Equidone
(domperidone 11% w/v)
Oral Gel
For Oral Use Only

DESCRIPTION:
Equidone® (domperidone 11% w/v) Oral Gel is supplied in a ready-to-use multi-dose oral syringe containing 25 cc (to deliver) of gel. Each cc of gel contains 110 mg of domperidone (11% w/v). Equidone® (domperidone) is designed to be delivered as an orally administered gel. Equidone® (domperidone) is not a sterile product.
Each syringe of Equidone® (domperidone) contains enough gel to provide five (5) doses of therapy for one (1) 500 kg (1 100 lb) mare at a dose rate of 1.1 mg/kg (0.5 mg/lb) body weight. The plunger contains a dosage ring that allows for accurate dosing.
Domperidone is a selective D-2 dopamine receptor antagonist that competitively blocks dopamine receptor sites from activation by toxic D-2 dopamine receptor agonists such as those produced by the endophyte Neotyphodium coenophialum (a fungus that is found n endophyte-infected fescue seed grass and/or hay). Unlike other D-2 dopamine receptor antagonists in its class of therapeutic agents domperidone does not readily cross the blood brain barrier thereby reducing the likelihood of serious neuroleptic side effects.

CHEMISTRY:
Chemically the active pharmaceutical ingredient in Equidone® Oral Gel is domperidone: [5-chloro-1-[1-[3-(2 3-dihydro-2-oxo-1H-benzimidazol-1-yl)propyl]-4-piperidinyl]-1 3-dihydro-2H-benzimidazol-2-one].

DOSAGE:
Please follow the dosing instructions of a licensed veterinarian.

DOSAGE GUIDELINES:
Fescue Toxicosis and Related Agalactia : Equidone® (domperidone) has been used at a dose of 1.1 mg/kg (0.5 mg/lb) body weight once daily (PO SID) beginning 10-15 days after foaling. In the event that fescue toxicosis and/or related agalactia was diagnosed at less than 10 days prior to the expected foaling date dosing was begun immediately continuing until 5-10 days after foaling. On farms with a history of severe fescue toxicosis problems and where mares remain on toxic fescue up to foaling dosing has been initiated as early as 15-30 days prior to the expected foaling date continuing until 5-10 days after foaling.
Post-Partum Agalactia: For mares that have foaled but are agalactic or have a low level of milk flow Equidone® (domperidone) has been used at a dose of 1.1 mg/kg (0.5 mg/lb) body weight twice daily (PO BID) for 3-5 days and once daily (PO SID) for the next 5-7 days for a total of 10 days of treatment. Also Equidone® (domperidone) has been used to treat agalactia in other mammals.
Follicular Growth: For mares that are not developing ovulatory size follicles during the normal breeding season Equidone® (domperidone) has been used at a dose of 1.1 mg/kg (0.5 mg/lb) body weight once daily (PO SID) until ovulation (usually 8-15 days).
Follicular Growth (Transitional Mares): Equidone® (domperidone) has been used to promote follicular growth in transitional mares. Mares were initially placed under lights for two (2) weeks. Mares were continued under lights and Equidone® (domperidone) was administered at a done of 1.1 mg/kg (0.5 mg/lb) body weight once daily (PO SID) until ovulation occurred. In once study mares maintained outside under cold winter conditions did not respond well to this regimen. Current research suggests that in cold winter conditions mares kept inside respond better to treatment.

ADMINISTRATION:
Note: The gel syringe is a multi-dose package. Ensure that the correct dose if administered with each use.

STEP 1: Determine the correct weight of the mare.
STEP 2: Using the correct weight of the mare determine the appropriate dose [1 cc/100kg body weight (1cc/220lbs body weight)]. The appropriate dose for a mare weighing 500 kg (1 100 lbs.) is 5 cc. The following table may be used to assist in determining the appropriate dose:

STEP 3: To measure the dose turn the dosage ring (located on the plunger of the syringe) until he edge of the dosing ring nearest to the syringe tip lines up with the dose to be delivered.
STEP 4: Ensure that the mare&146;s mouth is free of food and/or other obstructions.
STEP 5: Remove the end cap from the tip of the syringe barrel.
STEP 6: The selected dose of gel should be deposited on the back and top of the mare’s tongue. Introduce the tip of the syringe into the side of the mare’s mouth at the interdental space between the front (incisor) and back (molar) teeth. Deposit the gel on the mare’s tongue by dosage ring permits. Remove the tip of the syringe from the horse’s mouth.
STEP 7: To aid in the swallowing of the get immediately raise the mare’s head for a few seconds after dosing.
STEP 8: Clean the tip of the syringe with a clean disposable towel. Recap the syringe by returning the end cap to the tip fo the syringe barrel and applying pressure until at least one "click" is heard.
STEP 9: For the next daily dose repeat steps 1-8.

CONTRAINDICATIONS:
Equidone® (domperidone) has gastroprokinetic effects and should not be used whenever stimulation of gastric motility would be contraindicated (e.g. in the presence of gastrointestinal hemorrhage mechanical obstruction or perforation).

WARNINGS:
For use in animals only. Do not use in animals intended for human consumption. Not for human use. Keep out of reach of children.

PRECAUTIONS:
In certain instances of Equidone® (domperidone) use pre-mature leaking of milk and/or colostrum may occur. If leaking should occur and foaling does not occur within 24 hours administer one-half (1/2) of the recommended dose twice daily at 12 hour intervals (PO BID) and continue through 5 days after foaling. If leaking continues administer one-third (1/3) of the recommended dose twice daily at 12 hour intervals (PO BID) and continue through 5 days after foaling. In some cases therapy may need to be reduced to very low levels or discontinued altogether. Please contact your licensed veterinarian for more information.
If excessive leaking of milk occurs foals should be tested for serum Immunoglobulin G (lgG) levels. Foals with sub-par serum lgG levels should be treated by your licensed veterinarian.
Use of Equidone® (domperidone) with concomitant therapies in mares has not been evaluated.

CLINICAL PHARMACOLOGY:
Animals that consume endophyte (Neotyphodium coenophialum) — infected fescue seed grass and/or hay generally manifest signs of fescue toxicosis and consistently exhibit in endophyte-infected fescue have been identified as probably causative agents of fescue toxicosis. On the basis of these observations an in vitro bioassay was developed to study the effects of individual alkaloids produced by the endophyte on prolactin release; to D-2 dopamine receptor level; and to compare the efficacy of two selective D-2 dopamine receptor antagonists domperidone and sulpiride in reversing the inhibitory effect of α-ergocryptine (10^-8 M) in prolactin release. However at a similar concentration the dose-response curve for sulpiride (quadratic fit) did not obtain a threshold concentration for reversal of the effect of α-ergocryptine (10^-8 M) in prolactin release.

STORAGE INformATION:
Store at Controlled Room Temperature 15°-30° C (59°-86° F). Do not freeze or expose to extremes of temperature.

Prescription items are NON-RETURNABLE and NON-REFUNDABLE.