Sileo Oromucosal Gel for Dogs, slide 1 of 1

Sileo Oromucosal Gel for Dogs, 0.09 mg/mL, 3 mL

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Description

Sileo (dexmedetomidine oromucosal gel) is the first and only FDA-approved treatment for dogs that suffer from noise aversion. This medication is prescribed by your veterinarian to help calm your dog when your pet is frightened by loud noises. Common noise aversion triggers include fireworks, thunder, construction work, traffic or street noise, celebrations, vacuum cleaners and smoke detectors. Sileo works by blocking norepinephrine, a brain chemical similar to adrenaline that pumps up anxiety.

Uses

Sileo treats dogs suffering from noise aversion, excessive fear, and anxiety caused by loud noises.

Possible Side Effects

No serious adverse reactions are attributed to the administration of dexmedetomidine oromucosal gel in dogs.

Drug & Food Interactions

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. 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

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. Sileo has not been evaluated in dogs younger than 16 weeks of age or in dogs with dental or gingival diseases. Sileo has also not been evaluated for aversion behaviors to thunderstorms. Administration to pregnant dogs may induce uterine contractions and/or decrease fetal blood pressure. 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.

  1. Package Insert

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  • Item Number
    146296
  • Common Brand Name(s)
    Sileo, Dexdomitor
  • For Use With
    Dogs
  • Generic Name
    Dexmedetomidine Oromucosal
  • Administration Form
    Oromucosal
  • Brand
    Zoetis
  • Product Form
    Gel
  • Health Condition
    Anxiety
  • Drug Type
    Sedative
Ingredients
Ingredients

Dexmedetomidine Oromucosal Gel.

Instructions
Recommended Dosage

Sileo is administered onto the lining of the mouth by placing the gel between your dog’s cheek and gums, allowing for transmucosal absorption. Since the gel is absorbed through the skin, it should not be swallowed by your dog. If the gel is swallowed, the product may not be effective and do not repeat the dose for at least two hours. A dose greater than 6 dots should be divided evenly between both sides of the mouth. Use gloves in the administration of Sileo. The dosing chart is by body weight and associated number of dots. Each dot is 0.25 mL; 4 dots is equivalent to 1 mL. See instructional video above for more detailed instructions.

Storage Instructions

Store opened and unopened syringes in the original package at controlled room temperatures of 68° - 77°F. Use contents within 4 weeks after opening the syringe.

FAQ

What is Sileo?

Sileo is the first and only FDA-approved treatment for canine noise aversion associated with fear and anxiety. Sileo has been proven to work on its own without other treatments or training.

What are the benefits of Sileo Gel?

  • Fast-acting and easy to administer.
  • Helps treat your dog's anxiety due to loud noises such as fireworks and thunder.

How does Sileo work?

Sileo is formulated as a gel that is absorbed into your dog’s body when you apply it to the mucous membranes between your dog’s cheek and gums. Dexmedetomidine (the active ingredient) calms your dog by preventing or reducing specific reactions in the nervous system.

What is noise aversion?

Noise aversion is the set of anxiety- or fear-based behaviors that dogs can display when subjected to “noise triggers.”

What is included in my supply of Sileo?

Sileo is supplied in a 3-milliliter oral syringe. Each syringe comes with a dosing ring and end cap along with a prescribing information leaflet.

Why should a dose greater than 6 dots be divided between both sides of the mouth?

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 maximizes absorption through the mucous membranes.

What if my dog receives more than the required dose of Sileo? Much of the excess gel may flow out of the mouth or be swallowed, which would limit the effects on your 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. As always, contact your veterinarian in any situation where you feel your dog has received too much of the prescribed medication.

How should any empty syringes or unused Sileo be disposed?

State and federal medical waste laws apply. The easiest method could be to place the used syringe back into the box and return it to the veterinary clinic. Ask your veterinarian about proper disposal of empty or partially used Sileo syringes.

Can Sileo be administered without using the syringe provided?

No. This will cause incorrect dosing. (Also, remember to wear impermeable gloves; see more in the Human Safety questions below.)

Can a partially used syringe be reused for additional doses?

Yes, within two weeks, but only if there is enough gel remaining for a complete dose (to minimize the risk of incorrect dosing).

Why are impermeable disposable gloves required for administration of Sileo?

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, you should wear impermeable disposable gloves when administering SILEO to your dog.

What if I'm exposed to Sileo?

In the case of accidental exposure to the skin, the area should be immediately and thoroughly washed; remove contaminated clothing and contact your physician if you have questions.If Sileo comes in contact with your eyes, nose or mouth, it can be absorbed into your body, so you should flush the exposed area with water for 15 minutes. If you are wearing contact lenses, flush the eyes and then remove contact lenses and continue flushing; 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 package information with your physician and tell him/her that SILEO contains an alpha-2 adrenoceptor agonist.

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