230 mg pyrantel embonate and 20 mg praziquantel.
Drontal Cat XL Film-coated Tablets are unscored coated white to yellowish, ellipsoid, biconvex tablets, each containing 345 mg pyrantel embonate and 30 mg praziquantel.
 

Uses

For the treatment of gastrointestinal roundworms and tapeworms of cats (see also ‘further information’).

Dosage and administration

Dosage
The recommended dose rates are 57.5 mg/kg pyrantel embonate and 5 mg/kg praziquantel. This is equivalent to one Drontal Cat Tablets per 4 kg body weight and 1 Drontal Cat XL Film-coated Tablets per 6 kg body weight.
See dosage chart below for examples:

Administration and Duration of Treatment
For single oral administration. The tablets should be given directly to the animal, but if necessary can be disguised in food.
Use During Pregnancy and Lactation
Not to be used during pregnancy but may be used during lactation.

Contra-indications, warnings, etc

Not intended for use in kittens less than 6 weeks of age.
Do not use simultaneously with piperazine compounds.
Until sufficient studies have been performed with this combination, do not use during pregnancy.
User Safety
In the interests of good hygiene, persons administering the tablets directly to a cat, or by adding them to the cat’s food, should wash their hands afterwards.
For animal treatment only.
Keep out of the reach of children
Environmental Safety
Unused product should be disposed of in accordance with any guidance from an appropriate waste regulation authority.
 

Pharmaceutical precautions

Do not store above 25°C.
Do not remove tablets from strip packing until required for use. Any part-used tablets should be discarded.
 

Legal category

NFA-VPS
 

Packaging Quantities

Further information

Drontal® Cat Tablets and Drontal® Cat XL Film-coated Tablets are an anthelmintic active against roundworms and tapeworms. The product contains two active ingredients, pyrantel embonate (pamoate) and praziquantel. Praziquantel is used widely as an anthelmintic for both human and veterinary use.
Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis and thereby allow expulsion from the gastro-intestinal (GI) system by peristalsis.
Praziquantel 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, especially calcium.
In this fixed combination product, the pyrantel is active against the following ascarids: Toxocara cati, and Toxascaris leonina; the praziquantel is effective against tapeworms, in particular Dipylidium caninum and Taenia taeniaeformis.
The product has been shown to be effective in the control of hookworms Ancylostoma tubaeforme and A. braziliense and the tapeworm Joyeuxiella pasqualei, none of which occur naturally in cats in the UK but may occasionally be found in imported animals.
Praziquantel is effective against Echinococcus multilocularis. E. multilocularis 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, it is recommended that all cats entering the country 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

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

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/­animalhealth
Incorporating the data sheets for the following products:
Drontal Cat Tablets
Drontal Cat XL Tablets
 

Presentation

Drontal Cat Tablets are white to yellowish, scored, coated tablets that can be divided into equal halves. Each tablet contains 230 mg pyrantel embonate and 20 mg praziquantel with 1.8 mg Titanium Dioxide (E171).
Drontal Cat XL Film-coated Tablets are unscored coated white to yellowish, ellipsoid, biconvex tablets, each containing 345 mg pyrantel embonate and 30 mg praziquantel with 2.6 mg Titanium Dioxide (E171).
 

Uses

For the treatment of gastrointestinal roundworms and tapeworms of cats: Toxocara cati, Toxascaris leonina, Dipylidium caninum, Taenia taeniaeformis (see ‘further information’).
 

Dosage and administration

Dosage
The recommended dose rates are 57.5 mg/kg pyrantel embonate and 5 mg/kg praziquantel. This is equivalent to one Drontal Cat Tablets per 4 kg body weight and 1 Drontal Cat XL Film-coated Tablets per 6 kg body weight.
See dosage chart below for examples:

Administration and Duration of Treatment
For single oral administration. The tablets should be given directly to the animal, but if necessary can be disguised in food.
Use During Pregnancy and Lactation
Not to be used during pregnancy but may be used during lactation.
 

Contra-indications, warnings, etc

Not intended for use in kittens less than 6 weeks of age.
Do not use simultaneously with piperazine compounds.
Until sufficient studies have been performed with this combination, do not use during pregnancy.
User Safety
In the interests of good hygiene, persons administering the tablets directly to a cat, or by adding them to the cat’s food, should wash their hands afterwards.
For animal treatment only.
Keep out of the reach of children
Environmental Safety
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
 

Pharmaceutical precautions

Do not store above 25°C.
Do not remove tablets from strip packing until required for use.
Any part-used tablets should be discarded.
Drontal Cat Tablets: Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
Drontal Cat XL Film-coated Tablets: Shelf-life of the veterinary medicinal product as packaged for sale: 4 years.
 

Legal category

NFA-VPS
 

Packaging Quantities

Further information

An anthelmintic active against roundworms and tapeworms. ATC VetCode: QP52 AA51. Pharmacotherapeutic Group: Anthelmintics, Praziquantel combinations. The product contains two active ingredients, pyrantel embonate (pamoate) a tetrahydropyrimidine derivative and praziquantel a partially hydrogenated pyrazino-isoquinoline derivative
Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis and thereby allow expulsion from the gastro-intestinal (GI) system by peristalsis.
Praziquantel 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, especially calcium.
In this fixed combination product, the pyrantel is active against the following ascarids: Toxocara cati, and Toxascaris leonina; the praziquantel is effective against tapeworms, in particular Dipylidium caninum and Taenia taeniaeformis.
The product has been shown to be efficacious in the control of hookworms Ancylostoma tubaeforme and A. braziliense and the tapeworm Joyeuxiella pasqualei, none of which occur naturally in cats in the UK but may occasionally be found in imported animals. Praziquantel is effective against Echinococcus multilocularis. E. multilocularis 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, it is recommended that all dogs and cats entering the country 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

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

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/­animalhealth
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

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

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

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/­animalhealth
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

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

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

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/­animalhealth

Presentation

A pale red suspension for oral administration to puppies and young dogs. Each ml of suspension contains 14.4 mg pyrantel embonate and 15 mg febantel. Sodium benzoate (E211) and sodium propionate (E281) are present as preservatives.

Uses

For the treatment and control of roundworms (ascarids), in particular Toxocara canis, of puppies and young dogs up to one year of age. The product will also be effective against:

Dosage and administration

The dose is 1 ml suspension/kg body weight (equivalent to 14.4 mg/kg pyrantel embonate and 15 mg/kg febantel).
Administration is by the oral route. The product may be given directly to the animal or mixed with the feed. No special dietary measures are necessary.
Mix the product by inversion of the container before withdrawing the required dose.
Through intrauterine and transmammary infection, ascarid infestation may occur in dogs at a very early age. For some animals, especially in case of severe infections, elimination of ascarids may be incomplete, and a potential risk of infections to humans can not be excluded. Where epidemiologically appropriate, it is recommended that treatment should be started at 2 weeks of age and should be performed repeatedly at suitable intervals (for example every two weeks) until weaning. Otherwise treatment should be based upon confirmed infection, for example the results of faecal examinations.
Use During Pregnancy and Lactation
This product is contra-indicated for pregnant and lactating bitches.

Contra-indications, warnings, etc

Do not use simultaneously with compounds containing piperazine.
Parasite resistance to any particular class of anthelmintic may develop following frequent repeated use of an anthelmintic of that class.
The safety of the product has not been assessed in puppies younger than 2 weeks and weighing less than 0.600 kg.
In very rare cases mild transient digestive tract signs (e.g., vomiting diarrhoea) may occur.
The anthelmintic effects of both pyrantel (spastic paralysis) and piperazine (neuromuscular paralysis) may be antagonised when the two drugs are used together.
Doses of up to 5 times the therapeutic level of the product have been administered to puppies and young dogs without clinical signs of intolerance arising. At 10 times the recommended dose the first sign of intolerance – vomiting – was evident.
User safety: Wash hands after use, avoid direct contact with the skin and eyes. In case of accidental spillage wash the affected area immediately with clean running water.
Environmental safety: Any unused product or waste materials should be disposed of in accordance with national requirements.

Pharmaceutical precautions

Once opened, the contents of the bottle should be used within 12 weeks.
Do not use after expiry date.
This unopened veterinary medicinal product does not require any special storage conditions. After opening, store the product at a temperature not exceeding 25 ºC.

Legal category

NFA-VPS

Packaging Quantities

White high density polyethylene bottles of 50 ml and 100 ml.
5ml transparent polypropylene syringe with rubber plunger.

Further information

In this fixed combination product, the pyrantel and febantel act synergistically against nematodes (ascarids, hookworms and whipworms) of dogs. In particular, the spectrum of activity covers Toxocara canis, Ancyclostoma caninum and Trichuris vulpis. Published data are also available to confirm that Toxascaris leonina and Uncinaria stenocephala are also susceptible to this particular combination of actives.
Febantel, N-{2-[2,3-bis,(methoxycarbonyl)-guanidino]-5-(phenylthio) phenyl}-2-methoxyacetamide, is a pro-benzimidazole. 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 to structures vital to the normal functioning of the helminth. Glucose uptake, in particular, is affected, leading to depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2-3 days later. Pyrantel, (E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine pamoate belongs to the tetrahydropyrimidine type. Its mode of action is to stimulate nicotinic cholinergic receptors inducing spastic paralysis and thereby allowing removal from the gastro-intestinal (GI) system by peristalsis.
Literature reports indicate after oral application of the recommended dose of 1 ml/kg bodyweight (corresponding to 14.4mg/kg pyrantel embonate and 15 mg/kg febantel) maximum serum concentrations for febantel were found between 1 and 6 hours with a Cmax of 0.019 mg/l two hours after dosing. As febantel as a pro-drug is metabolised to fenbendazole which is further converted to oxfendazole, also these metabolites were measured. Cmax of febendazole was 0.130 mg/l after 3 hours and Cmax of oxfendazole was 0.157 mg/l at about 5 hours after application.
The Cmax of pyrantel (measured as pyrantel base) was 0.084 mg/l 2.5 hours after application.

Marketing authorisation number

Vm 00010/4102

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

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/­animalhealth

Presentation

A pale red suspension for oral administration to puppies and young dogs. Each ml of suspension contains 14.4 mg pyrantel embonate and 15 mg febantel. Sodium benzoate (E211) and sodium propionate (E281) are present as preservatives.

Uses

For the treatment and control of roundworms (ascarids), in particular Toxocara canis, of puppies and young dogs up to one year of age. The product will also be effective against:

Dosage and administration

The dose is 1 ml suspension/kg body weight (equivalent to 14.4 mg/kg pyrantel embonate and 15 mg/kg febantel).
Administration is by the oral route. The product may be given directly to the animal or mixed with the feed. No special dietary measures are necessary.
Mix the product by inversion of the container before withdrawing the required dose.
Through intrauterine and transmammary infection, ascarid infestation may occur in dogs at a very early age. For some animals, especially in case of severe infections, elimination of ascarids may be incomplete, and a potential risk of infections to humans can not be excluded. Where epidemiologically appropriate, it is recommended that treatment should be started at 2 weeks of age and should be performed repeatedly at suitable intervals (for example every two weeks) until weaning. Otherwise treatment should be based upon confirmed infection, for example the results of faecal examinations.
Use During Pregnancy and Lactation
This product is contra-indicated for pregnant and lactating bitches.

Contra-indications, warnings, etc

Do not use simultaneously with compounds containing piperazine.
Parasite resistance to any particular class of anthelmintic may develop following frequent repeated use of an anthelmintic of that class.
The safety of the product has not been assessed in puppies younger than 2 weeks and weighing less than 0.600 kg.
In very rare cases mild transient digestive tract signs (e.g., vomiting diarrhoea) may occur.
The anthelmintic effects of both pyrantel (spastic paralysis) and piperazine (neuromuscular paralysis) may be antagonised when the two drugs are used together.
Doses of up to 5 times the therapeutic level of the product have been administered to puppies and young dogs without clinical signs of intolerance arising. At 10 times the recommended dose the first sign of intolerance – vomiting – was evident.
User safety: Wash hands after use, avoid direct contact with the skin and eyes. In case of accidental spillage wash the affected area immediately with clean running water.
Environmental safety: Any unused product or waste materials should be disposed of in accordance with national requirements.

Pharmaceutical precautions

Once opened, the contents of the bottle should be used within 12 weeks.
Do not use after expiry date.
This unopened veterinary medicinal product does not require any special storage conditions. After opening, store the product at a temperature not exceeding 25 ºC.

Legal category

NFA-VPS

Packaging Quantities

White high density polyethylene bottles of 50 ml and 100 ml.
5ml transparent polypropylene syringe with rubber plunger.

Further information

In this fixed combination product, the pyrantel and febantel act synergistically against nematodes (ascarids, hookworms and whipworms) of dogs. In particular, the spectrum of activity covers Toxocara canis, Ancyclostoma caninum and Trichuris vulpis. Published data are also available to confirm that Toxascaris leonina and Uncinaria stenocephala are also susceptible to this particular combination of actives.
Febantel, N-{2-[2,3-bis,(methoxycarbonyl)-guanidino]-5-(phenylthio) phenyl}-2-methoxyacetamide, is a pro-benzimidazole. 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 to structures vital to the normal functioning of the helminth. Glucose uptake, in particular, is affected, leading to depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2-3 days later. Pyrantel, (E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine pamoate belongs to the tetrahydropyrimidine type. Its mode of action is to stimulate nicotinic cholinergic receptors inducing spastic paralysis and thereby allowing removal from the gastro-intestinal (GI) system by peristalsis.
Literature reports indicate after oral application of the recommended dose of 1 ml/kg bodyweight (corresponding to 14.4mg/kg pyrantel embonate and 15 mg/kg febantel) maximum serum concentrations for febantel were found between 1 and 6 hours with a Cmax of 0.019 mg/l two hours after dosing. As febantel as a pro-drug is metabolised to fenbendazole which is further converted to oxfendazole, also these metabolites were measured. Cmax of febendazole was 0.130 mg/l after 3 hours and Cmax of oxfendazole was 0.157 mg/l at about 5 hours after application.
The Cmax of pyrantel (measured as pyrantel base) was 0.084 mg/l 2.5 hours after application.

Marketing authorisation number

Vm 00010/4102