Sileo (dexmedetomidine oromucosal gel)

INDICATIONS: SILEO is indicated for the treatment of noise aversion in dogs.

DOSAGE AND ADMINISTRATION: Always provide the Client Information Sheet with SILEO and instruct the client how 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

Table 1. Dosage by body weight Bodyweight (lb)

Number of dots

4.4-12.1 1 ●

12.2-26.5 2 ●●

26.6-44.0 3 ●●●

44.1-63.9 4 ●●●●

64.0-86.0 5 ●●●●●

86.1-110.2 6 ●●●●●●

110.3-137.8 7 ●●●●●●●

137.9-166.4 8 ●●●●●●●●

166.5-196.2 9 ●●●●●●●●● 

196.3-220.5 10 ●●●●●●●●●●

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

ADVERSE REACTIONS:Possible side effects include vomiting, diarrhea, sedation, decreased heart rate, decreased respiratory rate and pale gums. a well-controlled European field study, which included a total of 182 dogs ranging from 2 to 17 years of age and representing both mixed and pure breed dogs (89 treated with dexmedetomidine oromucosal gel and 93 treated with control), no serious adverse reactions were attributed to administration of dexmedetomidine oromucosal gel.

 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 and/or defecation, and salivation.

SILEO is packaged in a syringe that can be used to apply more than one dose. The medication should not be swallowed by your dog but should be placed in the dog’s mouth between the cheek and gum, so that it can be absorbed into the bloodstream.

If SILEO is swallowed, it may not be effective. If you think this has happened, you should wait for two hours and if your dog is showing signs of fear and/or anxiety, then administer another dose.

How should the product be handled? You should wear impermeable disposable gloves when administering the product and when handling the dosing syringe. Avoid administering the product if pregnant, as exposure may induce uterine contractions and/or decrease fetal blood pressure.

When to administer and what should I expect after administering SILEO? The first dose of SILEO should be given immediately after your dog shows first signs of fear and/or anxiety associated with noise, or when the typical noise stimulus (e.g. sound of fireworks) inducing anxiety and/or fear in your dog is detected. If the dose for your dog is more than 6 dots, divide the dose between both sides of the mouth. The drug takes effect after approximately 30 minutes to one hour. Your dog should show less intense noise aversion behavior, despite the ongoing noise. Some dogs might be more sensitive to the drug; if your dog appears drowsy, keep it warm and do not offer food or water until the effect of the drug has worn off. This will normally happen within a few hours.

What should I do if SILEO does not work? If you think that SILEO is not working, do not re-dose and contact your veterinarian to discuss further treatment options.

If needed, is it possible to give another dose of SILEO? If noise lasts longer than 2-3 hours and your dog is still showing signs of fear and/or anxiety or the signs of fear and anxiety reappear, you may need to give your dog another dose. To avoid overdosing, there should always be at least two hours’ pause between dosages.

Dogs sedated from previous dosing should not be given SILEO. No more than 5 doses can be given during one noise event. You can use a partially used syringe again within 4 weeks after initial opening, if there is enough gel for a complete dose for your dog. To minimize the risk of incorrect dosing, do not use a partially used syringe that does not have enough gel for a complete dose. Any unused product or waste material should be disposed of according to local law and Federal prescription drug disposal guidelines. Ask your veterinarian for this information.

What should I do if I have accidently given my dog too much SILEO? Contact your veterinarian immediately.

What if I get the gel in my eyes, nose, or mouth? The drug can be absorbed into your body through your eyes, nose, or mouth. If it comes in contact with your eyes, nose, or mouth, 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. If the drug is absorbed into your body, it can cause symptoms such as lowered blood pressure (which may result in dizziness; fainting; lack of concentration; blurred vision; nausea; cold, clammy, or pale skin; rapid, shallow breathing), sleepiness, and slower heart rate. Share the package information with your physician and tell the physician that the product contains an alpha-2 adrenoceptor agonist.

What if I get the gel on my skin? You should wear impermeable disposable gloves when administering this product. If you have cuts or chapped skin, the drug can be absorbed into your body. In case of skin contact, wash immediately with large amounts of water. Remove contaminated clothing. Contact your physician if you have any questions or concerns. To report adverse reactions, call: 1-888-963-8471.

What else should I know about SILEO? As with all prescription medicine, SILEO should only be given to the dog for which it was prescribed. This sheet provides a summary of information about SILEO. If you have any questions or concerns about SILEO or its effects on your dog, talk to your veterinarian or health care provider.

Which dogs should not take SILEO? Dogs with severe cardiovascular, respiratory, liver or kidney disease or in dogs sedated from previous dosing should not be given SILEO.

How do I store SILEO? Store unopened and opened syringes at room temperature in the original package, as SILEO is sensitive to light. If syringe contents are not used within 4 weeks after opening the syringe, the syringe should be discarded. Keep the package out of sight and reach of children at all times.