Dormosedan Gel 10 x 3ml
Dormosedan (detomidine hydrochloride) Gel is a synthetic alpha2-adrenoreceptor agonist that is indicated for sedation and restraint in horses only. It produces sedation when administered sublingually at 0.018 mg/lb (0.040 mg/kg). It must be placed beneath the tongue of the horse and is not meant to be swallowed. Impermeable gloves must be used during drug administration and during procedures that require contact with the horse’s mouth.
DORMOSEDAN GEL®
Zoetis
(detomidine hydrochloride)
Alpha2-agonist oromucosal gel
Rx only
For Sedation and Restraint in Horses Only
NADA #141-306, Approved by FDA
CAUTION:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION:
DORMOSEDAN (detomidine hydrochloride) GEL is a synthetic alpha2-adrenoreceptor agonist with sedative properties. Each mL of DORMOSEDAN GEL contains 7.6 mg detomidine hydrochloride. The chemical name is 1H imidazole, 4-[(2,3-dimethylphenyl) methyl]-hydrochloride. Detomidine hydrochloride is a white, crystalline, water-soluble substance having a molecular weight of 222.7. The molecular formula is C12H14N2•HCl and the structural formula is
INDICATIONS:
DORMOSEDAN GEL is indicated for sedation and restraint in horses.
DOSAGE AND ADMINISTRATION:
DORMOSEDAN GEL produces sedation when administered sublingually at 0.018 mg/lb (0.040 mg/kg). DORMOSEDAN GEL must be placed beneath the tongue of the horse and is not meant to be swallowed. 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 (Table 1).
Table 1: Sublingual dosing of DORMOSEDAN GEL
|
Approximate body weight (lb)
|
Range of doses (mg/lb)
|
Approximate body weight (kg)
|
Range of doses (mg/kg)
|
Dose volume (mL)
|
|
330 - 439
|
0.023 - 0.017
|
150 - 199
|
0.051 - 0.038
|
1.00
|
|
440 - 549
|
0.022 - 0.017
|
200 - 249
|
0.047 - 0-038
|
1.25
|
|
550 - 659
|
0.021 - 0.017
|
250 - 299
|
0.046 - 0.038
|
1.50
|
|
660 - 769
|
0.020 - 0.017
|
300 - 349
|
0.044 - 0.038
|
1.75
|
|
770 - 879
|
0.019 - 0.017
|
350 - 399
|
0.043 - 0.038
|
2.00
|
|
880 - 989
|
0.019 - 0.017
|
400 - 449
|
0.043 - 0.038
|
2.25
|
|
990 - 1099
|
0.019 - 0.017
|
450 - 499
|
0.042 - 0.038
|
2.50
|
|
1100 - 1209
|
0.019 - 0.017
|
500 - 549
|
0.042 - 0.038
|
2.75
|
|
1210 - 1320
|
0.019 - 0.017
|
550 - 600
|
0.041 - 0.038
|
3.00
|
CONTRAINDICATIONS:
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.
WARNINGS:
For sublingual use in horses only. Do not use in horses intended for human consumption.
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.
Note to physician: This product contains an alpha2-adrenoceptor agonist.
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.
DVERSE REACTIONS:
Clinical field study:
In a US field study of 270 horses sedated to facilitate completion of various veterinary and husbandry procedures, the following adverse reactions were reported in 202 horses treated with DORMOSEDAN GEL and 68 horses treated with placebo:
Table 2: Adverse reactions (number of horses) during the clinical field study
|
Clinical Sign
|
DORMOSEDAN GEL
N = 202
|
Placebo
N =68
|
|
Sweating
|
20
|
0
|
|
Penile relaxation
|
12
|
0
|
|
Bradycardia (≤ 20 bpm)
|
11
|
0
|
|
Second degree AV block
|
9
|
0
|
|
Frequent urination
|
9
|
0
|
|
Piloerection
|
4
|
0
|
|
Marked ataxia
|
3
|
0
|
|
Facial/oral edema
|
3
|
0
|
|
Hypersalivation
|
2
|
0
|
|
Nasal discharge
|
2
|
0
|
|
Flatulence
|
1
|
0
|
|
Muscle tremors
|
1
|
1
|
|
Epiphora
|
1
|
0
|
|
Pale mucous membranes
|
1
|
0
|
|
Swollen sheath
|
1
|
0
|
STORAGE INFORMATION:
Store at controlled room temperature 20-25°C (68-77°F), with excursions permitted to 15-30°C (59-86°F), in the original package.
HOW SUPPLIED:
3.0 mL graduated oral dosing syringe, 7.6 mg/mL detomidine hydrochloride.
DORMOSEDAN® is a trademark of Orion Corporation.
