Ivermectin/Praziquantel

Uses and Indications

This drug is indicated for the treatment and control of various parasites in horses. The specific indications include:

Parasites Treated

• Tapeworms: Anoplocephala perfoliata

• Large Strongyles (adults):

  • Strongylus vulgaris (including early forms in blood vessels)

  • S. edentatus (including tissue stages)

  • S. equinus

  • Triodontophorus spp. (including T. brevicauda and T. serratus)

  • Craterostomum acuticaudatum

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

  • Coronocyclus spp. (including C. coronatus, C. labiatus, C. labratus)

  • Cyathostomum spp. (including C. catinatum and C. pateratum)

  • Cylicocyclus spp. (including C. insigne, C. leptostomum, C. nassatus, C. brevicapsulatus)

  • Cylicodontophorus spp.

  • Cylicostephanus spp. (including C. calicatus, C. goldi, C. longibursatus, C. minutus)

  • Petrovinema poculatum

• 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. (including G. intestinalis and G. nasalis)

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

• Intestinal Threadworms (adults): Strongyloides westeri

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

• Dermatitis caused by neck threadworm microfilariae: Onchocerca sp.

Usage Instructions

This drug is for oral use in horses only and is effective for treating horses weighing up to 1250 lb.

Dosage and Administration

The recommended dosage for both Equimax and Zimecterin Gold is based on the horse's body weight. For Equimax, the dosage is 91 mcg of ivermectin per lb (200 mcg/kg) and 0.68 mg of praziquantel per lb (1.5 mg/kg). For Zimecterin Gold, the dosage is 91 mcg of ivermectin per lb (200 mcg/kg) and 454 mcg of praziquantel per lb (1 mg/kg).

Each syringe is designed to treat a specific weight range: Equimax can treat a horse weighing up to 1320 lb, while Zimecterin Gold is suitable for a horse weighing up to 1250 lb. Each weight marking on the syringe plunger corresponds to a dosage sufficient for 220 lb (100 kg) for Equimax and 250 lb for Zimecterin Gold.

Administration steps are as follows:

1. While holding the plunger, the knurled ring should be turned 1/4 turn to the left and slid to the prescribed weight marking.

2. The ring must be locked in place by turning it 1/4 turn to the right.

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

4. Remove the cover from the syringe tip.

5. Insert the syringe tip into the horse's mouth, positioning it 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 after dosing.

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 horses intended for human consumption and in humans. Zimecterin Gold Paste has not been tested 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 used in other animal species, as severe adverse reactions, including fatalities in dogs, may occur.

Warnings and Precautions

Do not use in horses intended for human consumption. This product is not for use in humans and should be kept out of reach of children.

General Precautions This medication is for oral use in horses only and is intended for the treatment and control of worms and bots in horses with a single dose. It is safe for horses 4 weeks of age and older, with contents capable of treating up to 1320 lb body weight.

Occupational Safety When handling this product, refrain from smoking and eating. It is important to wash hands after use and avoid contact with eyes. For more detailed occupational safety information, refer to the Safety Data Sheet (SDS).

Adverse Reactions To report adverse reactions in users or to obtain more information, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.

Side Effects

Patients may experience a range of adverse reactions associated with the use of Equimax and Zimecterin Gold. The following adverse reactions have been reported:

Serious Adverse Reactions

• Severe adverse reactions, including fatalities, have been reported in dogs when these products are used in species other than horses.

Common Adverse Reactions

• Abdominal pain

• Diarrhea

• Depression/lethargy

• Anorexia

Warnings

• Both Equimax and Zimecterin Gold should not be used in horses intended for human consumption.

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

Precautions

• Equimax and Zimecterin Gold are specifically formulated for use in horses only and should not be administered to other animal species due to the risk of severe adverse reactions.

Drug Interactions

No specific drug interactions have been identified for Equimax or Zimecterin Gold. However, it is important to note that Zimecterin Gold (ivermectin/praziquantel) has not been tested in conjunction with other drugs, leaving the potential for drug interactions unknown.

Drug & Laboratory Test Interactions

For both Equimax and Zimecterin Gold, fecal examinations or other diagnostic tests, along with a thorough parasite management history, should be utilized to determine the appropriateness of the product for the herd or flock prior to administering any dewormer.

After the use of any dewormer, it is essential to monitor the effectiveness of the treatment. This can be achieved through methods such as fecal egg count reduction tests or other appropriate diagnostic techniques. A decrease in a drug's effectiveness over time, as indicated by fecal egg count reduction tests, may suggest the development of resistance to the dewormer administered.

Pediatric Use

Pediatric patients, specifically foals, can be treated with Equimax starting at 4 weeks of age and with Zimecterin Gold starting at 2 months of age.

Efficacy and Safety:

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

• Foals born to mares treated with Equimax at three times the recommended dose exhibited a higher incidence of transient ocular discharge and gastrointestinal disturbances, including loose stools and diarrhea, requiring medical intervention compared to foals born to control mares.

• Zimecterin Gold has been shown to be safe in 2-month-old foals at doses up to three times the maximum recommended dose, although it has not been tested in foals younger than 2 months.

Dosing Recommendations:

• Equimax should be administered to foals initially at 4 weeks of age, with routine treatments repeated as appropriate.

• Zimecterin Gold should be administered to foals starting at 2 months of age, with routine treatments repeated as necessary.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, or safety concerns for elderly patients is provided for Equimax or Zimecterin Gold. Both products lack data on special precautions or monitoring requirements for geriatric patients. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing these medications to elderly patients.

Pregnancy

Pregnant patients may be treated with EQUIMAX Oral Paste without adverse effects on fertility, as indicated by a reproductive safety study involving eleven mares treated with a 3X dose every two weeks throughout breeding, pregnancy, and lactation. However, an increased incidence of colic was observed in treated mares compared to control mares. Additionally, elevations of GGT and AST were more frequent in the 3X treated group, with two mares experiencing elevated enzyme levels during colic episodes. Notably, one treated mare did not conceive after three breeding attempts, and two mares exhibited abnormally short diestrous periods following foaling, with one failing to ovulate in subsequent cycles.

Foals born to mares treated with the 3X dose showed a higher incidence of transient ocular discharge, gastrointestinal disturbances, and depression requiring medical intervention in the early weeks of life compared to foals from control mares.

In contrast, ZIMECTERIN GOLD Paste has not been tested in pregnant or lactating mares, nor in breeding stallions, and specific safety data regarding its use in this population is not available. Therefore, caution is advised when considering ZIMECTERIN GOLD for use in pregnant patients.

Lactation

Lactating mothers treated with Equimax have shown no adverse effects on fertility during breeding, pregnancy, or lactation. In a reproductive safety study involving mares treated with a 3X dose of Equimax Oral Paste every two weeks, it was observed that foals born to these mares experienced a higher incidence of transient ocular discharge, gastrointestinal disturbances (including loose stools and diarrhea), and depression requiring medical intervention compared to foals born to control mares.

In contrast, Zimecterin Gold Paste has not been tested in lactating mares, and its use in this population is not recommended due to the lack of safety data. Additionally, Zimecterin Gold should not be administered to other animal species, as severe adverse reactions, including fatalities in dogs, have been reported.

Healthcare professionals should consider these factors when advising lactating mothers on the use of these products.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available labeling for Equimax and Zimecterin Gold. There are no dosage adjustments, special monitoring requirements, or safety considerations provided for individuals with reduced kidney function in the respective inserts. Therefore, healthcare professionals should exercise caution and consider the lack of data when prescribing these medications to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically addressed in the labeling for Equimax and Zimecterin Gold. There are no dosage adjustments, special monitoring requirements, or precautions outlined for this patient population in the respective product inserts. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing these medications to patients with liver problems.

Overdosage

In the event of an overdose, specific information regarding the management and symptoms associated with Equimax and Zimecterin Gold is not provided in the available data. Therefore, it is recommended that individuals monitor for any unusual reactions or symptoms following administration.

In the absence of detailed overdose information, it is prudent to seek immediate veterinary assistance if an overdose is suspected. Veterinary professionals may provide supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is advised to ensure any adverse effects are promptly addressed.

Nonclinical Toxicology

Teratogenic Effects

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, foals born to these mares exhibited a higher incidence of transient ocular discharge and gastrointestinal disturbances, including loose stools and diarrhea, requiring medical intervention compared to foals born to control mares. ZIMECTERIN GOLD Paste has not been tested in mares at or near the time of breeding, pregnant or lactating mares, and breeding stallions.

Non-Teratogenic Effects

EQUIMAX demonstrated that 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 compared to controls. Additionally, elevations of GGT and AST were more frequent in the 3X treated mares, with two mares exhibiting elevated enzyme levels during 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 and eight days during the first estrous cycle following the birth of the study foal, with one of these mares failing to ovulate in subsequent cycles. In a tolerance study involving 3- to 4-week-old foals treated at 10X once, one foal exhibited loose watery stools on post-treatment days 1, 2, and 5-9, which resolved without treatment by day 10, with no other foals affected. ZIMECTERIN GOLD Paste, when tested at 1, 3, and 5 times the maximum recommended dose in 5-month-old foals, did not elicit any adverse clinical signs of toxicity. In a foal safety study, ZIMECTERIN GOLD Paste was found safe at up to 3 times the maximum recommended dose in 2-month-old foals.

Animal Pharmacology and Toxicology

Swelling and itching reactions following treatment with ivermectin paste have been reported in horses with heavy infections of neck threadworm (Onchocerca sp. microfilariae), likely due to the mass die-off of microfilariae. Symptomatic treatment may be advisable. ZIMECTERIN GOLD Paste has not been tested in foals younger than two months of age.

Storage and Handling

Equimax and Zimecterin Gold are supplied in paste form.

Equimax should be stored at room temperature, specifically at 25°C (77°F), with permissible excursions between 15°–30°C (59°–86°F). Zimecterin Gold can be stored at temperatures up to 30°C (86°F), with transient exposure to temperatures as high as 40°C (104°F) allowed.

Both products require the disposal of the syringe in an approved landfill or by incineration.