Equimax

Description

EQUIMAX is a pharmaceutical formulation that combines ivermectin and praziquantel. Ivermectin is characterized as a white to off-white crystalline solid with a molecular weight of 875.0 g/mol. Praziquantel is presented as a white to off-white crystalline powder, possessing a molecular weight of 312.3 g/mol. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, and iron oxide.

Uses and Indications

This drug is indicated for the treatment and control of various parasitic infections in horses. It is effective against the following parasites:

• Tapeworms: Anoplocephala perfoliata.

• Large Strongyles (adults), including:

  • Strongylus vulgaris (also effective against early forms in blood vessels).

  • S. edentatus (including tissue stages).

  • S. equinus.

  • Triodontophorus spp.

• Small Strongyles (adults), including those resistant to certain benzimidazole class compounds:

  • Cyathostomum spp.

  • Cylicocyclus spp.

  • Cylicostephanus spp.

  • Cylicodontophorus spp.

• Small Strongyles (fourth-stage larvae).

• Pinworms (adults and fourth-stage larvae): Oxyuris equi.

• Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum.

• Hairworms (adults): Trichostrongylus axei.

• Large-mouth Stomach Worms (adults): Habronema muscae.

• Bots (oral and gastric stages): Gasterophilus spp.

• Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi.

• Intestinal Threadworms (adults): Strongyloides westeri.

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

• Dermatitis caused by microfilariae of the Neck Threadworm: Onchocerca spp.

Limitations of use have not been specified; however, it is essential to consider the presence of resistant parasite populations when selecting treatment options.

Dosage and Administration

This syringe is designed to deliver a precise dosage of ivermectin and praziquantel for the treatment of equine parasites. The recommended dosage for a horse is 91 mcg of ivermectin per pound (200 mcg/kg) and 0.68 mg of praziquantel per pound (1.5 mg/kg) of body weight. The syringe contains sufficient paste to treat a horse weighing up to 1320 lb.

Each weight marking on the syringe plunger corresponds to a dosage sufficient for 220 lb (100 kg) of body weight.

To administer the medication, healthcare professionals should follow these steps:

1. While holding the plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it to align the side nearest the barrel with the prescribed weight marking.

2. Lock the ring in place by making a 1/4 turn to the right.

3. Ensure that the horse’s mouth is free of feed.

4. Remove the cover from the tip of the syringe.

5. Insert the syringe tip into the horse’s mouth at the space between the teeth.

6. Depress the plunger fully to deposit the paste on the back of the tongue.

7. Immediately raise the horse’s head for a few seconds following the administration.

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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

The use of this product is contraindicated in horses intended for human consumption. It is imperative that healthcare professionals adhere to this warning to ensure safety and compliance with regulatory standards.

This product is designated for oral use in horses only and is intended for the treatment and control of worms and bots. It is administered as a single dose, making it a convenient option for equine care. The formulation is safe for horses that are 4 weeks of age and older, and it is effective for horses weighing up to 1320 lb.

Healthcare professionals should ensure that the product is used exclusively in the specified population to avoid any adverse effects or regulatory issues. No laboratory tests or additional monitoring parameters are specified for the use of this product. However, practitioners should remain vigilant for any signs of adverse reactions in treated horses and provide appropriate care as needed.

Side Effects

In clinical practice, various adverse reactions have been reported in patients receiving this product. Among the serious adverse reactions, it is important to note that the product should not be used in horses intended for human consumption, as this poses significant safety concerns. Additionally, the use of this product in other animal species is contraindicated due to the potential for severe adverse reactions, including fatalities observed in dogs.

Common adverse reactions reported during postmarketing experience include abdominal pain, diarrhea, depression or lethargy, and anorexia. These reactions may vary in frequency and severity among patients, and healthcare providers should monitor for these effects during treatment.

Drug Interactions

No specific drug interactions have been identified for the product. However, it is essential to consider the following recommendations regarding drug and laboratory test interactions.

Prior to administering any dewormer, fecal examinations or other diagnostic tests, along with a thorough parasite management history, should be conducted to ascertain the appropriateness of the product for the herd. This assessment is crucial to ensure effective treatment and to avoid unnecessary use of dewormers.

Post-treatment, the effectiveness of the dewormer should be monitored. This can be achieved through methods such as a fecal egg count reduction test or other suitable evaluation techniques. It is important to note that a decrease in the drug's effectiveness over time, as indicated by these tests, may suggest the development of resistance to the dewormer used. Regular monitoring and assessment are recommended to maintain effective parasite control and to inform future treatment decisions.

Packaging & NDC

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

Pediatric Use

Pediatric patients, specifically foals, can be treated safely starting at 4 weeks of age. Initial treatment should occur at this age, with routine follow-up treatments administered as appropriate.

In a tolerance study involving 3- to 4-week-old foals treated at a dosage of 10X, one foal experienced loose watery stools on post-treatment days 1, 2, and 5-9. These symptoms resolved without intervention by day 10, and no other foals in the study exhibited adverse effects.

It is important to note that foals born to mares treated with a 3X dosage in the first few weeks of life showed a higher incidence of transient ocular discharge, gastrointestinal disturbances (including loose stools and diarrhea), and depression that required medical intervention compared to foals born to control mares.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

EQUIMAX Oral Paste may be administered to stallions and breeding, pregnant, or lactating mares without adverse effects on fertility. In a reproductive safety study involving eleven mares treated with a 3X dose of EQUIMAX Oral Paste every two weeks throughout breeding, pregnancy, and lactation, an increased incidence of colic was observed in treated mares compared to control mares. Additionally, elevations of gamma-glutamyl transferase (GGT) and aspartate aminotransferase (AST) were more frequent in the 3X treated mares, with two mares exhibiting elevated enzyme levels coinciding with colic episodes.

One treated mare was removed from the study due to failure to conceive after three breeding attempts. Furthermore, two treated mares experienced abnormally short diestrous periods of two days and eight days during the first estrous cycle following the birth of their foal, with one of these mares failing to ovulate in the subsequent two estrous cycles.

Foals born to the 3X treated mares exhibited a higher incidence of transient ocular discharge and gastrointestinal disturbances, including loose stools and diarrhea, as well as signs of depression requiring medical intervention, compared to foals born to control mares during the first few weeks of life. These findings suggest that while EQUIMAX Oral Paste may be used in breeding and pregnant mares, careful monitoring for potential adverse effects in both mares and foals is warranted.

Lactation

Lactating mothers may be treated with EQUIMAX Oral Paste without adverse effects on fertility. In a reproductive safety study, eleven mares received a 3X dose of EQUIMAX Oral Paste every two weeks throughout breeding, pregnancy, and lactation, continuing until the foal was three months of age.

However, it is important to note that in the first few weeks of life, foals born to mares treated with the 3X dose exhibited a higher incidence of transient ocular discharge and gastrointestinal disturbances, including loose stools and diarrhea, as well as signs of depression requiring medical intervention, compared to foals born to control mares. Therefore, healthcare professionals should consider these potential effects when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

In a reproductive safety study, eleven mares were treated with a 3X dose of EQUIMAX Oral Paste every two weeks throughout breeding, pregnancy, and lactation, continuing until the foal was three months of age. Foals born to the mares treated with the 3X dose exhibited a higher incidence of transient ocular discharge and gastrointestinal disturbances, including loose stools and diarrhea, as well as signs of depression requiring medical intervention, compared to foals born to control mares.

Stallions and breeding, pregnant, or lactating mares may be treated without adverse effects on fertility. However, an increased incidence of colic was observed in treated mares relative to control mares. Additionally, elevations of gamma-glutamyl transferase (GGT) and aspartate aminotransferase (AST) were more frequent in the 3X treated mares, with two mares showing elevated enzyme levels coinciding with colic episodes. One treated mare was removed from the study due to failure to conceive after three breeding attempts. Furthermore, two treated mares experienced abnormally short diestrous periods of two days and eight days during the first estrous cycle following the birth of the study foal, with one of these mares failing to ovulate in the subsequent two estrous cycles.

In a tolerance study involving 3- to 4-week-old foals treated at a 10X dose once, loose watery stools were noted on post-treatment days 1, 2, and 5-9 in one foal. These signs resolved without treatment by day 10, and no other foals were affected.

Swelling and itching reactions following treatment with ivermectin paste have been reported in horses with heavy infections of neck threadworm (Onchocerca sp. microfilariae). These reactions are likely attributable to the mass die-off of microfilariae. Symptomatic treatment may be advisable in such cases.

Postmarketing Experience

Post-approval adverse drug experience reporting with Equimax has identified several adverse events. It is important to note that not all adverse reactions are reported to the FDA Center for Veterinary Medicine (CVM), and it may not be feasible to reliably estimate the frequency of these events or establish a causal relationship to product exposure based on the available data.

The adverse events reported, listed in decreasing order of frequency, include abdominal pain, diarrhea, depression/lethargy, and anorexia.

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 crucial to emphasize the importance of administering the complete dose of EQUIMAX Oral Paste based on the current body weight of each animal, as underdosing may lead to ineffective treatment and contribute to the development of parasite resistance.

Patients should be informed that all horses must be included in a regular parasite control program, with particular attention given to mares, foals, and yearlings. Foals should receive their initial treatment at 4 weeks of age, with routine treatments repeated as appropriate. Healthcare providers are encouraged to work with veterinarians to develop a control program tailored to the specific needs of the horses.

Regular treatment with EQUIMAX Oral Paste can significantly reduce the risk of colic caused by Anoplocephala perfoliata and verminous arteritis caused by Strongylus vulgaris. It is important to note that EQUIMAX Oral Paste is specifically formulated for use in horses and ponies only and should not be administered to other animal species, as this may result in severe adverse reactions, including fatalities in dogs.

Patients must be reminded that this product is not for human use and should be kept out of the reach of children. They should refrain from eating or smoking while handling the product and wash their hands thoroughly after use. Additionally, patients should avoid contact with their eyes.

Healthcare providers should inform patients about the potential for swelling and itching reactions following treatment with ivermectin paste, particularly in horses with heavy infections of neck threadworm (Onchocerca sp. microfilariae). These reactions are likely due to the large number of microfilariae dying. If such reactions occur, symptomatic treatment may be advisable, and consultation with a veterinarian is recommended.

In cases of summer sores involving extensive tissue changes, patients should be made aware that healing may require additional appropriate therapy alongside the use of EQUIMAX Oral Paste. Reinfection and preventive measures should also be considered, and patients should consult their veterinarian if the condition does not improve.

To report any adverse reactions, patients should be directed to contact Bimeda Inc. at 1-888-524-6332.

Storage and Handling

The product is supplied in a syringe format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, ideally at 25°C (77°F). Temporary excursions in temperature are permissible, provided they remain within the range of 15°C to 30°C (59°F to 86°F).

For disposal, the syringe must be disposed of in an approved landfill or through incineration to ensure safe and compliant waste management.

Additional Clinical Information

Laboratory tests are essential for determining the appropriateness of the product for the herd prior to administering any dewormer. Clinicians should utilize fecal examinations or other diagnostic tests, along with the parasite management history. After dewormer administration, the effectiveness of the treatment must be monitored, potentially through a fecal egg count reduction test or another suitable method. A noted decrease in the drug's effectiveness over time, as indicated by these tests, may suggest the development of resistance to the administered dewormer.

Postmarketing experience has identified several adverse events associated with Equimax, including abdominal pain, diarrhea, depression or lethargy, and anorexia. To report side effects, clinicians and patients can contact Bimeda Inc. at 1-888-524-6332. For further information regarding the reporting of side effects for animal drugs, the FDA can be reached at 1-888-FDA-VETS or through their website at www.fda.gov/reportanimalae.

Drug Information (PDF)

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

View veterinary label (PDF)