Panacur

Description

Panacur® (fenbendazole) is a dewormer formulated for use in beef and dairy cattle. It is presented as a 10% suspension, containing 100 mg of fenbendazole per milliliter. The product is supplied in a 1-gallon container, which is equivalent to 3,785 milliliters. Panacur® is manufactured by MERCK Animal Health.

Uses and Indications

This drug is indicated for the treatment and control of various parasitic infections in beef and dairy cattle. Specifically, it is effective against:

Lungworms

• Adult Dictyocaulus viviparus

Stomach Worms

• Adult brown stomach worms (Ostertagia ostertagi)

• Adult and fourth stage larvae barberpole worms (Haemonchus contortus and H. placei)

• Adult and fourth stage larvae small stomach worms (Trichostrongylus axei)

Intestinal Worms

• Adult and fourth stage larvae hookworms (Bunostomum phlebotomum)

• Adult and fourth stage larvae thread-necked intestinal worms (Nematodirus helvetianus)

• Adult and fourth stage larvae small intestinal worms (Cooperia punctata and C. oncophora)

• Adult and fourth stage larvae bankrupt worms (Trichostrongylus colubriformis)

• Adult and fourth stage larvae nodular worms (Oesophagostomum radiatum)

For the treatment and control of the aforementioned conditions, the recommended dosage is 2.3 mg/lb (5 mg/kg) of body weight.

For beef cattle only, a higher dosage of 4.6 mg/lb (10 mg/kg) is indicated for the treatment and control of:

• Stomach worms (fourth stage inhibited larvae) (Ostertagia ostertagi - Type II Ostertagiasis)

• Tapeworms (Moniezia benedeni)

Caution is advised as this drug should not be used in dairy cattle at the dosage of 10 mg/kg.

Dosage and Administration

The drug is to be administered orally. For beef and dairy cattle, the recommended dosage is 2.3 mg/lb (5 mg/kg), which corresponds to 2.3 mL of the drug for every 100 lb of body weight.

In beef cattle specifically, a higher dosage of 4.6 mg/lb (10 mg/kg) is indicated for the treatment and control of Type II Ostertagiasis (4th stage inhibited larvae) or tapeworms. This dosage is achieved by administering 4.6 mL of the drug for each 100 lb of body weight.

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.

• This product is not intended for human use.

• It should not be administered to beef calves under 2 months of age, dairy calves, or veal calves.

Additionally, milk from treated cows must 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

The product is strictly contraindicated for use in humans. It is imperative to ensure that this product is kept out of reach of children to prevent accidental ingestion or exposure.

For comprehensive occupational safety information, healthcare professionals should refer to the Safety Data Sheet (SDS), which provides detailed guidance on handling and potential hazards associated with the product. Should there be a need for customer service assistance, reporting of adverse effects, or obtaining a copy of the SDS, professionals can contact the dedicated helpline at 1-800-211-3573.

In the event of adverse drug experiences related to animal drugs, healthcare providers are encouraged to report these incidents to the FDA. This can be done by calling 1-888-FDAVETS or visiting the FDA's website at http://www.fda.gov/reportanimalae for further instructions and information.

Side Effects

The product is not intended for use in humans and should be kept out of reach of children. Due to the lack of specific adverse reactions listed, it is essential for patients and caregivers to adhere strictly to these warnings to prevent potential harm.

Drug Interactions

Parasite resistance may develop to any dewormer, and this phenomenon has been reported across most classes of dewormers. To mitigate the risk of resistance, it is recommended that dewormers be used in conjunction with appropriate parasite management practices tailored to the specific geographic area and the animal(s) being treated.

Prior to administering any dewormer, it is essential to conduct fecal examinations or other diagnostic tests, along with a review of the parasite management history, to ascertain the suitability of the product for the herd. Following treatment with a dewormer, the effectiveness of the intervention should be monitored. This can be achieved through methods such as fecal egg count reduction tests or other appropriate diagnostic techniques. A noted decrease in the effectiveness of a dewormer, as indicated by these tests, may suggest the emergence of resistance to the administered agent. Consequently, it is advisable to adjust the parasite management plan based on the results of regular monitoring to ensure continued efficacy in controlling parasitic infections.

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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, 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 may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. Additionally, there are no dosage modifications required for pregnant animals, indicating a lack of identified risks in animal studies. Furthermore, the prescribing information does not mention any special precautions regarding the use of this medication during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

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. Lactating mothers should be advised to avoid breastfeeding during the specified period to ensure the safety of the nursing infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

There is no available information regarding teratogenic or non-teratogenic effects in the insert. Additionally, the insert does not provide any details related to nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

Adverse effects have been reported voluntarily and through surveillance programs. Notably, there have been instances of parasite resistance developing to various dewormers, which has been documented across most classes of these medications. Following the administration of any dewormer, it is recommended that the effectiveness of the treatment be monitored. This can be achieved through methods such as fecal egg count reduction tests or other appropriate assessments. A decrease in the drug's effectiveness over time, as determined by these tests, may suggest the emergence of resistance to the dewormer used.

For customer service inquiries, including adverse effects reporting or requests for a copy of the Safety Data Sheet (SDS), individuals may contact 1-800-211-3573. For further information regarding adverse drug experience reporting for animal drugs, the FDA can be reached at 1-888-FDAVETS or through their website at http://www.fda.gov/reportanimalae.

Patient Counseling

Healthcare providers should advise patients that this product is not to be used in dairy cattle at a dosage of 10 mg/kg. It is crucial to ensure that each animal receives a complete dose based on its current body weight, as underdosing may lead to ineffective treatment and promote the development of parasite resistance.

Patients must be informed that this product is not for human use and should be kept out of reach of children. For detailed occupational safety information, patients can refer to the Safety Data Sheet (SDS). Should they require customer service, wish to report adverse effects, or need a copy of the SDS, they can call 1-800-211-3573.

Healthcare providers should discuss the potential for parasite resistance, which may develop with any dewormer and has been reported for most classes of dewormers. It is recommended that treatment with a dewormer be used in conjunction with appropriate parasite management practices tailored to the geographic area and the specific animals being treated, as this may help slow the development of resistance.

Prior to administering 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 treatment, the effectiveness 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 these tests, may suggest the development of resistance, necessitating adjustments to the parasite management plan based on regular monitoring.

Patients should be instructed to store the product at or below 25°C (77°F) and to protect it from freezing. It is important to shake the product well before use. Additionally, milk from treated cows must not be used for human consumption during treatment and for 48 hours after the last treatment. Cattle must not be slaughtered for human consumption within 8 days following the last treatment with this drug product.

Healthcare providers should also inform patients that this product is not for use in beef calves less than 2 months of age, dairy calves, or veal calves, and that a withdrawal period has not been established for this product in pre-ruminating calves. Finally, it is essential to communicate that federal law restricts this drug to use by or on the order of a licensed veterinarian.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at or below 25°C (77°F) to maintain its efficacy. Additionally, the product must be protected from freezing to prevent any potential degradation. Prior to administration, it is recommended to shake the product well to ensure proper mixing and uniformity.

Additional Clinical Information

Fecal examinations or 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, the effectiveness should be monitored, for instance, through a fecal egg count reduction test. A decline in drug effectiveness over time may suggest the development of resistance, necessitating adjustments to the parasite management plan based on regular monitoring.

The product is administered orally, with a recommended dose of 2.3 mg/lb (5 mg/kg) for beef and dairy cattle, corresponding to 2.3 mL per 100 lb of body weight. For beef cattle specifically, a higher dose of 4.6 mg/lb (10 mg/kg) is indicated for the treatment and control of Type II Ostertagiasis or tapeworms, achieved by administering 4.6 mL per 100 lb of body weight. 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 or contact customer service at 1-800-211-3573. Adverse drug experience reporting for animal drugs can be directed to the FDA at 1-888-FDAVETS or through their website.

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)