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SILEO (0.1mg/ml), 3 ml
(dexmedetomidine oromucosal gel)
SILEO (dexmedetomidine oromucosal gel) is indicated for the treatment of noise aversion in dogs. The fear and anxiety associated with noise is commonly called noise sensitivity, anxiety or phobia depending upon the types and severity of clinical signs. SILEO is presented as an oromucosal gel formulation of dexmedetomidine hydrochloride. Using the syringe, SILEO is administered between the cheek and gum, allowing for oral transmucosal absorption.
Review Instructions for Use on full Prescribing Information with owners before dispensing SILEO.
Dosage and Administration:
Always provide the Client Information Sheet with SILEO and instruct the client how to properly operate the SILEO dosing syringe . 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. 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 list 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.
Dosage by body weight
Bodyweight (lb): Number of dots
- 4.4-12.1 - 1 Dot •
- 12.2-26.5 - 2 Dots ••
- 26.6-44.0 - 3 Dots •••
- 44.1-63.9 - 4 Dots ••••
- 64.0-86.0 - 5 Dots •••••
- 86.1-110.2 - 6 Dots ••••••
- 110.3-137.8 - 7 Dots •••••••
- 137.9-166.4 - 8 Dots ••••••••
- 166.5-196.2 - 9 Dots •••••••••
- 196.3-220.5 - 10 Dots ••••••••••
If the dose is more than 6 dots, divide the dose between both sides of the mouth.
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 (e.g. sound of fireworks) eliciting anxiety or fear in the dog. 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.
Administering SILEO without use of the SILEO syringe will result in incorrect dosing, which may result in lack of efficacy or overdose.
Dosing should be performed by an adult. Impermeable disposable gloves should be worn when administering SILEO and when handling the SILEO syringe.
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. A partially used syringe can be used again within 4 weeks after initial opening, if there is enough gel for a complete dose for the dog. To minimize the risk of incorrect dosing, a partially used syringe that does not have enough gel for a complete dose should not be used. Any unused product or waste material should be disposed of according to local law and Federal prescription drug disposal guidelines.
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.
WARNINGS:
Human Safety: 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.
If skin is damaged, dexmedetomidine can be absorbed into the body. In case of skin contact, wash with soap and 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.
Accidental exposure may cause sedation and changes in 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.
Animal Safety: 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, and may appear sedated. 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:
SILEO is not meant to be swallowed. Instead, it must be placed onto the mucosa between the 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 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 SILEO’s absorption. 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.
Each mL of SILEO contains 0.09 mg dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride). For oromucosal use in dogs only. Not intended for ingestion.
Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
STORAGE: Store unopened and opened syringes in the original package at controlled room temperature 20-25°C (68-77°F) with excursions permitted to 15-30°C (59-86°F). Use syringe contents within 4 weeks after opening the syringe.
Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.
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