Rx, Dormosedan Gel, 3 mL

The dosing syringe delivers the product in 0.25 mL increments. The following dosing table may be used to determine the correct dose of Dormosedan Gel.

Approximate body weight (lb)/ Dose Volume (mL)

330-439 lbs.....1.00 mL
440-549 lbs.....1.25 mL
550-659 lbs.....1.50 mL
660-769 lbs.....1.75 mL
770-879 lbs.....2.00 mL
880-989 lbs.....2.25 mL
990-1099 lbs.....2.50 mL
1100-1209 lbs.....2.75 mL
1210-1320 lbs.....3.00 mL

Use impermeable gloves when handling the product. Remove the syringe from the outer carton. While holding the plunger, turn the ring-stop on the plunger until the ring is able to slide freely up and down the plunger. Position the ring in such a way that the side nearest the barrel is at the desired volume marking. Turn the ring to secure it in place. Make sure that the horse’s mouth contains no feed. Remove the cap from the tip of the syringe and save for cap replacement. Insert the syringe tip into the horse’s mouth from the side of the mouth, placing the syringe tip beneath the tongue at the level of the commisure of the mouth. Depress the plunger until the ring-stop contacts the barrel, depositing the product beneath the tongue.

Cautions:

DORMOSEDAN GEL is contraindicated in horses with known hypersensitivity to detomidine. Intravenous potentiated sulfonamides should not be used in anesthetized or sedated horses as potentially fatal dysrhythmias may occur.

Do not use DORMOSEDAN GEL in horses with pre-existing atrioventricular (AV) or sino-atrial (SA) blocks, respiratory disease, or chronic renal failure.

HUMAN WARNINGS:Not for human use. Keep out of the reach of children. Use impermeable gloves during drug administration and during procedures that require contact with the horse’s mouth. Following sublingual administration of detomidine oromucosal gel, drug concentrations up to 0.072 mg/mL were measured at 30 minutes post dose in equine saliva, equivalent to less than one percent of the original detomidine concentration in the gel. Mean drug concentrations fall to less than 0.010 mg/mL by 2 hours after drug administration, after which a slow decline occurs for several additional hours.

DORMOSEDAN GEL can be absorbed following direct exposure to skin, eyes, or mouth, and may cause irritation. Skin and mucosal contact with the product should be avoided. Use impermeable gloves at all times. In case of accidental eye exposure, rinse abundantly with fresh water. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Appropriate precautions should be taken while handling and using gel syringes. Accidental exposure could cause adverse reactions, including sedation, hypotension, and bradycardia. Seek medical attention immediately but do not drive because sedation or changes in blood pressure may occur.
Individuals with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid exposure to this product.
Caution should be exercised when handling sedated horses. Handling or any other sudden stimuli, including noise, may cause a defense reaction in an animal that appears to be heavily sedated. Rare cases of human abuse of detomidine products have been reported. DORMOSEDAN GEL should be managed to prevent the risk of diversion, through such measures as restriction of access and the use of drug accountability procedures appropriate to the clinical setting.

PRECAUTIONS:DORMOSEDAN GEL must be placed beneath the tongue of the horse. Unlike most oral veterinary products, this product is not meant to be swallowed. Swallowing could result in ineffectiveness.
DORMOSEDAN GEL does not provide analgesia. Do not use for painful procedures.
Do not use with other sedative drugs because the effects may be additive.
Repeat dosing has not been evaluated.
The use of an alpha2-agonist reversal agent with DORMOSEDAN GEL has not been evaluated.
Before initiating any procedure, allow sedation to fully develop. Nervous or excited horses with high levels of endogenous catecholamines may exhibit a reduced pharmacological response to alpha2-adrenoceptor agonists like detomidine. In agitated horses, the onset of sedative effects could be slowed, or the depth and duration of effects could be diminished or nonexistent. When the product is administered, the animal should be allowed to rest in a quiet place for a minimum of 40 minutes.
Do not use DORMOSEDAN GEL in horses with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold, fatigue, or high altitude. Protect treated horses from temperature extremes. As with all alpha2-adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists.
DORMOSEDAN GEL has not been evaluated in ponies, miniature horses, or horses younger than one year of age.
DORMOSEDAN GEL has not been evaluated for use in breeding, pregnant, or lactating horses.