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Doramectin
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- Active ingredient
- Doramectin 10 mg/1 mL
- Other brand names
- Dosage form
- Injection
- Routes
- Intramuscular
- Subcutaneous
- Prescription status
- Animal
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- August 7, 2024
- Veterinary Document
- Prescribing information, PDF file
- Active ingredient
- Doramectin 10 mg/1 mL
- Other brand names
- Dosage form
- Injection
- Routes
- Intramuscular
- Subcutaneous
- Prescription status
- Animal
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2024
- Label revision date
- August 7, 2024
- Manufacturer
- Durvet, Inc.
- Registration number
- ANADA200750
- NDC root
- 30798-545
- Veterinary Document
- Prescribing information, PDF file
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Drug Overview
Doramectin Injectable Solution is a ready-to-use, sterile solution designed for use in cattle and swine. It contains 1% w/v doramectin (10 mg/mL), a medication that helps treat and control various parasitic infections. In cattle, it is effective against gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites. For swine, it addresses similar issues, including gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites.
This medication works by effectively controlling infections and providing protection against reinfection from specific parasites for set durations. For example, it can protect cattle from certain parasites for up to 28 days. Doramectin is administered through injections, with specific dosages recommended based on the animal's weight.
Uses
Doramectin Injectable Solution is used to treat and control various parasitic infections in cattle and swine. For cattle, it effectively targets gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites. Some of the specific parasites it addresses include Ostertagia ostertagi, Haemonchus placei, and Dictyocaulus viviparus. This treatment not only helps eliminate these parasites but also protects cattle from reinfection for specific periods, such as 14 days for certain roundworms and up to 28 days for others.
In swine, Doramectin is indicated for the treatment and control of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites. It targets parasites like Ascaris suum and Metastrongylus spp., ensuring that your pigs remain healthy and free from these harmful infections. By using Doramectin, you can help maintain the well-being of your livestock and prevent the complications associated with parasitic infestations.
Dosage and Administration
When using Doramectin Injectable Solution for your cattle or swine, it's important to follow the correct dosage based on their body weight to ensure effective treatment. For cattle, you should administer 200 micrograms (mcg) of doramectin for every kilogram (kg) of body weight. Each milliliter (mL) of the solution contains 10 mg of doramectin, which is enough to treat a 110-pound (50 kg) animal. For example, if your cattle weigh 220 pounds, you would give them 2 mL, and for 330 pounds, you would give 3 mL, continuing this pattern up to 10 mL for 1,100 pounds.
For swine, the recommended dosage is higher at 300 mcg of doramectin per kg of body weight. Again, each mL contains 10 mg of doramectin, which can treat a 75-pound (34 kg) pig. For instance, a 150-pound pig would require 2 mL, while a 450-pound pig would need 6 mL. It's crucial to weigh your animals accurately and administer the full dose based on their current weight. Underdosing can lead to ineffective treatment and may contribute to the development of resistance in parasites, so always ensure each animal receives the complete dosage.
What to Avoid
It’s important to follow specific guidelines when using this product to ensure safety and effectiveness. First, this product is not intended for human use and should not be given to female dairy cattle over 20 months old or calves meant for veal. Additionally, avoid using it in other animal species, as this can lead to severe adverse reactions, including fatalities in dogs.
You should also be aware of the restrictions regarding slaughtering animals for human consumption. Cattle should not be slaughtered within 35 days of treatment, and swine should not be slaughtered within 24 days. Make sure to administer the full dose based on the animal's current body weight, as underdosing can lead to ineffective treatment and may contribute to parasite resistance. Lastly, take care to prevent water runoff from feedlots from entering streams or ponds, and dispose of drug containers properly to avoid water contamination.
Side Effects
Using this medication can lead to serious side effects, especially if used in animals other than those intended. There have been reports of severe reactions, including fatalities in dogs. It's important to keep this product out of reach of children and not to use it in humans.
When treating cattle for certain parasites, there are risks of adverse reactions. For example, destroying Hypoderma larvae (cattle grubs) in critical areas can lead to severe host-parasite reactions, which may be fatal. Additionally, killing H. lineatum near the gullet can cause bloat, while treating H. bovis in the vertebral canal may result in staggering or paralysis. These risks are not unique to this medication and can occur with any effective treatment for these grubs.
Warnings and Precautions
This product is not intended for human use, so it's important to keep it out of reach of children to prevent any accidental ingestion. If you suspect any adverse effects or have questions about the product, you can reach out to Durvet, Inc. at 1-800-821-5570 for assistance or to obtain the Safety Data Sheet.
For reporting any adverse drug experiences related to animal medications, you can contact the FDA at 1-888-FDA-VETS or visit their website at www.fda.gov/reportanimalae. If you experience any unexpected reactions or side effects, stop using the product immediately and consult your doctor.
Overdose
If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.
In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.
Pregnancy Use
While Doramectin Injectable Solution is not specifically approved for use in pregnant animals, studies have shown that it is generally safe for females, such as cows and sows, during important stages of pregnancy, including folliculogenesis (the development of ovarian follicles), implantation, organogenesis (the formation of organs), and throughout gestation, even at doses three times higher than recommended.
Additionally, there were no negative effects on breeding performance observed in males (bulls and boars) or females (cows and sows) treated with doramectin during critical reproductive periods. The safety of doramectin has been well established in cattle and swine, with no toxic effects noted even at significantly higher doses—up to 25 times the recommended dose in cattle and 10 times in swine. If you are considering the use of this medication during pregnancy, it is important to consult with a healthcare professional for personalized advice.
Lactation Use
When it comes to breastfeeding, the information provided does not specifically address nursing mothers or lactation (the process of producing milk). This means that there are no clear guidelines or recommendations regarding the use of this medication while breastfeeding.
If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare provider to discuss any potential risks or concerns related to your specific situation. They can help you make informed decisions that prioritize both your health and your baby's well-being.
Pediatric Use
When considering medication for your child, it's important to know that studies have shown safety in young animals, such as neonatal calves and piglets, even when treated with doses up to three times higher than what is typically recommended. This suggests that, at least in these cases, higher doses may not pose significant risks.
However, while these findings are reassuring, always consult with your child's healthcare provider before administering any medication. They can provide guidance tailored to your child's specific needs and ensure that any treatment is safe and appropriate for their age and health status.
Geriatric Use
When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.
Drug Interactions
It's important to talk to your healthcare provider about any medications you are taking, especially dewormers. Over time, parasites can become resistant to these treatments, which means they may not work as effectively. To help prevent this, your provider may recommend using dewormers alongside proper parasite management practices that are suitable for your specific area and the animals involved.
Before using a dewormer, your healthcare provider should assess your situation through fecal examinations or other diagnostic tests. After treatment, it's also crucial to monitor how well the dewormer worked, often through a fecal egg count reduction test. If you notice a decrease in effectiveness, it could signal that the parasites are developing resistance, and your provider can help you adjust your treatment plan accordingly.
Storage and Handling
To ensure the best results with Doramectin Injectable Solution, store the product in a cool, dry place away from direct sunlight. It comes in multi-dose glass vials of 100 mL, 250 mL, and 500 mL, each sealed with a rubber stopper to maintain sterility (the condition of being free from bacteria or other living microorganisms).
When handling the vials, always use a clean technique to avoid contamination. Make sure to check the integrity of the vial before use, and if you notice any damage or if the solution appears cloudy or discolored, do not use it. After opening, follow any specific disposal instructions provided to ensure safe and responsible disposal of the product.
Additional Information
No further information is available.
FAQ
What is Doramectin Injectable Solution?
Doramectin Injectable Solution is a ready-to-use, sterile solution containing 1% w/v doramectin, formulated for use in cattle and swine.
What parasites does Doramectin treat in cattle?
In cattle, Doramectin is indicated for the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites.
What is the recommended dosage for cattle?
The recommended dosage for cattle is 200 mcg/kg of body weight, administered via subcutaneous or intramuscular injection.
What is the recommended dosage for swine?
For swine, the recommended dosage is 300 mcg/kg of body weight, administered via intramuscular injection.
How long does Doramectin protect cattle from reinfection?
Doramectin effectively controls infections and protects cattle from reinfection for specified durations, such as 14 days for certain roundworms and up to 28 days for others.
Are there any contraindications for using Doramectin?
Yes, Doramectin is not for human use, should not be used in female dairy cattle 20 months or older, and should not be used in calves intended for veal.
What should I do if I suspect an adverse reaction?
To report suspected adverse drug events or for technical assistance, contact Durvet, Inc. at 1-800-821-5570.
Is Doramectin safe for pregnant animals?
Doramectin is not specifically indicated for use in pregnant animals, but studies have shown it to be safe during critical reproductive stages when given at three times the recommended dose.
What should I avoid when using Doramectin?
Do not underdose, as this may lead to ineffective treatment and encourage parasite resistance. Also, do not allow water runoff from feedlots to enter streams or ponds.
What forms is Doramectin Injectable Solution available in?
Doramectin Injectable Solution is available in 100-mL, 250-mL, and 500-mL multi-dose, rubber-stoppered glass vials.
Packaging Info
The table below lists each NDC Code for Doramectin veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection | 10 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Injection | 10 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Injection | 10 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
Drug Information (PDF)
This PDF provides official product information for Doramectin, which is intended for animal use only.
Description
Doramectin Injectable Solution is a ready-to-use, colorless to pale yellow, sterile solution containing 1% w/v doramectin (10 mg/mL). In cattle, it is designed to provide the recommended dosage of 200 mcg/kg of body weight when administered by subcutaneous (SC) or intramuscular (IM) injection at a rate of 1 mL per 110 lb of body weight. For swine, the formulation allows for the delivery of the recommended dosage of 300 mcg/kg of body weight when given by IM injection at a rate of 1 mL per 75 lb of body weight.
Uses and Indications
Doramectin Injectable Solution is indicated for the treatment and control of various parasitic infections in cattle and swine.
In cattle, Doramectin is effective against gastrointestinal roundworms, lungworms, eyeworms, grubs, sucking lice, and mange mites. The specific gastrointestinal roundworms targeted include Ostertagia ostertagi (including inhibited larvae), Haemonchus placei, Trichostrongylus axei, T. colubriformis, T. longispicularis, Cooperia oncophora, C. pectinata, C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus. Lungworms include Dictyocaulus viviparus, while eyeworms are represented by Thelazia spp. Grubs targeted are Hypoderma bovis and H. lineatum. Sucking lice include Haematopinus eurysternus, Linognathus vituli, Solenopotes capillatus, and C. surnabada (syn. mcmasteri). Mange mites include Psoroptes bovis and Sarcoptes scabiei. Doramectin has demonstrated efficacy in controlling infections and protecting cattle from reinfection for specified durations: Cooperia oncophora and Haemonchus placei for 14 days, Ostertagia ostertagi for 21 days, and C. punctata, Oesophagostomum radiatum, and Dictyocaulus viviparus for 28 days post-treatment.
In swine, Doramectin is indicated for the treatment and control of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites. The specific gastrointestinal roundworms targeted include Ascaris suum, Oesophagostomum dentatum, Oesophagostomum quadrispinulatum, Strongyloides ransomi, and Hyostrongylus rubidus. Lungworms include Metastrongylus spp., while kidney worms are represented by Stephanurus dentatus. Mange mites include Sarcoptes scabiei var. suis, and sucking lice are represented by Haematopinus suis.
Limitations of use have not been established for Doramectin in specific populations or conditions beyond the indications listed.
Dosage and Administration
Cattle should receive Doramectin Injectable Solution at a dosage of 200 mcg doramectin per kg (91 mcg/lb) of body weight. Each mL of the solution contains 10 mg of doramectin, which is adequate to treat 110 lb (50 kg) of body weight. The following dosing guidelines based on body weight are recommended:
For 110 lb: administer 1 mL
For 220 lb: administer 2 mL
For 330 lb: administer 3 mL
For 440 lb: administer 4 mL
For 550 lb: administer 5 mL
For 660 lb: administer 6 mL
For 770 lb: administer 7 mL
For 880 lb: administer 8 mL
For 990 lb: administer 9 mL
For 1,100 lb: administer 10 mL
Swine should be treated with Doramectin Injectable Solution at a dosage of 300 mcg doramectin per kg (136 mcg/lb) of body weight. Each mL of the solution contains 10 mg of doramectin, sufficient for treating 75 lb (34 kg) of body weight. The following dosing guidelines based on body weight are recommended:
For 15 lb: administer 0.2 mL
For 30 lb: administer 0.4 mL
For 45 lb: administer 0.6 mL
For 60 lb: administer 0.8 mL
For 75 lb: administer 1.0 mL
For 150 lb: administer 2.0 mL
For 225 lb: administer 3.0 mL
For 300 lb: administer 4.0 mL
For 375 lb: administer 5.0 mL
For 450 lb: administer 6.0 mL
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.
Contraindications
Use of this product is contraindicated in the following situations:
This product is not intended for human use.
It should not be administered to female dairy cattle aged 20 months or older.
The product is contraindicated in calves intended for veal processing.
Use in other animal species is prohibited due to the risk of severe adverse reactions, including fatalities observed in dogs.
Additionally, the following precautions must be observed:
Cattle treated with this product should not be slaughtered for human consumption within 35 days post-treatment.
Swine treated with this product should not be slaughtered for human consumption within 24 days post-treatment.
Underdosing is contraindicated, as it may lead to ineffective treatment and the development of parasite resistance.
Water runoff from feedlots must not be allowed to enter streams or ponds.
Direct application of the product or improper disposal of drug containers that may contaminate water is prohibited. Containers should be disposed of in an approved landfill or incinerated.
Warnings and Precautions
It is imperative to note that this product is not intended for human use. Healthcare professionals must ensure that it is stored securely and kept out of reach of children to prevent accidental ingestion or misuse.
In the event of suspected adverse drug events, healthcare providers are encouraged to report these occurrences. For technical assistance or to obtain a copy of the Safety Data Sheet, professionals should contact Durvet, Inc. at 1-800-821-5570.
For further information regarding the reporting of adverse drug experiences related to animal drugs, healthcare professionals may reach out to the FDA at 1-888-FDA-VETS or visit their website at www.fda.gov/reportanimalae. This ensures that all potential safety concerns are documented and addressed appropriately.
Side Effects
Severe adverse reactions, including fatalities, have been reported in dogs following the use of this product in other animal species. It is important to note that this product is not intended for human use and should be kept out of reach of children.
In clinical settings, the destruction of Hypoderma larvae (cattle grubs) during critical periods may lead to undesirable host-parasite reactions, which can include fatalities. Specifically, the elimination of H. lineatum when located in the tissue surrounding the gullet has been associated with the occurrence of bloat. Additionally, the treatment of H. bovis when situated in the vertebral canal may result in staggering or paralysis.
These adverse reactions are not exclusive to the use of Doramectin Injectable Solution; they can occur with any effective treatment aimed at grubs. Therefore, careful consideration and monitoring are advised when administering this product to ensure the safety and well-being of the treated animals.
Drug Interactions
Parasite resistance may develop to any dewormer, and this phenomenon has been reported across most classes of dewormers. To mitigate the risk of resistance, it is recommended that dewormers be used in conjunction with appropriate parasite management practices tailored to the specific geographic area and the animal(s) being treated. This combined approach may help slow the development of resistance.
Prior to administering any dewormer, it is essential to conduct fecal examinations or other diagnostic tests, along with a review of the parasite management history, to ascertain the appropriateness of the product for the herd. Following the administration of a dewormer, the effectiveness of the treatment should be monitored. This can be achieved through methods such as fecal egg count reduction tests or other suitable techniques. A noted decrease in the effectiveness of a dewormer over time, as indicated by these tests, may suggest the emergence of resistance to the administered dewormer.
Packaging & NDC
The table below lists each NDC Code for Doramectin veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Injection | 10 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Injection | 10 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
| Injection | 10 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
| ||||
Pediatric Use
Studies have demonstrated the safety of the treatment in neonatal calves and piglets when administered doses up to three times the recommended amount. Additionally, in male (bulls and boars) and female (cows and sows) pediatric populations, the use of a dose three times the recommended amount during critical reproductive phases, including folliculogenesis, implantation, organogenesis, and throughout gestation, did not adversely affect breeding performance.
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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.
Pregnancy
Doramectin Injectable Solution is not specifically indicated for use in pregnant animals; however, studies have demonstrated its safety in females, including cows and sows, during critical reproductive stages such as folliculogenesis, implantation, organogenesis, and throughout gestation when administered at doses up to three times the recommended amount. No adverse effects on breeding performance were observed in treated males (bulls and boars) or females (cows and sows) during these critical reproductive periods.
The safety margin of doramectin injection has been well established in both cattle and swine. In clinical studies, no toxic signs were observed in cattle administered doses up to 25 times the recommended dose, nor in swine given doses up to 10 times the recommended dose. Given this data, healthcare professionals should consider the available evidence when evaluating the use of doramectin in pregnant patients or in those of childbearing potential.
Lactation
There is no specific information available regarding the use of this medication in lactating mothers. The effects on breastfed infants and the excretion of the drug in human milk have not been addressed in the prescribing information. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to 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 outlined 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
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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.
Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.
Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.
Nonclinical Toxicology
Studies have demonstrated the safety margin of doramectin injection in cattle and swine. In both male and female animals, including bulls, boars, cows, and sows, a dose three times the recommended amount did not adversely affect breeding performance during critical developmental stages such as folliculogenesis, implantation, organogenesis, and throughout gestation.
Further investigations into non-teratogenic effects revealed that neonatal calves and piglets treated with doses up to three times the recommended amount exhibited no safety concerns. Additionally, trials conducted in the USA indicated that no toxic signs were observed in cattle administered doses up to 25 times the recommended level, nor in swine receiving doses up to 10 times the recommended level.
Doramectin is recognized as a highly active, broad-spectrum parasiticide intended for parenteral administration to cattle and swine. Its primary mode of action involves the modulation of chloride ion channel activity within the nervous systems of nematodes and arthropods. Macrocyclic lactones, such as doramectin, 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 from postmarketing experience indicate that Doramectin Injectable Solution is intended exclusively for use in cattle and swine. Use in other animal species may lead to severe adverse reactions, including fatalities in dogs.
Voluntary reports and data from surveillance programs have highlighted the potential for parasite resistance to develop with any dewormer, including Doramectin. This resistance has been documented 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, it is recommended that fecal examinations or other diagnostic tests be conducted to assess the suitability of the product for the herd. Following treatment, the effectiveness of the dewormer should be monitored, for instance, through fecal egg count reduction tests. A noted decrease in effectiveness over time may suggest the emergence of resistance, necessitating adjustments to the parasite management plan based on regular monitoring.
Additionally, cattle treated with Doramectin Injectable Solution after the heel fly season may safely receive re-treatment during winter for internal parasites, mange mites, or sucking lice, without the risk of grub-related reactions. A structured parasite control program is recommended to ensure optimal efficacy and management of parasitic infections.
For reporting suspected adverse drug events or for technical assistance, individuals are encouraged to contact Durvet, Inc. at 1-800-821-5570. For further 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.
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 emphasize that the product is not intended for human use and should be kept out of reach of children.
Patients should be informed about the potential for parasite resistance to develop with any dewormer, as this has been reported for most classes of dewormers. To mitigate this risk, treatment with a dewormer should be used in conjunction with appropriate parasite management practices tailored to the geographic area and the specific animal(s) being treated. Prior to the use of any dewormer, fecal examinations or other diagnostic tests, along with a review of the parasite management history, should be conducted to determine the product's appropriateness for the herd.
Following the administration of any dewormer, healthcare providers should recommend monitoring the effectiveness of the treatment. This can be achieved through methods such as fecal egg count reduction tests. A decrease in the drug's effectiveness over time, as indicated by these tests, may suggest the development of resistance to the dewormer used. Consequently, patients should be encouraged to adjust their parasite management plan based on regular monitoring results.
For cattle treated with Doramectin Injectable Solution after the heel fly season, it is safe to re-treat during the winter for internal parasites, mange mites, or sucking lice without the risk of grub-related reactions. A planned parasite control program is recommended to ensure effective management.
Patients should also be informed about the process for reporting suspected adverse drug events. They can contact Durvet, Inc. at 1-800-821-5570 for technical assistance or to obtain a copy of the Safety Data Sheet. For additional information regarding adverse drug experience reporting for animal drugs, patients can reach out to the FDA at 1-888-FDA-VETS or visit www.fda.gov/reportanimalae.
Finally, healthcare providers should instruct patients on the proper disposal of containers, recommending that they be disposed of in an approved landfill or by incineration.
Storage and Handling
Doramectin Injectable Solution is supplied in multi-dose, rubber-stoppered glass vials with the following configurations: 100 mL, 250 mL, and 500 mL.
For optimal storage, it is recommended that the solution be kept at a temperature range of 20°C to 25°C (68°F to 77°F). It is important to protect the vials from light and to ensure that they are stored in a secure environment to maintain the integrity of the product. Special handling precautions should be observed to prevent contamination and ensure the solution remains sterile.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This document includes the full labeling information for Doramectin, as submitted by Durvet, Inc. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.