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Date: Wednesday, April 30, 2025 8:31

Release 2.61
FRONTLINE Wormer 230 mg/20 mg Film-Coated Tablets for Cats
 
Species: Cats
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cats, Tapeworm products
Active ingredient: Praziquantel, Pyrantel Embonate
Product:FRONTLINE Wormer 230 mg/20 mg Film-Coated Tablets for Cats
Product index: FRONTLINE Wormer for Cats
Incorporating:
Qualitative and quantitative composition
Active substances:
Each film-coated tablet contains Pyrantel embonate 230 mg and Praziquantel 20 mg
Excipients:
For the full list of excipients, see "Pharmaceutical particulars" section.
Pharmaceutical form
Film-coated tablets.
A white to off white round, biconvex coated tablet with a breakline on one side and plain on the other side.
The tablet can be divided in half.
Clinical particulars
Target species
Cats
Indications for use, specifying the target species
For the treatment of mixed infections caused by the following gastrointestinal roundworms and tapeworms:
Roundworms: Toxocara cati, Toxascaris leonina,
Tapeworms: Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis.
Contraindications
Do not use simultaneously with piperazine compounds as piperazine may block the action of pyrantel embonate contained in the product.
Other worming products may contain piperazine.
Do not use simultaneously with other deworming products without veterinary advice.
Do not use in kittens less than 6 weeks of age.
Do not use in animals with known hypersensitivity to the active substances or to any of the excipients.
Do not use during pregnancy.
Special warnings for each target species
Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum.
Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.
Parasitic resistance to a certain class of anthelmintics can occur after frequent and repeated use of an anthelmintic from this class.
Special precautions for use
Special precautions for use in animals
Not intended for use in cats weighing less than 1 kg bodyweight.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the interests of good hygiene, persons administering the tablets directly to the cat, or by adding them to the cat’s food, should wash their hands afterwards.
In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.
Other precautions
Echinococcosis represents a hazard for humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Adverse reactions (frequency and seriousness)
Mild and short-lived digestive tract disorders such as excessive salivation and/or vomiting and mild and short-lived disorders of the nervous system such as loss of balance may occur in extremely rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy, lactation or lay
Do not use during pregnancy but may be used during lactation.
Interaction with other medicinal products and other forms of interaction
Do not use simultaneously with piperazine compounds (see section 'Contraindications' above).
Amounts to be administered and administration route
To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Dosage
The recommended dose is: 20 mg/kg pyrantel (57.5 mg/kg pyrantel embonate) and 5 mg/kg praziquantel. This is equivalent to 1 tablet per 4 kg bodyweight.
Body weight
tablets
1.0 - 2.0 kg
½
Greater than 2.0 up to 4.0 kg
1
Greater than 4.0 up to 6.0 kg
1 ½
Greater than 6.0 kg
2
Administration and duration of treatment
For oral administration. The tablet should be given directly to the cat, but if necessary can be disguised in food.
In roundworm infestation, especially in kittens, complete elimination cannot be expected, so a risk of infection for humans can persist. Repeat treatments should, therefore, be carried out with a suitable roundworm product at 14-day intervals until 2-3 weeks after weaning.
If signs of disease persist or appear, consult a veterinary surgeon.
Overdose (symptoms, emergency procedures, antidotes), if necessary
After doses higher than 5 times the recommended dose, signs of intolerance such as vomiting have been observed.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: Anthelmintics, praziquantel combinations.
ATC vet code: QP52AA51
Pharmacodynamic properties
This product contains anthelmintics active against gastrointestinal roundworms and tapeworms. The product contains two active substances, as follows:
1. Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative
and
2. Praziquantel, a partially hydrogenated pyrazinoisoquinoline 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 vitro and in vivo 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 vacuolization of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.
In this fixed combination, pyrantel is active against the following ascarids: Toxocara cati, and Toxascaris leonina. Praziquantel is effective against tapeworms in particular Dipylidium caninum and Taenia taeniaeformis.
Since it contains praziquantel, the product is effective against Echinococcus multilocularis.
Pharmacokinetic particulars
Praziquantel is rapidly absorbed, metabolised and distributed in the body. It is also believed to be excreted back into the intestinal lumen by the mucous membrane.
Following administration of the product to cats, peak plasma concentrations of praziquantel were achieved by approximately 2 hours.
Pyrantel is poorly absorbed so it is expected that a large proportion of the administered dose remains in the GIT where it exerts its therapeutic effect and it is excreted largely unchanged in the faeces.
Following administration of the product to cats, peak plasma concentrations of pyrantel were achieved by approximately 3 hours.
Pharmaceutical particulars
List of excipients
Core tablet:
Maize starch
Microcrystalline cellulose
Crospovidone
Magnesium stearate
Colloidal anhydrous silica
Film coat
Grilled meat flavour
Opadry Complete Film Coating System 03F28415 White consisting of HPMC 2910/Hypromellose (E464), Macrogol/PEG 4000 (E1521), Titanium Dioxide (E171).
Major incompatibilities
Not applicable
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years
Special precautions for storage
This veterinary medicinal product does not require any special temperature storage restrictions.
Unused halved tablets should be discarded.
Do not remove tablets from blister packaging until required for use.
Keep blister in outer carton.
Nature and composition of immediate packaging
The product is presented in either:
Individual blisters made up of a PVC/PE/PCTFE white opaque copolymer and a 20µm heat seal lacquer/aluminium containing 1, 2, 4, 6, or 8 tablets.
or
Individual blisters made up of 45µm PVC/aluminium/orientated polyamide and a 20µm heat seal lacquer/aluminium containing 1, 2 or 8 tablets.
The blisters are packed into cartons containing either: 1, 2, 4, 6, or 8 tablets
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
C&H Generics Ltd
C/o Michael McEvoy and Co
Seville House
New Dock Street
Galway Ireland
Marketing Authorisation Number
Vm 40162/4028
Significant changes
Date of the first authorisation or date of renewal
12 January 2021
Date of revision of the text
March 2022
Any other information
Legal category
Legal category: AVM-GSL
GTIN
GTIN description:Carton of 2 tablets
GTIN:5099299042438