Drontal Plus Taste Tabs

Description

Each Drontal Plus Taste Tabs Tablet for Puppies and Small Dogs contains 22.7 mg praziquantel, 22.7 mg pyrantel base as pyrantel pamoate, and 113.4 mg febantel. Each tablet for Medium Sized Dogs contains 68.0 mg praziquantel, 68.0 mg pyrantel base as pyrantel pamoate, and 340.2 mg febantel. Each tablet for Large Dogs contains 136.0 mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate, and 680.4 mg febantel.

Uses and Indications

Drontal Plus (praziquantel/pyrantel pamoate/febantel) Taste Tabs are indicated for the removal of various intestinal parasites in dogs. This formulation is specifically designed for use in puppies and small dogs weighing between 2 to 25 pounds.

This drug is indicated for the removal of tapeworms, including:

• Dipylidium caninum

• Taenia pisiformis

• Echinococcus granulosus

• Echinococcus multilocularis (for removal and control)

Additionally, Drontal Plus is indicated for the removal of hookworms, specifically:

• Ancylostoma caninum

• Uncinaria stenocephala

The drug also targets ascarids, including:

• Toxocara canis

• Toxascaris leonina

Furthermore, it is indicated for the removal of whipworms, specifically:

• Trichuris vulpis

Limitations of use include its specific application for dogs only, and it is not intended for use in other animal species.

Dosage and Administration

The presence of parasites must be confirmed through a laboratory fecal examination prior to treatment. Weigh the animal to determine the appropriate dosage, which should be administered as a single oral treatment according to the following dosage chart:

Drontal Plus Taste Tabs Tablets Dosage Chart

| Body Weight (lbs.) | Number of Tablets | Body Weight (lbs.) | Number of Tablets | Body Weight (lbs.) | Number of Tablets ||---------------------|-------------------|---------------------|-------------------|---------------------|-------------------|| 2 - 4 | 0.5 | 26 - 30 | 1.0 | 45 - 60 | 1.0 || 5 - 7 | 1.0 | 31 - 44 | 1.5 | 61 - 90 | 1.5 || 8 - 12 | 1.5 | 45 - 60 | 2.0 | 91 - 120 | 2.0 || 13 - 18 | 2.0 | | | | || 19 - 25 | 2.5 | | | | |

Drontal Plus Taste Tabs Tablets are generally well accepted by dogs. The tablets can be administered by hand, given directly into the mouth, or mixed with a small amount of food. It is not necessary to fast the animal before or after treatment.

Contraindications

Use of this product is contraindicated in pregnant animals. Administration of elevated levels of the combination of febantel and praziquantel in dogs during early pregnancy has been associated with an increased incidence of abortion and fetal abnormalities. The effects of Drontal Plus Anthelmintic Tablets on pregnant animals have not been established. There are no known contraindications for the use of praziquantel or pyrantel pamoate in dogs.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals should ensure that patients are aware of the importance of storing this medication securely. In addition, it is recommended that patients be educated on the potential risks associated with improper use, particularly in pediatric populations.

Regular monitoring and patient education are essential components of safe medication management.

Side Effects

In clinical studies involving Drontal Plus Anthelmintic Tablets, none of the 103 dogs treated exhibited drug-related side effects, indicating a favorable safety profile for this formulation. However, adverse reactions were reported in dogs treated with Drontal Plus Taste Tabs Tablets. Specifically, two dogs experienced vomiting, while one puppy presented with bloody or mucoid stool, and another puppy had watery or profuse stool.

It is important to note that strict hygienic precautions should be observed when handling dogs or feces that may harbor E. multilocularis. Infected dogs receiving their first treatment with Drontal Plus Taste Tabs Tablets, as well as those treated at intervals exceeding 28 days, may shed eggs in their feces post-treatment. To mitigate this risk, it is recommended that these animals be held in a clinical setting during this period, and all feces should be incinerated or autoclaved. If incineration or autoclaving is not feasible, feces can be treated by soaking in a sodium hypochlorite (bleach) solution of 3.75% or greater. Additionally, all areas where the animal was maintained or had contact should be thoroughly cleaned with sodium hypochlorite and allowed to dry completely before reuse.

Patients and caregivers should be advised to keep this medication out of reach of children. Furthermore, Drontal Plus Anthelmintic Tablets are contraindicated in pregnant animals. Dogs treated with elevated levels of the combination of febantel and praziquantel during early pregnancy have shown an increased incidence of abortion and fetal abnormalities. The effects of Drontal Plus Anthelmintic Tablets on pregnant animals have not been determined, and there are no known contraindications against the use of praziquantel or pyrantel pamoate in dogs.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists each NDC Code for Drontal Plus Taste Tabs (praziquantel, pyrantel pamoate, febantel) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not be administered this product if they are puppies less than 3 weeks of age or dogs weighing less than 2 lbs.

For dosing, the following guidelines apply based on body weight:

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

• 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

Medium Sized Dogs (26 - 60 lbs.):

• 26 - 30 lbs: 1.0 tablet

• 31 - 44 lbs: 1.5 tablets

• 45 - 60 lbs: 2.0 tablets

Large Dogs (45 lbs. and greater):

• 45 - 60 lbs: 1.0 tablet

• 61 - 90 lbs: 1.5 tablets

• 91 - 120 lbs: 2.0 tablets

It is essential to keep this product out of reach of children.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments or safety concerns. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should not be treated with this medication, as its effects on pregnant animals have not been determined. In a study involving dogs, administration of elevated levels of the combination of febantel and praziquantel during early pregnancy (specifically, 6 consecutive days at 3 times the labeled dosage rate) resulted in an increased incidence of abortion and fetal abnormalities. Therefore, healthcare professionals are advised to exercise caution and avoid prescribing this medication to pregnant individuals due to the potential risks to fetal outcomes.

Lactation

There are no specific statements regarding nursing mothers or lactation considerations in the provided drug insert for Drontal Plus Taste Tabs. Therefore, the effects on lactating mothers and breastfed infants remain undefined. Healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function. Regular renal function tests should be performed to assess kidney health and guide treatment decisions. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with therapy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any concerning signs or symptoms develop, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

Nonclinical Toxicology

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

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

In a separate evaluation, vomition was the only side effect recorded when dogs were administered a single treatment of 61 mg praziquantel, 61 mg pyrantel pamoate, and 305 mg febantel per kg. One dog in this group also exhibited an elevated SGPT reading at 24 hours post-treatment, which returned to normal by seven days.

Postmarketing Experience

In postmarketing surveillance, no drug-related side effects were reported in 103 dogs treated with Drontal Plus Anthelmintic Tablets during clinical field studies. However, in laboratory studies involving 40 dogs treated with Drontal Plus Taste Tabs Tablets, two dogs experienced vomiting, while one puppy exhibited bloody/mucoid stool and another puppy presented with watery/profuse stool.

Controlled safety evaluations of Drontal Plus (praziquantel/pyrantel pamoate/febantel) Anthelmintic Tablets indicated that dogs receiving doses up to five times the labeled dosage (35 mg praziquantel, 35 mg pyrantel pamoate, and 179 mg febantel per kg of body weight) for three consecutive days (three times the labeled duration) displayed clinical signs of vomiting and non-formed stools. Additionally, one dog that received a three times labeled dose showed elevated SGPT, SGOT, CPK, and GGT levels at six days post-treatment, although no other abnormalities were noted in hematology or clinical chemistry parameters, nor were there any treatment-related histological lesions.

In instances of a single treatment with 61 mg praziquantel, 61 mg pyrantel pamoate, and 305 mg febantel per kg, vomiting was the only side effect observed. One dog exhibited an elevated SGPT reading at 24 hours post-treatment, which returned to normal by seven days.

Patient Counseling

Healthcare providers should advise patients that the use of Drontal Plus Anthelmintic Tablets in dogs during early pregnancy, particularly at elevated dosage levels (three times the labeled dosage for six consecutive days), has been associated with an increased incidence of abortion and fetal abnormalities. It is important to communicate that the effects of this medication on pregnant animals have not been fully determined.

Patients should be informed about the necessity of strict hygienic precautions when handling dogs or feces that may harbor Echinococcus multilocularis. Infected dogs, especially those treated for the first time with Drontal Plus Taste Tabs 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 the clinic during this period, and all feces should be incinerated or autoclaved. If incineration or autoclaving is not feasible, feces should be soaked in a sodium hypochlorite (bleach) solution of 3.75% or greater to destroy the eggs. Additionally, all areas where the animal was maintained or had contact should be thoroughly cleaned with sodium hypochlorite and allowed to dry completely before reuse.

Patients must be reminded to keep this medication out of reach of children. For animals living in environments where reinfections are likely, clients should be instructed on preventive measures to minimize the risk of reinfection. This is particularly relevant in cases of Dipylidium caninum, where reinfection is almost certain if fleas are not eliminated from the animal and its surroundings. For effective control of Echinococcus multilocularis, a regular treatment program every 21 to 26 days may be necessary.

Pet owners should also be counseled on how to minimize the risk of Echinococcus multilocularis infection, emphasizing the importance of proper restraint of dogs and adherence to the recommended dosing schedule for Drontal Plus Taste Tabs Tablets. A follow-up fecal examination should be conducted 2 to 4 weeks after treatment to assess the need for any retreatment.

Storage and Handling

Drontal Plus Taste Tabs Tablets are supplied in a package that includes NDC numbers relevant to the product. These tablets should be stored at or below 77 °F (25 °C) to maintain their efficacy.

Un-blistered whole or partial tablets must be kept in a tightly sealed container to protect them from moisture and contamination. Proper storage conditions are essential to ensure the integrity and effectiveness of the tablets.

Additional Clinical Information

The presence of parasites in patients should be confirmed through laboratory fecal examination. Most dogs find Drontal Plus Taste Tabs Tablets palatable, and these tablets can be administered by hand, directly by mouth, or mixed with a small amount of food. It is important to note that fasting is neither necessary nor recommended before or after treatment.

Clinicians should counsel pet owners on minimizing the risk of E. multilocularis infection, emphasizing the importance of proper restraint of dogs and adherence to the dosing schedule and precautions associated with Drontal Plus Taste Tabs Tablets.

Drug Information (PDF)

This document includes the full labeling information for Drontal Plus Taste Tabs, as submitted by Elanco US Inc. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)