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In horses, intravenous dosages of Repeated administration of butorphanol at 1 mg/kg DOSAGE ranging from 0.05 to 0.4 mg/kg were shown to be (10 times the recommended dose) every four hours The recommended dosage in the horse is 0.1 mg 7. Popio, K.A. et al: “Hemodynamic and Respiratory eff ective in alleviating visceral and superfi cial pain for 48 hours caused constipation in one of two of butorphanol per kilogram of body weight Eff ects of and Butorphanol,” Clin. for at least 4 hours, as illustrated in the following horses. (0.05 mg/lb) by intravenous injection. This is Pharmacol. Ther. 23: 281–287, 1978. fi gure: equivalent to 5 mL of TORBUGESIC for each 1000 lbs 8. Robertson, J.T. and Muir, W.W.: “Cardiopulmonary Subacute Equine Studies body weight. Eff ects of Butorphanol Tartrate in Horses,” Am. J. Eff ects of Butorphanol Given at Horses were found to tolerate butorphanol given The dose may be repeated within 3 to 4 hours Vet. Res. 42: 41–44, 1981. Various Dosages in Horses with Abdominal Pain intravenously at dosages of 0.1, 0.3 and 0.5 mg/kg but treatment should not exceed 48 hours. 9. Kalpravidh, M. et al: “Eff ects of Butorphanol, every 4 hours for 48 hours followed by once daily Pre-clinical model studies and clinical fi eld trials in Flunixin, , Morphine, injections for a total of 21 days. The only detectable horses demonstrate that the analgesic eff ects of and Xylazine in Ponies,” Am. J. Vet. Res. 45: drug eff ects were slight transient ataxia observed TORBUGESIC are seen within 15 minutes following 217–223, 1984. occasionally in the high dosage group. No clinical, injection and persist for about 4 hours. laboratory, or gross or histopathologic evidence of Distributed by: any butorphanol-related toxicity was encountered HOW SUPPLIED Zoetis Inc. in the horses. 50 mL vials TORBUGESIC (butorphanol tartrate) Kalamazoo, MI 49007 Veterinary Injection, 10 mg base activity per mL. INDICATIONS 10 mL vials TORBUGESIC (butorphanol tartrate) Made in Spain TORBUGESIC (butorphanol tartrate) is indicated for Veterinary Injection, 10 mg base activity per mL. the relief of pain associated with colic in adult horses Revised: March 2015 and yearlings. Clinical studies in the horse have Store at controlled room temperature 20°-25°C shown that TORBUGESIC alleviates abdominal pain (68°-77°F) with excursions between 15°-30°C (59°- associated with torsion, impaction, intussusception, 86°F). *Pain threshold in butorphanol-treated colicky horses relative spasmodic and tympanic colic and postpartum pain. to placebo controls. REFERENCES CLINICAL PHARMACOLOGY WARNINGS 1. Pircio, A.W. et al: “The Pharmacology of Comparative Pharmacology A defi nite dosage-response relationship was DO NOT USE IN HORSES INTENDED FOR HUMAN Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): In animals, butorphanol has been demonstrated to NADA 135-780, Approved by FDA detected in that butorphanol dosage of 0.1 mg/kg CONSUMPTION. NOT FOR HUMAN USE. 231–257, 1976. be 4 to 30 times more potent than morphine and was more eff ective than 0.05 mg/kg but not 2. Dobkin, A.B. et al: “Butorphanol and Pentazocine pentazocine (Talwin®-V) respectively.1 diff erent from 0.2 mg/kg in alleviating deep CAUTION in Patients with Severe Postoperative Pain,” Clin. In humans,In horses, butorphanol intravenous has beendosages shown of tobutorphanol have Repeated administration of butorphanol at 1 mg/kg DOSAGE Torbugesic® abdominal pain. TORBUGESIC, a potent analgesic, should be used Pharmacol. Ther. 18: 547–553, 1975. 5 to 7ranging times the from analgesic 0.05 to activity 0.4 mg/kg of morphine were shown and to be (10 times the recommended dose) every four hours The recommended dosage in the horse is 0.1 mg 7. Popio, K.A. et al: “Hemodynamic and Respiratory BUTORPHANOL TARTRATE eff ective in alleviating visceral2,3 and superfi cial pain for 48 withhours caution caused with constipation other sedative in oneor analgesic of two drugs of butorphanol3. Gilbert, perM.S. kilogramet al: “Intramuscular of body weight Butorphanol Eff ects of Morphine and Butorphanol,” Clin. 20 times thatAcute of pentazocine. Equine Studies Veterinary Injection for at least 4 hours, as illustrated in the following horses.as these are likely to produce additive eff ects. (0.05 mg/lb)and byMeperidine intravenous in Postoperativeinjection. This Pain,” is Clin. Pharmacol. Ther. 23: 281–287, 1978. ButorphanolRapid has 15 intravenous to 20 times administration the oral antitussive of butorphanol at fi gure: There are no well-controlled studies using equivalentPharmacol. to 5 mL of Ther.TORBUGESIC 20: 359–364, for each 1976. 1000 lbs 8. Robertson, J.T. and Muir, W.W.: “Cardiopulmonary activity of codeinea dosage or of 2 mg/kg (20 times in the dogs recommended 4 Subacutebutorphanol Equine Studies in breeding horses, weanlings and body weight.4. Cavanagh, R.L. et al: “Antitussive Properties of Eff ects of Butorphanol Tartrate in Horses,” Am. J. and guinea pigs.dosage) to a previously unmedicated horse resulted Analgesic Eff ects of Butorphanol Given at Horses foals.were Therefore,found to toleratethe drug butorphanol should not givenbe used in The dose Butorphanol,”may be repeated Arch. Int. within Pharmacodyn. 3 to 4 hoursTher. 220 (2): Vet. Res. 42: 41–44, 1981. CAUTION As an antagonist,in a brief butorphanol episode ofis inabilityapproximately to stand, muscle Various Dosages in Horses with Abdominal Pain intravenouslythese groups. at dosages of 0.1, 0.3 and 0.5 mg/kg but treatment258–268, should 1976. not exceed 48 hours. 9. Kalpravidh, M. et al: “Eff ects of Butorphanol, Federal law restricts this drug to use by or on the equivalent tofasciculation, nalorphine anda convulsive30 times more seizure potent of 6 seconds 1 every 4 hours for 48 hours followed by once daily Pre-clinical5. S churig,model studiesJ.E. et aland: “Eff clinical ect of fi eldBut trialsorphanol in and Flunixin, Levorphanol, Morphine, Pentazocine order of a licensed veterinarian. than pentazocine.duration and recovery within three minutes. injections for a total ofADVERSE 21 days. REACTIONSThe only detectable horses demonstrateMorphine onthat Pulmonary the analgesic Mechanics, eff ects ofArte rial and Xylazine in Ponies,” Am. J. Vet. Res. 45: CardiopulmonaryThe same depressant dosage administeredeff ects are minimal after 10 successive drug effIn ects clinical were trialsslight in transient horses, ataxiathe most observed commonly TORBUGESICBlood are P seenressure, within and 15Venous minutes Plasma following Histamine in 217–223, 1984. DESCRIPTION after treatmentdaily with 1 mg/kgbutorphanol dosages as demonstratedof butorphanol resulted 5 6,7 8 occasionallyobserved in the side high eff ect dosage was slightgroup. ataxia No clinical, which lasted injection andthe persistAnesthetized for about Dog,” 4 hours. Arch. Int. Pharmacodyn. TORBUGESIC (butorphanol tartrate) is a totally in dogs , humansonly in transientand horses. sedative eff ects. During the 10-day laboratory,3 to 10or minutes.gross or histopathologic evidence of Ther. 233: 296–304, 1978. Distributed by: synthetic, centrally acting, - Unlike classicalcourse narcotic of administration agonist at 1 mg/kg which (10 times the any butorphanol-related toxicity was encountered 6. Nagashmina,HOW SUPPLIEDH. et al: “Respiratory and Zoetis Inc. antagonist analgesic with potent antitussive are associatedrecommended with decreases use inlevel) blood in twopressure, horses, the only in the horses.Marked ataxia was reported in 1.5% of the 50 mL vialsCir culatoryTORBUGESIC Eff ects (butorphanol of Intravenous tartrate) Butorphanol Kalamazoo, MI 49007 activity. It is a member of the phenanthrene reduction in detectableheart rate anddrug concomitant eff ects were release transient of behavioral 327 horses treated. Mild sedation was reported in Veterinaryand Injection, Morphine,” 10 mg baseClin. activity Pharmacol. per mL. Ther. 19: series. The chemical name is -3, 14- histamine, butorphanolchanges typical does of not narcotic cause agonisthistamine activity. These 1 9% of the horses.INDICATIONS 10 mL vials735–745, TORBUGESIC 1976. (butorphanol tartrate) Made in Spain diol, 17-(cyclobutylmethyl)-, (-)-, (S- (R*, R*))-2,3- release. included muscle fasciculation about the head and TORBUGESIC (butorphanol tartrate) is indicated for Veterinary Injection, 10 mg base activity per mL. dihydroxybutanedioate (1:1) (salt). It is a white, Furthermore,neck, the ,cardiopulmonary lateral nystagmus,eff ects of ataxia and the relief of pain associated with colic in adult horses Revised: March 2015 crystalline,In horses, water intravenous soluble substancedosages ofhaving butorphanol a butorphanol Repeatedsalivation. are administration not distinctly of dosage-related butorphanol at but 1 mg/kg DOSAGE molecularranging weight from of 0.05 477.55; to 0.4 its molecularmg/kg were formula shown is to berather (10 reach times a ceilingthe recommended eff ect beyond dose) which every further four hours and yearlings.The recommended Clinical studies dosage in inthe the horse horse have is 0.1 mg 7.Store Popio, at controlledK.A. et al: “Hemodynamic room temperature and Respiratory 20°-25°C C21H29NO2eff ective•C4H6O6. in alleviating visceral and superfi cial paindosage for increases 48 hours result caused in relatively constipation lesser in eff oneects. of two shown ofthat butorphanol TORBUGESIC peralleviates kilogram abdominal of body pain weight (68°-77°F)Eff ects withof Morphine excursions and between Butorphanol,” 15°-30°C (59°-Clin. for at least 4 hours, as illustrated in the followingReproduction: horses. Studies performed in mice and associated(0.05 with mg/lb) torsion, by impaction, intravenous intussusception, injection. This is 86°F).Pharmacol. Ther. 23: 281–287, 1978. Chemicalfi gure: Structure rabbits*Pain revealed threshold no in evidence butorphanol-treated of impaired colicky fertility horses or relative spasmodicequivalent and tympanic to 5 mL colic of TORBUGESIC and postpartum for each pain. 1000 lbs 8. Robertson, J.T. and Muir, W.W.: “Cardiopulmonary to placebo controls. harm Subacuteto the fetus Equine due to Studies butorphanol tartrate. In the body weight. REFERENCESEff ects of Butorphanol Tartrate in Horses,” Am. J. Analgesic Eff ects of Butorphanol Given at femaleHorses rat, parenter were foundal administration to tolerate was butorphanol associated given The dose mayWARNINGS be repeated within 3 to 4 hours 1. Vet.Pircio, Re s. A.W.42: 41–44, et al:1981. “The Pharmacology of A defi nite dosage-response relationship was Various Dosages in Horses with Abdominal Pain with increasedintravenously nervousness at dosages and of decreased 0.1, 0.3 and care 0.5 for mg/kg DO NOTbut USE treatment IN HORSES should INTENDED not FORexceed HUMAN 48 hours. 9. Kalpravidh,Butorphanol,” M. Arch. et Int.al: Pharmacodyn.“Eff ects of Butorphanol Ther. 220 (2):, detected in that butorphanol dosage of 0.1 mg/kg the newborn,every 4 hoursresulting for in48 a hours decreased followed survival by once rate daily CONSUMPTION.Pre-clinical NOT model FOR studiesHUMAN and USE. clinical fi eld trials in F231–257,lunixin, 1976.Levorphanol, Morphine, Pentazocine was more eff ective than 0.05 mg/kg but not of theinjections newborn. for This a totalnervousness of 21 days. was The seen only only detectable in horses demonstrate that the analgesic eff ects of 2. andDobkin, Xylazine A.B. et al:in “ButorphanolPonies,” Am. andJ. Vet. Pentazocine Res. 45: diff erent from 0.2 mg/kg in alleviating deep the ratdrug species. eff ects were slight transient ataxia observed TORBUGESIC areCAUTION seen within 15 minutes following 217–223,in Patients 1984. with Severe Postoperative Pain,” Clin. occasionallyabdominal pain. in the high dosage group. No clinical, TORBUGESIC,injection a andpotent persist analgesic, for about should 4 hours. be used Pharmacol. Ther. 18: 547–553, 1975. Equinelaboratory, Pharmacology or gross or histopathologic evidence of with caution with other sedative or analgesic drugs 3. Gilbert, DistributM.S. et edal: by“Intramuscular: Butorphanol Acute Equine Studies Followingany butorphanol-related intravenous injection toxicity wasin encounteredhorses, as these are likely to produceHOW additiveSUPPLIED eff ects. and MeperidineZoetis Inc. in Postoperative Pain,” Clin. Rapid intravenous administration of butorphanol at butorphanolin the horses. is largely eliminated from the There 50are mL no vials well-controlled TORBUGESIC (butorphanolstudies using tartrate) Pharmacol.Kalamazoo, Ther. 20: MI359–364, 49007 1976. a dosage of 2 mg/kg (20 times the recommended Each mL of TORBUGESIC contains 10 mg blood within 3 to 4 hours. The drug is extensively butorphanolVeterinary in breeding Injection, horses,10 mg baseweanlings activity and per mL. 4. Cavanagh, R.L. et al: “Antitussive Properties of dosage) to a previously unmedicated horse resulted butorphanol base (as butorphanol tartrate, USP), metabolized in the liver INDICATIONSand excreted in the urine. foals. Therefore,10 mL vials the TORBUGESIC drug should (butorphanolnot be used intartrate) Butorphanol,”Made Arch.in Spain Int. Pharmacodyn. Ther. 220 (2): in a brief episode of inability to stand, muscle these groups. 258–268, 1976. 3.3 mg citric acid, USP, 6.4 mg sodium citrate, In ponies,TORBUGESIC butorphanol (butorphanol given intramuscularlytartrate) is indicated at for Veterinary Injection, 10 mg base activity per mL. CLINICAL PHARMACOLOGY fasciculation, a convulsive seizure of 6 seconds 5. Schurig, J.E. et al: “Eff ect of Butorphanol and USP, 4.7 mg sodium chloride, USP, and 0.1 mg a dosagethe relief of 0.22 of pain mg/kg, associated was shown with colic to inalleviate adult horses Revised: March 2015 Comparative Pharmacology duration and recovery within three minutes. ADVERSE REACTIONS Morphine on Pulmonary Mechanics, Arterial benzethonium chloride, USP, q.s. with water for experimentallyand yearlings. induced Clinical visceral studies pain in thefor abouthorse have Store at controlled room temperature 20°-25°C In animals, butorphanol has been demonstrated to The9 same dosage administered after 10 successive In clinical trials in horses, the most commonly Blood Pressure, andNADA Venous 135-780, Plasma Approved Histamineby FDA in injection, USP. 4 hours.shown that TORBUGESIC alleviates abdominal pain (68°-77°F) with excursions between 15°-30°C (59°- be 4 to 30 times more potent than morphine and daily 1 mg/kg dosages of butorphanol resulted observed side eff ect was slight ataxia which lasted the Anesthetized Dog,” Arch. Int. Pharmacodyn. associated with torsion, impaction, intussusception, 86°F). pentazocine (Talwin®-V) respectively.1 *Pain threshold in butorphanol-treated colicky horses relative only in transient sedative eff ects. During the 10-day 3 to 10 minutes. Ther. 233: 296–304, 1978. spasmodic and tympanic colic and postpartum pain. In humans, butorphanol has been shown to have to placebo controls. course of administration at 1 mg/kg (10 times the 6. Nagashmina,Torbugesic® H. et al: “Respiratory and CLINICAL PHARMACOLOGY REFERENCES 5 to 7 times the analgesic activity of morphine and P1106-308US/03-14A&P recommended use level) in two horses, the only Marked ataxia was reported in 1.5% of the Circulatory EffBUTORPHANOL ects of Intravenous TARTRATE Butorphanol Comparative Pharmacology WARNINGS 1. Pircio, A.W. et al: “The Pharmacology of 20 times that of pentazocine.2,3 A defi nite dosage-response relationship was detectable drug eff ects were transient behavioral 327 horses treated. Mild sedation was reported in and Morphine,” Clin. Pharmacol. Ther. 19: In animals, butorphanol has been demonstrated to DO NOT USE IN HORSES INTENDED FOR HUMAN Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): Veterinary Injection Butorphanol has 15 to 20 times the oral antitussive NADA 135-780, Approved by FDA detected in that butorphanol dosage of 0.1 mg/kg changes typical of narcotic agonist activity. These 9% of the horses. 735–745, 1976. be 4 to 30 times more potent than morphine and CONSUMPTION. NOT FOR HUMAN USE. 231–257, 1976. activity of or dextromethorphan in dogs was more eff ective than 0.051 mg/kg but not included muscle fasciculation about the head and pentazocine (Talwin®-V) respectively. 2. Dobkin, A.B. et al: “Butorphanol and Pentazocine and guinea pigs.4 In humans,diff erent butorphanol from 0.2 hasmg/kg been inshown alleviating to have deep neck, dysphoria, lateralCAUTION nystagmus, ataxia and in Patients with Severe Postoperative Pain,” Clin. Torbugesic® abdominal pain. salivation. CAUTION As an antagonist, butorphanol is approximately 5 to 7 times the analgesic activity of morphine and TORBUGESIC, a potent analgesic, should be used Pharmacol. Ther. 18: 547–553, 1975. Federal law restricts this drug to use by or on the equivalent to nalorphine and 30 times more potent BUTORPHANOL TARTRATE 2,3 20 timesIn horses, that of pentazocine.intravenous dosages of butorphanol Repeatedwith caution administration with other sedative of butorphanol or analgesic at 1 mg/kg drugs 3. Gilbert, M.S. et alDOSAGE: “Intramuscular Butorphanol order of a licensed veterinarian. than pentazocine.1 Veterinary Injection ButorphanolAcute Equine has 15 Studies to 20 times the oral antitussive as these are likely to produce additive eff ects. and Meperidine in Postoperative Pain,” Clin. rangingRapid intravenous from 0.05 toadministration 0.4 mg/kg were of butorphanol shown to be at (10 times the recommended dose) every four hours The recommended dosage in the horse is 0.1 mg 7. Popio, K.A. et al: “Hemodynamic and Respiratory Cardiopulmonary depressant eff ects are minimal activityeff ectiveof codeine in alleviating or dextromethorphan visceral and superfi in dogs cial pain forThere 48 hoursare nocaused well-controlled constipation instudies one ofusing two of Pharmacol.butorphanol Ther. per 20: kilogram359–364, 1976.of body weight Eff ects of Morphine DESCRIPTIONand Butorphanol,” Clin. after treatment with butorphanol as demonstrated a dosage of4 2 mg/kg (20 times the recommended and guineafor at leastpigs. 4 hours, as illustrated in the following horses.butorphanol in breeding horses, weanlings and (0.054. Cavanagh, mg/lb) R.L.by intravenouset al: “Antitussive injection. Proper Thisties ofis Pharmacol.TORBUGESIC Ther. 23: (butorphanol 281–287, 1978. tartrate) is a totally in dogs5, humans6,7 and horses.8 CAUTION As andosage) antagonist, to a previously butorphanol unmedicated is approximately horse resulted foals. Therefore, the drug should not be used in Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): fiin gure: a brief episode of inability to stand, muscle equivalent to 5 mL of TORBUGESIC for each 1000 lbs 8. Robertson,synthetic, J.T. andcentrally Muir, W.W.: acting, “Cardiopulmonary narcotic agonist- Unlike classical narcotic agonist analgesics which Federal law restricts this drug to use by or on the equivalent to nalorphine and 30 times more potent Subacutethese groups. Equine Studies body258–268, weight. 1976. Eff ectsantagonist of Butorphanol analgesic Tartrate with in Horses,”potent Am.antitussive J. are associated with decreases in blood pressure, fasciculation,1 a convulsive seizure of 6 seconds order of a licensed veterinarian. than pentazocine.Analgesic Eff ects of Butorphanol Given at Horses were found to tolerate butorphanol given The5. S churig,dose may J.E. beet repeatedal: “Eff ect withinof But orphanol3 to 4 hours and Vet. Reactivity.s. 42: 41–44, It is 1981.a member of the phenanthrene reduction in heart rate and concomitant release of Cardiopulmonaryduration and depressant recovery effwithin ects are three minimal minutes. ADVERSE REACTIONS Morphine on Pulmonary Mechanics, Arterial TheVarious same Dosages dosage inadministered Horses with after Abdominal 10 successive Pain intravenously at dosages of 0.1, 0.3 and 0.5 mg/kg but treatment should not exceed 48 hours. 9. Kalpravidh,series. TheM. etchemical al: “Eff ectsname of isButorphanol Morphinan-3,, 14- histamine, butorphanol does not cause histamine DESCRIPTION after treatment with butorphanol as demonstrated everyIn clinical 4 hours trials for in48 horses,hours followed the most by commonlyonce daily Pre-clinicalBlood P ressure,model studiesand Venous and clinicalPlasma fiHistamine eld trials inin Flunixin,diol, 17-(cyclobutylmethyl)-,Levorphanol, Morphine, (-)-, Pentaz (S- (R*,ocine R*))-2,3- release.1 daily5 1 mg/kg6,7 dosages 8of butorphanol resulted TORBUGESIC (butorphanol tartrate) is a totally in dogs , humans and horses. injectionsobserved forside a efftotal ect of was 21 days.slight The ataxia only which detectable lasted horsesthe demonstrateAnesthetized thatDog,” the Arch. analgesic Int. Pharmac eff ectsodyn. of and dihydroxybutanedioateXylazine in Ponies,” Am.(1:1) J. (salt).Vet. Res.It is45: a white, Furthermore, the cardiopulmonary eff ects of synthetic, centrally acting, narcotic agonist- Unlikeonly classical in transient narcotic sedative agonist eff ects.analgesics During which the 10-day 3 to 10 minutes. Ther. 233: 296–304, 1978. course of administration at 1 mg/kg (10 times the drug eff ects were slight transient ataxia observed TORBUGESIC are seen within 15 minutes following 217–223,crystalline, 1984. water soluble substance having a butorphanol are not distinctly dosage-related but antagonist analgesic with potent antitussive are associated with decreases in blood pressure, occasionally in the high dosage group. No clinical, injection6. Nagashmina, and persist H. for et about al: 4“Respirat hours. ory and molecular weight of 477.55; its molecular formula is rather reach a ceiling eff ect beyond which further activity. It is a member of the phenanthrene reductionrecommended in heart rate use and level) concomitant in two horses, release the of only Marked ataxia was reported in 1.5% of the Circulatory Eff ects of Intravenous Butorphanol detectable drug eff ects were transient behavioral laboratory, or gross or histopathologic evidence of C21H29NO2Distributed•C4H6O6. by: dosage increases result in relatively lesser eff ects. series. The chemical name is Morphinan-3, 14- histamine, butorphanol does not cause histamine any327 butorphanol-relatedhorses treated. Mild toxicitysedation was was encountered reported in and Morphine,”HOW Clin. SUPPLIED Pharmacol. Ther. 19: Zoetis Inc. Reproduction: Studies performed in mice and changes1 typical of narcotic agonist activity. These diol, 17-(cyclobutylmethyl)-,In horses, intravenous (-)-,dosages (S- (R*, of R*))-2,3-butorphanolrelease. Repeated administration of butorphanol at 1 mg/kg 9% of the horses. DOSAGE 735–745, 1976. included muscle fasciculation about the head and in the horses. 50 mL vials TORBUGESIC (butorphanol tartrate) ChemicalKalamazoo, Structure MI 49007 rabbits revealed no evidence of impaired fertility or dihydroxybutanedioateranging from 0.05 to(1:1) 0.4 (salt). mg/kg It wereis a shownwhite, to beFurthermore, (10 times the recommendedcardiopulmonary dose) effevery ects four of hours The recommended dosage in the horse is 0.1 mg 7. Popio, K.A. et al: “Hemodynamic and Respiratory neck, dysphoria, lateral nystagmus, ataxia and Veterinary Injection, 10 mg base activity per mL. harm to the fetus due to butorphanol tartrate. In the crystalline,eff ective water in alleviating soluble visceralsubstance and havingsuperfi ciala painbutorphanol for 48 hoursare not caused distinctly constipation dosage-related in one but of two of butorphanol per kilogram of body weight Eff ects of Morphine and Butorphanol,” Clin. salivation. INDICATIONS 10 mL vials TORBUGESIC (butorphanol tartrate) Made in Spain female rat, parenteral administration was associated molecularfor at weight least 4of hours, 477.55; as its illustrated molecular in formula the following is rather horses. reach a ceiling eff ect beyond which further TORBUGESIC(0.05 (butorphanolmg/lb) by intravenoustartrate) is indicated injection. for This is VeterinaryPharmacol. Injection, Ther. 23: 10 281– mg base287, 1978.activity per mL. with increased nervousness and decreased care for C21H29NO2fi gure:•C4H6O6. dosage increases result in relatively lesser eff ects. the reliefequivalent of pain associated to 5 mL of with TORBUGESIC colic in adult for horseseach 1000 lbs 8. Robertson, J.T. and Muir, W.W.: “Cardiopulmonary Revised: March 2015 the newborn, resulting in a decreased survival rate Reproduction:Subacute EquineStudies Studiesperformed in mice and and yearlings.body weight. Clinical studies in the horse have StoreEff ectsat controlled of Butorphanol room Tartrate temperature in Horses,” 20°-25°C Am. J. of the newborn. This nervousness was seen only in Chemical StructureAnalgesic Eff ects of Butorphanol Given at rabbitsHorses revealed were no found evidence to tolerateof impaired butorphanol fertility or given shown Thethat TORBUGESICdose may be alleviates repeated abdominal within 3 painto 4 hours (68°-77°F)Vet. Re s.with 42: 41–44,excursions 1981. between 15°-30°C (59°- the rat species. Various Dosages in Horses with Abdominal Pain harm intravenouslyto the fetus due at todosages butorphanol of 0.1, tartrate. 0.3 and In 0.5 the mg/kg associatedbut withtreatment torsion, impaction,should not intussusception, exceed 48 hours. 86°F).9. Kalpravidh, M. et al: “Eff ects of Butorphanol, female*Painevery rat, threshold parenter 4 hours inal butorphanol-treatedfor administration 48 hours followed was colicky associated by horses once relative daily spasmodicPre-clinical and tympanic model colic studies and andpostpartum clinical fipain. eld trials in Flunixin, Levorphanol, Morphine, Pentazocine Equine Pharmacology with toincreasedinjections placebo controls. nervousnessfor a total of and21 days. decreased The only care detectable for horses demonstrate that the analgesic eff ects of REFERENCESand Xylazine in Ponies,” Am. J. Vet. Res. 45: Following intravenous injection in horses, the newborn,drug eff ectsresulting were inslight a decreased transient survival ataxia rateobserved TORBUGESICWARNINGS are seen within 15 minutes following 1. Pircio,217–223, A.W. 1984. et al: “The Pharmacology of butorphanol is largely eliminated from the of theAoccasionally newborn.defi nite This indosage-response thenervousness high dosage was relationship group.seen only No inclinical, was DO NOTinjection USE IN andHORSES persist INTENDED for about FOR 4 hours. HUMAN Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): Each mL of TORBUGESIC contains 10 mg blood within 3 to 4 hours. The drug is extensively the ratdetectedlaboratory, species. in orthat gross butorphanol or histopathologic dosage of evidence 0.1 mg/kg of CONSUMPTION. NOT FOR HUMAN USE. 231–257,Distribut 1976. ed by: butorphanol base (as butorphanol tartrate, USP), metabolized in the liver and excreted in the urine. wasany butorphanol-relatedmore eff ective than toxicity 0.05 wasmg/kg encountered but not HOW SUPPLIED 2. Dobkin, ZA.B.oetis et Inc.al: “Butorphanol and Pentazocine 3.3 mg citric acid, USP, 6.4 mg sodium citrate, In ponies, butorphanol given intramuscularly at Equinediffin Pharmacology theerent horses. from 0.2 mg/kg in alleviating deep 50 mL vials CAUTIONTORBUGESIC (butorphanol tartrate) in PatientsKalamazoo, with Severe MI 49007 Postoperative Pain,” Clin. USP, 4.7 mg sodium chloride, USP, and 0.1 mg a dosage of 0.22 mg/kg, was shown to alleviate Followingabdominal intravenous pain. injection in horses, TORBUGESIC,Veterinary a potent Injection, analgesic, 10 mg shouldbase activity be used per mL. Pharmacol. Ther. 18: 547–553, 1975. benzethonium chloride, USP, q.s. with water for experimentally induced visceral pain for about butorphanol is largelyINDICATIONS eliminated from the with caution10 mL with vials other TORBUGESIC sedative or (butorphanolanalgesic drugs tartrate) 3. Gilbert, MadeM.S. etin Spainal: “Intramuscular Butorphanol injection, USP. 4 hours.9 Each mL of TORBUGESIC contains 10 mg bloodAcuteTORBUGESIC within Equine 3 to 4Studies(butorphanol hours. The drug tartrate) is extensively is indicated for as theseVeterinary are likely toInjection, produce 10 additive mg base eff activity ects. per mL. and Meperidine in Postoperative Pain,” Clin. butorphanol base (as butorphanol tartrate, USP), metabolizedRapidthe relief intravenous in of the pain liver associated administration and excreted with colic inof thebutorphanol in urine.adult horses at There are no well-controlled studies using Revised:Pharmacol. March Ther. 2015 20: 359–364, 1976. 3.3 mg citric acid, USP, 6.4 mg sodium citrate, In ponies,aand dosage yearlings.butorphanol of 2 mg/kgClinical given (20 studies timesintramuscularly thein the recommended horse at have butorphanolStore atin breedingcontrolled horses, room temperatureweanlings and 20°-25°C 4. Cavanagh, R.L. et al: “Antitussive Properties of USP, 4.7 mg sodium chloride, USP, and 0.1 mg a dosagedosage)shown of thatto0.22 a TORBUGESICpreviously mg/kg, was unmedicated alleviatesshown to abdominal horsealleviate resulted pain foals. Therefore,(68°-77°F) thewith drug excursions should betweennot be used 15°-30°C in (59°- Butorphanol,” Arch. Int. Pharmacodyn.P1106-308US/03-14 Ther. 220 (2): A&P benzethonium chloride, USP, q.s. with water for experimentallyinassociated a brief withinducedepisode torsion, ofvisceral inabilityimpaction, pain to intussusception,forstand, about muscle these groups.86°F). 258–268, 1976. 9 injection,*Pain USP. threshold in butorphanol-treated colicky horses relative4 hours.fasciculation,spasmodic and a tympanicconvulsive colic seizure and postpartum of 6 seconds pain. 5. Schurig, J.E. et al: “Eff ect of Butorphanol and to placebo controls. duration and recovery within three minutes. REFERENCESADVERSE REACTIONS Morphine on Pulmonary Mechanics, Arterial The same dosage administeredWARNINGS after 10 successive In clinical1. Pircio,trials inA.W. horses, et al:the “Themost Pharmaccommonlyology of Blood Pressure, and Venous Plasma Histamine in A defi nite dosage-response relationship was dailyDO NOT1 mg/kg USE IN dosages HORSES of INTENDED butorphanol FOR resultedHUMAN Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): P1106-308US/03-14A&P observed side eff ect was slight ataxia which lasted the Anesthetized Dog,” Arch. Int. Pharmacodyn. detected in that butorphanol dosage of 0.1 mg/kg onlyCONSUMPTION. in transient sedativeNOT FOR eff HUMAN ects. During USE. the 10-day 3 to 10 minutes.231–257, 1976. Ther. 233: 296–304, 1978. was more eff ective than 0.05 mg/kg but not course of administration at 1 mg/kg (10 times the 2. Dobkin, A.B. et al: “Butorphanol and Pentazocine 6. Nagashmina, H. et al: “Respiratory and diff erent from 0.2 mg/kg in alleviating deep recommended use level)CAUTION in two horses, the only Marked ataxiain Patients was withreported Severe inPostoperative 1.5% of thePain,” Clin. Circulatory Eff ects of Intravenous Butorphanol abdominal pain. detectableTORBUGESIC, drug a potenteff ects analgesic,were transient should behavioral be used 327 horsesPharmacol. treated. Mild Ther. sedation 18: 547–553, was 1975.reported in and Morphine,” Clin. Pharmacol. Ther. 19: changeswith caution typical with of other narcotic sedative agonist or analgesic activity. These drugs 9% of the3. horses.Gilbert, M.S. et al: “Intramuscular Butorphanol 735–745, 1976. Acute Equine Studies includedas these aremuscle likely fasciculation to produce additiveabout the eff headects. and and Meperidine in Postoperative Pain,” Clin. Rapid intravenous administration of butorphanol at neck,There dysphoria,are no lateralwell-controlled nystagmus, studies ataxia usingand Pharmacol. Ther. 20: 359–364, 1976. a dosage of 2 mg/kg (20 times the recommended salivation.butorphanol in breeding horses, weanlings and 4. Cavanagh, R.L. et al: “Antitussive Properties of dosage) to a previously unmedicated horse resulted foals. Therefore, the drug should not be used in Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): in a brief episode of inability to stand, muscle these groups. 258–268, 1976. fasciculation, a convulsive seizure of 6 seconds 5. Schurig, J.E. et al: “Eff ect of Butorphanol and duration and recovery within three minutes. ADVERSE REACTIONS Morphine on Pulmonary Mechanics, Arterial The same dosage administered after 10 successive In clinical trials in horses, the most commonly Blood Pressure, and Venous Plasma Histamine in daily 1 mg/kg dosages of butorphanol resulted observed side eff ect was slight ataxia which lasted the Anesthetized Dog,” Arch. Int. Pharmacodyn. only in transient sedative eff ects. During the 10-day 3 to 10 minutes. Ther. 233: 296–304, 1978. course of administration at 1 mg/kg (10 times the 6. Nagashmina, H. et al: “Respiratory and recommended use level) in two horses, the only Marked ataxia was reported in 1.5% of the Circulatory Eff ects of Intravenous Butorphanol detectable drug eff ects were transient behavioral 327 horses treated. Mild sedation was reported in and Morphine,” Clin. Pharmacol. Ther. 19: changes typical of narcotic agonist activity. These 9% of the horses. 735–745, 1976. included muscle fasciculation about the head and neck, dysphoria, lateral nystagmus, ataxia and salivation.