Panacur

Description

Panacur is a suspension formulation containing fenbendazole as the active ingredient. It is available in a concentration of 10%, which corresponds to 100 mg/mL.

Uses and Indications

This drug is indicated for the treatment and control of various parasitic infections in horses, beef cattle, and dairy cattle.

In horses, the drug is administered at a dosage of 2.3 mg/lb (5 mg/kg) for the treatment and control of large strongyles (including Strongylus edentatus, S. equinus, S. vulgaris, and Triodontophorus spp.), small strongyles (including Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., and Cylicodontophorus spp.), and pinworms (Oxyuris equi). For the treatment and control of ascarids (Parascaris equorum), a higher dosage of 4.6 mg/lb (10 mg/kg) is recommended.

In beef and dairy cattle, the drug is indicated at a dosage of 2.3 mg/lb (5 mg/kg) for the treatment and control of lungworms (adult Dictyocaulus viviparus), stomach worms (including adult Ostertagia ostertagi, adult and fourth stage larvae of barberpole worms (Haemonchus contortus & H. placei), and adult and fourth stage larvae of small stomach worms (Trichostrongylus axei), as well as intestinal worms (adult and fourth stage larvae) such as hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).

For beef cattle only, the drug is indicated at a dosage of 4.6 mg/lb (10 mg/kg) for the treatment and control of stomach worms (fourth stage inhibited larvae of Ostertagia ostertagi, Type II Ostertagiasis) and tapeworms (Moniezia benedeni). It is important to note that this higher dosage should not be used in dairy cattle.

Dosage and Administration

The drug is to be administered orally using a suitable dosing syringe. The nozzle of the syringe should be inserted through the interdental space, and the drug should be deposited on the back of the tongue by depressing the plunger. Alternatively, the drug may be administered via a stomach tube.

Dosing is based on the animal's body weight, with the following recommended dosages:

• For a 100 lb animal:

  • At a dose of 5 mg/kg: 2.3 mL

  • At a dose of 10 mg/kg: 4.6 mL

• For a 200 lb animal:

  • At a dose of 5 mg/kg: 4.6 mL

  • At a dose of 10 mg/kg: 9.2 mL

• For a 300 lb animal:

  • At a dose of 5 mg/kg: 6.9 mL

  • At a dose of 10 mg/kg: 13.8 mL

• For a 400 lb animal:

  • At a dose of 5 mg/kg: 9.2 mL

  • At a dose of 10 mg/kg: 18.4 mL

• For a 500 lb animal:

  • At a dose of 5 mg/kg: 11.5 mL

  • At a dose of 10 mg/kg: 23.0 mL

• For a 1000 lb animal:

  • At a dose of 5 mg/kg: 23.0 mL

  • At a dose of 10 mg/kg: 46.0 mL

• For a 1500 lb animal:

  • At a dose of 5 mg/kg: 34.5 mL

  • At a dose of 10 mg/kg: 69.0 mL

It is imperative to avoid underdosing. Each animal must receive a complete dose based on its current body weight to ensure effective treatment and to prevent the development of parasite resistance.

Contraindications

Use of this product is contraindicated in the following situations:

• Administration in dairy cattle at a dosage of 10 mg/kg is prohibited.

• The product must not be used in horses intended for human consumption.

• It is contraindicated for use in beef calves less than 2 months of age, as well as in dairy calves and veal calves.

Additionally, milk from treated cows should not be consumed by humans during treatment and for 48 hours post-treatment. Cattle must not be slaughtered for human consumption within 8 days following the last treatment with this product.

Warnings and Precautions

It is imperative to note that this product is not intended for use in humans. Strict adherence to this guideline is essential to ensure safety and efficacy.

To prevent accidental ingestion, the product must be kept out of reach of children. This precaution is critical in safeguarding against potential harm.

For comprehensive occupational safety information, healthcare professionals are encouraged to consult the Safety Data Sheet (SDS). This document provides detailed insights into handling, storage, and emergency measures related to the product.

In the event of adverse effects or for customer service inquiries, healthcare professionals can reach out by calling 1-800-211-3573. This line is also available for obtaining a copy of the SDS.

For further information regarding the reporting of adverse drug experiences associated with animal drugs, professionals should contact the FDA at 1-888-FDAVETS or visit their website at http://www.fda.gov/reportanimalaehttp://www.fda.gov/reportanimalae. This resource is vital for ensuring the safety and well-being of animal patients.

Side Effects

The product is not intended for use in humans and should be kept out of reach of children. Detailed occupational safety information can be found in the Safety Data Sheet (SDS). For customer service inquiries, reporting of adverse effects, or to obtain a copy of the SDS, individuals may contact 1-800-211-3573.

For additional information regarding the reporting of adverse drug experiences related to animal drugs, individuals are encouraged to reach out to the FDA at 1-888-FDAVETS or visit http://www.fda.gov/reportanimalae.

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 necessary at this time.

Packaging & NDC

The table below lists each NDC Code for Panacur (fenbendazole) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product in beef calves less than 2 months of age, dairy calves, or veal calves. Additionally, a withdrawal period has not been established for this product in pre-ruminating calves, indicating the need for caution in this population.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available data regarding the use of this medication during pregnancy do not indicate any specific safety concerns. There are no explicit recommendations for dosage modifications in pregnant animals, nor are there any special precautions outlined for the use of this medication in pregnant patients.

Healthcare professionals should consider the absence of detailed safety information when prescribing this medication to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes, as the effects of this medication during pregnancy have not been thoroughly studied.

Lactation

Lactating mothers should be aware that milk taken from cows during treatment and for 48 hours after the last treatment must not be used for human consumption. There is no available data on the excretion of this product in human breast milk or its effects on breastfed infants. Therefore, caution is advised when considering the use of this product in lactating mothers.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive administration of the medication.

Healthcare providers should be aware that symptoms of overdosage may vary depending on the pharmacological properties of the drug and the individual patient's response. In cases where overdosage is suspected, immediate medical evaluation is recommended.

Management of overdosage should include supportive care and symptomatic treatment. Healthcare professionals are advised to monitor the patient closely for any adverse effects and to implement appropriate interventions based on the clinical presentation.

In the event of an overdose, contacting a poison control center or seeking guidance from a medical toxicologist may be beneficial for tailored management strategies. It is crucial to document the incident thoroughly and report any adverse events to the relevant regulatory authorities as per local guidelines.

Overall, while specific overdosage information is not provided, the importance of prompt recognition and management cannot be overstated in ensuring patient safety.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that resistance to dewormers may develop in parasites, a phenomenon reported across most classes of deworming agents. It is noted that the use of a dewormer in conjunction with appropriate parasite management practices tailored to the specific geographic area and the animals being treated may help mitigate the development of such resistance.

Prior to administering any dewormer, it is recommended that fecal examinations or other diagnostic tests, along with a review of the parasite management history, be conducted to assess the suitability of the product for the herd. Following treatment with a dewormer, it is essential to monitor the effectiveness of the intervention, which can be evaluated through methods such as fecal egg count reduction tests.

A decline in the effectiveness of a dewormer, as determined by these tests, may suggest the emergence of resistance to the administered agent. Consequently, it is advised that the parasite management plan be adjusted based on the results of regular monitoring to ensure continued efficacy.

Patient Counseling

Healthcare providers should advise patients not to use this product in dairy cattle at a dosage of 10 mg/kg. It is important to instruct patients to shake the product well before use and to store it at or below 25°C (77°F), ensuring it is protected from freezing.

Patients should be informed on the proper administration of the product. It should be administered orally using a suitable dosing syringe. The nozzle of the syringe should be inserted through the interdental space, and the drug should be deposited on the back of the tongue by depressing the plunger. Alternatively, the drug may also be administered via a stomach tube. Emphasize the importance of not underdosing, as each animal must receive a complete dose based on its current body weight. Underdosing may lead to ineffective treatment and could encourage the development of parasite resistance.

It is critical to communicate that this product is not for use in humans and should be kept out of reach of children. Additionally, patients should be made aware that the Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service inquiries, adverse effects reporting, or to obtain a copy of the SDS, patients can call 1-800-211-3573. For further information regarding adverse drug experience reporting for animal drugs, they should contact the FDA at 1-888-FDAVETS or visit http://www.fda.gov/reportanimalae.

Patients should also be cautioned against using this product in horses intended for human consumption. It is important to discuss the potential for parasite resistance, which may develop with any dewormer, as has been reported for most classes of dewormers. Treatment with a dewormer, in conjunction with appropriate parasite management practices tailored to the geographic area and the specific animals being treated, may help slow the development of parasite resistance.

Before using any dewormer, fecal examinations or other diagnostic tests, along with a review of the parasite management history, should be conducted to determine the appropriateness of the product for the herd. Following the use of any dewormer, the effectiveness of the treatment should be monitored, for example, through a fecal egg count reduction test or another suitable method. A decrease in the drug's effectiveness over time, as indicated by fecal egg count reduction tests, may suggest the development of resistance to the administered dewormer. Therefore, patients should be encouraged to adjust their parasite management plan based on regular monitoring.

Storage and Handling

The product is supplied in a configuration that requires careful handling. It is essential to shake well before use to ensure proper mixing of the contents.

For optimal storage, the product should be maintained at or below 25°C (77°F). It is crucial to protect the product from freezing to preserve its efficacy and integrity.

Additional Clinical Information

Fecal examinations and other diagnostic tests, along with a history of parasite management, should be utilized to assess the appropriateness of the product for the herd prior to administering any dewormer. Following treatment, clinicians should monitor the effectiveness of the dewormer, for instance, through fecal egg count reduction tests. A decline in drug effectiveness over time may suggest the emergence of resistance, necessitating adjustments to the parasite management plan based on regular monitoring.

The product is administered orally using a suitable dosing syringe, with the nozzle inserted through the interdental space to deposit the drug on the back of the tongue. It may also be given via stomach tube. It is crucial to note that this product is not for human use and should be kept out of reach of children. For further information regarding safety and adverse effects, clinicians can refer to the Safety Data Sheet (SDS) or contact customer service. Additionally, it is important to recognize that parasite resistance can develop with any dewormer, and employing a comprehensive parasite management strategy may help mitigate this risk.

Drug Information (PDF)

This document includes the full labeling information for Panacur, as submitted by Merck Sharp & Dohme Corp. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)