Doramectin

Uses and Indications

This drug is indicated for the treatment and control of various parasitic infections in cattle and swine.

Cattle

The drug is indicated for the treatment and control of:

• Gastrointestinal Roundworms (adults and fourth stage larvae):

  • Ostertagia ostertagi (including inhibited larvae)

  • O. lyrata

  • Haemonchus placei

  • Trichostrongylus axei

  • T. colubriformis

  • T. longispicularis

  • Cooperia oncophora

  • C. pectinata

  • C. punctata

  • C. surnabada (syn. mcmasteri)

  • Bunostomum phlebotomum

  • Oesophagostomum radiatum

  • Trichuris spp.

• Lungworms (adults and fourth stage larvae):

  • Dictyocaulus viviparus

• Eyeworms (adults):

  • Thelazia spp. (including Thelazia gulosa and T. skrjabini)

• Grubs (parasitic stages):

  • Hypoderma bovis

  • H. lineatum

• Sucking Lice (adults and immature stages):

  • Haematopinus eurysternus

  • Linognathus vituli

  • Solenopotes capillatus

  • Bovicola (Damalinia) bovis

• Mange Mites (adults and immature stages):

  • Psoroptes bovis

  • Sarcoptes scabiei

  • Chorioptes bovis

• Horn Flies:

  • Haematobia irritans

The drug effectively controls infections and protects cattle from reinfection for specified durations:

• 14 days: Cooperia oncophora, Haemonchus placei

• 21 days: Ostertagia ostertagi

• 28 days: C. punctata, Oesophagostomum radiatum, Dictyocaulus viviparus

• 35 days: Cooperia punctata, Haemonchus placei

• 77 days: Bovicola (Damalinia) bovis

• 42 days: Linognathus vituli

Swine

The drug is indicated for the treatment and control of:

• Gastrointestinal Roundworms (adults and fourth stage larvae):

  • Ascaris suum

  • Oesophagostomum dentatum

  • Oesophagostomum quadrispinulatum

  • Strongyloides ransomi

  • Hyostrongylus rubidus

• Lungworms (adults):

  • Metastrongylus spp.

• Kidney Worms (adults):

  • Stephanurus dentatus

• Mange Mites (adults and immature stages):

  • Sarcoptes scabiei var. suis

• Sucking Lice (adults and immature stages):

  • Haematopinus suis

Limitations of Use

The specific conditions or diseases treated or prevented by Doracide are not specified in the provided text.

Dosage and Administration

Administer Dectomax, Doramectin, Doraject, Doracide, or DectoGard according to the following guidelines for cattle and swine.

Cattle:The recommended dosage for injectable solutions (Dectomax, Doramectin, Doraject) is 200 mcg doramectin per kg (91 mcg/lb) of body weight. Each mL contains 10 mg of doramectin, sufficient to treat 110 lb (50 kg) of body weight. The dosage based on body weight is as follows:

• 110 lb: 1 mL

• 220 lb: 2 mL

• 330 lb: 3 mL

• 440 lb: 4 mL

• 550 lb: 5 mL

• 660 lb: 6 mL

• 770 lb: 7 mL

• 880 lb: 8 mL

• 990 lb: 9 mL

• 1,100 lb: 10 mL

For topical solutions (Doracide and DectoGard), administer at a dosage of 500 mcg doramectin per kg (227 mcg/lb) of body weight. Each mL contains 5 mg of doramectin, sufficient to treat 22 lb (10 kg) of body weight. The application should be made topically along the mid-line of the back in a narrow strip between the withers and tailhead.

Swine:The recommended dosage for injectable solutions (Dectomax, Doramectin, Doraject) is 300 mcg doramectin per kg (136 mcg/lb) of body weight. Each mL contains 10 mg of doramectin, sufficient to treat 75 lb (34 kg) of body weight. The dosage based on body weight is as follows:

• 15 lb: 0.2 mL

• 30 lb: 0.4 mL

• 45 lb: 0.6 mL

• 60 lb: 0.8 mL

• 75 lb: 1.0 mL

• 150 lb: 2.0 mL

• 225 lb: 3.0 mL

• 300 lb: 4.0 mL

• 375 lb: 5.0 mL

• 450 lb: 6.0 mL

Administration Notes:It is critical to avoid underdosing. Each animal must receive a complete dose based on its current body weight to ensure effective treatment and to prevent the development of parasite resistance. For topical applications, dosing cups or applicators may be used to ensure accurate dosing. When using applicators, follow the manufacturer's instructions for setup and administration.

Contraindications

Not for use in female dairy cattle 20 months of age or older. This product should not be used in calves to be processed for veal. It is contraindicated for use in other animal species, as severe adverse reactions, including fatalities in dogs, may result.

Underdosing is not recommended, as it may lead to ineffective treatment and encourage the development of parasite resistance. The product should not be administered orally or parenterally, nor applied to areas of skin that are caked with mud or manure.

Cattle should not be permitted to enter lakes, streams, or ponds for at least 6 hours after treatment. Additionally, the product should not be used in a manner that contaminates water through direct application or improper disposal of drug containers.

Slaughter for human consumption is prohibited within 35 days of treatment.

Warnings and Precautions

Not for human use. Keep out of reach of children.

Serious Warnings

• WARNING: Flammable! Keep away from heat, sparks, open flame, and other sources of ignition.

• Dectomax, Doramectin, Doracide, and DectoGard Pour-On solutions for cattle may be irritating to human skin and eyes. Users should be careful not to apply these products to themselves or to other persons.

Protective Measures

• Operators should wear protective clothing, including a long-sleeved shirt, protective gloves, and boots with a waterproof coat when applying the product.

• Protective clothing should be washed after use.

First Aid Measures

• If accidental skin contact occurs, wash the affected area immediately with soap and water.

• If accidental eye exposure occurs, flush the eyes immediately with water and seek medical attention.

Reporting Adverse Effects

• To report adverse effects in users, obtain more information, or request a Safety Data Sheet (SDS), contact the respective manufacturers:

  • Dectomax: 1-888-963-8471

  • Doramectin: 1-800-821-5570

  • DectoGard: 1-888-215-1256

  • Doraject: 1-844-227-6687 (1-844-2-CRONUS)

• For additional information about adverse drug experience reporting for animal drugs, contact the FDA at 1-888-FDA-VETS or visit www.fda.gov/reportanimalae.

Occupational Safety Information

• The Safety Data Sheet (SDS) contains more detailed occupational safety information.

Side Effects

Severe adverse reactions, including fatalities in dogs, may occur if these products are used in species other than cattle and swine. The following adverse reactions have been reported:

Serious Adverse Reactions

• Fatalities in dogs due to use in non-target species.

• Destruction of Hypoderma larvae (cattle grubs) during critical periods may lead to undesirable host-parasite reactions, including:

  • Bloat from killing H. lineatum when it is in the tissue surrounding the gullet.

  • Staggering or paralysis from killing H. bovis when it is in the vertebral canal.

Common Adverse Reactions

• Skin and eye irritation in humans upon accidental contact with the products. Users are advised to wash affected areas immediately with soap and water and seek medical attention for eye exposure.

Warnings

• All products are flammable and should be kept away from heat, sparks, open flames, and other ignition sources.

• These products are not for human use and should be kept out of reach of children.

Precautions

• Protective clothing, including long-sleeved shirts, gloves, and boots, should be worn during application to minimize exposure.

• If accidental skin contact occurs, wash the area immediately. In case of eye exposure, flush with water and seek medical attention.

These reactions are not specific to any one product but can occur with any successful treatment of grubs.

Drug Interactions

There are no documented drug interactions for Dectomax, which is available in injection and solution forms. Similarly, Dectogard, provided as a solution, also lacks any reported drug interactions. Additionally, there is no information regarding interactions with laboratory tests for either product. Therefore, healthcare professionals can consider these medications as having no known interactions based on the available data.

Pediatric Use

Safety has been demonstrated in neonatal calves and piglets treated with doses up to three times the recommended amount for Dectomax and DectoGard. In studies involving male and female cattle, including during critical reproductive stages such as folliculogenesis, implantation, organogenesis, and gestation, doses up to three times the recommended amount did not adversely affect breeding performance.

DectoGard is specifically indicated for use in cattle and should not be administered to other animal species, including children, due to the potential for severe adverse reactions. There is no established withdrawal period for DectoGard in preruminating calves, and it is contraindicated in calves intended for veal processing.

For swine, it is recommended to use a tuberculin syringe with a 20 gauge × 1" needle to ensure accurate dosing in piglets.

Geriatric Use

There is no specific information regarding geriatric use, dosage adjustments, or safety concerns for elderly patients provided in the inserts for Dectomax and Dectogard. Healthcare professionals should exercise caution and consider individual patient factors when prescribing these medications to geriatric patients, as the absence of data does not preclude the need for careful monitoring and assessment of treatment effects in this population.

Pregnancy

Dectomax and Dectogard are not indicated for use in pregnant patients, and safety during pregnancy has not been established for either product. In studies involving female cattle, including cows and sows, a dose of Dectomax that was three times the recommended amount showed no adverse effects on breeding performance during critical periods such as folliculogenesis, implantation, organogenesis, and throughout gestation. Similarly, a study with Dectogard demonstrated that doramectin injectable solution was safe for breeding animals during these same developmental stages, with no impact on breeding performance at the same elevated dose.

Healthcare professionals are advised to consult with veterinarians for guidance on the diagnosis, treatment, and management of parasitism in pregnant patients. It is also important to note that cattle treated with these products must not be slaughtered for human consumption within 45 days post-treatment. Additionally, Dectogard is contraindicated in female dairy cattle aged 20 months or older.

Lactation

There is limited information available regarding the use of Dectomax and Dectogard in lactating mothers or the effects on breastfed infants. The product inserts do not specifically address lactation or the excretion of these medications in breast milk.

Healthcare professionals should exercise caution when considering the use of these products in lactating individuals, as the potential effects on breastfed infants remain unclear. Additionally, the absence of established withdrawal periods for Dectogard in calves suggests that further research may be necessary to fully understand the implications for lactation.

Given the lack of specific guidance, it is advisable for lactating mothers to consult with their healthcare provider before using these products.

Renal Impairment

Patients with renal impairment may not have specific dosing adjustments, monitoring requirements, or safety considerations outlined for the following products: Dectomax (Injection, Solution), Doramectin (Injection, Solution), Doracide (Solution), Dectogard (Solution), and Doraject (Injection, Solution). The available label information does not provide guidance on the management of these medications in individuals with reduced kidney function. Therefore, healthcare professionals should exercise caution and consider individual patient circumstances when prescribing these products to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically addressed in the available product information for Dectomax, Doramectin, Doracide, Dectogard, and Doraject. There are no dosage adjustments, special monitoring requirements, or precautions indicated for this patient population across the various formulations, including injections and solutions. Consequently, healthcare providers should exercise caution and consider individual patient factors when administering these medications to patients with liver problems, as the lack of specific guidance necessitates careful clinical judgment.

Overdosage

In the event of an overdose, specific information regarding the management and symptoms associated with overdose for Dectomax, Doramectin, Doracide, Dectogard, and Doraject is not provided in the available literature.

Given the absence of detailed overdosage information, it is recommended that healthcare professionals monitor the patient closely for any unusual symptoms or adverse reactions following administration. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation.

In cases where overdose is suspected, it is advisable to contact a poison control center or seek immediate medical attention for further guidance on management strategies.

Nonclinical Toxicology

Teratogenicity

In studies involving breeding animals, including bulls and cows, a dose of doramectin three times the recommended amount demonstrated no adverse effects on breeding performance during critical developmental stages such as folliculogenesis, organogenesis, implantation, and throughout gestation. Similar findings were observed in swine, where no teratogenic effects were noted at the same dosage levels.

Non-Teratogenic Effects

Extensive trials conducted in the United States have established a significant safety margin for doramectin. Cattle administered doses up to 25 times the recommended amount exhibited no toxic signs. Additionally, safety was confirmed in neonatal calves treated with doses up to three times the recommended level. Comparable results were observed in swine, indicating a robust safety profile across species.

Animal Pharmacology and Toxicology

Doramectin, derived from selected strains of the soil organism Streptomyces avermitilis, functions primarily by modulating chloride ion channel activity within the nervous systems of nematodes and arthropods. The mechanism involves binding 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, including doramectin, are predominantly localized within the central nervous system (CNS), where only negligible concentrations of the compound are present.

Impairment of Fertility

No evidence of fertility impairment was observed in studies involving both male and female breeding animals at doses three times the recommended level. This suggests that doramectin does not adversely affect reproductive performance in the evaluated species.

Carcinogenesis and Mutagenesis

No specific data regarding carcinogenic or mutagenic effects of doramectin were provided in the available studies. Further investigation may be warranted to fully assess these potential risks.

Storage and Handling

Dectomax is supplied as an injection and solution in various packaging configurations. The injection form is available in 100 mL multi-dose, rubber-capped glass vials, while the solution form is offered in 1-L, 2.5-L, and 5-L multi-dose containers. Dectomax should be stored below 30°C (86°F) and protected from light. It is recommended to use this product within 90 days of the first puncture, with a maximum of 25 punctures. If more than 25 punctures are anticipated, the use of automatic injection equipment or a repeater syringe is advised. Any remaining product in the vial should be discarded immediately after use if a draw-off spike or needle with a bore diameter larger than 16 gauge is utilized. Containers should be disposed of in an approved landfill or by incineration.

Doramectin is available as an injectable solution in 100 mL, 250 mL, and 500 mL multi-dose, rubber-stoppered glass vials. The storage conditions for Doramectin require it to be kept below 25°C (77°F) and protected from light.

Doracide is supplied as a solution and must be stored below 25°C (77°F) while also being protected from light. Disposal of containers should follow the same guidelines as other products, either in an approved landfill or by incineration.

DectoGard is provided as a solution in 1-L, 2.5-L, and 5-L multi-dose containers. It should be stored below 30°C (86°F) and protected from light.

Doraject is available in both injection and solution forms, with the injection provided in 100 mL, 250 mL, and 500 mL multi-dose, rubber-stoppered glass vials.

All products should be handled according to the specified storage conditions to ensure their efficacy and safety.