Dormosedan
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Questions & Answers
Side Effects & Adverse Reactions
For sublingual use in horses only. Do not use in horses intended for human consumption.
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.
The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the MSDS for this product call 1-800-366- 5288.
Note to physician: This product contains an alpha2-adrenoceptor agonist.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
DORMOSEDAN GEL is indicated for sedation and restraint in horses.
History
There is currently no drug history available for this drug.
Other Information
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
Sources
Dormosedan Manufacturers
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Pfizer Animal Health
![Dormosedan (Detomidine Hydrochloride) Gel [Pfizer Animal Health]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dormosedan | Pfizer Animal Health
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 3.00Use 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.
The following picture demonstrates correct administration of DORMOSEDAN GEL beneath the tongue.
Take the syringe out of the horse's mouth, recap the syringe and return it to the outer carton for disposal. Remove gloves for disposal.
For the best results, allow adequate time (a minimum of 40 minutes) between administration of DORMOSEDAN GEL and beginning the procedure. In general, horses show sedative effects lasting approximately 90-180 minutes.
Withhold food and water until the sedative effects of the product wear off.
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