(dexmedetomidine oromucosal gel)
SILEO® (dexmedetomidine oromucosal gel) is the first and only FDA-approved treatment for canine noise aversion. SILEO is designed for easy, at-home administration by the pet owner.
As with any new medication, it is important that the dog owner receives hands-on training on how to administer the treatment.
Review the dosing administration instructions to:
- Ensure that the pet owner wears gloves
- Confirm the correct dose
- Reinforce that the locking ring needs to be in the lock position before administering
- Be sure that the pet owner understands that SILEO is administered between the cheek and gum and that it is not swallowed
SILEO gel is presented in a 3 mL multidose oral syringe that can be used for repeated doses on an as-needed basis. The gel is applied between the cheek and gum for transmucosal absorption. If SILEO is ingested, due to extensive first pass metabolism by the liver, little dexmedetomidine will be absorbed; therefore SILEO may be ineffective. If swallowed, allow at least two hours before applying the next dose.
SILEO Dosing is Tailored to the Situation
The first dose can be administered:
- Approximately 30 to 60 minutes before the fear and/or anxiety eliciting noise stimulus
- Or 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., fireworks) eliciting anxiety or fear in the dog
If noise lasts greater than 2–3 hours and the dog’s signs of fear and/or anxiety reappear, another dose may be given:
- At minimum intervals of 2 hours between doses
- Up to five doses can be given during one noise event
If there is any SILEO remaining in the syringe, the syringe should be returned to the carton to protect it from light. If the remaining portion of the syringe is not used within 2 weeks, it should be discarded according to local and federal regulations.
How to Administer Sileo® Correctly
Dosing by Body Weight
A pet owner can easily determine the appropriate dose by looking up their dog’s weight on this dosing chart, which will indicate the corresponding number of dots the dog should receive.
Important Safety Information: Do not use SILEO in dogs with severe cardiovascular disease, respiratory, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue or in dogs hypersensitive to dexmedetomidine or to any of the excipients. SILEO should not be administered in the presence of preexisting hypotension, hypoxia, or bradycardia. Do not use in dogs sedated from previous dosing. SILEO has not been evaluated in dogs younger than 16 weeks of age or in dogs with dental or gingival disease that could have an effect on the absorption of SILEO. SILEO has not been evaluated for use in breeding, pregnant, or lactating dogs or for aversion behaviors to thunderstorms. Transient pale mucous membranes at the site of application may occur with SILEO use. Other uncommon adverse reactions included emesis, drowsiness or sedation. Handlers should avoid direct exposure of SILEO to their skin, eyes or mouth. Failure to lock the ring-stop on the syringe before dosing SILEO could potentially lead to an accidental overdose. Always review INSTRUCTIONS FOR USE before dispensing and dosing. See full Prescribing Information.
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