Safe-Guard

Description

safe-guard is a canine dewormer formulated as granules containing the active ingredient Fenbendazole at a concentration of 22.2% (222 mg/g). This product is indicated for use in dogs aged 6 weeks and older.

Uses and Indications

This drug is indicated for the treatment of intestinal parasitic infections in dogs, specifically for those 6 weeks of age and older, including pregnant bitches. It is effective against the following conditions:

• Tapeworms (Taenia pisiformis)

• Roundworms (Toxocara canis, Toxascaris leonina)

• Hookworms (Ancylostoma caninum, Uncinaria stenocephala)

• Whipworms (Trichuris vulpis)

Healthcare professionals are advised to consult with a veterinarian for the accurate diagnosis of the illness and for guidance on the treatment and control of parasitism. It is important to note that this drug should not be administered to dogs or puppies that are currently ill.

Dosage and Administration

The recommended daily dose of Safe-Guard® Canine is 50 mg/kg (22.7 mg/lb) of body weight, administered for a duration of three consecutive days. The following dosing guidelines are provided based on the weight of the dog:

For dogs weighing 10 lbs, administer 1 gram daily. For those weighing between 11 to 20 lbs, the daily dose is 2 grams. Dogs weighing 21 to 30 lbs should receive a combination of 1 gram and 2 grams, totaling 3 grams daily. For dogs in the 31 to 40 lbs range, the daily dose is 4 grams.

For dogs weighing 41 to 50 lbs, the recommended dosage is 1 gram combined with 4 grams, resulting in a total of 5 grams daily. Dogs weighing 51 to 60 lbs should receive 2 grams plus 4 grams, equating to 6 grams daily. For dogs weighing 61 to 80 lbs, the daily dose is two pouches of 4 grams each, totaling 8 grams.

For dogs over 80 lbs, specific dosing information is not provided; therefore, consultation with a veterinarian is advised for appropriate dosing.

The daily dose should be mixed with a small amount of the dog's usual food to ensure complete consumption. It may be necessary to moisten dry dog food to facilitate the mixing process. It is essential that the dog consumes all of the medicated food to ensure the full dose is administered. Repeat the dosing regimen for three consecutive days to achieve the desired therapeutic effect.

Contraindications

Deworming is contraindicated in dogs or puppies that are exhibiting signs of illness. It is essential to consult a veterinarian for a proper diagnosis of the underlying condition before proceeding with deworming treatment.

Warnings and Precautions

It is imperative that deworming procedures are not initiated in dogs or puppies exhibiting signs of illness. A thorough consultation with a veterinarian is essential for accurate diagnosis and appropriate management of any underlying health issues.

Roundworms and hookworms present significant health risks to humans. Regular deworming practices are recommended to mitigate these risks effectively.

Veterinarians should be consulted for assistance in diagnosing, treating, and managing parasitic infections. Specific diagnoses necessitate laboratory testing to ensure accurate identification and treatment protocols.

In cases where tapeworm segments persist in the dog's stool following treatment with Safe-Guard Canine, it is crucial to seek veterinary advice promptly. Continued observation of these segments may indicate the need for further intervention.

To ensure safety, this product must be kept out of reach of children. In the event of any adverse reactions or concerns, immediate medical assistance should be sought.

Side Effects

In U.S. clinical studies, vomiting was reported as an adverse reaction in approximately 1% of the treated dogs, with 3 out of 240 subjects experiencing this effect associated with the use of the product. This reaction should be considered when evaluating the overall safety profile of the treatment in canine patients.

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. It is advisable to continue standard clinical practices and monitor for any potential interactions as new data becomes available.

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

Safe-Guard Canine is indicated for use in puppies 6 weeks of age and older, as well as in adult dogs, including pregnant bitches. For weaned puppies aged 6 to 8 weeks, deworming is recommended at 6, 8, 10, and 12 weeks of age to ensure effective parasite control. It is important to treat the dam concurrently with the puppies to maximize efficacy. Additionally, dogs over 6 months of age should receive deworming treatment at least twice annually to maintain optimal health.

Geriatric Use

Elderly patients may not have specific information regarding the use of Safe-Guard (fenbendazole) in this population. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for geriatric patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to elderly patients. Monitoring for any potential adverse effects or changes in response to treatment may be warranted in this demographic.

Pregnancy

Safe-Guard Canine is considered safe for use in pregnant bitches. Clinical data indicate that the product can be administered to puppies 6 weeks or older and adult dogs without adverse effects on fetal outcomes. However, as with any medication, healthcare professionals should weigh the benefits against potential risks when prescribing this product to pregnant patients. It is advisable to monitor the health of both the mother and the developing fetuses during treatment.

Lactation

Nursing mothers should consult their veterinarian regarding the use of Safe-Guard (fenbendazole) while breastfeeding. There is a potential for excretion of fenbendazole in breast milk; therefore, caution is advised when administering this medication to nursing mothers. The effects of fenbendazole on nursing infants are not well studied, and the risk to the infant should be considered before use.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to Safe-Guard (fenbendazole). Consequently, there is no information available regarding dosage adjustments, special monitoring, or safety considerations for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to Safe-Guard (fenbendazole). Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for this population. It is recommended that healthcare providers exercise caution when prescribing Safe-Guard to patients with compromised liver function, given the lack of data on its safety and efficacy in this group.

Overdosage

In the event of an overdosage of Safe-Guard (fenbendazole), specific details regarding the effects and management are not explicitly outlined in the available literature. It is imperative for healthcare professionals to consult a veterinarian for comprehensive guidance on the potential symptoms associated with overdosage and the appropriate management strategies.

Healthcare providers should remain vigilant for any signs of adverse reactions in animals that may indicate an overdosage scenario. Prompt veterinary consultation is essential to ensure the safety and well-being of the patient. The veterinarian may recommend supportive care and monitoring, depending on the severity of the situation and the clinical presentation of the animal.

In summary, due to the lack of detailed information on overdosage, the primary course of action is to seek veterinary advice for tailored management and intervention strategies.

Nonclinical Toxicology

Safe-Guard Canine has been evaluated for teratogenic effects and is considered safe for use in puppies aged 6 weeks and older, as well as in adult dogs, including pregnant bitches.

In terms of non-teratogenic effects, clinical studies conducted in the United States indicated that approximately 1% of the treated dogs (3 out of 240) experienced vomiting associated with the use of the product.

No additional data regarding nonclinical toxicology or animal pharmacology and toxicology were provided.

Postmarketing Experience

In U.S. clinical studies, vomiting was reported in 3 of 240 dogs treated with the product, representing approximately 1% of the treated population. This event was documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to weigh their dogs to ensure the correct dosage is administered, which includes the appropriate gram amount and number of pouches. It is important to inform pet owners that their dogs must receive the prescribed dose for three consecutive days. The daily dose should be mixed with a small amount of the dog's usual food, and providers should emphasize the necessity of ensuring that the dog consumes all of the medicated food. In some cases, it may be beneficial to moisten dry dog food to facilitate mixing.

For weaned puppies aged 6 to 8 weeks, deworming should occur at 6, 8, 10, and 12 weeks of age. It is also crucial to treat the dam simultaneously with the puppies. Additionally, dogs over six months of age should be dewormed at least twice a year to maintain their health.

Healthcare providers should encourage pet owners to consult their veterinarian for assistance with the diagnosis, treatment, and control of parasitism, as specific diagnoses may require laboratory testing. If pet owners continue to observe tapeworm segments in their dog's stool after treatment with Safe-Guard Canine, they should be advised to consult their veterinarian.

It is important to communicate that roundworms and hookworms can pose serious health risks to humans, and regular deworming may help mitigate these risks. Safe-Guard Canine is deemed safe for use in puppies aged six weeks and older, as well as adult dogs, including pregnant bitches. However, pet owners should be cautioned against deworming a dog or puppy that is unwell and should seek veterinary diagnosis for any illness.

In clinical studies conducted in the U.S., approximately 1% of treated dogs experienced vomiting associated with the use of the product. Lastly, healthcare providers should remind pet owners to keep the medication out of reach of children.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 68-77°F (20-25°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Specific diagnoses in patients require laboratory testing to ensure accurate assessment and treatment. Safe-Guard Canine is administered orally at a daily dose of 50 mg/kg (22.7 mg/lb) of body weight for a duration of three consecutive days. Clinicians should advise pet owners to consult their veterinarian for assistance with the diagnosis, treatment, and control of parasitism. If tapeworm segments persist in the dog's stool post-treatment, further veterinary consultation is necessary. It is recommended that dogs over six months of age be dewormed at least twice a year, and deworming should not be performed on sick dogs or puppies.

In postmarketing experience from U.S. clinical studies, approximately 1% of treated dogs (3 out of 240) experienced vomiting associated with the use of the product.

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)