What is the indication for DORMOSEDAN GEL in horses?
DORMOSEDAN GEL is indicated for sedation in horses. For example, DORMOSEDAN GEL has been shown effective in procedures such as clipping, sheath cleaning, hoof trimming and/or shoeing.
What is the horse’s minimum age for administering DORMOSEDAN GEL?
DORMOSEDAN GEL has not been evaluated in horses younger than 1 year of age.
What is the dose and route of administration of DORMOSEDAN GEL in horses?
DORMOSEDAN GEL produces sedation when administered under the tongue 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.
What would happen if my horse spit it out or swallowed part of the dose?
If after 40 minutes there is inadequate sedation and you suspect that the horse swallowed or spit out some of the gel, contact your prescribing veterinarian. Do not repeat the dose.
Can I mix DORMOSEDAN GEL with feed?
No. DORMOSEDAN GEL needs to be in contact with sublingual oral mucosa (under the tongue) to allow for proper absorption. Mixing it with feed increases the chance of it being swallowed and not being properly absorbed.
Mouths should be cleaned of feed prior to administration of DORMOSEDAN GEL. All feed and water should be removed from the stall while the product takes effect until the horse is fully recovered.
My horse is larger than 1,300 pounds, how do I dose?
One DORMOSEDAN GEL syringe contains a label dose of 0.018 mg/lb (0.040 mg/kg) for a horse weighing up to 1,320 pounds (600 kg). For a heavier horse, administer additional gel from a second syringe to provide the total labeled dose calculated for the body weight of the horse.
How long after dosing my horse do I have to wait before he can compete?
It has not been determined how soon prior to a show DORMOSEDAN GEL can be given. Please contact the USEF/FEI, AQHA or other drug testing authority for guidance on shows under their jurisdiction.
What is the best way to store DORMOSEDAN GEL?
DORMOSEDAN GEL is a single use veterinary prescription product, which when stored at room temperature (68°F - 77°F), will last until the expiration date.
What is the shelf life?
The expiration date is two years from the date of manufacture.
Is DORMOSEDAN GEL sensitive to light?
Yes. DORMOSEDAN GEL should be kept in its original carton until use to protect from direct sunlight.
Can a partially used DORMOSEDAN GEL syringe be re-used at a later time?
No. There is no data to support the sterility/safety or efficacy of the unused portion. DORMOSEDAN GEL is designed to be used one time at a proper dose prescribed by your veterinarian. The remaining product should be disposed of properly, being sure to follow any local requirements for prescription medications.
How long will sedation last?
In general, horses show sedative effects lasting approximately 90 to 180 minutes.
What will my horse look like when he is sedated? How will he act?
If your horse is properly sedated he should have a lowered head, droopy eyelids and his legs should appear stiff and difficult to move. Horses commonly adopt a “saw horse” stance naturally to balance themselves when sedated. In addition, a horse's usual heart rate will be lowered. He will act as if he does not care about his surroundings.
Even so, one must be careful, as sudden movements and noises will still be able to startle some horses that appear sedated. The most important rule of thumb around a sedated horse is to treat the horse with the same respect as one would if he was not sedated.
Will my horse fall down?
Sedated horses may sway, lean or hang their heads, but it is highly unlikely they will fall down.
What do I do if I administered the product but it didn’t seem to work?
Following appropriate dosing of the gel, your horse should be kept in a quiet area until sedation is achieved. If after 40 minutes there is inadequate sedation and you suspect that the horse swallowed or spit out some of the gel, contact your prescribing veterinarian. Do not repeat the dose.
If you believe the correct dose of DORMOSEDAN GEL was administered but the horse remains inadequately sedated, contact the prescribing veterinarian for further guidance. Do not repeat the dose.
Can my horse feel pain while he is sedated?
DORMOSEDAN GEL has not been shown to provide pain relief (analgesia) and should not be used for painful procedures. DORMOSEDAN GEL should not be used with other sedative drugs because the effects may be additive. Be sure to discuss with your veterinarian any additional measures necessary for pain management if you think a procedure will hurt your horse.
How soon after dosing can I feed and water my horse?
Do not provide feed and water until the horse is fully recovered.
Can I use DORMOSEDAN GEL in pregnant mares?
DORMOSEDAN GEL has not been evaluated for use in breeding, pregnant or lactating horses.
Can I vaccinate my horse while he is sedated?
There are no specific contraindications; however, it is recommended you consult your veterinarian as they know what is best for your horse.
Is DORMOSEDAN GEL safe to use in donkeys and mules?
Data to support safety and efficacy has not been established in donkeys and mules. Please consult your veterinarian.
Can DORMOSEDAN GEL be used in miniature horses?
There is no contraindication for specific breeds of horses.
Can DORMOSEDAN GEL be used with other sedation products if needed?
DORMOSEDAN GEL should not be used with other sedative drugs because the effects may be additive.
Can DORMOSEDAN GEL be mixed with other products like a paste dewormer?
No. It is not recommended to mix DORMOSEDAN GEL with anything. Safety and efficacy data has not been established to support mixing the product.
Can DORMOSEDAN GEL be used if my horse is on daily medications or supplements? (e.g. NSAIDs, nutraceuticals, herbal supplements, daily anthelmintics, feed-through fly control products, antihistamines, hormone replacement therapy, etc.)
No studies have been conducted in which horses were on known concurrent medications. As with all prescription medications, discuss with your attending veterinarian the appropriateness of using DORMOSEDAN GEL in your horse.
Can DORMOSEDAN GEL be given to my horse if he is showing signs of colic?
DORMOSEDAN GEL is indicated for sedation to facilitate restraint for noninvasive veterinary and minor husbandry procedures only, not for pain relief (analgesia). A horse exhibiting signs of colic should be examined by a veterinarian before any medication is given.
Can DORMOSEDAN GEL be used when trailering or hauling a horse?
DORMOSEDAN GEL has not been evaluated for this purpose.
Can DORMOSEDAN GEL be given to spooky or hot horses before riding?
DORMOSEDAN GEL has not been evaluated for this purpose, and it is not recommended to ride a horse that has been sedated with DORMOSEDAN GEL.
What should I do if my dog or cat ingests DORMOSEDAN GEL?
If you suspect your dog or cat has possibly ingested and/or come in contact with DORMOSEDAN GEL, please contact your veterinarian immediately. DORMOSEDAN GEL has sedative effects in dogs and cats. Please have the package insert with you when you call your veterinarian.
Do I need to wear gloves while using DORMOSEDAN GEL?
Always wear impermeable gloves when handling the DORMOSEDAN GEL dosing syringe. For a minimum of two hours after administration, wear impermeable gloves when performing any tasks that require contact with the horse’s mouth.
What should be done if there is human exposure?
DORMOSEDAN GEL can be absorbed into the body after direct exposure through the eyes or mouth, and may cause irritation to these areas. In case of accidental eye exposure, flush with water for 15 minutes. If DORMOSEDAN GEL is exposed to the mucous membranes of the mouth, rinse without swallowing.
In all cases of accidental exposure and possible ingestion, the person exposed should seek immediate medical attention. Accidental exposure could result in the drug affecting the person exposed, causing symptoms that include sleepiness, low blood pressure and slower heart rate.
DO NOT ALLOW THE EXPOSED PERSON TO DRIVE because DORMOSEDAN GEL may cause the person exposed to feel drowsy or sleepy. Be sure to have the package insert for DORMOSEDAN GEL present when contacting a healthcare provider and tell the physician that the product contains an alpha2-adrenoceptor agonist.
DORMOSEDAN GEL can be absorbed into your body after direct exposure through the skin. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Contact your physician if you have any questions or concerns. The material safety data sheet (MSDS) contains more detailed occupational safety information.
Always wear impermeable gloves when handling the DORMOSEDAN GEL dosing syringe.
What precautions should be taken if a product handler has a known cardiovascular disease or arrhythmia?
If you have or have had a history of cardiovascular disease (for example, hypertension or heart attack) take special precautions and avoid direct exposure to the dosing syringe. Do not come in contact with the mouth or any saliva of any horse that was treated with DORMOSEDAN GEL for a minimum of two hours.
IMPORTANT SAFETY INFORMATION
Do not use DORMOSEDAN GEL in horses with pre-existing atrioventricular (AV) or sinoatrial (SA) block, with severe coronary insufficiency, cerebrovascular disease, respiratory disease, or chronic renal failure. Do not use in anesthetized or sedated horses, or in conditions of shock, severe debilitation or stress due to extreme heat, cold, fatigue or high altitude. Do not use in horses intended for human consumption. Handle gel-dosing syringes with caution to avoid direct exposure to skin, eyes or mouth. See full Prescribing Information.
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