Zimecterin Gold

Description

ZIMECTERIN® GOLD is a paste formulation containing ivermectin at a concentration of 1.55% and praziquantel at 7.75%. This product is indicated for the removal of roundworms, tapeworms, and bots in horses, requiring only a single dose for effective treatment. It is intended for oral administration exclusively in horses and is formulated to treat animals weighing up to 1250 lb. The net weight of the product is 0.26 oz (7.35 g).

Uses and Indications

This drug is indicated for the treatment and prevention of various parasitic infections in horses. Specifically, it is effective against the following conditions:

• Tapeworms caused by Anoplocephala perfoliata.

• Large Strongyles, including adult forms of Strongylus vulgaris (including early forms in blood vessels), S. edentatus (including tissue stages), S. equinus, Triodontophorus species (including T. brevicauda and T. serratus), and Craterostomum acuticaudatum.

• Small Strongyles, including adults resistant to certain benzimidazole class compounds, such as Coronocyclus species (including C. coronatus, C. labiatus, C. labratus), Cyathostomum species (including C. catinatum and C. pateratum), Cylicocyclus species (including C. insigne, C. leptostomum, C. nassatus, C. brevicapsulatus), Cylicodontophorus species, and Cylicostephanus species (including C. calicatus, C. goldi, C. longibursatus, C. minutus), as well as Petrovinema poculatum.

• Fourth-stage larvae of Small Strongyles.

• Pinworms, including adults and fourth-stage larvae of Oxyuris equi.

• Ascarids, including adults and third- and fourth-stage larvae of Parascaris equorum.

• Hairworms, including adults of Trichostrongylus axei.

• Large-mouth Stomach Worms, including adults of Habronema muscae.

• Bots, including oral and gastric stages of Gasterophilus species (including G. intestinalis and G. nasalis).

• Lungworms, including adults and fourth-stage larvae of Dictyocaulus arnfieldi.

• Intestinal Threadworms, including adults of Strongyloides westeri.

• Summer Sores caused by cutaneous third-stage larvae of Habronema and Draschia species.

• Dermatitis caused by neck threadworm microfilariae of Onchocerca species.

This drug is for oral use in horses only and is formulated to treat animals weighing up to 1250 lb.

Dosage and Administration

The syringe is designed to deliver a complete dose of the medication for a horse weighing up to 1250 lb. The recommended dosage is 91 mcg of ivermectin per lb (200 mcg/kg) of body weight and 454 mcg of praziquantel per lb (1 mg/kg) of body weight.

Each weight marking on the syringe plunger corresponds to a dosage sufficient to treat 250 lb of body weight. It is imperative that healthcare professionals ensure that each horse receives a complete dose based on its current body weight. Underdosing should be strictly avoided, as it may lead to ineffective treatment and contribute to the development of parasite resistance.

For administration, the paste should be delivered orally, ensuring that the entire dose is consumed by the horse. Proper dosing is critical for the efficacy of the treatment and the health of the animal.

Contraindications

ZIMECTERIN GOLD Paste is contraindicated in the following situations:

Use is prohibited in horses intended for human consumption and in humans. The safety and efficacy of this product have not been established in foals younger than two months of age, mares at or near the time of breeding, pregnant or lactating mares, and breeding stallions. Additionally, this product should not be administered to other animal species, as severe adverse reactions, including fatalities in dogs, may occur.

Underdosing is also contraindicated, as it may lead to ineffective treatment and the development of parasite resistance. It is advised to refrain from smoking and eating while handling the product, and to wash hands thoroughly after use. Contact with eyes should be avoided.

Warnings and Precautions

The use of this product is contraindicated in horses intended for human consumption. It is imperative to emphasize that this product is not approved for use in humans. Healthcare professionals must ensure that this and all medications are kept out of reach of children to prevent accidental ingestion.

When handling this product, it is essential to refrain from smoking or eating to minimize the risk of exposure. Proper hygiene practices should be followed, including thorough handwashing after use. Care should be taken to avoid contact with the eyes, as this may lead to irritation or other adverse effects.

For detailed occupational safety information, including handling and emergency measures, refer to the Safety Data Sheet (SDS). In the event of adverse reactions or for further inquiries, healthcare professionals are encouraged to contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.

Side Effects

The use of ZIMECTERIN® GOLD (ivermectin/praziquantel) Paste is contraindicated in horses intended for human consumption and is not approved for use in humans. It is imperative to keep this and all medications out of reach of children to prevent accidental ingestion.

ZIMECTERIN® GOLD has been specifically formulated for use in horses. Caution is advised, as the administration of this product to other animal species may lead to severe adverse reactions, including fatalities in dogs. Therefore, it is essential that this product is used exclusively in the intended equine population to mitigate the risk of serious adverse outcomes.

Drug Interactions

ZIMECTERIN GOLD (ivermectin/praziquantel) Paste has not undergone testing in combination with other medications; consequently, the potential for drug interactions remains undetermined.

In terms of laboratory test interactions, it is essential to conduct fecal examinations or other diagnostic assessments, along with a review of the parasite management history, to ascertain the appropriateness of this product for the herd or flock prior to administering any dewormer.

Post-treatment, the effectiveness of the deworming should be monitored. This can be achieved through methods such as a fecal egg count reduction test or other suitable evaluation techniques.

Packaging & NDC

The table below lists each NDC Code for Zimecterin Gold (ivermectin and praziquantel) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, specifically foals, should be treated with ZIMECTERIN GOLD Paste starting at 2 months of age, with routine treatment repeated as appropriate. The product is indicated for use in horses aged two months or older. It is important to note that ZIMECTERIN GOLD Paste has not been tested in foals younger than two months of age. In a safety study involving 2-month-old foals, ZIMECTERIN GOLD Paste was found to be safe even at doses up to three times the maximum recommended dose.

Geriatric Use

ZIMECTERIN GOLD Paste may be administered to horses that are two months of age or older. However, it is important to note that the product has not been evaluated for safety and efficacy in foals younger than two months of age, as well as in mares at or near the time of breeding, pregnant or lactating mares, and breeding stallions.

While there are no specific dosage adjustments or safety concerns indicated for elderly horses, healthcare providers should exercise caution and monitor geriatric patients closely when administering this product. Regular assessments of the horse's health status and response to treatment are recommended to ensure optimal safety and efficacy.

Pregnancy

ZIMECTERIN GOLD Paste has not been evaluated for safety in pregnant mares, mares at or near the time of breeding, or lactating mares. Consequently, there is insufficient data to assess the potential risks or fetal outcomes associated with its use during pregnancy. While ZIMECTERIN GOLD Paste is indicated for use in horses two months of age or older, healthcare professionals should exercise caution when considering its administration to pregnant mares due to the lack of specific safety data. It is recommended that veterinarians weigh the potential benefits against the unknown risks before prescribing this product to pregnant patients.

Lactation

ZIMECTERIN GOLD Paste has not been tested in lactating mares. Therefore, there is no available data regarding its excretion in breast milk or its effects on breastfed infants. Due to the lack of safety and efficacy information in this population, caution is advised when considering the use of this product in lactating mothers. Additionally, ZIMECTERIN GOLD Paste is not intended for use in other animal species, as severe adverse reactions, including fatalities in dogs, may occur.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

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 toxicology experts for guidance on specific management strategies tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

ZIMECTERIN GOLD Paste has not been evaluated in mares at or near the time of breeding, nor in pregnant or lactating mares, or breeding stallions, thus the potential for teratogenic effects remains undetermined.

In terms of non-teratogenic effects, ZIMECTERIN GOLD Paste, when administered at 1, 3, and 5 times the maximum recommended dose every two weeks to 5-month-old foals, did not produce any adverse clinical signs of toxicity. Additionally, a safety study conducted in younger animals demonstrated that ZIMECTERIN GOLD Paste was safe at doses up to 3 times the maximum recommended dose in 2-month-old foals.

ZIMECTERIN GOLD Paste has not been tested in foals younger than two months of age. It is noteworthy that swelling and itching reactions have been observed in horses treated with ivermectin, particularly in those with heavy infections of neck threadworm (Onchocerca sp.) microfilariae. These reactions are likely attributable to the death of microfilariae in significant numbers following treatment.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily following the approval of ZIMECTERIN® GOLD. Notably, there have been rare instances of swelling and irritation of the mouth, lips, and tongue after administration of the product. These reactions have generally been transitory.

Additionally, swelling and itching reactions have been observed in horses treated with ivermectin, particularly in those with heavy infections of neck threadworm (Onchocerca sp.) microfilariae. These reactions are likely associated with the die-off of a significant number of microfilariae. In cases where such reactions occur, symptomatic treatment may be advisable, and consultation with a veterinarian is recommended.

Patient Counseling

Healthcare providers should advise patients to consult their veterinarian for assistance in the diagnosis, treatment, and control of parasitism in horses. It is important to emphasize that all horses should be included in a regular parasite control program, with particular attention given to mares, foals, and yearlings.

Patients should be informed that foals should receive their initial treatment at 2 months of age, with routine treatments repeated as appropriate. It is crucial to ensure that each animal receives a complete dose based on its current body weight, as underdosing may lead to ineffective treatment and contribute to the development of parasite resistance.

Healthcare providers should make patients aware that swelling and itching reactions may occur after treatment with ivermectin, particularly in horses carrying heavy infections of neck threadworm (Onchocerca sp.) microfilariae. These reactions are likely due to the large number of microfilariae dying. Patients should be advised to consult their veterinarian if any such reactions occur.

In cases of summer sores involving extensive tissue changes, healing may require additional appropriate therapy alongside treatment with ZIMECTERIN GOLD Paste. Patients should be reminded to consider reinfection and preventive measures, and to consult their veterinarian if the condition does not improve.

It is essential to inform patients that this product is not intended for use in horses that are meant for human consumption and is not for use in humans. Patients should be instructed to keep this and all medications out of reach of children.

Healthcare providers should also advise patients to refrain from smoking and eating while handling the product, to wash their hands after use, and to avoid contact with their eyes. For more detailed occupational safety information, patients can refer to the Safety Data Sheet (SDS). To report adverse reactions or to obtain further information, patients should contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.

Storage and Handling

The product is supplied in a syringe format. It should be stored at temperatures not exceeding 86°F (30°C). Transient exposure to temperatures up to 104°F (40°C) is permissible.

For disposal, the syringe must be disposed of in an approved landfill or by incineration to ensure safe handling and environmental compliance.

Additional Clinical Information

Fecal examinations and other diagnostic tests, along with a history of parasite management, should be utilized to assess the appropriateness of the product for the herd or flock prior to administering any dewormer. Following treatment, the effectiveness should be monitored, for instance, through a fecal egg count reduction test. A decrease in drug effectiveness over time may suggest the development of resistance, necessitating adjustments to the parasite management plan based on regular monitoring.

The product is administered orally. Clinicians should be aware that swelling and itching reactions may occur in horses with heavy infections of neck threadworm microfilariae after treatment with ivermectin, likely due to the death of a large number of microfilariae. Symptomatic treatment may be necessary, and consultation with a veterinarian is advised if such reactions arise. Additionally, healing of summer sores with significant tissue changes may require supplementary therapy alongside ZIMECTERIN GOLD Paste. Reinfection and preventive measures should also be considered, and veterinary consultation is recommended if the condition does not improve. Postmarketing experience has indicated rare, transitory reports of swelling and irritation of the mouth, lips, and tongue following administration of ZIMECTERIN GOLD.

Drug Information (PDF)

This document includes the full labeling information for Zimecterin Gold, as submitted by Boehringer Ingelheim Animal Health USA Inc. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)