EQUIDONE- domperidone gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

domperidone (UNII: 5587267Z69) (domperidone - UNII:5587267Z69)

Available from:

Dechra Veterinary Products

INN (International Name):

domperidone

Composition:

domperidone 110 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Horses with hypersensitivity to domperidone should not receive EQUIDONE Gel.

Product summary:

EQUIDONE Gel is supplied in disposable, multi-dose, 25 cc syringes, each containing 2.75 g of domperidone suspended in an oral gel. Each cc of gel contains 110 mg of domperidone. The net weight of each syringe is approximately 26 g. Syringe is supplied in a single carton. Approved by FDA under NADA # 141-314

Authorization status:

New Animal Drug Application

Summary of Product characteristics

EQUIDONE- DOMPERIDONE GEL
DECHRA VETERINARY PRODUCTS
----------
EQUIDONE GEL
(DOMPERIDONE)
For oral use in horses only.
CAUTION
Federal law (USA) restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Domperidone is a D 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
H
CIN O MOLECULAR WEIGHT: 425.91
INDICATION
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
1. 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
®
2
22 24
5
2
1101-1320
501-600
6
660
2. Turn the dial ring until the edge of the ring nearest the tip of
the syringe lines up with
the dose to be delivered.
3. Remove the syringe cap.
4. Make sure the horse's mouth is free of food or other obstructions.
5. 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.
6. 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 im