Dectogard

Description

No description information is available for the specified drug.

Uses and Indications

DectoGard Pour-On solution is indicated for the treatment and control of various parasitic infections in cattle. This formulation effectively targets the following gastrointestinal roundworms: Ostertagia ostertagi (adults and L4, including inhibited larvae), O. lyrata (adults), Haemonchus placei (adults and L4), Trichostrongylus axei (adults and L4), T. colubriformis (adults and L4), Cooperia oncophora (adults and L4), C. pectinata (adults), C. punctata (adults and L4), C. surnabada (adults), Bunostomum phlebotomum (adults), Oesophagostomum radiatum (adults and L4), and Trichuris spp. (adults).

Additionally, DectoGard is effective against lungworms, specifically Dictyocaulus viviparus (adults and fourth stage larvae), and eyeworms, including Thelazia gulosa and T. skrjabini (adults). The solution also controls grubs caused by Hypoderma bovis and H. lineatum, as well as lice infestations, targeting both biting lice (Bovicola (Damalinia) bovis) and sucking lice (Haematopinus eurysternus, Linognathus vituli, and Solenopotes capillatus). Furthermore, it is indicated for the management of horn flies (Haematobia irritans) and mange mites (Chorioptes bovis and Sarcoptes scabiei).

Limitations of Use: Doramectin topical solution has demonstrated efficacy in controlling infections and providing protection against reinfection for specific parasites over defined durations. It effectively controls Cooperia oncophora, Dictyocaulus viviparus, Ostertagia ostertagi, and Oesophagostomum radiatum for 28 days; Cooperia punctata and Haemonchus placei for 35 days; Bovicola (Damalinia) bovis for 77 days; and Linognathus vituli for 42 days post-treatment.

Dosage and Administration

DectoGard Pour-On solution is 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.

For optimal efficacy, DectoGard Pour-On solution should be integrated into a comprehensive parasite control program targeting both internal and external parasites. It is advisable to consult with a veterinarian or an entomologist to determine the most effective timing for applications based on the epidemiology of the parasites in the specific environment.

It is critical to ensure that each animal receives a complete dose according to its current body weight. Underdosing may lead to ineffective treatment and may promote the development of resistance among parasites.

Contraindications

This product is contraindicated in the following situations:

Use in other animal species is prohibited due to the potential for severe adverse reactions, including fatalities in dogs. It is not indicated for female dairy cattle aged 20 months or older. Additionally, the product should not be administered to calves intended for veal processing.

The product is classified as a restricted drug (CA) and must be used only as directed. It is not intended for human use.

To ensure effective treatment and prevent the development of parasite resistance, it is critical to avoid underdosing; each animal must receive a complete dose based on current body weight. The product should not be administered orally or parenterally, nor applied to areas of skin that are caked with mud or manure.

Handlers must refrain from smoking or eating while handling the product. Cattle should not be allowed to enter lakes, streams, or ponds for at least 6 hours post-treatment. Furthermore, care must be taken to avoid contaminating water sources through direct application or improper disposal of drug containers.

Warnings and Precautions

Flammable materials should be handled with extreme caution. DectoGard Pour-On solution for cattle is highly flammable; therefore, it must be kept away from heat sources, sparks, open flames, and any other potential ignition sources to prevent fire hazards.

This product is strictly not for human use and must be kept out of reach of children to avoid accidental exposure. For comprehensive occupational safety information, users are advised to consult the Safety Data Sheet (SDS). To report any adverse effects experienced by users, to obtain further information, or to request an SDS, please contact 1-888-215-1256.

DectoGard Pour-On solution may cause irritation to human skin and eyes. Users must exercise caution to prevent application on themselves or others. It is recommended that operators 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 imperative to flush the eyes with water immediately and seek medical attention without delay.

Side Effects

DectoGard Pour-On solution for cattle may cause irritation to human skin and eyes. In the event of accidental skin contact, it is advised that the affected area be washed immediately with soap and water. Should accidental eye exposure occur, it is crucial to flush the eyes with water and seek medical attention.

This product is contraindicated for use in other animal species, as severe adverse reactions, including fatalities in dogs, may occur. Additionally, the destruction of Hypoderma larvae (cattle grubs) during critical periods may lead to undesirable host-parasite reactions, which can result in fatalities. Specifically, the elimination of H. lineatum while it is located in the tissue surrounding the gullet may lead to bloat, while the destruction of H. bovis in the vertebral canal may result in staggering or paralysis.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

DectoGard Pour-On solution is indicated exclusively for use in cattle and is contraindicated in other animal species, including children, due to the potential for severe adverse reactions. Safety studies have shown that doramectin is safe for use in neonatal calves when treated with doses up to three times the recommended amount. It is important to note that there is no established withdrawal period for this product in preruminating calves. Additionally, DectoGard should not be administered to calves intended for veal processing.

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

DectoGard Pour-On solution is contraindicated for use in pregnant cattle. However, data from a study involving doramectin injectable solution indicate that it is safe for use in breeding animals, including bulls and cows, during critical reproductive phases such as folliculogenesis, organogenesis, implantation, and throughout gestation. This study demonstrated no adverse effects on breeding performance at doses up to three times the recommended level.

It is important to note that cattle treated with DectoGard Pour-On solution must not be slaughtered for human consumption within 45 days following treatment. Additionally, the product is not approved for use in female dairy cattle that are 20 months of age or older. Therefore, healthcare professionals should exercise caution and adhere to these guidelines when considering treatment options for pregnant cattle or those of childbearing potential.

Lactation

Lactating mothers should be aware that this product is not intended for use in female dairy cattle 20 months of age or older. Additionally, a withdrawal period has not been established for this product in preruminating calves, and it is contraindicated for use in calves that are to be processed for veal. There is no specific data available regarding excretion in human breast milk or effects on breastfed infants. Therefore, caution is advised when considering the use of this product in lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the patient's condition.

Healthcare professionals are encouraged to report any cases of suspected overdosage to the relevant authorities to contribute to the ongoing assessment of the medication's safety profile.

Nonclinical Toxicology

Doramectin injectable solution has been evaluated for teratogenic effects in breeding animals, including bulls and cows, during critical developmental stages such as folliculogenesis, organogenesis, implantation, and throughout gestation. Administration of a dose three times the recommended level did not adversely affect breeding performance.

In terms of non-teratogenic effects, extensive studies 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, safety was confirmed in neonatal calves treated with doses up to three times the recommended level.

A pharmacokinetic study indicated that systemic exposure to doramectin from the topical solution was lower than that from the injectable formulation, suggesting differences in absorption and distribution between the two delivery methods.

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 in the central nervous system (CNS), where doramectin achieves only negligible concentrations.

Postmarketing Experience

In the postmarketing experience for DectoGard Pour-On solution, no specific adverse reactions have been reported. It is recommended that any reports of adverse reactions in users be directed to 1-888-215-1256 for further evaluation. Additionally, it is noted that parasite resistance may develop to any dewormer, and such resistance has been reported for most classes of dewormers.

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 the importance of administering the complete dose of DectoGard Pour-On solution based on the current body weight of each animal, as underdosing may lead to ineffective treatment and promote the development of parasite resistance.

Patients should be instructed on the proper application of DectoGard Pour-On solution, which should be applied topically along the mid-line of the back in a narrow strip between the withers and tailhead. Providers must inform patients that the product is flammable and should be kept away from heat, sparks, open flame, and other sources of ignition. It is not intended for human use and should be kept out of reach of children.

Healthcare providers should caution patients that DectoGard Pour-On solution may cause skin and eye irritation in humans. Users should avoid applying the product to themselves or others and are encouraged 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. In the event of accidental skin contact, patients should wash the affected area immediately with soap and water. If the product comes into contact with the eyes, they should be flushed immediately with water, and medical attention should be sought.

Patients should be made aware that parasite resistance can develop to any dewormer, and this has been reported for most classes of dewormers. Therefore, treatment with a dewormer should be used in conjunction with appropriate parasite management practices tailored to the geographic area and the specific animals being treated 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 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. A decrease in the drug's effectiveness over time, as indicated by these tests, may suggest the development of resistance to the administered dewormer, necessitating adjustments to the parasite management plan based on regular monitoring.

Healthcare providers should inform patients that cattle must not be slaughtered for human consumption within 45 days of treatment and that DectoGard Pour-On solution is not for use in female dairy cattle 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. The product 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.

Patients should be instructed that DectoGard Pour-On solution is to be applied only to the skin surface and must not be administered orally or parenterally. It should not be applied to areas of skin that are caked with mud or manure. After handling the product, patients should wash their hands thoroughly and avoid smoking or eating during the process.

Finally, healthcare providers should inform patients that cloudiness in the formulation may occur when DectoGard Pour-On solution is stored at temperatures below 0°C (32°F), but allowing it to warm to room temperature will restore its normal appearance without affecting efficacy. Patients should consult their veterinarian regarding the appropriate timing for treatment and are encouraged to establish a planned parasite control program.

Storage and Handling

DectoGard Pour-On solution is available in multi-dose containers of 1 liter, 2.5 liters, and 5 liters.

For optimal storage, the solution should be kept below 30°C (86°F) and must be protected from light to maintain its efficacy. Proper handling and storage conditions are essential to ensure the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View veterinary label (PDF)