Medication: Dexmedetomidine (oromucosal gel)

Your dog has been prescribed the active ingredient dexmedetomidine to alleviate acute anxiety and fear associated with noise.

Key points:
• The dexmedetomidine is presented as a green gel for applying to the inside of the mouth.
• If the gel is swallowed it will be ineffective.
• Dexmedetomidine causes sedation in high doses.
• Gloves should be worn when handling the product.
• Dosage: according to dog’s bodyweight. Redosing can occur every 2 hours for up to a maximum of 5 doses in a 24 hour period.

This information sheet is designed to help answer commonly asked questions and help you give the medication safely and effectively to your pet. It does not contain all available information for this medication. If you have other questions or need more information, contact your veterinarian or pharmacist.

Always follow the dosing instructions provided by your veterinarian.  

Name

• Dexmedetomidine (deks-meh-deh-toe-mih-deen).

Brand name

• Sileo®.

Class of medication

• Alpha-2 adrenoreceptor agonist.

Storage

• Store the syringe at room temperature and in the accompanying carton in order to protect from light.

Your dog has been prescribed dexmedetomidine to alleviate acute anxiety and fear associated with noise such as fireworks or thunder. Typical signs of anxiety and fear are panting, trembling, pacing or seeking people, hiding, trying to escape or inappropriate urination and defecation.

The medication is given by administering the correct dose onto the mucosa of the mouth between the dog’s cheek and gum. The Sileo oral syringe is capable of delivering the product on 0.25 ml increments, with each increment shown as one dot on the plunger. Your veterinarian will tell you how many “dots” to administer via the plunger to your dog, this will be dependent on bodyweight. The drug is absorbed from the inside of the mouth. If your dog swallows the gel the medication will not work. Therefore you should avoid feeding the dog or giving treats within 15 minutes after administration of the gel. If the gel is swallowed the dog can be given another dose after a gap of least 2 hours.

Give the first dose 30 to 60 minutes prior to anticipated noise events. If unable to predict and premedicate, give the first dose as soon as your dog shows the first signs of anxiety or fear or when you first detect a noise trigger. Redosing can occur every 2 hours for up to a maximum of 5 doses in a 24-hour period.

Dexmedetomidine is also available as an injectable preparation for administration by your veterinarian.

In extremely nervous or agitated dogs the natural levels of stress hormones will be high and this may make the product less effective. Thus, the suggestion to administer the medication 30 to 60 minutes prior to anticipated fear-inducing sounds. Sedation, vomiting and gastroenteritis were the most commonly observed side effects to dogs in clinical trials. However, side effects were infrequent. There might be a lower than normal heart rate. Short-lasting paleness of the mucous membranes may also occur.

If the dog is also receiving other medicines, side-effects such as sedation might be increased.

Your dog may need to receive this medication intermittently throughout his/her life to control anxiety and fear associated with noise.

Dispose of any unused dexmedetomidine safely – don’t flush down the toilet or sink. Ask your veterinary team if they take back medication for disposal. Do not give to other pets.

Dexmedetomidine is designed to be used during noise events that have historically resulted in signs of fear and anxiety in your dog. Repeat doses may be given every 2 hours during each event up to a maximum of 5 doses. If you exceed the recommended dose please contact your veterinarian.

If the gel is swallowed the dog can be given another dose if necessary 2 hours after the previous dose.

If your pet is unwell, contact your veterinarian for advice. An antidote is available for dexmedetomidine and it may be appropriate to administer the antidote to your dog.

Dexmedetomidine should only be given to the dog that it has been prescribed for. Do not administer to:

• Dogs younger than 16 weeks of age or dogs older than 17 years
• Dogs with severe cardiovascular disorders
• Dogs with severe systemic disease that are unwell

Keep out of reach of children – if accidentally swallowed or if it comes into contact with mucous membranes, speak to your primary care physician or poison control center.

It should only be administered to dogs by an adult and gloves should be worn. Symptoms after absorption include dose dependent sedation, respiratory depression, a low heart rate, a dry mouth and heart rhythm abnormalities. Since the effects are dose dependent, they are more pronounced in children than in adults.

Monitor your dog for signs of excessive sedation. If your dog appears very sedated do not give subsequent doses during a noise event and contact your veterinarian.

Further information 

If you have any concerns, further information on dexmedetomidine can be found on the package insert and the following websites:

Europe & UK

• European Medicines Agency. Sileo® oromucosal gel. Website: www.ema.europa.eu/en/documents/product-information/sileo-epar-product-information_en.pdf
• Zoetis (UK) Sileo® (dexmedetomidine). Website: www.zoetis.co.uk/sileo/about-sileo.aspx

USA

• Zoetis (USA) Sileo® (dexmedetomidine). Website: www.zoetispetcare.com/products/sileo 

Always follow the recommended dosage and contact your veterinary team or pharmacist if you have any questions regarding your dog’s medication.