Sileo

What is Sileo?

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. Sileo is available in a 3.0 ml oral syringe and requires a prescription from your veterinarian.

Stuiable For:

Dogs (16+ weeks of age, weighing 4.4+ lbs)

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.

Cautions:

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. Always review INSTRUCTIONS FOR USE before dispensing and dosing.

Brand Name

Sileo

Generic Name

Dexmedetomidine (dex-me-de-to-mi-deen) hydrochloride oromucosal gel

Manufacturer:

Zoetis

What is this medication used for:

Sileo is used for the treatment of noise aversion in dogs.

Availability:

Sileo is available as an oromucosal gel that is presented in a 3 ml oral syringe enabling doses from 0.25 to 3 ml and requires a prescription from your veterinarian.

How this medicine should be used:

Sileo is not meant to be swallowed. Instead, it must be placed onto the mucosa between your 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 amount of Sileo to be administered is based on your dog's weight. Each dose corresponds to the number of dots on the syringe (each dot (•) represents 0.25 ml of Sileo): dogs 4.4-12.1 lbs give 0.24 ml (1 •), dogs 12.2-26.5 lbs give 0.5 ml (2 •), dogs 26.6-44.0 lbs give 0.75 ml (3 •), dogs 44.1-63.9 lbs give 1.0 ml (4 •), dogs 64.0-86.0 lbs give 1.25 ml (5 •), dogs 86.1-110.2 lbs give 1.5 ml (6 •), dogs 110.3-137.8 lbs give 1.75 ml (7 •), dogs 137.9-166.4 lbs give 2 ml (8 •), dogs 166.5-196.2 lbs give 2.25 ml (9 •), dogs 196.3-220.5 lbs give 2.5 ml (10 •). For dogs weighing over 86.0 lbs, divide the dose between both sides of the mouth.

If noise lasts longer than 2-3 hours and your 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.

What are the side effects:

Transient pale mucous membranes at the site of application may occur with Sileo use. Other uncommon adverse reactions include emesis, drowsiness or sedation.

What special precautions are there:

Not for human use. Keep out of reach of children. 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 the absorption of Sileo. 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.

IMPORTANT SAFETY INFORMATION: Do not use Sileo in dogs with severe cardiovascular, respiratory, liver or kidney diseases. Do not use on dogs in conditions of shock, severe debilitation, 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. Handle gel-dosing syringes with caution to avoid direct exposure to skin, eyes or mouth. See full Prescribing Information included in the package.

Avoid administering the product if you are 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 your dog's mouth after application. If skin is damaged, dexmedetomidine can be absorbed into the body. In case of skin contact, wash with large amounts of 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. If the drug is absorbed into your body, it can cause symptoms such as lowered 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.

In the event of an overdose:

Contact your veterinarian immediately.

How should I store this medication:

Store unopened and opened syringes in the original package at controlled room temperature 68-77°F (20-25°C) with excursions permitted to 59-86°F (15-30°C). Use syringe contents within 4 weeks after opening the syringe.