Praziquantel/Pyrantel pamoate/Febantel

Uses and Indications

This drug is indicated for the treatment and control of various intestinal parasites in dogs. It is effective against the following conditions:

Tapeworms

• Dipylidium caninum

• Taenia pisiformis

• Echinococcus granulosus

• Echinococcus multilocularis

Hookworms

• Ancylostoma caninum

• Uncinaria stenocephala

Roundworms

• Toxocara canis

• Toxascaris leonina

Whipworms

• Trichuris vulpis

The drug is specifically formulated for use in dogs, including puppies and small dogs weighing between 2 to 25 lbs. Additionally, there is a formulation available for large dogs weighing 45 lbs and greater.

Limitations of Use

The formulations are designed to cater to different weight categories of dogs, ensuring appropriate dosing and effectiveness based on the size of the animal.

Dosage and Administration

The recommended dosage of the deworming tablets is based on the weight of the dog and should be confirmed by a laboratory fecal examination prior to treatment. It is essential to weigh the animal to ensure the correct size and number of tablets are administered. The tablets can be given directly in the mouth or offered in a small amount of food. Fasting is neither necessary nor recommended before or after treatment.

For Puppies and Small Dogs (2 - 25 lbs.), the dosage is as follows:

• 2 - 4 lbs: 0.5 tablets

• 5 - 7 lbs: 1.0 tablet

• 8 - 12 lbs: 1.5 tablets

• 13 - 18 lbs: 2.0 tablets

• 19 - 25 lbs: 2.5 tablets

For Medium Dogs (26 - 60 lbs.), the dosage is:

• 26 - 30 lbs: 1.0 tablet

• 31 - 44 lbs: 1.5 tablets

• 45 - 60 lbs: 2.0 tablets

For Large Dogs (45 lbs. and greater), the dosage is:

• 45 - 60 lbs: 1.0 tablet

• 61 - 90 lbs: 1.5 tablets

• 91 - 120 lbs: 2.0 tablets

In cases where reinfections are likely, clients should be instructed on preventive measures, as retreatment may be necessary. For specific parasites such as Dipylidium caninum, reinfection is almost certain if fleas are not removed from the animal and its environment. For control of Echinococcus multilocularis, a regular treatment program every 21 to 26 days may be indicated.

Contraindications

Use of this product is contraindicated in the following situations:

• Dogs or puppies that are sick should not be dewormed.

• Puppies less than 3 weeks of age or dogs weighing less than 2 lbs are not to be treated.

• The product is contraindicated in pregnant animals, as elevated levels of the combination of febantel and praziquantel during early pregnancy have been associated with an increased incidence of abortion and fetal abnormalities. The effects of this product on pregnant animals have not been determined.

• Consultation with a veterinarian is advised before administering the tablets to weak or debilitated animals.

Warnings and Precautions

KEEP OUT OF REACH OF CHILDREN.

All formulations of the following products—Quad Dewormer, Drontal Plus, Durvet Dog Worm Tabs, and Drontal Plus Taste Tabs—must be stored securely to prevent accidental ingestion by children.

Side Effects

Isolated incidents of adverse reactions have been reported following the administration of various anthelmintic treatments.

Common Adverse Reactions

• Vomiting: Observed in 2 dogs treated with Drontal Plus Taste Tabs.

• Bloody Stool: Reported in 1 puppy treated with Drontal Plus Taste Tabs and in isolated incidents following treatment with Quad Dewormer and Durvet Dog Worm Tabs.

• Watery/Profuse Stool: Noted in 1 puppy treated with Drontal Plus Taste Tabs and in isolated incidents following treatment with Quad Dewormer and Durvet Dog Worm Tabs.

Clinical Study Findings

• In clinical field studies involving 103 dogs treated with Drontal Plus Anthelmintic Tablets, no drug-related side effects were observed.

Warnings and Precautions

• All products should be kept out of reach of children.

• Strict hygienic precautions are advised when handling dogs or feces suspected of harboring E. multilocularis. Infected dogs treated for the first time with Drontal Plus Tablets or those treated at intervals greater than 28 days may shed eggs in their feces post-treatment. It is recommended that these animals be held in a clinic during this period, and all feces should be incinerated or autoclaved. If incineration or autoclaving is not feasible, feces can be treated with a sodium hypochlorite (bleach) solution of 3.75% or greater to destroy the eggs. All areas where the animal was maintained or had contact should be thoroughly cleaned with sodium hypochlorite and allowed to dry completely before reuse.

Contraindications

• Drontal Plus and Drontal Plus Taste Tabs should not be used in pregnant animals. Elevated dosages of febantel and praziquantel during early pregnancy have been associated with an increased incidence of abortion and fetal abnormalities. The effects of Drontal Plus on pregnant animals have not been determined, although praziquantel and pyrantel pamoate do not have known contraindications in dogs.

Drug Interactions

There is no available information regarding drug interactions for Quad Dewormer, Drontal Plus, or Drontal Plus Taste Tabs. Each of these products does not list any known interactions with other drugs or laboratory tests. Therefore, healthcare professionals should consider this lack of interaction data when prescribing or administering these medications.

Pediatric Use

Pediatric patients should not be treated with Quad Dewormer, Drontal Plus, or Drontal Plus Taste Tabs if they are puppies less than 3 weeks of age or dogs weighing less than 2 lbs.

Dosage Information for Puppies and Small Dogs (2 - 25 lbs.):

• For all three products, the recommended dosages are as follows:

  • 2 - 4 lbs: 0.5 tablets

  • 5 - 7 lbs: 1.0 tablet

  • 8 - 12 lbs: 1.5 tablets

  • 13 - 18 lbs: 2.0 tablets

  • 19 - 25 lbs: 2.5 tablets

Efficacy and Safety:

• Controlled safety evaluations for Drontal Plus have shown that dogs receiving up to 5 times the label dosage for 3 consecutive days exhibited clinical signs of vomiting and non-formed stools. However, no adverse reactions were noted in clinical field studies involving 103 dogs treated with Drontal Plus Anthelmintic Tablets.

Cautions:

• Fasting is neither necessary nor recommended prior to administration of these medications.

• It is important to keep these medications out of reach of children.

Geriatric Use

Elderly patients may require special consideration when administering deworming medications. For Quad Dewormer, it is advised to consult a veterinarian before administering the tablets to weak or debilitated animals, as these patients may have altered pharmacokinetics or increased sensitivity to medications. Additionally, it is important not to deworm a dog or puppy that is sick without first obtaining a proper diagnosis and appropriate care from a veterinarian.

For Drontal Plus and Drontal Plus Taste Tabs, there is no specific information provided regarding geriatric use, dosage adjustments, or safety concerns for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing these medications to geriatric patients. Monitoring for adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety and efficacy of Quad Dewormer (praziquantel/pyrantel pamoate/febantel) in pregnant patients have not been established. It is contraindicated for use in pregnant dogs unless the benefits outweigh the risks. Potential risks to the fetus have not been fully evaluated; therefore, consultation with a veterinarian is advised prior to administration.

Drontal Plus and Drontal Plus Taste Tabs are contraindicated for use in pregnant animals. Studies indicate that dogs treated with elevated levels (6 consecutive days with 3 times the labeled dosage rate) of the combination of febantel and praziquantel during early pregnancy exhibited an increased incidence of abortion and fetal abnormalities. The effects of Drontal Plus on pregnant animals have not been determined, underscoring the need for caution.

Veterinarians should be consulted for guidance when considering treatment options for pregnant patients.

Lactation

There is no specific information available regarding the use of Quad Dewormer, Drontal Plus, or Drontal Plus Taste Tabs in lactating mothers. The drug inserts for these products do not provide any lactation considerations, precautions, or modifications for women who are breastfeeding. Consequently, healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of these medications.

Renal Impairment

Patients with renal impairment may require dosage adjustments when using certain medications. Specifically, for those with reduced renal function, it is advisable to monitor renal function tests regularly to ensure kidney health.

In particular, for patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to mitigate potential risks associated with impaired kidney function. Special monitoring is also recommended for patients with significant renal impairment to ensure safe and effective use of the medication.

Overall, careful assessment and ongoing evaluation of renal function are essential for patients with reduced kidney function to optimize treatment outcomes.

Hepatic Impairment

Patients with hepatic impairment do not have specific dosage adjustments, special monitoring requirements, or precautions outlined for the following products: Quad Dewormer (Tablet, Chewable), Drontal Plus (Tablet), Durvet Dog Worm Tabs (Tablet, Chewable), and Drontal Plus Taste Tabs (Tablet, Chewable). As such, healthcare providers should exercise caution and consider individual patient factors when prescribing these medications to patients with liver problems.

Overdosage

In the event of an overdose, specific information regarding the management and symptoms is not provided for the products Quad Dewormer, Drontal Plus, Durvet Dog Worm Tabs, and Drontal Plus Taste Tabs. As such, it is recommended that individuals monitor for any unusual symptoms or adverse reactions following administration.

In the absence of detailed overdosage information, it is prudent to seek immediate veterinary assistance if an overdose is suspected. Veterinary professionals may recommend supportive care and symptomatic treatment based on the clinical presentation of the animal. Monitoring vital signs and overall health status is advised until professional guidance is obtained.

Nonclinical Toxicology

Teratogenicity

No information is available regarding teratogenic effects for the products evaluated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There is no information provided concerning carcinogenicity, mutagenicity, or impairment of fertility for the products evaluated.

Animal Toxicology

Controlled safety evaluations have been conducted in dogs with Drontal Plus (praziquantel/pyrantel pamoate/febantel) and Drontal Plus Taste Tabs. In these studies, dogs receiving up to 5 times the labeled dosage (35 mg praziquantel, 35 mg pyrantel pamoate, and 179 mg febantel per kg of body weight) for 3 consecutive days exhibited clinical signs of vomition and non-formed stools.

One dog that received a 3 times labeled dose demonstrated elevated levels of SGPT, SGOT, CPK, and GGT at 6 days post-treatment, which were outside of the normal range. However, no additional findings were noted in hematology or clinical chemistry parameters, nor were there any treatment-related histological lesions observed.

Vomition was the only side effect recorded when dogs received a single treatment of 61 mg praziquantel, 61 mg pyrantel pamoate, and 305 mg febantel per kg, with one dog showing an elevated SGPT reading at 24 hours post-treatment, which returned to normal by 7 days.

Storage and Handling

Quad Dewormer, Drontal Plus, Durvet Dog Worm Tabs, and Drontal Plus Taste Tabs are available in tablet and chewable forms.

Tablets should be stored at controlled room temperatures, ideally at or below 77 °F (25 °C). For Drontal Plus Tablets, a temperature range of 59-86°F (15-30°C) is acceptable.

Un-blistered whole or partial tablets must be kept in a tightly sealed container to maintain their integrity and effectiveness.