DRONTAL ELLIPSOID CATS 2 TABLETS

Drontal
frontal for cats

Pyrantel Embonate/Praziquantel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 339 mg film-coated tablet contains:

3. PHARMACEUTICAL FORM

Film-coated, divisible tablet for oral administration.
4. CLINICAL DATA
4.1 Target species
Cats
4.2 Indications for use, specifying the target species
For the treatment of mixed infestations in cats caused by nematodes and
cestodes:

Since a cestode infestation cannot occur in the cat as very
early until the third week of life, treatment with Drontal is not indicated
until after the third week of the animal's life.
4.3 Contraindications
Until sufficient studies on the association have been carried out, it is not
Drontal will be used during pregnancy.
4.4 Special warnings
None.
4.5 Special precautions for use
Special precautions for use in animals
None.
Specific precautions to be taken by the person administering the
medicine to animals
Wash hands after administration.
4.6 Adverse reactions (frequency and seriousness)
None known.
4.7 Use during pregnancy or lactation
Until sufficient studies on the association have been carried out, it is not
Drontal will be used during pregnancy (see Contraindications section).
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
Dosage regimen:
1 x 5 mg praziquantel and 57,5 mg pyrantel embonate (20 mg pyrantel base)
per kg of weight. This corresponds to 1 tablet per 4 kg of weight.

Kittens weighing less than 1 kg should not be treated with Drontal.
Method of administration:
Orally.
The tablets can be administered directly or mixed with food. No
special dietary measures are necessary.
Treatment duration:
Single administration.
Note:
In case of ascarid infestations, especially in kittens, the elimination of the
themselves may not be complete, therefore a possible risk of
infestation in man. Therefore, treatments should be repeated with a
appropriate medication against nematodes at 14-day intervals until after 2 p.m.
or 3 weeks after weaning.
In case of echinococcosis, specific treatment guidelines should be followed
and monitoring, as well as security for people. It is recommended to consult
veterinary experts or parasitology institutes.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No symptoms of overdose appear when administering doses less than 5 times the
recommended dose. The first expected symptom of poisoning is vomiting.
4.11 Timeout
Not applicable.
Do not administer to food-producing animals.

5. PHARMACOLOGICAL PROPERTIES
   Pharmacotherapeutic group: Anthelmintics, quinoline derivatives and substances

related, Praziquantel in combination.
ATCvet code: QP52AA51
5.1 Pharmacodynamic properties
Drontal is an anthelmintic against nematodes and cestodes whose active substances are
the pyrazinoisoquinoline derivative praziquantel, and the pyrazinoisoquinoline derivative
tetrahydropyrimidine pyrantel (as embonate salt).
In this established association, praziquantel acts against cestodes, and its spectrum of
action encompasses all important cestode species of the cat, especially
Hydatigera (Taenia) taeniaeformis, Joyeuxiella pasqualei, Dipylidium caninum,
Mesocestoides spp. and Echinococcus multilocularis. Praziquantel acts on all
stages of development of these intestinal parasites of the cat.
Pyrantel is the specific active substance against nematodes and has a good
efficacy against all important cat nematodes, especially toxocara cati
(syn. mystax), Ancylostoma tubaeformae and Ancylostoma braziliense. Pyrantel works
as a cholinergic agonist similar to nicotine, and causes spastic paralysis of the
nematodes by depolarizing neuromuscular blockade.
Praziquantel is rapidly absorbed through the parasite surface and is
distributed regularly within it. It is rapidly produced both in vitro and in
I live a serious lesion of the integument of the parasite resulting in the final
contraction and paralysis of the same. The speed with which the onset of the
action is mainly due to changes, induced by praziquantel, of
permeability of the parasite membrane to Ca++ ions causing a
dysregulation of your metabolism.
5.2 Pharmacokinetic data
Praziquantel is absorbed almost completely and rapidly from the stomach and intestine.
thin after oral administration in all species studied. The
maximum levels in serum are already reached between 0,3 and 2 hours.
Praziquantel is distributed very rapidly within all organs. Life
mean elimination of 14C-praziquantel and those of its metabolites are included
between 2 and 3 hours in all species studied. Praziquantel is metabolized
rapidly in the liver. In addition to other metabolites, the main metabolite that is
found in all cases is the 4-hydroxycyclohexyl derivative of praziquantel.
Praziquantel is completely eliminated within 48 hours in the form of its
metabolites – between 40 and 71% in urine and, via bile, between 13 and 30% in feces.
Pyrantel embonate salt is very poorly absorbed from the gastrointestinal tract in
all species studied.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Microcrystalline cellulose
Povidone K25
Magnesium stearate
colloidal anhydrous silica
Cornstarch
hypromellose
Polyethylene glycol
Titanium dioxide E171
6.2 Incompatibilities
None known.
6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 4 years.
6.4. Special storage precautions
This veterinary medicinal product does not require special storage conditions.
6.5 Nature and composition of immediate packaging
Package with 2, 4, 6, 8, 20, 24, 96, 100 or 144 tablets in Al/PE blister.
Not all formats may be marketed.
6.6 Special precautions for disposal of the veterinary medicinal product not
used or, where appropriate, the residues derived from its use
Any unused veterinary medicinal product or residues derived from it must be
disposed of in accordance with current regulations.
7. MARKETING AUTHORIZATION HOLDER
Bayer Pharmaceutical Chemistry, SL
Av. Baix Llobregat, 3-5
08970 Sant Joan Despi (Barcelona)
8. MARKETING AUTHORIZATION NUMBER
1098 ESP
9. DATE OF THE FIRST AUTHORIZATION OR RENEWAL OF THE
AUTHORIZATION
June 4, 1996 / April 22, 2009
10. DATE OF REVISION OF THE TEXT
December 03th 2009
PROHIBITION OF SALE, DISPENSATION AND/OR USE
Medicine subject to a veterinary prescription.

See technical sheet

Data sheet

Drontal