Domperidone

Indications

For prevention of fescue toxicosis in periparturient mares.

Dosage and Administration

Orally administer 0.5 mg/lb (1.1 mg/kg) once daily starting 10 to 15 days prior to Expected Foaling Date (EFD). Treatment may be continued for up to 5 days after foaling if mares are not producing adequate milk after foaling. DIRECTIONS FOR ADMINISTRATION Determine the appropriate dose for the body weight of the mare based on the dosing table below. One cc will treat 220 lb (100 kg) of body weight. Table 1. Dosing Table Weight (lb) Weight (kg) cc Domperidone (mg) 550-660 250-300 3 330 661-880 301-400 4 440 881-1100 401-500 5 550 1101-1320 501-600 6 660 Turn the dial ring until the edge of the ring nearest the tip of the syringe lines up with the dose to be delivered. Remove the syringe cap. Make sure the horse's mouth is free of food or other obstructions. Insert the nozzle of the syringe through the interdental space of the horse's mouth and deposit the gel on the back of the tongue by depressing the plunger. Recap the syringe. This is a 25 cc multi-dose syringe. Please note that for subsequent doses, it will be necessary to adjust for previous doses. For example, if the intended dose for a horse is 5 cc, then the dial ring is set at 5 cc for the first dose, at 10 cc for the second dose, at 15 cc for the third dose, at 20 cc for the fourth dose, and at 25 cc for the fifth dose.

Contraindications

Horses with hypersensitivity to domperidone should not receive EQUIDONE Gel.

Warnings

Failure of passive transfer of immunoglobulins (IgG) may occur when using EQUIDONE Gel even in the absence of leakage of colostrum or milk. All foals born to mares treated with EQUIDONE Gel should be tested for serum IgG concentrations. Do not use in horses intended for human consumption. HUMAN WARNINGS Not for use in humans. For oral use in animals only. Keep this and all drugs out of the reach of children. Pregnant and lactating women should use caution when handling EQUIDONE Gel, as systemic exposure to domperidone may affect reproductive hormones. Domperidone is not approved for any indication in humans in the US. The safety of domperidone in lactating women and their nursing children has not been evaluated. Consult a physician in case of accidental human exposure.

Precautions

EQUIDONE Gel may lead to premature birth, low birth weight foals or foal morbidity if administered >15 days prior to the expected foaling date. Accurate breeding date(s) and an expected foaling date are needed for the safe use of EQUIDONE Gel. The safety of EQUIDONE Gel has not been evaluated in breeding, pregnant and lactating mares other than in the last 45 days of pregnancy and the first 15 days of lactation (see Animal Safety ). The safety in stallions has not been evaluated. The long term effects on foals born to mares treated with EQUIDONE Gel have not been evaluated. Do not use in horses with suspected or confirmed gastrointestinal blockage, as domperidone is a prokinetic drug (it stimulates gut motility). Use of EQUIDONE Gel may cause a false positive on the milk calcium test used to predict foaling. Domperidone is a known P-glycoprotein substrate1 and its main metabolic pathway in humans is through CYP3A4. Significant inhibition of domperidone metabolism may occur when co-administered with drugs such as erythromycin 2 and ketoconazole 3 . This could result in significantly greater domperidone drug exposure (multi-fold increase) when used with these drugs.

Adverse Reactions

The most common adverse reactions associated with treatment with EQUIDONE Gel are premature lactation (dripping of milk prior to foaling) and failure of passive transfer. In a laboratory effectiveness study with 32 periparturient mares (17 treated with EQUIDONE Gel and 15 treated with vehicle control) 3/17 (18%) mares treated with EQUIDONE Gel experienced premature lactation. In the 25 foals (16 foals of mares treated with EQUIDONE Gel and 9 foals of vehicle control mares) evaluated for passive transfer, failure of passive transfer occurred in 13/16 (81%) foals of mares treated with EQUIDONE Gel and 8/9 (89%) foals of control mares. Failure of passive transfer in foals of mares treated with EQUIDONE Gel was not solely due to physical loss of colostrum through premature lactation, because 77% of EQUIDONE Gel treated mares that did not drip milk prior to foaling had foals with failure of passive transfer. In a field study with 279 periparturient mares treated with EQUIDONE Gel, premature lactation was reported in 3 mares (1%) and failure of passive transfer was reported in 3 foals (1%). In two additional field studies, a total of 2,556 mares were treated with EQUIDONE Gel or a bioequivalent formulation for 2,730 breeding seasons. Horses in these studies were treated with EQUIDONE Gel for varying durations. Of the 2,730 breeding seasons evaluated, premature lactation was reported in 262 mares (9.6%), failure of passive transfer was reported in 50 foals (1.8%), and premature parturition (gestation length ≤320 days) occurred in 13 mares (<0.5%). To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Dechra at (866) 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or online at http://www.fda.gov/reportanimalae INFORMATION FOR HORSE OWNERS Owners should be aware that treatment with EQUIDONE Gel may result in failure of passive transfer of immunoglobulins to the foal and that this may occur even when the mare does not drip milk. Owners should be advised that all foals born to mares treated with EQUIDONE Gel should be tested for serum immunoglobulin (IgG) concentrations. Owners should be informed that EQUIDONE Gel causes false positives on the milk calcium test used to predict foaling. Owners should be directed on the proper use of the multi-dose dosing syringe, including how to set the dial ring for accurate dosing after the first dose.

Description

Domperidone is a D 2 dopamine receptor antagonist. Chemically, domperidone is 6-chloro-3-[1-[3-(2-oxo-3H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1H-benzimidazol-2-one. The structural formula is: Molecular Formula: C 22 H 24 CIN 5 O 2 Molecular Weight: 425.91 Chemical Structure

Storage

Store at controlled room temperature 25°C (77°F) with excursions between 15°-30°C (59°-86°F) permitted. Recap after each use.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming domperidone as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.