DORMOSEDAN GEL is a registered trademark of Orion Corporation and is distributed by Pfizer Inc. ©2010 Pfizer Inc. All rights reserved. DOR0710058 iMpORtANt SAfEty iNfORMAtiON DORMOSEDAN GEL® is contraindicated in horses with known hypersensitivity to detomidine. Intravenous potentiated sulfonamides should not be used in anesthetized or sedated horses, as potentially fatal dysrhythmias may occur. Do not use DORMOSEDAN GEL in horses with pre-existing atrio-ventricular (AV) or sino-atrial (SA) blocks, cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation or stress due to extreme heat, cold, fatigue or high altitude. Appropriate precautions should be taken while handling and using gel dosing syringes, as DORMOSEDAN GEL can be absorbed following direct exposure to skin, eyes or mouth, and may cause irritation. The use of impermeable gloves is advised. Please see the full prescribing information, or go to www.DormosedanGel.com. www.DormosedanGel.com PerfEct for routine procedures on horses hERE’S hOw DORMOSEDAN GEL wORkS: DORMOSEDAN GEL cAN bE ADMiNiStERED by yOuR thAt don’t want tO hAvE anything tO do cLiENtS fOR A wiDE vARiEty Of routiNE procEDuRES. Detomidine is a potent and relatively selective α2-adrenoceptor agonist with a with routine procedures. central effect inhibiting the transmission of norepinephrine-mediated nervous Depending on the horse’s specific needs, DORMOSEDAN GEL® is impulses. In the animal, the level of consciousness is lowered. The well-characterized an effective standing sedation for use prior to stressful situations profile of detomidine at the receptor level explains its predictable, dose-dependent and minor, nonpainful husbandry procedures, including: pharmacological effects. • Shoeing • Body clipping • Bridle path trimming • Mane pulling • Sheath cleaning norepinephrine • First time turnouts for fractious horses α1-adrenoceptors It’s important to withhold food and water until the sedative α2-adrenoceptors effect of the product has worn off. When used prior to first time DORMOSEDAN GEL turnouts, horse should be supervised to prevent grazing until the Dosing REferencE Guide sedative has worn off. DORMOSEDAN GEL is administered sub- and after treatment. It is important to Approximate Dose Volume NORMAL NERvE ADMiNiStRAtiON Of DORMOSEDAN GEL has not been shown to provide lingually at 40 mcg/kg (18 mcg/lb), and also withhold food and water until the body weighT (lb) (mL) tRANSMiSSiON dormosedan GEL the dosing syringe delivers the product in sedative effects have worn off. analgesia and should not be used for painful procedures. 330 –439 1.00 Norepinephrine is released Administration of DORMOSEDAN GEL should not be used with other sedative 0.25 mL increments. The dosing syringe 440 –549 1.25 is intended for one-time use and then ONSEt AND DuRAtiON Of sedatiON and binds with alpha1 (α1) DORMOSEDAN GEL drugs, as the effects may be additive. 550 – 659 1.50 should be properly discarded. The follow- and alpha2 (α2) adrenoceptors results in a mild sedation. The duration and level of sedation are 660 –769 1.75 to send a nerve impulse or DORMOSEDAN GEL selectively ing dosing table provides the dose volume dose dependent. At the recommended 770 – 879 2.00 to be administered for the corresponding cause a muscle to contract. binds to the α2-adrenoceptors, 40 mcg/kg dose, the onset of sedation 880 – 989 2.25 causing the nerve to stop body weight in 0.25 mL increments. was observed at approximately 40 990 –1,099 2.50 releasing norepinephrine and The horse should be kept in a quiet, minutes with a duration of sedation 1,100–1,209 2.75 blocking the nerve impulse. comfortable environment before, during lasting between 90 to 180 minutes. 1,210–1,320 3.00 practitioner’s guide One hundred and twenty-nine DORMOSEDAN GEL-treated and 42 NADA #141-306, Approved by FDAFDA CONTRAINDICATIONS:CONTRAINDICATIONS: TableTable 2: 2: Adverse Adverse reactions reactions (number (number of of horses) horses) during during the the clini clini-- placebo-treated horses were included in the statistical analysis of ef- calcal field field studystudy DORMOSEDANDORMOSEDAN GELGEL isis contraindicatedcontraindicated inin horseshorses withwith knownknown hyhy-- fectiveness. Ninety-nine horses were excluded from the analysis due CLIENT INFORMATION SHEET FOR OWNER/HANDLER USE AND SAFETY persensitivitypersensitivity toto detomidine.detomidine. IntravenousIntravenous potentiatedpotentiated sulfonamidessulfonamides to failure to meet inclusion criteria or due to major protocol deviations. shouldshould notnot bebe usedused inin anesthetizedanesthetized oror sedatedsedated horseshorses asas potentiallypotentially DORMOSEDANDORMOSEDAN GEL GEL PlaceboPlacebo The veterinary or husbandry procedure was successfully completed This summary contains important information about delivered beneath the tongue (sublingually) and is not meant to fatalfatal dysrhythmiasdysrhythmias maymay occur.occur. ClinicalClinical Sign Sign NN = = 202 202 NN = = 68 68 for 98 of 129 DORMOSEDAN GEL-treated horses (76%) but only 3 of DORMOSEDAN GEL. You should read this information before be swallowed. Make sure there is no food in the horse’s mouth (detomidine(detomidine hydrochloride)hydrochloride) DoDo notnot useuse DORMOSEDANDORMOSEDAN GELGEL inin horses horses with with pre-existing pre-existing atrioven atrioven-- SweatingSweating 2020 00 42 placebo-treated horses (7%) (Table 3). The difference between the you administer DORMOSEDAN GEL to your horse. This sheet prior to administration. Alpha -agonist-agonist oromucosaloromucosal gelgel two treatments was statistically significant (p=0.0005). is provided only as a summary and does not take the place of 22 triculartricular (AV)(AV) oror sinoatrialsinoatrial (SA)(SA) blocks,blocks, respiratoryrespiratory disease,disease, oror chronicchronic PenilePenile relaxation relaxation 1212 00 The following drawing demonstrates correct administration of Rx only renalrenal failure.failure. instructions from your veterinarian. Talk to your veterinarian if For Sedation andand RestraintRestraint inin HorsesHorses OnlyOnly Table 3: Treatment success rates (number of horses) by treat- you do not understand any of this information or if you want to DORMOSEDAN GEL beneath the tongue. BradycardiaBradycardia (≤ (≤ 20 20 bpm) bpm) 1111 00 ment group WWARNINGSARNINGS:: know more about DORMOSEDAN GEL. CAUTION: SecondSecond degree degree AV AV block block 99 00 ForFor sublingualsublingual useuse inin horseshorses only.only. DoDo notnot useuse inin horseshorses intendedintended forfor Ability to perform the DORMOSEDAN GEL Placebo What is DORMOSEDAN GEL? Federal law restrictsrestricts thisthis drugdrug toto useuse byby oror onon thethe orderorder ofof aa licensedlicensed humanhuman consumption.consumption. FrequentFrequent urination urination 99 00 veterinarian. procedure score* N = 129 N = 42 DORMOSEDAN GEL is an oromucosal sedative containing HUMANHUMAN WARNINGS:WARNINGS: NotNot forfor humanhuman use.use. KeepKeep outout ofof thethe reach reach of of PiloerectionPiloerection 44 00 0 16 38 detomidine hydrochloride. It is prescribed by veterinarians to al- DESCRIPTION: children.children. UseUse impermeableimpermeable glovesgloves duringduring drugdrug administrationadministration low procedures to be done in an anxious horse. DORMOSEDAN MarkedMarked ataxia ataxia 33 00 DORMOSEDAN (detomidine (detomidine hydrochloride) hydrochloride) GEL isGEL a synthetic is a synthetic alpha - andand duringduring proceduresprocedures thatthat requirerequire contactcontact withwith thethe horse’shorse’s 1 15 1 GEL has not been shown to provide analgesia and should not be iNtroduciNG A MiLD sedatiON ALtERNAtivE yOuR cLiENtS cAN safELy ADMiNiStER thEMSELvES. 2 adrenoreceptor agonist with sedative properties. Each mL of mouth.mouth. FollowingFollowing sublingualsublingual administrationadministration ofof detomidinedetomidine oromuco oromuco-- Facial/oralFacial/oral edema edema 33 00 used for painful procedures. alpha2-adrenoreceptor agonist with sedative properties. Each mL 2 44 2 DORMOSEDANof DORMOSEDAN GEL GEL contains contains 7.6 mg7.6 detomidinemg detomidine hydrochloride. hydrochloride. The salsal gel,gel, drugdrug concentrationsconcentrations up up to to 0.072 0.072 mg/mL mg/mL were were measured measured at at 30 30 HypersalivationHypersalivation 22 00 horses are unpredictable creatures. As you know, the most routine of procedures such as grooming or shoeing can chemicalThe chemical name name is 1H is 1Himidazole, imidazole, 4-[(2,3-dimethylphenyl) 4-[(2,3-dimethylphenyl) methyl]-0 methyl]- minutesminutes postpost dosedose inin equineequine saliva,saliva, equivalentequivalent toto less less than than 1% 1% of of the the 3 54 1 How should the product be handled? hydrochloride. DetomidineDetomidine hydrochloridehydrochloride isis aa white,white, crystalline,crystalline, water-water- originaloriginal detomidinedetomidine concentrationconcentration inin thethe gel.gel. MeanMean drugdrug concentraconcentra-- NasalNasal discharge discharge 22 00 Success (score 2 or 3) 98 3 Always wear impermeable gloves when handling the dosing soluble substancesubstance havinghaving aa molecularmolecular weightweight ofof 222.7.222.7. TheThe molecularmolecular tionstions fallfall toto lessless thanthan 0.0100.010 mg/mLmg/mL byby 22 hourshours afterafter drugdrug administra administra-- syringe with detomidine hydrochloride gel. Ask the veterinar- make some horses anxious. And when an animal that large is anxious, it can be challenging