Product
Sileo® Oromucosal Gel
Product Information
Sileo® Oromucosal Gel is indicated for the treatment of canine noise aversion (e.g. fireworks, thunder, celebrations, construction, traffic).
For
Dogs (at least 16 weeks old)
Generic Name
Dexmedetomidine
Brand Names
Sileo®
Drug Class
Alpha-2-Adrenergic Agonist, Sedative
Manufacturer
Zoetis
Product Description & Form
Sileo® Oromucosal Gel 0.1 mg/ml 3 ml Syringe: turquoise (green-blue) gel. (NDC 54771-1050-01)
Benefits
- New packaging with improved syringe design that requires the administrator to twist the dosing ring along a threaded plunger, it will no longer move FREELY along the plunger and WILL NOT require a separate locking step once the dose has been selected
- Dosed based on weight and administered via a dosing syringe that uses a dot system for accurate dosing
- Easy to administer gel is placed onto the oral mucosa between the dog’s cheek & gum
- Used for 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
- Calming without sedating, allowing for normal dog-owner interactions
- Quick onset of action
Active Ingredients
Dexmedetomidine
Usage
Sileo® should be administered as directed by your veterinarian. See Client Information Sheet inside the package for full administration guidelines and safety.
To prevent accidental overdose, it is important to make sure that the ring-stop on the dosing syringe is threaded appropriately to the correct dose. See Client Information Sheet for full instructions.
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.
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).
If the dose is more than 6 dots, divide the dose between both sides of the 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. Use syringe contents within 2 weeks after opening the syringe.
Missed Doses
DO NOT give more medication than directed or give more often than directed. Give the dose as soon as possible. If it is almost time for the next dose, skip the missed dose, and continue with the regular schedule. Do not give 2 doses at once.
Side Effects
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.
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.
Drug & Food Interactions
The following drugs can potentially interact with dexmedetomidine: enalapril, benazepril. acepromazine, amlodipine, atenolol, sotalol, tramadol, sildenafil, and anesthetics. Contact your veterinarian if your pet experiences any unusual reactions when different medications are given together.
Make sure to tell your veterinarian what other medication or supplements you are giving to your pet. Quite often your veterinarian may prescribe two different medications, even if a drug interaction may occur. In this case, your veterinarian may vary the dose and/or monitor your pet more closely. Contact your veterinarian if your pet experiences any unusual reactions when different medications are given together.
Cautions
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.
Administering Sileo® without use of the Sileo® syringe will result in incorrect dosing, which may result in lack of efficacy or overdose.
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 use of other central nervous system depressants is expected to increase the effects of Sileo® and an appropriate dose adjustment should be made.
Adverse Reactions
If you are concerned that your pet has experienced an adverse reaction to this medication, please contact the manufacturer Zoetis at 888-963-8471 or Vetsource customer service at 877-738-4443.
Storage
Store at 68°F to 77°F in controlled room temperature, excursions permitted between 59°F to 86°F. Store in original carton to protect from light. Keep this medicine out of reach of children. Store in a childproof container. Store this medicine in a cool, dry place at room temperature. Store away from heat and direct sunlight. Do not store this medicine in the bathroom, near the kitchen sink or in damp places. The medicine may break down if exposed to heat or moisture.
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