Effective Standing Sedation and Analgesia...Dormosedan® (detomidine hydrochloride) is a synthetic...
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In today’s equine veterinary practices, standing sedation is a critical part of many key procedures done on-farm and in the referral clinic. When choosing between the molecules available, veterinarians must consider safety, cost effectiveness for the client and the practice, and – above all – the ultimate efficacy of the product in achieving an appropriate level of sedation for the needed procedure. Sedation and Analgesia Sedation may be the practitioners’ first consideration in standing proce- dures such as dental care, suturing wounds and castrations, but choosing a molecule that provides a proven level of analgesia offers a more humane option for clients and their horses. While sedation works to depress the horse’s brain, a molecule with an 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. 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- an during the procedure. Dormosedan ® (detomidine hydrochloride) is a synthetic alpha-2 adrenoreceptor agonist with sedative and significant analgesic properties, which is dose dependent in its depth and duration. This product provides veterinarians with the benefits of analgesia at a much higher level than that offered by molecules such as xylazine hydrochloride or romifidine hydrochloride 1, 2 . The value of an analgesic effect added to sedation can be clearly seen in equine dental practice; particularly during extensive dental procedures and standing surgeries. “I think that Dormosedan gives us, as practitioners, the repeatable results that we need,” said Travis Henry, DVM, of Midwest Equine Services. “It also provides good analgesic properties when used at the 1.2 ml intra- venous dose for an average sized [1,000 – 1,200 lb.] and temperament horse. I have been using Dormosedan for 13 years and began using it for standing castrations in the early 90s. The benefit I feel that Dormosedan gives in den- tal procedures is enough analgesia for the average procedure on the major- ity of cases so that I only need to use one drug. Any time I can get it done with the least amount or number of drugs, I feel that we are being safer for the horse’s sake.” Dental Practice In recent years Dr. Henry has used Dormosedan as a critical element in his dental procedures – now one of his biggest practice interests. While the bulk of his dental practice consists of maintenance on performance horses, approximately 30% of his cases are more extensive and need prolonged sedation. “I typically give 1.2 mls or 12 mgs of Dormosedan to the average 1,000 – 1,200 pound horse for the initial dose,” he said. “This is after I have done a physical exam on the horse and decided what the personality of the horse is going to be like.” Dr. Henry has used Dormosedan as a tool to help expedite dental proce- dures – an area he has found to be of great benefit to the health of his clients’ horses and to his entire practice. “Dentistry is a scheduled visit that can be made in advance,” said Dr. Henry. “It can contribute to the bottom line of the practice due to the fact 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 more time to devote to the procedure – such as fall or winter.” In charging clients for the sedation and analgesia portion of their hors- es’ dentistry needs, Dr. Henry finds that charging for “dental sedation” helps to get clients thinking about the fact that this type of sedation is different than that given for shorter procedures, such as joint injections. It therefore carries a slightly higher price tag in comparison with those pro- cedures. True Value Charging clients for the use of Dormosedan in any procedure is slightly different than the flat rate for sedation traditionally utilized by veterinarians. Bimbo Welker, DVM, MS, has developed a simple formula that allows him to arrive at a price for Dormosedan use. Dr. Welker multiplies the dose by his cost for that amount and adds the percent markup and a $20 injection fee. So, for a typical 1.2 ml dose the cost to the client would be $38.60. “I started using Dormosedan by itself, at full label dose, in March of 2003 … I’ve been ecstatic about its results,” said Welker. “I’m a real convert. With this one drug we get great analgesia and profound sedation in dura- tion. It has an extensive dosage range so that the veterinarian can achieve the exact level of sedation they need. You don’t need to worry about combi- nations with this drug; and as it is a single drug, if you don’t get the effects you need you can simply give more.” Welker’s confidence in Dormosedan comes from his participation in an ongoing study during which he has administered the drug to over 1,400 horses. The level of safety he has seen for both horses and veterinarians has been particularly exciting. “I haven’t seen any toxicity or adverse reactions on any dose level I’ve used – even on extremely high doses I’ve administered during wet labs. The only result of the high dose was that the sedation lasted a long time. I’m not an advocate of giving high doses necessarily, but with Dormosedan you can use the higher dose if you need it.” Dormosedan has been available in the U.S. for over 16 years, according to John Donecker, VMD, MS, diplomate ABVP (equine), FAAVPT and Senior Veterinarian at Pfizer Animal Health. “It offers the benefits of significant analgesia, a huge safety margin and hypertension in the face of significant sedation.” Dr. Donecker reports that the full label dosage for Dormosedan – critical for achieving optimum levels of sedation and analgesia – is 20 to 40 micro- grams per kilogram of body weight; or 1 to 2 ml IV or IM to a 1,100 lb. horse. At this rate of dosage the product produces a non-narcotic, reliable, dose-dependent sedation and analgesia, with flexible dosing that allows 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. Effective Standing Sedation and Analgesia Dormosedan ® (detomidine hydrochloride) from Pfizer Animal Health – Provide the best for your patients and your clients PF2912 Dormosedan flyer v4 11/29/06 3:30 PM Page 1
Transcript of Effective Standing Sedation and Analgesia...Dormosedan® (detomidine hydrochloride) is a synthetic...
Intoday’s equine veterinary practices, standing sedation is a criticalpart of many key procedures done on-farm and in the referral clinic.When choosing between the molecules available, veterinariansmust consider safety, cost effectiveness for the client and the
practice, and – above all – the ultimate efficacy of the product in achievingan appropriate level of sedation for the needed procedure.
Sedation and Analgesia
Sedation may be the practitioners’ first consideration in standing proce-dures such as dental care, suturing wounds and castrations, but choosinga molecule that provides a proven level of analgesia offers a more humaneoption for clients and their horses.
While sedation works to depress the horse’s brain, a molecule with ananalgesic effect will also help to deaden pain for the animal – allowing forless reliance on the twitch and fewer reactions during a painful procedure.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-an during the procedure.
Dormosedan® (detomidine hydrochloride) is a synthetic alpha-2adrenoreceptor agonist with sedative and significant analgesic properties,which is dose dependent in its depth and duration. This product providesveterinarians with the benefits of analgesia at a much higher level than thatoffered by molecules such as xylazine hydrochloride or romifidinehydrochloride1, 2.
The value of an analgesic effect added to sedation can be clearly seenin equine dental practice; particularly during extensive dental procedures andstanding surgeries.
“I think that Dormosedan gives us, as practitioners, the repeatableresults that we need,” said Travis Henry, DVM, of Midwest Equine Services.“It also provides good analgesic properties when used at the 1.2 ml intra-venous dose for an average sized [1,000 – 1,200 lb.] and temperament horse.I have been using Dormosedan for 13 years and began using it for standingcastrations in the early 90s. The benefit I feel that Dormosedan gives in den-tal procedures is enough analgesia for the average procedure on the major-ity of cases so that I only need to use one drug. Any time I can get it donewith the least amount or number of drugs, I feel that we are being safer forthe horse’s sake.”
Dental Practice
In recent years Dr. Henry has used Dormosedan as a critical element in hisdental procedures – now one of his biggest practice interests. While thebulk of his dental practice consists of maintenance on performance horses,approximately 30% of his cases are more extensive and need prolongedsedation.
“I typically give 1.2 mls or 12 mgs of Dormosedan to the average 1,000 –1,200 pound horse for the initial dose,” he said. “This is after I have done aphysical exam on the horse and decided what the personality of the horseis going to be like.”
Dr. Henry has used Dormosedan as a tool to help expedite dental proce-dures – an area he has found to be of great benefit to the health of hisclients’ horses and to his entire practice.
“Dentistry is a scheduled visit that can be made in advance,” said Dr.Henry. “It can contribute to the bottom line of the practice due to the factthat 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 hasmore time to devote to the procedure – such as fall or winter.”
In charging clients for the sedation and analgesia portion of their hors-es’ dentistry needs, Dr. Henry finds that charging for “dental sedation”helps to get clients thinking about the fact that this type of sedation is different than that given for shorter procedures, such as joint injections. It therefore carries a slightly higher price tag in comparison with those pro-cedures.
True Value
Charging clients for the use of Dormosedan in any procedure is slightly different than the flat rate for sedation traditionally utilized by veterinarians.Bimbo Welker, DVM, MS, has developed a simple formula that allows him toarrive at a price for Dormosedan use. Dr. Welker multiplies the dose by hiscost for that amount and adds the percent markup and a $20 injection fee.So, for a typical 1.2 ml dose the cost to the client would be $38.60.
“I started using Dormosedan by itself, at full label dose, in March of 2003… I’ve been ecstatic about its results,” said Welker. “I’m a real convert.With this one drug we get great analgesia and profound sedation in dura-tion. It has an extensive dosage range so that the veterinarian can achievethe exact level of sedation they need. You don’t need to worry about combi-nations with this drug; and as it is a single drug, if you don’t get the effectsyou need you can simply give more.”
Welker’s confidence in Dormosedan comes from his participation in anongoing study during which he has administered the drug to over 1,400horses. The level of safety he has seen for both horses and veterinarianshas been particularly exciting.
“I haven’t seen any toxicity or adverse reactions on any dose level I’veused – even on extremely high doses I’ve administered during wet labs. Theonly result of the high dose was that the sedation lasted a long time. I’m notan advocate of giving high doses necessarily, but with Dormosedan you canuse the higher dose if you need it.”
Dormosedan has been available in the U.S. for over 16 years, accordingto John Donecker, VMD, MS, diplomate ABVP (equine), FAAVPT and SeniorVeterinarian at Pfizer Animal Health. “It offers the benefits of significantanalgesia, a huge safety margin and hypertension in the face of significantsedation.”
Dr. Donecker reports that the full label dosage for Dormosedan – criticalfor achieving optimum levels of sedation and analgesia – is 20 to 40 micro-grams per kilogram of body weight; or 1 to 2 ml IV or IM to a 1,100 lb. horse.
At this rate of dosage the product produces a non-narcotic, reliable,dose-dependent sedation and analgesia, with flexible dosing that allowsthe 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 theveterinarian has more control over the level of sedation and analgesia. Inaddition, more accurate dosing can be achieved, decreasing the need for“topping up” with second doses during the procedure. Given Dormosedan’sproven safety record and wide therapeutic safety margin, veterinarians canuse this option with a great deal of confidence.”
As with all alpha-2 agonists, occasional reports of anaphylactic-likereactions have been received. The use of epinephrine should be avoidedsince epinephrine may potentiate the effects of alpha-2 agonists. Do notuse in horses intended for human consumption.
Effective Standing Sedation and AnalgesiaDormosedan® (detomidine hydrochloride) from Pfizer Animal Health – Provide the best for your patients and your clients
PF2912 Dormosedan flyer v4 11/29/06 3:30 PM Page 1
For more information, please see the brief summary included with this article. For the full Dormosedan prescribing information,please visit www.pfizer.com/equine.
References
1. Hamm, D., Turchi, P., Joechle, W. Sedative and analgesic effects of deto-midine and romifidine in horses. Veterinary Record (1995) 136, 324 -327.
2. Moens, Y., Lanz, F., Doherr, MG., Schatzmann, U. A comparison of theantinociceptive effects of xylazine, detomidine and romifidine on exper-imental pain in horses. Vet Anesth Analg (2003) Jul; 30(3); 183 – 190.
Pfizer Animal Health
Sedative and Analgesic For Use in Horses Only
Sterile Solution10 mg/mL
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: Dormosedan® is a synthetic alpha-2 adrenoreceptor agonist with sedative and analgesicproperties. The chemical name is 1H imidazole, 4-[(2,3-dimethylphenyl) methyl]-hydrochloride and thegeneric name is detomidine hydrochloride. It is a white, crystalline, water-soluble substance having amolecular weight of 222.7. The molecular formula is C12H14N2•HCl.CHEMICAL STRUCTURE:
Each mL of Dormosedan® contains 10.0 mg detomidine hydrochloride, 1.0 mg methyl paraben, 5.9 mgsodium chloride, and water for injection, q.s.CLINICAL PHARMACOLOGY: Dormosedan®, a non-narcotic sedative and analgesic, is a potent α2-adrenoreceptor agonist which produces sedation and superficial and visceral analgesia which is dosedependent in its depth and duration. Profound lethargy and a characteristic lowering of the head withreduced sensitivity to environmental stimuli (sounds, etc.) are seen with detomidine. A short period ofincoordination is characteristically followed by immobility and a firm stance with front legs well spread.The analgesic effect is most readily seen as an increase in the pain threshold at the body surface.Sensitivity to touch is little affected and in some cases may actually be enhanced.With detomidine administration, heart rate is markedly decreased, blood pressure is initially elevated,and then a steady decline to normal is seen. A transient change in the conductivity of the cardiac musclemay occur, as evidenced by partial atrioventricular (AV) and sinoauricular (SA) blocks. This change in theconductivity of the cardiac muscle may be prevented by IV administration of atropine at 0.02 mg/kg ofbody weight.No effect on blood clotting time or other hematological parameters was encountered at dosages of 20 or40 mcg/kg of body weight. Respiratory responses include an initial slowing of respiration within a fewseconds to 1–2 minutes after administration, increasing to normal within 5 minutes. An initial decrease intidal volume is followed by an increase.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 the following: to calm fractious horses, to provide relief from abdominal pain, to facilitate bronchoscopy,bronchoalveolar lavage, nasogastric intubation, non reproductive rectal palpations, suturing of skinlacerations, and castrations. Additionally, an approved, local infiltration anesthetic is indicated forcastration.CONTRAINDICATIONS: Dormosedan® should not be used in horses with pre-existing AV or SA block,with severe coronary insufficiency, cerebrovascular disease, respiratory disease, or chronic renal failure.Intravenous potentiated sulfonamides should not be used in anesthetized or sedated horses as potentiallyfatal dysrhythmias may occur. Information on the possible effects of detomidine hydrochloride in breeding horses is limited to uncontrolledclinical reports; therefore, this drug is not recommended for use in breeding animals.
WARNINGS: Not for use in horses intended for food. Not for human use. Keep out of reach of children.
HUMAN SAFETY INFORMATION: Care should be taken to assure that detomidine hydrochloride is notinadvertently ingested as safety studies have indicated that the drug is well absorbed when administeredorally. 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 to5 times the proposed market concentration of detomidine hydrochloride on intact and abraded skin havedemonstrated that the drug is nonirritating to skin and is apparently poorly absorbed dermally. However,in accordance with prudent clinical procedures, exposure of eyes or skin should be avoided and affectedareas should be washed immediately if exposure does occur. As with all injectable drugs causing profound
physiological effects, routine precautions should be employed by practitioners when handling and usingloaded syringes to prevent accidental self-injection.PRECAUTIONS: Before administration, careful consideration should be given to administeringDormosedan® 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. Protecttreated horses from temperature extremes. Some horses, although apparently deeply sedated, may stillrespond to external stimuli. Routine safety measures should be employed to protect practitioners andhandlers. Allowing the horse to stand quietly for 5 minutes before administration and for 10–15 minutesafter injection may improve the response to Dormosedan®.Dormosedan® is a potent α2-agonist, and extreme caution should be exercised in its use with othersedative or analgesic drugs for they may produce additive effects.When using any analgesic to help alleviate abdominal pain, a complete physical examination anddiagnostic work-up are necessary to determine the etiology of the pain.Food and water should be withheld until the sedative effect of Dormosedan® has worn off.ADVERSE REACTIONS: Occasional reports of anaphylactic-like reactions have been received, including1 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 maypotentiate the effects of α2-agonists. Reports of mild adverse reactions have resolved uneventfullywithout 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 anadaptive baroreceptor response to the increased pressure and inconsistent with a primary drug-inducedbradycardia. Piloerection, sweating, salivation, and slight muscle tremors are frequently seen afteradministration. Partial transient penis prolapse may be seen.Partial AV and SA blocks may occur withdecreased heart and respiratory rates. Urination typically occurs during recovery at about 45–60 minutesposttreatment, depending on dosage. Incoordination or staggering is usually seen only during the first3–5 minutes after injection,until animals have secured a firm footing.Because of continued lowering of the head during sedation, mucus discharges from the nose and,occasionally, edema of the head and face may be seen. Holding the head in a slightly elevated positiongenerally prevents these effects.OVERDOSAGE: Detomidine hydrochloride is tolerated in horses at up to 200 mcg/kg of bodyweight (10times the low dosage and 5 times the high dosage). In safety studies in horses,detomidine hydrochlorideat 400 mcg/kg of body weight administered daily for 3 consecutive days produced microscopic foci ofmyocardial necrosis in 1 of 8 horses.DOSAGE AND ADMINISTRATION:For Sedation: Administer Dormosedan® IV or IM at the rates of 20 or 40 mcg detomidine hydrochlorideper kg of body weight (0.2 or 0.4 mL of Dormosedan® per 100 kg or 220 lb), depending on the depth andduration of sedation required. Onset of sedative effects should be reached within 2–4 minutes after IVadministration and 3–5 minutes after IM administration.Twenty mcg/kg will provide 30–90 minutes ofsedation and 40 mcg/kg will provide approximately 90 minutes to 2 hours of sedation.For Analgesia: Administer Dormosedan® IV at the rates of 20 or 40 mcg detomidine hydrochloride per kgof body weight (0.2 or 0.4 mL of Dormosedan® per 100 kg or 220 lb), depending on the depth and durationof analgesia required. Twenty mcg/kg will usually begin to take effect in 2–4 minutes and provide 30–45minutes of analgesia. The 40 mcg/kg dose will also begin to take effect in 2–4 minutes and provide 45–75minutes of analgesia.For Both Sedation and Analgesia: Administer Dormosedan® IV at the rates of 20 or 40 mcgdetomidine hydrochloride per kg of body weight (0.2 or 0.4 mL of Dormosedan® per 100 kg or 220 lb),depending on the depth and duration of sedation and analgesia required.Before and after injection, the animal should be allowed to rest quietly.STORAGE: Store at controlled room temperature 15°–30°C (59°–86°F) in the absence of light.HOW SUPPLIED: Dormosedan® is supplied in 5- and 20-mL multidose vials.U.S. Patent Nos. 4,443,466 and 4,584,383NADA #140-862, Approved by FDAManufactured by:
DORMOSEDAN® (detomidine hydrochloride) Sterile Solution
Distributed by:
Exton, PA 19341, USADiv. of Pfizer IncNY, NY 10017
75-6290-09107224US-8 January 2004Made in Finland Jaakkoo-Taara Oy
DOR06019
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