Hypertension in Cats

SILEO is packaged in HDPE dosing syringe enabling doses from 0.25 to 3 ml. The syringe is fitted with plunger, dosing ring and end cap. Each syringe is further packed into a carton with a label and a leaflet. Package sizes: (1 syringe per carton) 1 x 3 ml, 3 x 3 ml, 5 x 3 ml, 10 x 3 ml, 20 x 3 ml. Trade Name: Dexdomitor®, Sileo. Dexmedetomidine) that have a better adverse effect profile in dogs and cats. Labeled dose (FDA-approved): 1.1 mg/kg. Sileo must not be used in dogs with sev ere disorders of the heart and blood vessels, with severe disease such as kidney or liver failure or in dogs if unexpectedly sedated from a previous dose. For a full list of all restrictions and side -effects reported with Sileo, see the package leaflet. Sileo® 0.1 mg/ml oromucosal gel for dogs. Sileo® 0.1 mg/ml oromucosal gel for dogs. Zoetis UK Limited. (in dots) to be administered for the corresponding bodyweight. If the dose for the dog is more than 6 dots (1.5 ml), half of the dose should be administered to the oral mucosa on one side of the dog’s mouth and the other. If cats have pale mucous membranes and unacceptably slow pulses (less than 80 bpm) or hypotension - stimulate them by handling and if this does not resolve the problem administer 10 to 20% of the calculated atipamazole dose IM. If you feel that the cat is in crisis, the full atipamazole dose can be given IV slowly by titration over 2.

A silent disease

While hypertension can be a common problem in older cats, the condition can be difficult to diagnose.^3,4

Hypertension can affect many parts of the body before detection and is strongly associated with target organ damage^3,4:

• Eyes
• Heart and vascular system
• Brain
• Kidneys

Without treatment, this silent disease can lead to serious illness and, sometimes, death.^3,4

Most often develops as secondary hypertension to diseases such as CKD and hyperthyroidism.³

Efficacy

Proven to lower systolic blood pressure^1,10

A pilot dose determination laboratory study was conducted to evaluate the effectiveness of multiple oral doses and dose strategies of telmisartan on the reduction of systolic blood pressure (SBP) in clinically normal, healthy laboratory cats within a 14-day time period.¹¹

* Endpoint at day 14 was significant reduction from baseline compared to placebo (P < 0.0005).

† A clinically relevant reduction in group mean SBP was predefined to be ≥ 20 mmHg in the telmisartan group from baseline to Day 28. The number of cats available at Day 28 for comparison is less than at enrollment because of removal of cats for hypertension rescue or adverse reactions.

The only angiotensin receptor blocker (ARB) for first-line treatment of hypertension in cats

Because ARBs feature a unique, targeted mode of action that specifically blocks the harmful vasoconstrictive effects of the renin-angiotensin-aldosterone system (RAAS), SEMINTRA is shown to quickly lower blood pressure within 14 days‡

• Shown to be effective in cats with primary and secondary hypertension
• Proven to be safe and effective^10–13

Safety and Dosing

Flexible dosing to safely lower and maintain blood pressure in cats

• SEMINTRA offers a dose-dependent response—an initial 1.5 mg/kg (0.68 mg/lb) dose twice daily for 14 days lowers blood pressure to a healthy level quickly, followed by a 2 mg/kg (0.91 mg/lb) once daily dose to maintain control¹¹
• Dose may be reduced by 0.5 mg/kg (0.23 mg/lb) increments to a minimum of 0.5 mg/kg to optimize dosing and prevent hypotensive state

Easily given as oral liquid

Easy-to-use Syringe

— Flexible delivery of dose straight into the mouth or on top of food²

— Selection of accurate dose

Safe for long-term administration

— Safety shown to extend through 6 months in multiple studies^10–13

Convenient liquid formulation

As demonstrated in a study:

— 91.2% of cat owners perfer a liquid formulation²

Mode of Action

SEMINTRA is a highly targeted treatment

Telmisartan, the active substance in SEMINTRA, is an ARB, a class of medication that modulates the RAAS by selectively blocking receptors in the effector step of the RAAS. Unlike angiotensin-converting enzyme inhibitors (ACEis), ARBs do not block the conversion of angiotensin I to angiotensin II by angiotensin-converting enzyme in the RAAS cascade, thereby also blocking the activation of some of the receptor types with beneficial effects. And, unlike a calcium channel blocker, a class of pharmaceuticals that block the influx of calcium into cardiac and smooth muscle cells through calcium channels and potentially activate the RAAS, ARBs help to manage the RAAS.

Chronic activation of the RAAS can be harmful to tissues, including the kidney.

Watch this video for more information

• Activation of RAAS can be complex, but conditions like chronic kidney disease, cardiac disease, and hyperthyroidism typically increase RAAS activity
• Chronic, excessive RAAS activation can result in systemic hypertension because it promotes salt and water retention and increases blood pressure^14,15
• ACEis reduce the conversion of circulating angiotensin I to angiotensin II, which reduces all of the effects of angiotensin II at all receptors
• ARBs have a more targeted mode of action. They bind only to the AT₁ receptor, preventing activation of this receptor by angiotensin II
• Because ARBs do not bind to AT₂ receptors, the potentially beneficial effects of angiotensin II at these receptors are preserved

Watch this video for more information

Target-specific mode of action of ARBs

IMPORTANT SAFETY INFORMATION

• SEMINTRA is for oral use in cats only.
• The most common side effects reported in field studies include vomiting, diarrhea, lethargy, dehydration, poor appetite, and weight loss. If side effects should occur, pet owners should contact their veterinarian. Click here for full prescribing information.
• SEMINTRA has not been evaluated in cats with systolic blood pressure > 200 mmHg. The safe use of SEMINTRA has not been evaluated in cats with hepatic disease, cats less than 9 months of age, or cats that are pregnant, lactating, or intended for breeding.
• The safe use of SEMINTRA with other anti-hypertensive medications has not been evaluated.
• Mild anemia or non-regenerative anemia has been reported.
• Pregnant women should avoid contact with SEMINTRA because substances that act on the renin-angiotensin-aldosterone system (RAAS), such as angiotensin receptor blockers (ARBs), can cause fetal and neonatal morbidity and death during pregnancy in humans.
• Not for human use. Keep out of reach of children. If SEMINTRA is accidentally ingested, contact a physician.
• SEMINTRA is a clear, colorless to yellowish viscous solution containing 10 mg/mL telmisartan.

References:1. SEMINTRA^® (telmisartan oral solution) Prescribing Information. Boehringer Ingelheim Vetmedica, Inc. 2018. 2. Zimmering T. Ease of use of SEMINTRA and its effects on quality of life—update on cat owner feedback (“EASY Programme”) [abstract]. In: Proceedings from the 21st Federation of European Companion Animal Veterinary Associations (FECAVA); October 15–17, 2015; Barcelona, Spain. Poster. 3. Elliott J, Fletcher M, Syme HM. Idiopathic feline hypertension: epidemiologic study [abstract]. J Vet Intern Med. 2003;17:754. 4. Taylor SS, Sparkes AH, Briscoe K, et al. ISFM Consensus Guidelines on the diagnosis and management of hypertension in cats. J Feline Med Surg. 2017;19(3):288–303. 5. Maggio F, DeFrancesco TC, Atkins CE, et al. Ocular lesions associated with systemic hypertension in cats: 69 cases (1985–1998). J Am Vet Med Assoc. 2000;217:695–702. 6. Littman MP. Spontaneous systemic hypertension in 24 cats. J Vet Intern Med. 1994;8:79–86. 7. Stiles J, Polzin D, Bistner SI. The prevalence of retinopathy in cats with systemic hypertensionand chronic renal failure or hyperthyroidism. J Am Anim Hosp Assoc. 1994;30:564–572. 8. Syme HM, Barber PJ, Markwell PJ, et al. Prevalence of systolic hypertension in cats with chronic renal failure at initial evaluation. J Am Vet Med Assoc. 2002;220:1799–1804. 9. Kobayashi DL, Peterson ME, Graves TK, et al. Hypertension in cats with chronic renal failure orhyperthyroidism. J Vet Intern Med. 1990;4:58–62. 10. Coleman AE. Efficacy of oral telmisartan for the treatment of systemic hypertension in cats. In: Proceedings from the American College of Veterinary Internal Medicine; June 14–16, 2018; Seattle, WA. Abstract RRS08-E. 11. Coleman AE, Brown SA, Stark M. Evaluation of orally administered telmisartan for the reduction of indirect systolic arterial blood pressure in awake, clinically normal cats [published online ahead of print March 7, 2018]. 12. Glaus AM, Elliott J, Albrecht B, et al. Efficacy of telmisartan in hypertensive cats: results of a large European clinical trial [abstract]. J Vet Intern Med. 2018;32:577. 13. SEMINTRA^® (telmisartan oral solution) [Freedom of Information Summary]. St. Joseph, MO: Boehringer Ingelheim Vetmedica, Inc.; 2018. J Feline Med Surg. doi:10.1177/1098612X18761439. 14. Williams TL, Elliott J, Syme HM. Renin-angiotensin-aldosterone system activity in hyperthyroid cats with and without concurrent hypertension. J Vet Intern Med. 2013;27(3):522–529. 15. Syme H. Hypertension in small animal kidney disease. Vet Clin North Am Small Anim Pract. 2011;41(1):63–89.

SILEO- dexmedetomidine gel
Zoetis Inc.

NADA 141-456, Approved by FDA

Sileo

(dexmedetomidine oromucosal gel)

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.

CAUTION

Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian

DESCRIPTION

SILEO (dexmedetomidine oromucosal gel) is a synthetic alpha-2 adrenoceptor agonist. Each ml of SILEO contains 0.09 mg dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride). The chemical name is (+)-4-[1-(2,3-dimethylphenyl) ethyl]-1H-imidazole monohydrochloride. It is a white, or almost white, crystalline, water soluble substance having a molecular weight of 236.7. The molecular formula is C13 H16 N2 HCl and the structural formula is:

Structure

INDICATIONS

SILEO is indicated for the treatment of noise aversion in dogs.

DOSAGE AND ADMINISTRATION

Always provide the Client Information Sheet with SILEO and instruct the client how to properly operate the SILEO dosing syringe (see Client Information Sheet for Owner/Handler Use and Safety).
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 at the dose of 125 mcg/m2. 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 table 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.

Table 1. Dosage by body weight

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 2 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

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.

Sileo Dose In Cats Symptoms

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.

Sileo For Cats

The safety data sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for this product call 1-888-963-8471.

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.

ADVERSE REACTIONS

In a well-controlled European field study, which included a total of 182 dogs ranging from 2 to 17 years of age and representing both mixed and pure breed dogs (89 treated with dexmedetomidine oromucosal gel and 93 treated with control), no serious adverse reactions were attributed to administration of dexmedetomidine oromucosal gel.

Table 2 shows the number of dogs displaying adverse reactions (some dogs experienced more than one adverse reaction).

Table 2. Adverse Reactions — Number (%) of dogs

Pale mucous membranes were frequently seen in dogs treated with dexmedetomidine oromucosal gel. In most cases, the effect was transient and no adverse reactions due to mucosal irritation were reported.

In a second well-controlled European field study which included a total of 36 dogs ranging from 2 to 17 years of age and representing both mixed and pure breed dogs (12 treated with dexmedetomidine oromucosal gel at 125 mcg/m2, 12 treated with dexmedetomidine oromucosal gel at 250 mcg/m2, and 12 treated with a vehicle control), no serious adverse reactions were attributed to administration of dexmedetomidine oromucosal gel.Table 3 shows the number of dogs displaying adverse reactions (some dogs experienced more than one adverse reaction).

Table 3. Adverse Reactions — Number (%) of dogs

To report suspected adverse events, for technical assistance or to obtain a copy of the SDS call 1-888-963-8471.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth

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