Dectomax

Description

The product is identified by the SPL code 34089-3 and contains Doramectin as the active ingredient. It is presented as a clear, colorless to pale yellow liquid. The formulation includes inactive ingredients such as propylene glycol, isopropyl alcohol, and water.

Uses and Indications

Dectomax Pour-On solution is indicated for the treatment and control of various parasitic infections in cattle, including gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, and horn flies.

This drug 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).

For lungworm infections, Dectomax Pour-On solution is effective against Dictyocaulus viviparus (adults and fourth stage larvae). It also treats eyeworms, specifically Thelazia gulosa and T. skrjabini (adults), and grubs, including Hypoderma bovis and H. lineatum.

In terms of ectoparasites, this solution is indicated for the treatment of biting lice such as Bovicola (Damalinia) bovis, Haematopinus eurysternus, Linognathus vituli, and Solenopotes capillatus, as well as sucking lice including Chorioptes bovis and Sarcoptes scabiei. Additionally, it is effective against horn flies, specifically Haematobia irritans.

Dectomax Pour-On solution has demonstrated efficacy in controlling infections and protecting cattle from reinfection with Cooperia oncophora, Dictyocaulus viviparus, Ostertagia ostertagi, and Oesophagostomum radiatum for 28 days post-treatment, and with Cooperia punctata and Haemonchus placei for 35 days post-treatment. Furthermore, it effectively controls infestations and protects against reinfestation with Bovicola (Damalinia) bovis for 77 days and Linognathus vituli for 42 days after treatment.

Dosage and Administration

Dectomax Pour-On solution is available in multi-dose containers of 1-L (0.26 gal), 2.5-L (0.66 gal), and 5-L (1.32 gal).

Healthcare professionals should refer to specific guidelines for the appropriate route, method, and frequency of administration, as this information is not detailed in the provided data. It is essential to follow established protocols and recommendations for the administration of this product to ensure optimal efficacy and safety.

Contraindications

This product is contraindicated for use in the following situations:

Use in other animal species is prohibited due to the risk of 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, do not underdose; each animal must receive a complete dose based on current body weight to prevent ineffective treatment and the development of parasite resistance. Application should not occur on areas of skin that are caked with mud or manure.

Handlers 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. 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. Dectomax 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.

This product is strictly not for human use and must be kept out of reach of children to prevent accidental exposure. For comprehensive occupational safety information, including details on adverse effects and the Safety Data Sheet (SDS), healthcare professionals can contact 1-888-963-8471.

Dectomax Pour-On solution may cause irritation to human skin and eyes. Users are advised to avoid applying the product to themselves or to others. To minimize the risk of exposure, operators should don appropriate protective clothing, which includes a long-sleeved shirt, protective gloves, and waterproof boots. A waterproof coat is also recommended during application.

After use, it is essential to wash protective clothing thoroughly to remove 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 critical to flush the eyes with water immediately and seek medical attention.

Side Effects

Patients using Dectomax Pour-On solution for cattle should be aware of several important safety warnings and precautions associated with the product. The solution is flammable and must be kept away from heat, sparks, open flames, and other sources of ignition. It is strictly not for human use and should be kept out of reach of children.

In terms of application, Dectomax Pour-On may cause irritation to human skin and eyes. Users are advised to take precautions by wearing protective clothing, including a long-sleeved shirt, protective gloves, and waterproof boots during application. After use, protective clothing should be washed thoroughly. In the event of accidental skin contact, the affected area should be washed immediately with soap and water. If the solution comes into contact with the eyes, they should be flushed immediately with water, and medical attention should be sought.

Dectomax Pour-On solution has been specifically developed for use in cattle and should not be administered to other animal species. The use of this product in non-target species may lead to severe adverse reactions, including fatalities in dogs.

Additionally, the destruction of Hypoderma larvae (cattle grubs) during treatment can lead to undesirable host-parasite reactions, which may include fatalities. For instance, killing H. lineatum when it is located in the tissue surrounding the gullet may result in bloat, while killing H. bovis in the vertebral canal may lead to staggering or paralysis. These adverse reactions are not unique to Dectomax Pour-On solution and can occur with any effective treatment of grubs.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Dectomax Pour-On solution is contraindicated for use in female dairy cattle 20 months of age or older. In preruminating calves, a withdrawal period has not been established, and the product should not be used in calves intended for veal processing.

Safety studies indicate that doramectin is safe for neonatal calves when treated with doses up to three times the recommended amount.

Geriatric Use

There is no specific information regarding the use of Dectomax Pour-On (doramectin solution) in geriatric patients, including dosage adjustments or safety concerns. Healthcare providers should exercise caution when considering the administration of this medication to elderly patients, as the absence of data necessitates careful monitoring and assessment of individual patient needs. It is advisable to evaluate the overall health status and potential comorbidities of geriatric patients prior to prescribing this treatment.

Pregnancy

Dectomax Pour-On solution is not indicated for use in pregnant animals, and specific safety concerns regarding its use during pregnancy are not detailed in the prescribing information. In studies involving breeding animals, such as bulls and cows, a dose three times the recommended dose of Dectomax Injectable solution did not adversely affect breeding performance, suggesting a potential level of safety; however, specific data related to pregnancy outcomes is lacking. There are no dosage modifications or special precautions provided for the use of Dectomax Pour-On solution during pregnancy. While the insert does not explicitly contraindicate the use of Dectomax Pour-On in pregnant animals, the absence of supportive safety data necessitates caution when considering its use in this population.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further data may be necessary to inform clinical decisions.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific recommendations are not provided in the current prescribing information.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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, even in the absence of documented effects. Symptoms of overdose 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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

Teratogenic effects were evaluated in breeding animals, including bulls and cows, with a dose three times the recommended dose of Dectomax Injectable solution showing no adverse impact on breeding performance during folliculogenesis, organogenesis, implantation, and throughout gestation.

Non-teratogenic effects have been substantiated through various studies demonstrating the safety margin of doramectin. In trials conducted in the USA, no toxic signs were observed in cattle administered doses up to 25 times the recommended dose of Dectomax Injectable solution. Additionally, safety was confirmed in neonatal calves treated with doses up to three times the recommended amount.

A pharmacokinetic study indicated that systemic exposure to doramectin from Dectomax Pour-On was lower than that from Dectomax Injectable solution.

Doramectin is derived from fermentations of selected strains of the soil organism Streptomyces avermitilis. The primary mode of action of 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

Severe adverse reactions, including fatalities in dogs, have been reported following the use of Dectomax Pour-On solution in species other than cattle. Additionally, there have been observations of parasite resistance developing to various dewormers, which is a noted concern across most classes of deworming agents. It is recommended that treatment with a dewormer be accompanied by appropriate parasite management practices to potentially slow the development of resistance. Furthermore, it is advised that the effectiveness of any dewormer be monitored post-treatment, as a decrease in efficacy over time may suggest the emergence of resistance to the administered dewormer.

Patient Counseling

Healthcare providers should advise patients to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism. For optimal horn fly control, it is recommended to seek guidance from a veterinarian or a livestock entomologist.

When administering Dectomax Pour-On solution to cattle, it is important to apply the product topically at a dosage of 500 mcg doramectin per kg (227 mcg/lb) of body weight. Each animal must receive a complete dose based on its current body weight, as underdosing may lead to ineffective treatment and encourage the development of parasite resistance. The solution should be applied in a narrow strip along the mid-line of the back, between the withers and tailhead.

In the event of accidental skin contact, patients should be instructed to wash the affected area immediately with soap and water. If there is accidental eye exposure, they should flush the eyes with water and seek medical attention promptly. Operators applying the product should wear protective clothing, including a long-sleeved shirt, protective gloves, and boots, along with a waterproof coat. It is essential that protective clothing is washed after use.

Patients should be cautioned against applying the product to areas of skin that are caked with mud or manure. Additionally, they should wash their hands after use and refrain from smoking or eating while handling the product.

It is critical to inform patients that cattle must not be slaughtered for human consumption within 45 days of treatment. The product is not intended for use in female dairy cattle 20 months of age or older. Furthermore, 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.

Lastly, healthcare providers should emphasize that parasite resistance may develop to any dewormer, and resistance has been reported for most classes of dewormers. Therefore, patients should adjust their parasite management plan based on regular monitoring.

Storage and Handling

Dectomax Pour-On solution is available in the following multi-dose container sizes: 1-L (0.26 gal), 2.5-L (0.66 gal), and 5-L (1.32 gal).

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 Dectomax, as submitted by Zoetis Inc. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)