Fenbendazole

Description

FENBENPRO is a pharmaceutical product containing the active ingredient fenbendazole, with a purity exceeding 99.95%. It is presented in a powder dosage form, with a net weight of 250 grams (10.5 ounces). The chemical structure is represented by the molecular formula C1H12N2O,S, and it has a molecular weight of 299.35. FENBENPRO is specifically formulated as a dewormer for pets only. The product includes a silica gel packet to prevent moisture absorption and should be stored in a cool, dry place, away from direct sunlight. The chemical substance is identified by the CAS number 43210-67-9.

Uses and Indications

This drug is indicated for the treatment of intestinal parasitic infections in pets, specifically targeting the following conditions: roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis).

For optimal efficacy, it is essential to weigh the pet accurately to determine the correct dosage. The recommended daily doses based on pet weight are as follows: 227 mg for pets weighing 10 lbs, 450 mg for those weighing 20 lbs, and 680 mg for pets weighing 30 lbs.

Healthcare professionals should ensure that pet owners adhere to these dosage guidelines to achieve the desired therapeutic outcomes.

Dosage and Administration

It is essential to weigh the pet accurately to ensure the correct dosage is administered. The recommended daily doses based on pet weight are as follows:

• For a pet weighing 10 lbs, the daily dose is 227 mg.

• For a pet weighing 20 lbs, the daily dose is 450 mg.

• For a pet weighing 30 lbs, the daily dose is 680 mg.

Administration should be performed according to the prescribed dosage, ensuring that the pet receives the appropriate amount based on its weight. The route of administration is not applicable for this medication.

Contraindications

Deworming is contraindicated in pets that are currently ill. The administration of deworming agents in this context may exacerbate the underlying health condition.

Additionally, the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is advised.

Warnings and Precautions

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Centre should be contacted without delay.

Deworming should not be performed on pets that are exhibiting signs of illness. In such cases, it is essential to consult a veterinarian for proper diagnosis, treatment, and management of parasitic infections. This precaution is critical to ensure the health and safety of the animal.

No specific laboratory tests or general precautions have been identified for the use of this product. However, adherence to the aforementioned warnings and recommendations is crucial for safe and effective use.

Side Effects

Patients should be advised to keep Fenbendazole out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Centre is recommended.

It is important to note that Fenbendazole should not be administered to pets that are ill. Consultation with a veterinarian is essential for the proper diagnosis, treatment, and management of parasitism in such cases.

Currently, there are no specific adverse reactions or side effects associated with Fenbendazole documented in the available data.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

The table below lists each NDC Code for Fenbenpro Purity and Precision Fenbendazole veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is recommended.

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

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 this population. Healthcare professionals should exercise caution when considering the use of Fenbendazole in women of childbearing potential and weigh the potential risks and benefits. Further studies may be necessary to determine the implications of Fenbendazole exposure during pregnancy and its effects on fetal outcomes.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Fenbendazole. Therefore, the effects on lactating mothers and breastfed infants remain undetermined. Healthcare professionals should exercise caution and consider the potential risks versus benefits when prescribing this medication to lactating mothers.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Centre without delay to ensure appropriate management and intervention.

Prompt recognition of symptoms associated with overdosage is crucial for effective treatment. While specific symptoms are not detailed in the provided information, healthcare providers should remain vigilant for any unusual or severe reactions following ingestion.

Management of overdosage should be guided by the severity of symptoms and the clinical judgment of the healthcare provider. It is essential to follow established protocols for the assessment and treatment of overdosage cases, which may include supportive care and symptomatic treatment as necessary.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Centre immediately.

It is important to inform patients that they should not deworm a pet that is currently sick. Patients should be encouraged to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism in their pets.

Additionally, healthcare providers should emphasize the necessity of weighing the pet prior to administering the medication to ensure the correct dosage is used. This step is crucial for the safety and effectiveness of the treatment.

Storage and Handling

The product is supplied in a configuration that includes a silica gel packet to prevent moisture. It is essential to store the product in a cool, dry place, away from direct sunlight, to maintain its integrity. Additionally, it is crucial to keep the product out of reach of children to ensure safety during storage and handling.

Additional Clinical Information

Laboratory tests indicate that the product has a purity greater than 99.95%. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Centre immediately if it is swallowed. It is also important to inform patients not to deworm a pet that is sick and to consult a veterinarian for guidance on the diagnosis, treatment, and control of parasitism. No additional information is available regarding abuse, administration routes, or postmarketing experiences.

Drug Information (PDF)

This document includes the full labeling information for Fenbenpro Purity and Precision Fenbendazole, as submitted by HUBIHOL, UAB for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)