Doramectin

Description

Doramectin is a topical solution formulated for use in cattle, specifically as a pour-on antiparasitic treatment. This ready-to-use formulation contains 0.5% w/v doramectin, equating to 5 mg/mL. The solution is clear and light blue in appearance. It is designed to provide a recommended dosage of 500 mcg/kg (227 mcg/lb) of body weight when administered topically 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 conditions and diseases as determined by healthcare professionals. Specific species and conditions are not detailed in the available information.

Healthcare providers are advised to assess the individual needs of patients to determine the appropriate usage of this drug. Further guidance on usage instructions should be obtained from relevant clinical guidelines or product literature.

Dosage and Administration

Doramectin Pour-On solution is to be administered topically to cattle at a dosage of 500 mcg doramectin per kg (227 mcg/lb) of body weight. Each mL 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 body 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 administration using applicators with 5-L backpacks, the following procedures are recommended for two specific applicator systems:

Phillips Pour-on Applicator System:

1. Replace the shipping cap on the 5-L backpack with the provided draw-off cap and tighten it firmly.

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. Adjust the dose as required and administer.

Syrvet Pour-on Applicator System:

1. Replace the shipping cap on the 5-L backpack with the provided draw-off cap and tighten it firmly.

2. Invert the backpack.

3. Set the dose to the maximum of 50 mL by unscrewing the adjuster at the base of the handle.

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

These procedures ensure accurate dosing and effective administration of Doramectin Pour-On solution for the treatment of cattle.

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 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 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! Doramectin 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 if irritation persists.

Side Effects

Patients using Doramectin Pour-On solution for cattle may experience various adverse reactions, which can be categorized based on their seriousness and frequency.

Serious adverse reactions include the potential for severe host-parasite reactions following the destruction of Hypoderma larvae (cattle grubs). Specifically, the treatment may lead to fatalities if the larvae are killed in critical areas. For instance, the destruction of H. lineatum in the tissue surrounding the gullet may result in bloat, while the elimination of H. bovis in the vertebral canal may cause staggering or paralysis. It is important to note that these reactions are not unique to Doramectin Pour-On solution but can occur with any effective treatment of grubs.

Common adverse reactions primarily relate to the product's handling and application. The solution is flammable, and users are advised to keep it away from heat, sparks, open flames, and other ignition sources. Additionally, the product may irritate human skin and eyes. Operators should take precautions by wearing protective clothing, including long-sleeved shirts, gloves, and waterproof boots during application. In the event of accidental skin contact, it is recommended to wash the affected area immediately with soap and water. If the solution comes into contact with the eyes, it is crucial to flush the eyes with water and seek medical attention.

Due to the specific formulation of Doramectin Pour-On solution for cattle, it is contraindicated for use in other animal species, as this may lead to severe adverse reactions, including fatalities in dogs. Therefore, it is essential to adhere strictly to the intended use of this product to minimize risks.

Drug Interactions

No specific drug interactions are identified for the product. However, considerations regarding laboratory test interactions are essential for effective management.

Prior to administering any dewormer, it is recommended that fecal examinations or other diagnostic tests, along with a thorough parasite management history, be conducted to ascertain 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 a dewormer, as indicated by fecal egg count reduction tests, may suggest the development of resistance to the administered dewormer. Regular monitoring and assessment are advised to ensure continued efficacy and to guide future treatment decisions.

Packaging & NDC

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

Pediatric Use

Doramectin Pour-On solution is indicated exclusively for use in cattle and is not intended for any other animal species, including children. There are no specific pediatric dosing or age recommendations provided, as the product is not for human use. It is essential to keep this product out of reach of children to prevent accidental exposure.

Caution is advised during application, as doramectin may cause irritation to human skin and eyes. Protective clothing should be worn to minimize the risk of contact. No specific safety concerns or special precautions for pediatric use are noted, as the formulation is solely intended for cattle.

Geriatric Use

There is no specific information available 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

Doramectin Pour-On solution is not indicated for use in pregnant cattle. Safety studies have shown that doramectin does not adversely affect breeding performance in cattle during pregnancy, including during critical periods such as folliculogenesis, organogenesis, implantation, and throughout gestation. In breeding animals, including bulls and cows, a dose three times the recommended dose of doramectin injectable solution had no effect on breeding performance. However, it is essential for healthcare professionals to consult with a veterinarian for guidance regarding the use of doramectin in pregnant animals to ensure the safety and well-being of both the animal and the developing fetus.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 consider 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance on the appropriate management of overdose is recommended.

Nonclinical Toxicology

In breeding studies involving bulls and cows during critical reproductive phases 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 evaluations have established a significant safety margin for doramectin. Trials conducted in the United States revealed no toxic signs in cattle administered doses up to 25 times the recommended level of doramectin injectable solution. Additionally, a study involving neonatal calves demonstrated that treatment with doramectin injectable solution at doses up to three times the recommended level was also safe.

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

Doramectin Pour-On solution has been shown to effectively treat and control a broad spectrum of roundworm and arthropod parasites that can compromise the health and productivity of cattle. The topical solution has been validated for its efficacy in controlling infections and preventing reinfection with Cooperia oncophora, Dictyocaulus viviparus, Ostertagia ostertagi, and Oesophagostomum radiatum for a duration of 28 days post-treatment, and with Cooperia punctata and Haemonchus placei for 35 days. Furthermore, it has been proven effective against infestations of Bovicola (Damalinia) bovis for 77 days and Linognathus vituli for 42 days following treatment.

It is important to note that the destruction of Hypoderma larvae (cattle grubs) during critical periods may lead to undesirable host-parasite reactions, including potential fatalities. 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. These adverse reactions are not unique to doramectin treatment but can occur with any effective treatment of grubs.

Postmarketing Experience

Reports of suspected adverse drug events related to Doramectin Pour-On solution for cattle have been received through voluntary reporting and surveillance programs. Users are advised to contact Bimeda, Inc. at 1-888-524-6332 for technical assistance or to obtain a copy of the Safety Data Sheet (SDS). For additional information regarding adverse drug experience reporting for animal drugs, the FDA can be contacted at 1-888-FDA-VETS or through their website at www.fda.gov/reportanimalae.

The product may cause skin and eye irritation in humans; therefore, it is recommended that operators wear protective clothing, including long-sleeved shirts, gloves, and waterproof boots, during application. In the event of accidental skin contact, the affected area should be washed immediately with soap and water. If the product comes into contact with the eyes, they should be flushed with water, and medical attention should be sought.

There is a potential for parasite resistance to develop with the use of any dewormer, including Doramectin. This phenomenon has been reported across various classes of dewormers. To mitigate the risk of resistance, it is advised that dewormers be used in conjunction with 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 ensure the product's suitability for the herd. Post-treatment effectiveness should be monitored, for instance, through fecal egg count reduction tests, as a decrease in effectiveness may indicate the development of resistance.

Doramectin 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 undesirable host-parasite reactions, including the risk of fatalities. For example, 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 Doramectin Pour-On solution and can occur with any effective treatment of grubs. It is recommended to consult a veterinarian to determine the appropriate timing for treatment, either before or after the migratory phase of grub development.

Patient Counseling

Healthcare providers should advise patients to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism. It is important to inform patients that Doramectin Pour-On solution may cause irritation to human skin and eyes; therefore, users should exercise caution to avoid applying the product to themselves or others.

Operators are encouraged to wear protective clothing, including a long-sleeved shirt, protective gloves, and boots with a waterproof coat during application. After use, protective clothing should be washed thoroughly. In the event of accidental skin contact, patients should wash the affected area immediately with soap and water. If accidental eye exposure occurs, they should flush the eyes with water and seek medical attention promptly.

Patients must be made aware that cattle should not be slaughtered for human consumption within 45 days following treatment with this product. Additionally, it 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.

Healthcare providers should discuss the potential for parasite resistance to develop with any dewormer. They should recommend that treatment with a dewormer be used in conjunction with appropriate parasite management practices to help slow the development of resistance. Fecal examinations or other diagnostic tests, along with a history of parasite management, should be utilized to determine the appropriateness of the product for the 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. Patients should adjust their parasite management plan based on regular monitoring results.

It is crucial to inform patients that this product should not be used in other animal species, as severe adverse reactions, including fatalities in dogs, may occur. The product is intended for application to the skin surface only 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 and should wash their hands after use. They should also be advised not to smoke or eat while handling the product.

Patients should be informed that cloudiness in the formulation may occur if Doramectin Pour-On solution is stored at temperatures below 0˚C (32˚F); allowing it to warm to room temperature will restore its normal appearance without affecting efficacy. Finally, healthcare providers should consult with patients regarding the appropriate timing for the treatment of cattle grubs and recommend a planned parasite control program.

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 to ensure safe and environmentally responsible disposal.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View veterinary label (PDF)