Doracide

Description

Doracide™ (doramectin topical solution) is a ready-to-use, systemically active antiparasitic formulation designed for cattle. This pour-on solution contains 0.5% w/v doramectin, equivalent to 5 mg/mL. The product is presented as a clear, light blue solution. It is intended for topical administration, delivering a recommended dosage of 500 mcg/kg (227 mcg/lb) of body weight at a rate of 1 mL per 22 lb (10 kg) of body weight.

Uses and Indications

This drug is indicated for the treatment and prevention of specified conditions and diseases as determined by healthcare professionals. The specific species and conditions for which this drug is indicated have not been detailed in the provided information.

Healthcare professionals are advised to refer to additional resources or clinical guidelines to ascertain the appropriate usage instructions and targeted patient populations for this drug.

Dosage and Administration

Doracide Pour-On solution is to be administered topically to cattle at a dosage of 500 mcg of doramectin per kg (227 mcg/lb) of body weight. Each milliliter of the solution contains 5 mg of doramectin, which is adequate to treat 22 lb (10 kg) of body weight.

The solution should be applied in a narrow strip along the mid-line of the back, specifically between the withers and the tailhead.

For administration using the provided dosing cup with 1-L bottles, the following steps should be followed:

1. Select the appropriate dose of 1 mL per 22 lb (10 kg) of body weight by adjusting the dose indicator on the cap.

2. If the animal's weight falls between the markings on the dosing cup, the higher dose volume should be utilized.

3. To fill the dosing reservoir, hold the bottle upright and squeeze until a slight excess is delivered, as indicated by the calibration lines.

4. Tilt the bottle to deliver the dose, ensuring that the solution is applied in a single pass from the withers to the tailhead.

For larger volumes using 2.5-L and 5-L backpacks, two applicator systems are recommended:

Phillips Pour-on Applicator System:

1. Replace the shipping cap on the backpack with the provided draw-off cap and tighten securely.

2. Thread the draw-off tubing through the anti-kink spring and attach it to the draw-off cap.

3. Invert the backpack.

4. Set the dose to the maximum of 50 mL and gently prime the applicator, checking for any leaks.

5. Set the required dose and administer accordingly.

Syrvet Pour-on Applicator System:

1. Replace the shipping cap on the backpack with the provided draw-off cap and tighten securely.

2. Thread the draw-off tubing through the anti-kink spring and attach it to the draw-off cap.

3. Invert the backpack.

4. Set the dose to the maximum of 50 mL and gently prime the applicator, checking for any leaks.

5. Administer each dose by fully depressing the handle to ensure the plunger travels its entire set length.

Healthcare professionals should ensure that the administration technique is followed precisely to achieve optimal therapeutic outcomes.

Contraindications

Use of this product is contraindicated in the following situations:

• Female dairy cattle 20 months of age or older should not be treated with this product due to potential adverse effects.

• The product is not to be used in calves intended for veal processing, as it may pose risks to food safety.

• This product is contraindicated in other animal species, as severe adverse reactions, including fatalities, have been reported in dogs.

Additionally, the following precautions must be observed to ensure safe and effective use:

• Underdosing is prohibited; each animal must receive a complete dose based on current body weight to prevent ineffective treatment and the development of parasite resistance.

• Application to areas of skin that are caked with mud or manure is not permitted.

• Users should refrain from smoking or eating while handling the product.

• Cattle must not be allowed to enter lakes, streams, or ponds for at least 6 hours post-treatment to prevent contamination.

• Direct application or improper disposal of drug containers that may contaminate water sources is strictly prohibited.

Warnings and Precautions

Flammable! Doracide Pour-On solution for cattle must be kept away from heat, sparks, open flame, and other sources of ignition. It is strictly not for human use and should be stored out of reach of children to prevent accidental exposure.

The solution may cause irritation to human skin and eyes. Therefore, it is imperative that users exercise caution to avoid applying the product to themselves or to others. Operators are advised to wear appropriate protective clothing, which includes a long-sleeved shirt, protective gloves, and boots, along with a waterproof coat during application. After use, all protective clothing should be thoroughly washed to eliminate any residual product.

In the event of accidental skin contact, the affected area should be washed immediately with soap and water. Should accidental exposure to the eyes occur, it is crucial to flush the eyes with water immediately and seek medical attention as necessary.

Side Effects

Patients using Doracide Pour-On solution for cattle may experience various adverse reactions, particularly if the product is misused or if there is accidental exposure.

Serious adverse reactions can occur if the product is applied to species other than cattle. Notably, severe reactions, including fatalities, have been reported in dogs when exposed to this formulation. Additionally, the destruction of Hypoderma larvae, specifically during critical developmental stages, may lead to significant host-parasite reactions. For instance, the elimination of H. lineatum in the tissue surrounding the gullet may result in bloat, while the destruction of H. bovis in the vertebral canal may lead to staggering or paralysis. It is important to note that these reactions are not unique to Doracide Pour-On solution but can occur with any effective treatment targeting these grubs.

Common adverse reactions associated with the use of Doracide Pour-On solution include skin and eye irritation in humans. Users are advised to avoid contact with skin and eyes, and in the event of accidental exposure, immediate washing of the affected area with soap and water is recommended. If the product comes into contact with the eyes, it is crucial to flush the eyes with water and seek medical attention.

Furthermore, it is essential to handle Doracide Pour-On solution with care, as it is flammable. Users should keep the product away from heat, sparks, open flames, and other ignition sources. The product should be stored out of reach of children and is strictly not for human use.

Drug Interactions

No specific drug interactions are documented for this product. However, it is essential to consider the following recommendations regarding laboratory test interactions and monitoring.

Prior to administering any dewormer, fecal examinations or other diagnostic tests, along with a thorough parasite management history, should be conducted to assess the appropriateness of the product for the herd. Following the administration of a dewormer, it is crucial to monitor the effectiveness of the treatment. This can be achieved through methods such as a fecal egg count reduction test or other suitable evaluation techniques.

It is important to note that a decrease in the effectiveness of the dewormer, as indicated by fecal egg count reduction tests, may suggest the development of resistance to the administered product. Regular monitoring and assessment are recommended to ensure continued efficacy and to guide future treatment decisions.

Packaging & NDC

The table below lists each NDC Code for Doracide (doramectin) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Doracide Pour-On solution is indicated for use in cattle, including neonatal calves. A study evaluating the safety of doramectin injectable solution demonstrated that neonatal calves can be treated with doses up to three times the recommended amount without adverse effects.

It is important to note that Doracide is not approved for use in female dairy cattle that are 20 months of age or older. Additionally, a withdrawal period has not been established for this product in preruminating calves, and it should not be used in calves intended for veal processing.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The use of Doracide Pour-On solution in pregnant patients has been evaluated in breeding animals, specifically bulls and cows, with no observed effects on breeding performance during critical developmental stages, including folliculogenesis, organogenesis, implantation, and throughout gestation. This assessment was conducted at a dose three times higher than the recommended dose of doramectin injectable solution.

Pharmacokinetic studies suggest that systemic exposure to doramectin from the pour-on formulation is lower than that from the injectable solution. As such, there are no specific pregnancy-related warnings or contraindications associated with the use of Doracide Pour-On solution. However, healthcare professionals should remain vigilant and consider the overall clinical context when prescribing this product to women of childbearing potential.

Lactation

Lactating mothers are not specifically addressed in the prescribing information. There is no available data regarding the excretion of the drug in breast milk or its effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers on the use of this medication.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, specific antidotes or treatments may be indicated depending on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide management decisions and optimize patient outcomes.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

Nonclinical Toxicology

In breeding studies involving bulls and cows during critical developmental stages such as folliculogenesis, organogenesis, implantation, and throughout gestation, administration of doramectin injectable solution at a dose three times the recommended level did not adversely affect breeding performance.

Safety assessments have demonstrated a significant safety margin for doramectin. In trials conducted in the United States, no toxic signs were observed in cattle administered doses up to 25 times the recommended level of doramectin injectable solution. Additionally, a study involving neonatal calves treated with doramectin injectable solution at doses up to three times the recommended level also confirmed its safety.

A pharmacokinetic evaluation indicated that systemic exposure to doramectin from the pour-on formulation was lower than that from the injectable solution.

Doramectin is derived from selected strains of the soil organism Streptomyces avermitilis. The primary mechanism of action for macrocyclic lactones, including doramectin, involves the modulation of chloride ion channel activity within the nervous systems of nematodes and arthropods. These compounds bind to specific receptors that enhance membrane permeability to chloride ions, leading to the inhibition of electrical activity in nerve cells of nematodes and muscle cells of arthropods, ultimately resulting in paralysis and death of the parasites. In mammals, the neuronal receptors targeted by macrocyclic lactones are primarily located within the central nervous system (CNS), where doramectin achieves only negligible concentrations.

Postmarketing Experience

Reports of adverse events associated with Doracide Pour-On solution for cattle have been received through voluntary reporting and surveillance programs. Users are advised to exercise caution, as the product may cause skin and eye irritation. Protective clothing, including long-sleeved shirts, gloves, and waterproof boots, is recommended during application. In the event of accidental skin contact, the affected area should be washed immediately with soap and water, and if the product comes into contact with the eyes, they should be flushed with water, followed by medical attention.

There is a potential for parasite resistance to develop with the use of any dewormer, including Doracide. This phenomenon has been documented across various classes of dewormers. It is recommended that fecal examinations or other diagnostic tests be conducted to assess the appropriateness of the product for the herd prior to administration. Monitoring the effectiveness of treatment through methods such as fecal egg count reduction tests is also advised, as a decrease in effectiveness may indicate the development of resistance.

Doracide Pour-On solution is specifically formulated for use in cattle and should not be administered to other animal species, as severe adverse reactions, including fatalities in dogs, may occur. Additionally, the destruction of Hypoderma larvae (cattle grubs) during critical developmental stages may lead to adverse host-parasite reactions, including the risk of fatalities. For instance, killing H. lineatum in the tissue surrounding the gullet may result in bloat, while killing H. bovis in the vertebral canal may cause staggering or paralysis. These reactions are not exclusive to Doracide Pour-On solution and can occur with any effective treatment of grubs. It is advisable to consult a veterinarian regarding the optimal timing for treatment to mitigate these risks.

Patient Counseling

Healthcare providers should advise patients that Doracide Pour-On solution may cause irritation to human skin and eyes, and caution should be exercised to avoid applying the product to themselves or others. Operators are recommended to wear protective clothing, including a long-sleeved shirt, protective gloves, and boots with a waterproof coat during application. It is important to wash protective clothing after use to prevent any potential irritation.

In the event of accidental skin contact, patients should be instructed to wash the affected area immediately with soap and water. If the product comes into contact with the eyes, they should flush the eyes immediately with water and seek medical attention.

Healthcare providers should inform patients that cattle must not be slaughtered for human consumption within 45 days of treatment with Doracide Pour-On solution. Additionally, this product is not intended for use in female dairy cattle that are 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves, and it should not be used in calves intended for veal processing.

Patients should be made aware that parasite resistance may develop to any dewormer. Therefore, treatment with a dewormer should be used in conjunction with appropriate parasite management practices to help slow the development of resistance. Fecal examinations or other diagnostic tests, along with the herd's parasite management history, should be utilized to determine the appropriateness of the product prior to use. Following the administration of any dewormer, the effectiveness of the treatment should be monitored, for example, through a fecal egg count reduction test or another suitable method. Patients should adjust their parasite management plan based on regular monitoring results.

It is crucial to emphasize that Doracide Pour-On solution is specifically developed for use in cattle only and should not be used in other animal species, as severe adverse reactions, including fatalities in dogs, may occur. The product is to be applied only to the skin surface and should not be administered orally or parenterally. Patients should avoid applying the solution to areas of skin that are caked with mud or manure.

After handling the product, patients should wash their hands thoroughly and refrain from smoking or eating. They should also be informed that cloudiness in the formulation may occur if Doracide Pour-On solution is stored at temperatures below 0˚C (32˚F); allowing the product to warm to room temperature will restore its normal appearance without affecting its efficacy.

Finally, healthcare providers should recommend consulting a veterinarian regarding the appropriate timing for treating cattle grubs. Cattle treated with Doracide Pour-On solution after the end of the heel fly season may be re-treated during the winter for internal parasites, mange mites, or biting and sucking lice without the risk of grub-related reactions.

Storage and Handling

The product is supplied in packaging that ensures its integrity and efficacy. It must be stored at temperatures below 25°C (77°F) to maintain its stability. Additionally, it is essential to protect the product from light exposure to prevent degradation.

Upon disposal, containers should be handled in accordance with local regulations, either by placing them in an approved landfill or by incineration. Proper disposal methods are crucial to ensure environmental safety and compliance with waste management standards.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This document includes the full labeling information for Doracide, as submitted by Bimeda, Inc. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)