PF2912 Dormosedan flyer v4 11/29/06 3:30 PM Page 1

Effective Standing Sedation and Analgesia

Dormosedan® (detomidine hydrochloride) from Pfizer Animal Health – Provide the best for your patients and your clients

today’s equine veterinary practices, standing sedation is a critical Dr. Henry has used Dormosedan as a tool to help expedite dental proce- part of many key procedures done on-farm and in the referral clinic. dures – an area he has found to be of great benefit to the health of his When choosing between the molecules available, veterinarians clients’ horses and to his entire practice. In must consider safety, cost effectiveness for the client and the “Dentistry is a scheduled visit that can be made in advance,” said Dr. practice, and – above all – the ultimate efficacy of the product in achieving Henry. “It can contribute to the bottom line of the practice due to the fact an appropriate level of sedation for the needed procedure. that all of the horses in the practice should have dental care once a year. Not to mention that dentistry can be scheduled when the veterinarian has Sedation and Analgesia more time to devote to the procedure – such as fall or winter.” In charging clients for the sedation and analgesia portion of their hors- Sedation may be the practitioners’ first consideration in standing proce- es’ dentistry needs, Dr. Henry finds that charging for “dental sedation” dures such as dental care, suturing wounds and castrations, but choosing helps to get clients thinking about the fact that this type of sedation is a molecule that provides a proven level of analgesia offers a more humane different than that given for shorter procedures, such as joint injections. option for clients and their horses. It therefore carries a slightly higher price tag in comparison with those pro- While sedation works to depress the horse’s brain, a molecule with an cedures. analgesic effect will also help to deaden pain for the animal – allowing for less reliance on the twitch and fewer reactions during a painful procedure. True Value Not only do these benefits mean a less traumatic experience for the horse, they also help to decrease the chance of injury to the owner or veterinari- Charging clients for the use of Dormosedan in any procedure is slightly an during the procedure. different than the flat rate for sedation traditionally utilized by veterinarians. Dormosedan® (detomidine hydrochloride) is a synthetic alpha-2 Bimbo Welker, DVM, MS, has developed a simple formula that allows him to adrenoreceptor agonist with sedative and significant analgesic properties, arrive at a price for Dormosedan use. Dr. Welker multiplies the dose by his which is dose dependent in its depth and duration. This product provides cost for that amount and adds the percent markup and a $20 injection fee. veterinarians with the benefits of analgesia at a much higher level than that So, for a typical 1.2 ml dose the cost to the client would be $38.60. offered by molecules such as xylazine hydrochloride or romifidine “I started using Dormosedan by itself, at full label dose, in March of 2003 hydrochloride1, 2. … I’ve been ecstatic about its results,” said Welker. “I’m a real convert. The value of an analgesic effect added to sedation can be clearly seen With this one drug we get great analgesia and profound sedation in dura- in equine dental practice; particularly during extensive dental procedures and tion. It has an extensive dosage range so that the veterinarian can achieve standing surgeries. the exact level of sedation they need. You don’t need to worry about combi- “I think that Dormosedan gives us, as practitioners, the repeatable nations with this drug; and as it is a single drug, if you don’t get the effects results that we need,” said Travis Henry, DVM, of Midwest Equine Services. you need you can simply give more.” “It also provides good analgesic properties when used at the 1.2 ml intra- Welker’s confidence in Dormosedan comes from his participation in an venous dose for an average sized [1,000 – 1,200 lb.] and temperament horse. ongoing study during which he has administered the drug to over 1,400 I have been using Dormosedan for 13 years and began using it for standing horses. The level of safety he has seen for both horses and veterinarians castrations in the early 90s. The benefit I feel that Dormosedan gives in den- has been particularly exciting. tal procedures is enough analgesia for the average procedure on the major- “I haven’t seen any toxicity or adverse reactions on any dose level I’ve ity of cases so that I only need to use one drug. Any time I can get it done used – even on extremely high doses I’ve administered during wet labs. The with the least amount or number of drugs, I feel that we are being safer for only result of the high dose was that the sedation lasted a long time. I’m not the horse’s sake.” an advocate of giving high doses necessarily, but with Dormosedan you can use the higher dose if you need it.” Dental Practice Dormosedan has been available in the U.S. for over 16 years, according to John Donecker, VMD, MS, diplomate ABVP (equine), FAAVPT and Senior In recent years Dr. Henry has used Dormosedan as a critical element in his Veterinarian at Pfizer Animal Health. “It offers the benefits of significant dental procedures – now one of his biggest practice interests. While the analgesia, a huge safety margin and hypertension in the face of significant bulk of his dental practice consists of maintenance on performance horses, sedation.” approximately 30% of his cases are more extensive and need prolonged Dr. Donecker reports that the full label dosage for Dormosedan – critical sedation. for achieving optimum levels of sedation and analgesia – is 20 to 40 micro- “I typically give 1.2 mls or 12 mgs of Dormosedan to the average 1,000 – grams per kilogram of body weight; or 1 to 2 ml IV or IM to a 1,100 lb. horse. 1,200 pound horse for the initial dose,” he said. “This is after I have done a At this rate of dosage the product produces a non-narcotic, reliable, physical exam on the horse and decided what the personality of the horse dose-dependent sedation and analgesia, with flexible dosing that allows is going to be like.” the veterinarian to regulate the depth and length of sedation. “Detomidine hydrochloride is not a controlled substance like butor- phanol tartrate used in combination with other molecules,” said Dr. Donecker. “By using Dormosedan as a simple, one-sedative variable the veterinarian has more control over the level of sedation and analgesia. In addition, more accurate dosing can be achieved, decreasing the need for “topping up” with second doses during the procedure. Given Dormosedan’s proven safety record and wide therapeutic safety margin, veterinarians can use this option with a great deal of confidence.” As with all alpha-2 agonists, occasional reports of anaphylactic-like reactions have been received. The use of epinephrine should be avoided since epinephrine may potentiate the effects of alpha-2 agonists. Do not use in horses intended for human consumption. PF2912 Dormosedan flyer v4 11/29/06 3:30 PM Page 2

For more information, please see the brief summary included References with this article. For the full Dormosedan prescribing information, 1. Hamm, D., Turchi, P., Joechle, W. Sedative and analgesic effects of deto- please visit www.pfizer.com/equine. midine and romifidine in horses. Veterinary Record (1995) 136, 324 -327. 2. Moens, Y., Lanz, F., Doherr, MG., Schatzmann, U. A comparison of the antinociceptive effects of xylazine, detomidine and romifidine on exper- imental pain in horses. Vet Anesth Analg (2003) Jul; 30(3); 183 – 190.

Pfizer Animal Health

DORMOSEDAN® (detomidine hydrochloride) Sterile Solution

physiological effects, routine precautions should be employed by practitioners when handling and using loaded syringes to prevent accidental self-injection. PRECAUTIONS: Before administration, careful consideration should be given to administering Dormosedan® to horses approaching or in endotoxic or traumatic shock, to horses with advanced liver or kidney disease, or to horses under stress from extreme heat, cold, fatigue, or high altitude. Protect Sedative and Analgesic For Use in Horses Only treated horses from temperature extremes. Some horses, although apparently deeply sedated, may still Sterile Solution respond to external stimuli. Routine safety measures should be employed to protect practitioners and 10 mg/mL handlers. Allowing the horse to stand quietly for 5 minutes before administration and for 10–15 minutes after injection may improve the response to Dormosedan®. ® CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dormosedan is a potent α2-agonist, and extreme caution should be exercised in its use with other DESCRIPTION: Dormosedan® is a synthetic alpha-2 adrenoreceptor agonist with sedative and analgesic sedative or analgesic drugs for they may produce additive effects. properties. The chemical name is 1H imidazole, 4-[(2,3-dimethylphenyl) methyl]-hydrochloride and the When using any analgesic to help alleviate abdominal pain, a complete physical examination and generic name is detomidine hydrochloride. It is a white, crystalline, water-soluble substance having a diagnostic work-up are necessary to determine the etiology of the pain. molecular weight of 222.7. The molecular formula is C12H14N2•HCl. Food and water should be withheld until the sedative effect of Dormosedan® has worn off. CHEMICAL STRUCTURE: ADVERSE REACTIONS: Occasional reports of anaphylactic-like reactions have been received, including 1 or more of the following: urticaria, skin plaques, dyspnea, edema of the upper airways, trembling, recumbency, and death. The use of epinephrine should be avoided since epinephrine may potentiate the effects of α2-agonists. Reports of mild adverse reactions have resolved uneventfully without treatment. Severe adverse reactions should be treated symptomatically. As with all α2-agonists, the potential for isolated cases of hypersensitivity exist,including paradoxical response (excitation). SIDE EFFECTS: Horses treated with Dormosedan® exhibit hypertension. Bradycardia routinely occurs 1 minute after injection. The relationship between hypertension and bradycardia is consistent with an

® adaptive baroreceptor response to the increased pressure and inconsistent with a primary drug-induced Each mL of Dormosedan contains 10.0 mg detomidine hydrochloride, 1.0 mg methyl paraben, 5.9 mg bradycardia. Piloerection, sweating, salivation, and slight muscle tremors are frequently seen after sodium chloride, and water for injection, q.s. administration. Partial transient penis prolapse may be seen.Partial AV and SA blocks may occur with ® CLINICAL PHARMACOLOGY: Dormosedan , a non-narcotic sedative and analgesic, is a potent α2- decreased heart and respiratory rates. Urination typically occurs during recovery at about 45–60 minutes adrenoreceptor agonist which produces sedation and superficial and visceral analgesia which is dose posttreatment, depending on dosage. Incoordination or staggering is usually seen only during the first dependent in its depth and duration. Profound lethargy and a characteristic lowering of the head with 3–5 minutes after injection,until animals have secured a firm footing. reduced sensitivity to environmental stimuli (sounds, etc.) are seen with detomidine. A short period of Because of continued lowering of the head during sedation, mucus discharges from the nose and, incoordination is characteristically followed by immobility and a firm stance with front legs well spread. occasionally, edema of the head and face may be seen. Holding the head in a slightly elevated position The analgesic effect is most readily seen as an increase in the pain threshold at the body surface. generally prevents these effects. Sensitivity to touch is little affected and in some cases may actually be enhanced. OVERDOSAGE: Detomidine hydrochloride is tolerated in horses at up to 200 mcg/kg of bodyweight (10 With detomidine administration, heart rate is markedly decreased, blood pressure is initially elevated, times the low dosage and 5 times the high dosage). In safety studies in horses,detomidine hydrochloride and then a steady decline to normal is seen. A transient change in the conductivity of the cardiac muscle at 400 mcg/kg of body weight administered daily for 3 consecutive days produced microscopic foci of may occur, as evidenced by partial atrioventricular (AV) and sinoauricular (SA) blocks. This change in the myocardial necrosis in 1 of 8 horses. conductivity of the cardiac muscle may be prevented by IV administration of atropine at 0.02 mg/kg of body weight. DOSAGE AND ADMINISTRATION: ® No effect on blood clotting time or other hematological parameters was encountered at dosages of 20 or For Sedation: Administer Dormosedan IV or IM at the rates of 20 or 40 mcg detomidine hydrochloride ® 40 mcg/kg of body weight. Respiratory responses include an initial slowing of respiration within a few per kg of body weight (0.2 or 0.4 mL of Dormosedan per 100 kg or 220 lb), depending on the depth and seconds to 1–2 minutes after administration, increasing to normal within 5 minutes. An initial decrease in duration of sedation required. Onset of sedative effects should be reached within 2–4 minutes after IV tidal volume is followed by an increase. administration and 3–5 minutes after IM administration.Twenty mcg/kg will provide 30–90 minutes of sedation and 40 mcg/kg will provide approximately 90 minutes to 2 hours of sedation. INDICATIONS: Dormosedan® is indicated for use as a sedative and analgesic to facilitate minor ® surgical and diagnostic procedures in mature horses and yearlings. It has been used successfully for For Analgesia: Administer Dormosedan IV at the rates of 20 or 40 mcg detomidine hydrochloride per kg ® the following: to calm fractious horses, to provide relief from abdominal pain, to facilitate bronchoscopy, of body weight (0.2 or 0.4 mL of Dormosedan per 100 kg or 220 lb), depending on the depth and duration bronchoalveolar lavage, nasogastric intubation, non reproductive rectal palpations, suturing of skin of analgesia required. Twenty mcg/kg will usually begin to take effect in 2–4 minutes and provide 30–45 lacerations, and castrations. Additionally, an approved, local infiltration anesthetic is indicated for minutes of analgesia. The 40 mcg/kg dose will also begin to take effect in 2–4 minutes and provide 45–75 castration. minutes of analgesia. ® CONTRAINDICATIONS: Dormosedan® should not be used in horses with pre-existing AV or SA block, For Both Sedation and Analgesia: Administer Dormosedan IV at the rates of 20 or 40 mcg ® with severe coronary insufficiency, cerebrovascular disease, respiratory disease, or chronic renal failure. detomidine hydrochloride per kg of body weight (0.2 or 0.4 mL of Dormosedan per 100 kg or 220 lb), Intravenous potentiated sulfonamides should not be used in anesthetized or sedated horses as potentially depending on the depth and duration of sedation and analgesia required. fatal dysrhythmias may occur. Before and after injection, the animal should be allowed to rest quietly. Information on the possible effects of detomidine hydrochloride in breeding horses is limited to uncontrolled STORAGE: Store at controlled room temperature 15°–30°C (59°–86°F) in the absence of light. clinical reports; therefore, this drug is not recommended for use in breeding animals. HOW SUPPLIED: Dormosedan® is supplied in 5- and 20-mL multidose vials. WARNINGS: Not for use in horses intended for food. Not for human use. Keep out of U.S. Patent Nos. 4,443,466 and 4,584,383 reach of children. NADA #140-862, Approved by FDA HUMAN SAFETY INFORMATION: Care should be taken to assure that detomidine hydrochloride is not Distributed by: inadvertently ingested as safety studies have indicated that the drug is well absorbed when administered Manufactured by: orally. Standard ocular irritation tests in rabbits using the proposed market formulation have shown deto- midine hydrochloride to be nonirritating to eyes. Primary dermal irritation tests in guinea pigs using up to Exton, PA 19341, USA 5 times the proposed market concentration of detomidine hydrochloride on intact and abraded skin have Div. of Pfizer Inc demonstrated that the drug is nonirritating to skin and is apparently poorly absorbed dermally. However, NY, NY 10017 in accordance with prudent clinical procedures, exposure of eyes or skin should be avoided and affected areas should be washed immediately if exposure does occur. As with all injectable drugs causing profound 75-6290-09 107224US-8 January 2004 Made in Finland Jaakkoo-Taara Oy

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