SILEO is an oromucosal formulation of dexmedetomidine and is the first and only FDA-approved treatment for canine noise aversion, which is an anxiety- and fear-based reaction to sounds. SILEO has been proven to work on its own without other treatments or training. The name is pronounced /si-lehh-o/. It's a Latin word that means to "be silent."
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Zoetis Sileo for Dogs - 3mL Syringes - [Relaxant]
Item# Z064650
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- Description
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Description
Sileo is the first FDA-approved treatment for dogs suffering from noise aversion, excessive fear, and anxiety caused by loud noises such as thunder and fireworks. It is clinically proven to be safe and effective without other treatments or training. Sileo is fast-acting and easy to administer orally between the cheek and gum. This breakthrough treatment does not sedate your pet, so there is no interference with normal activity or attentiveness. Sileo remains effective for up to 3 hours, and should be given immediately after your dog shows the first signs of fear and /or anxiety associated with fear, such as panting, trembling, trying to hide or escape, refusal to eat, salivation, or inappropriate urination and/or defecation.
Key Benefits
- First FDA-Approved treatment for noise aversion in dogs
- Calms dogs without sedation
- Easy-to-administer oral gel syringe
- Does not require additional treatments or training
- Effective for up to 3 hours
How it works
Sileo is an oromucosal gel formulation of dexmedetomidine hydrochloride provided in a 3 ml syringe at a concentration of 0.1 mg/ml. Using the syringe, Sileo is easily administered between the cheek and gum, allowing for transmucosal absorption. Because Sileo is formulated to provide a low dose of dexmedetomidine, your dog remains calm, yet fully functional, and is able to interact normally with your family.
Indications
SILEO is indicated for the treatment of noise aversion in dogs.
Directions
Always provide the Client Information Sheet with Sileo and instruct the client hot to properly operate the Sileo dosing syringe (see Client Information Sheet for Owner/Handler Use and Safety).
To prevent accidental overdose, it is important to make sure that the ring-stop on the dosing syringe is in the locked position prior to administration.
Sileo is administered onto the oral mucosa between the dog's cheek and gum at the dose of 125 mcg/m2. The gel is absorbed through the oral mucosa and therefore it should NOT be swallowed. If the gel is swallowed, the product may not be effective. If the gel is swallowed, do not repeat the dose for at least two hours.
The following table provides the acceptable dosage for each weight range. Each dot (•) represents 0.25 mL of Sileo.
Each ml contains the equivalent to 0.1mg dexmedetomidine hydrochloride.
If the dose is more than 6 dots, divide the dose between both sides of the mouth. The first dose of Sileo should be administered approximately 30-60 minutes before the fear and/or anxiety-eliciting noise stimulus, immediately after the dog shows first signs of anxiety or fear related to noise, or when the owner detects a typical noise stimulus (e.g. sound of fireworks) eliciting anxiety or fear in the dog. Typical signs of anxiety and fear associated with noise aversion are panting, trembling, pacing, seeking people, trying to hide, trying to escape, freezing behavior, refusing to eat food or treats, inappropriate urination or defecation, and salivation.
Administering Sileo without use of the Sileo syringe will result in incorrect dosing, which may result in lack of efficacy or overdose.
Dosing should be performed by an adult. Impermeable disposable gloves should be worn when administering Sileo and when handling the Sileo syringe.
If noise lasts longer than 2-3 hours and the dog's signs of fear and/or anxiety reappear, another dose may need to be given. To avoid overdosing, there should always be at least two hours' pause between dosages. No more than 5 doses can be given during one noise event.
A partially used syringe can be used again within 4 weeks after initial opening, if there is enough gel for a complete dose for the dog. To minimize the risk of incorrect dosing, a partially used syringe that does not have enough gel for a complete dose should not be used.
Any unused product or waste material should be disposed of according to local law and Federal prescription drug disposal guidelines.
Caution:
Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
Contraindications:
Do not use Sileo in dogs with severe cardiovascular, respiratory, liver or kidney disease, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. Do not use in dogs with hypersensitivity to dexmedetomidine or to any of the excipients.
Warnings:
Human Safety: Not for human use. Keep out of reach of children.
Avoid administering the product if pregnant, as exposure may induce uterine contractions and/or decrease fetal blood pressure.
Appropriate precautions should be taken while handling and using filled syringes. Impermeable disposable gloves should be worn when handling the syringe, administering Sileo, or when coming in contact with the dog's mouth after application.
If skin is damaged, dexmedetomidine can be absorbed into the body. In case of skin contact, wash with soap and water. Remove contaminated clothing.
Sileo can be absorbed following direct exposure to skin, eyes, or mouth. In case of accidental eye exposure, flush with water for 15 minutes. If wearing contact lenses, eyes should be rinsed first, then remove contact lenses and continue rinsing, then seek medical advice immediately.
Accidental exposure may cause sedation and changes in blood pressure. In case of accidental exposure, seek medical attention immediately. Exposure to the product may induce a local or systemic allergic reaction in sensitized individuals.
Note to physician:
This product contains an alpha-2 adrenoceptor agonist.
The safety data sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for this product call 1-888-963-8471.
Animal Safety:
Sileo should not be administered in the presence of pre-existing hypotension, hypoxia, or bradycardia. Sensitive dogs may experience a drop in body temperature and heart rate, and may appear sedated. These dogs should be kept warm and not offered food or water until Sileo's effects have worn off (usually within a few hours). Do not use in dogs sedated from previous dosing.
Precautions:
Sileo is not meant to be swallowed. Instead, it must be placed onto the mucosa between the dog's cheek and gum. If Sileo is swallowed, the product may not be effective. If Sileo is swallowed, do not repeat the dose for at least two hours. Feeding and giving treats within 15 minutes after administration should be avoided.
The use of other central nervous system depressants may potentiate the effects of Sileo.
As with all alpha-2 adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists.
Sileo has not been evaluated in dogs younger than 16 weeks of age or in dogs with dental or gingival diseases that could have an effect on Sileo's absorption. Sileo has not been evaluated for aversion behaviors to thunderstorms.
The safety and effectiveness of Sileo in breeding, pregnant, and lactating dogs has not been evaluated. Administration to pregnant dogs may induce uterine contractions and/or decrease fetal blood pressure.
Storage:
Store unopened and opened syringes in the original package at controlled room temperature 20-25°C (68-77°F) with excursions permitted to 15-30°C (59-86°F). Use syringe contents within 4 weeks after opening the syringe.
Client Information Sheet for Owner/Hanfler Use and Safety
This sheet summarizes the basic information about Sileo and does not replace the instructions from your veterinarian. Talk to your veterinarian if you have questions regarding any part of this information or if you want to know more about Sileo. The syringe must be used in order to correctly dose the drug to your dog. You may use either a full, unused syringe or a partially used syringe that contains enough gel for the desired dose.
FAQ
SILEO must be administered oral transmucosally. If swallowed, it may not be effective because dexmedetomidine undergoes extensive first-pass metabolism.
The anxiolytic actions of SILEO are thought to be mediated through the locus coeruleus. The locus coeruleus is an area in the brainstem that mediates stress and anxiety, fear learning and memory. The locus coeruleus neurons have a large number of alpha-2 receptors, and the main neurotransmitter is norepinephrine. Exposure to stressors increases the release of norepinephrine from the locus coeruleus.
Dexmedetomidine, the active ingredient in SILEO, is a potent and selective alpha-2 adrenoceptor agonist. Dexmedetomidine binds to alpha-2 adrenoceptors in the locus coeruleus, inhibiting release of norepinephrine, which can lead to a reduction in anxiety and the associated behavioral signs.
Although the dosage and active ingredient of SILEO are the same as dexmedetomidine injectable, because of the route of administration, the effects are very different. SILEO is administered oral transmucosally, which limits the bioavailability of dexmedetomidine to 28 percent. This means that only about one-fourth of the dexmedetomidine is absorbed. At this reduced plasma concentration of dexmedetomidine, study results found that SILEO had a calming effect that was not due to sedation, and the effect on heart rate was minimal.
Noise aversion is the set of anxiety - or fear-based behaviors that dogs can display when subjected to "noise triggers."
There are many noise aversion triggers that can be very specific to a dog. Doorbells, smoke alarms, sirens, garbage trucks and snow plows, high-pitched voices of children, as well as firearms and construction noise are some of the triggers that have been reported. Since pet owners may not always recognize that their dog's reactions to noise are signs of fear and anxiety, it is important to inquire at each visit if the pet owner has any concerns regarding their dog's behavior.
SILEO is supplied in a 3-milliliter oral syringe, and each syringe comes with a dosing ring and end cap. The syringe is packaged with the prescribing information leaflet in a cardboard carton.
SILEO is administered by placing the gel between the dog's cheek and gums, allowing for transmucosal absorption.
The dose volume of six dots is equivalent to 1.5 mL, a dose volume that is too great to administer effectively to one side of the mouth without the risk of some of the dose being swallowed or flowing out of the mouth. Administering half of the dose on one side of the mouth and half on the other side will maximize absorption through the mucous membranes.
No. This will cause incorrect dosing. (Also, remind your clients to wear impermeable gloves; see more in the Human Safety questions below.)
Yes, within four weeks, but only if there is enough gel remaining for a complete dose (to minimize the risk of incorrect dosing).
Since using the SILEO syringe and administering SILEO oral transmucosally will be new for your clients, it is important that you or one of your staff members take a few minutes to show the client how to use the syringe. The administration instructions can be found in the package insert inside the SILEO carton or downloaded from sileodvmus.com.
When speaking with your client about administration, it’s important to emphasize the following points:
- Wear disposable impermeable gloves
- Confirm the correct dose
- Ensure that the locking ring is in the locked position
- Place the syringe between the cheek and gums to ensure oral transmucosal absorption since SILEO will be less effective if swallowed
- If the dose is greater than six dots, divide the dose so that half is given on one side of the mouth and half is given on the other side of the mouth to ensure optimal absorption
- Dispose of the syringe in an appropriate manner
Both new and partially used syringes of SILEO should be stored in the carton provided (protected from light) at room temperature.
State and federal medical waste laws apply. The easiest method could be to have your client place the used syringe back into the box and and return it to your veterinary clinic.
Very few adverse events have been reported with the use of SILEO. Vomiting, sedation and/or drowsiness were infrequently reported.
Avoiding food and treats 15 minutes after dosing minimizes the risk of the dog swallowing any part of the dose.
Much of the excess gel may flow out of the mouth or be swallowed, which would limit the effects on the dog. In a worst case scenario where the entire syringe (3 mL) is accidentally applied to a smaller dog and is fully absorbed, mild to moderate sedation may occur. Advise your clients to call your clinic should they give a higher-thanprescribed dose.
Although dexmedetomidine (the active ingredient in SILEO) cannot be absorbed through intact skin, it can be absorbed through breaks in the skin and through mucous membranes. Therefore, as a precaution, your clients should wear impermeable disposable gloves when administering SILEO to their dog.
In the case of accidental exposure to the skin, the area should be thoroughly washed with soap and water. If exposure to the eyes occurs, thoroughly flush with water for 15 minutes; if the person is wearing contacts, flush the eyes thoroughly before removing contact(s), then flush again after removing the contact(s). Seek medical attention immediately. If a person is hypersensitive to SILEO, exposure may induce a local or systemic allergic reaction.
Although the active ingredient in SILEO, dexmedetomidine hydrochloride, is approved for use as a sedative for humans, it has not been evaluated in pregnant women. Therefore, pregnant women are warned not to administer SILEO to their dogs.
Reviews
Review Summary
4.5
2 Reviews
5
50% (1)
4
50% (1)
3
0% (0)
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100% Recommend this product (2 of 2 responses)
By Doug
KY
Storm Alert
January 30, 2023
Sileo is the only thing that has helped our 10 year old Pyranees mix with thunder, fireworks, or gunshots. The only thing I can say bad is that there is a small amount in a tube and it's expensive. But worth it to help settle her nerves. She sees lightning and immediately gets scared waiting for the thunder.
Pros
- Works well, easy to administer
Cons
- Expensive and only about three dosed per tube.
By Holly
Houston
Great product
April 22, 2020
We use this for bad anxiety in the dogs, thunderstorms mostly. Calms them down for a good 90 minutes with no side effects. Not sure what I’d do without it.
