Safe-Guard

Description

Fenbendazole is the active drug ingredient present at a concentration of 200 grams per kilogram (90.7 grams per pound). The formulation includes inert ingredients such as roughage products or a combination of roughage products and calcium carbonate, along with mineral oil.

Uses and Indications

This drug is indicated for the treatment of various parasitic infections in multiple species, including dairy and beef cattle, swine (growing pigs, gilts, pregnant sows, and boars), horses, zoo and wildlife animals, growing turkeys, and wild quail.

In cattle, the drug is effective against lungworms, specifically adult Dictyocaulus viviparus, and stomach worms, including adult brown stomach worms (Ostertagia ostertagi), adult and fourth stage larvae barberpole worms (Haemonchus contortus and H. placei), and adult and fourth stage larvae small stomach worms (Trichostrongylus axei). Additionally, it treats intestinal worms such as adult and fourth stage larvae hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).

The drug must be mixed with feed prior to administration, following the specified directions and permitted claims. It is intended for use exclusively in manufactured feeds.

Dosage and Administration

The recommended dosage of fenbendazole is 5 mg per kg of body weight, equivalent to 2.27 mg per pound, administered as a single treatment over one day. It is imperative that each animal receives the complete dose based on its current body weight, as underdosing may lead to ineffective treatment and contribute to the development of parasite resistance.

Fenbendazole should be administered by feeding it as the sole ration for one day, with no prior withdrawal of feed or water required. The medication can be provided in the form of Type C medicated cattle feeds containing SAFE-GUARD® 20%, which may be fed either pelleted or as a meal.

For Type C free-choice medicated feed, it must be produced by a licensed feed mill following an approved formula to ensure that a total of 5 mg per kg body weight of fenbendazole is delivered over a period of 3 to 6 days.

Contraindications

Use of this product is contraindicated in the following situations:

The product is not intended for human use. It should not be administered to beef calves less than 2 months of age, dairy calves, or veal calves. Additionally, it is contraindicated in horses that are intended for human consumption due to safety concerns.

Administration should also be avoided 14 days prior to or during the hunting season to prevent potential adverse effects. Underdosing is contraindicated, as it may lead to ineffective treatment and contribute to the development of parasite resistance.

Warnings and Precautions

It is imperative to keep this and all drugs out of the reach of children. This product is not intended for use in humans. For detailed occupational safety information, please refer to the Safety Data Sheet (SDS). For customer service inquiries, adverse effects reporting, or to obtain a copy of the SDS, contact 1-800-211-3573. For additional information regarding adverse drug experience reporting for animal drugs, please reach out to the FDA at 1-888-FDAVETS or visit http://www.fda.gov/reportanimalaehttp://www.fda.gov/reportanimalae.

Parasite resistance may develop with the use of any dewormer, and such resistance has been documented across most classes of dewormers. To mitigate the risk of resistance, it is recommended that treatment with a dewormer be accompanied by appropriate parasite management practices tailored to the specific geographic area and the animals being treated. Prior to administering any dewormer, fecal examinations or other diagnostic tests, along with a review of the parasite management history, should be conducted to ascertain the suitability of the product for the herd. Following dewormer administration, the effectiveness of the treatment should be monitored, for instance, through a fecal egg count reduction test or another suitable method. A decline in the drug's effectiveness, as indicated by fecal egg count reduction tests, may suggest the emergence of resistance to the administered dewormer. It is essential to adjust the parasite management plan based on regular monitoring results.

Regarding withdrawal periods and residue warnings, milk collected during treatment and for 60 hours post-treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following the last treatment with this drug product. This product is not approved for use 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.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this drug.

Warnings:This product is not intended for human use and should be kept out of the reach of children.

Other Warnings:There is a potential for parasite resistance to develop with any dewormer, including this product. Resistance has been reported across most classes of dewormers. To mitigate the risk of resistance, treatment with this dewormer should be accompanied by appropriate parasite management practices tailored to the specific geographic area and the animals being treated. 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 suitability of the product for the herd. Following treatment, the effectiveness of the dewormer should be monitored, for instance, through fecal egg count reduction tests. 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.

Residue Warning:Milk collected during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle treated with this product must not be slaughtered for human consumption within 13 days following the last treatment. This product is not approved for use 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.

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.

Following the administration of any dewormer, it is essential to monitor the effectiveness of the treatment. This can be achieved through methods such as fecal egg count reduction tests or other suitable diagnostic approaches. A noted decrease in the effectiveness of a dewormer, as indicated by these tests, may suggest the emergence of resistance to the administered drug.

Prior to the use of any dewormer, it is advisable to conduct fecal examinations or other relevant diagnostic tests, along with a review of the parasite management history. This assessment will help determine the appropriateness of the product for the herd in question.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not be administered this product, as it is not intended for human use. The product is contraindicated in beef calves less than 2 months of age, dairy calves, and veal calves. Additionally, a withdrawal period has not been established for this product in pre-ruminating calves.

For swine, including growing pigs, gilts, pregnant sows, and boars, the recommended drug feeding rate is 9 mg fenbendazole per kg body weight (4.08 mg fenbendazole per pound), to be administered as the sole ration over a period of 3 to 12 days.

In the case of growing turkeys, the product is indicated for the treatment and control of gastrointestinal worms, specifically roundworms (Ascaridia dissimilis) and cecal worms (Heterakis gallinarum). The recommended drug feeding rate is 14.5 g fenbendazole per ton of feed, to be fed as the sole ration for 6 days.

For wild quail, the product is also indicated for the treatment and control of gastrointestinal worms, particularly cecal worms (Aulonocephalus spp.). The recommended drug feeding rate is 90.7 g fenbendazole per ton of feed, to be administered for 21 days.

It is advised that users exercise clinical judgment regarding the need for retreatment within six weeks, based on the conditions of continued exposure to parasites, the health status of treated animals, and ambient temperatures.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients should be aware that this drug is not intended for human use and is specifically formulated for veterinary applications, including use in swine such as growing pigs, gilts, pregnant sows, and boars. There is no available data regarding the effects of this drug on human pregnancy or fetal outcomes, as it is not approved for use in humans.

Healthcare professionals should advise women of childbearing potential to avoid exposure to this drug. Additionally, it is important to note that swine treated with this drug must not be slaughtered for human consumption within 4 days following the last treatment, which underscores the need for caution in handling and administering this product.

As with all medications, it is crucial to keep this and all drugs out of the reach of children.

Lactation

Lactating mothers should be advised that milk expressed during treatment and for 60 hours after the last treatment must not be used for human consumption. There are no additional data available regarding the excretion of the drug in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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

No specific teratogenic effects have been identified in the studies conducted. Similarly, there are no reported non-teratogenic effects associated with the compound. The available data do not provide any specific insights into nonclinical toxicology, nor are there details regarding animal pharmacology and toxicology.

Postmarketing Experience

Adverse effects have been reported voluntarily and through surveillance programs. It is noted that parasite resistance may develop to any dewormer, which has been documented for most classes of dewormers. Accurate dosing is essential for optimal results, and the effectiveness of treatment should be monitored following the use of any dewormer. A decrease in effectiveness over time, as determined by fecal egg count reduction tests, may indicate the development of resistance to the administered dewormer. Consequently, the parasite management plan should be adjusted based on regular monitoring.

For customer service inquiries, adverse effects reporting, or to obtain a copy of the Safety Data Sheet (SDS), individuals may contact 1-800-211-3573. Additional information regarding adverse drug experience reporting for animal drugs can be obtained from the FDA at 1-888-FDAVETS or through the website http://www.fda.gov/reportanimalae. It is imperative to keep this and all drugs out of the reach of children and to note that this product is not for use in humans. The SDS contains more detailed occupational safety information.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of the reach of children and to note that this product is not intended for use in humans. For detailed occupational safety information, patients can refer to the Safety Data Sheet (SDS). Should patients require customer service, wish to report adverse effects, or need a copy of the SDS, they should be directed to call 1-800-211-3573. For additional information regarding adverse drug experience reporting for animal drugs, patients can contact the FDA at 1-888-FDAVETS or visit http://www.fda.gov/reportanimalae.

It is important to inform patients that parasite resistance may develop to any dewormer, and this has been reported for most classes of dewormers. Treatment with a dewormer, when used alongside appropriate parasite management practices for the specific geographic area and the animals being treated, may help slow the development of resistance. Patients should be encouraged to conduct fecal examinations or other diagnostic tests, along with reviewing the parasite management history, to determine the appropriateness of the product for their herd prior to administering any dewormer. 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 made aware of the withdrawal periods and residue warnings associated with this product. Specifically, milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following the last treatment with this drug product. Additionally, this product is not to be used in beef calves less than 2 months of age, dairy calves, or veal calves, as a withdrawal period has not been established for pre-ruminating calves.

Healthcare providers should emphasize the importance of avoiding underdosing. Each animal must receive a complete dose based on its current body weight, as underdosing may lead to ineffective treatment and promote the development of parasite resistance. Accurate dosing is essential for optimal results with all dewormers, and the effectiveness of treatment should be monitored post-administration. Any decrease in effectiveness over time may indicate resistance, prompting necessary adjustments to the parasite management plan.

Patients should also be cautioned against using this product in horses intended for human consumption. It is advisable for patients to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Finally, patients should be instructed to store the product at or below 25°C (77°F), with excursions permitted up to 40°C (104°F).

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at or below 25°C (77°F). Temporary excursions up to 40°C (104°F) are permissible. Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This document includes the full labeling information for Safe-Guard, 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)