Sileo® (dexmedetomidine oromucosal gel) is an oromucosal gel formulation of dexmedetomidine hydrochloride provided in a 3 mL syringe at a concentration of 0.09 mg/mL. It is the first and only FDA-approved treatment indicated for the treatment of canine noise aversion.
No serious side effects were discovered during trials. Some side effects may include vomiting, gastroenteritis, periorbital edema, drowsiness, sedation, transient paleness of the mucous membranes, & urinary incontinence. If you notice anything unusual, contact your veterinarian.
Dogs (at least 16 weeks old)
• Calming without sedating, allowing for normal dog-owner interactions
• Easy to administer at home, when needed
• Works on its own without any other treatments or training
• Quick onset of action
• An easy treatment for a challenging condition
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 eliciting anxiety or fear in the dog (e.g. fireworks, thunder, celebrations, construction, traffic). 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.
Sileo® is dosed based on weight and administered via a dosing syringe that uses a dot system for accurate dosing. Administering Sileo® without use of the Sileo® syringe will result in incorrect dosing, which may result in lack of efficacy or overdose.Sileo® is a translucent green gel that is administered onto the oral mucosa between the dog’s cheek & gum. The gel is absorbed through the oral mucosa & should NOT BE SWALLOWED. If swallowed it may not be effective & the dose cannot be repeated for at least 2 hours. Avoid feeding or giving treats within 15 minutes after administration.Impermeable disposable gloves should be worn when handling the syringe, administering Sileo®, or when coming in contact with the dog’s mouth after application. Avoid direct exposure to skin, eyes or mouth.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.
DO NOT give more medication than directed or give more often than directed. Store in original carton to protect from light. Use syringe contents within 2 weeks after opening the syringe.
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. Should not be used in dogs with pre-existing hypotension, hypoxia, or bradycardia. Do not use in dogs with hypersensitivity to dexmedetomidine or to any of the excipients. Sileo® has not been evaluated for use in breeding, pregnant or lactating dogs.
DO NOT administer Sileo® if you are pregnant as exposure may induce uterine contractions and/or decrease fetal blood pressure.
The following reactions are rare but if your pet experiences excessive sedation, confusion, or an allergic reaction such as irregular breathing, rash, fever, puffiness and swelling around the face contact your Veterinarian immediately. Other side effects may occur, contact your Veterinarian if you notice anything unusual.
The use of other central nervous system depressants is expected to increase the effects of Sileo® and an appropriate dose adjustment should be made.