Safe-Guard

Description

safe-guard® (fenbendazole) is a dewormer specifically formulated for goats. It is presented as a 10% suspension, containing 100 mg of fenbendazole per mL. The product is supplied in a 125 mL (4.2 fl oz) bottle and is manufactured by MERCK Animal Health.

Uses and Indications

This drug is indicated for the treatment and control of stomach worms in goats, specifically targeting adult infections caused by Haemonchus contortus and Teladorsagia circumcincta.

The recommended dosage is 2.3 mg per pound (5 mg per kg) of body weight.

Dosage and Administration

The medication is to be administered orally. The recommended dosage is 2.3 mg per pound of body weight, which corresponds to 5 mg per kilogram. For accurate dosing, healthcare professionals should administer 2.3 mL of the drug for every 100 pounds of body weight.

It is essential to ensure that the patient is properly weighed to determine the correct volume of the medication to be administered. Care should be taken to measure the dosage accurately to maintain therapeutic efficacy and minimize the risk of adverse effects.

Contraindications

Use is contraindicated in lactating goats due to potential adverse effects on milk production and quality.

This product is not intended for human use and should be kept out of reach of children. Additionally, it is essential to administer the full prescribed dose based on the current body weight of each animal to avoid underdosing.

Warnings and Precautions

It is imperative to note that this product is not intended for use in humans. Healthcare professionals must ensure that this product is stored securely and kept out of reach of children to prevent accidental exposure.

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

In the event of adverse drug experiences related to animal drugs, healthcare professionals 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 on reporting procedures.

Side Effects

The use of this product is contraindicated in humans. It is imperative to keep this product out of reach of children to prevent accidental ingestion or exposure. No specific adverse reactions have been documented in clinical trials or postmarketing experiences, but the warnings highlight the potential risks associated with human use.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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 use in humans. It is crucial to keep this product out of reach of children to prevent accidental ingestion or misuse.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for SAFE-GUARD (fenbendazole) suspension. As such, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of targeted data for this population. Monitoring for efficacy and potential adverse effects is advisable, given the general considerations for medication use in older adults.

Pregnancy

The safety of fenbendazole during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for the administration of fenbendazole in this population. Healthcare professionals should exercise caution when considering the use of fenbendazole in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. Further studies may be necessary to clarify the implications of fenbendazole use during pregnancy.

Lactation

Lactating mothers should be aware that a milk discard time has not been established for this product. Therefore, it is not recommended for use in lactating goats. There is no available data regarding excretion in human breast milk or effects on breastfed infants. Caution is advised when considering the use of this product 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 clinical trials for this medication. Consequently, there is no information available 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.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, the use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent. Consultation with a poison control center or toxicology expert is recommended for guidance on specific management strategies tailored to the situation.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 is a recognized phenomenon across most classes of these medications. A decrease in the effectiveness of a drug over time, as determined by fecal egg count reduction tests, may suggest the emergence of resistance to the administered dewormer. Additionally, underdosing has been associated with ineffective treatment outcomes and may contribute to the development of resistance in parasites.

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. 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 to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is crucial to emphasize that the product is not for use in humans and must be kept out of reach of children.

Providers should inform patients that the Safety Data Sheet (SDS) contains detailed occupational safety information, and for customer service, adverse effects reporting, or to obtain a copy of the SDS, they can call 1-800-211-3573. Additionally, for further information regarding adverse drug experience reporting for animal drugs, patients should be directed to contact the FDA at 1-888-FDAVETS or visit http://www.fda.gov/reportanimalae.

Patients should be made aware that parasite resistance may develop to any dewormer, and this has been reported for most classes of dewormers. It is important to discuss that treatment with a dewormer, when used in conjunction with appropriate parasite management practices tailored to the geographic area and the specific animal(s) being treated, may help slow the development of parasite resistance.

Healthcare providers should recommend that fecal examinations or other diagnostic tests, along with a history of parasite management, be utilized to determine the appropriateness of the product for the herd prior to administering any dewormer. Following the use of a 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.

Patients should be advised to adjust their parasite management plan based on regular monitoring. It is essential to stress the importance of not underdosing; each animal must receive a complete dose based on its current body weight. Underdosing may lead to ineffective treatment and promote the development of parasite resistance.

Finally, providers should instruct patients on proper storage conditions, advising them to store the product at or below 25°C (77°F), protect it from freezing, and shake well before use. In California, it is important to note that this is a restricted drug and should be used only as directed.

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

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)