In horses, intravenous dosages of butorphanol 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 Morphine 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. Analgesic Eff ects of Butorphanol Given at Horses were found to tolerate butorphanol given The dose may be repeated within 3 to 4 hours but 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 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 Use contents within 4 months of fi rst puncture. Flunixin, Levorphanol, Morphine, Pentazocine injections for a total of 21 days. The only detectable Pre-clinical model studies and clinical fi eld trials in and Xylazine in Ponies,” Am. J. Vet. Res. 45: drug eff ects were slight transient ataxia observed horses demonstrate that the analgesic eff ects of 217–223, 1984. occasionally in the high dosage group. No clinical, TORBUGESIC are seen within 15 minutes following laboratory, or gross or histopathologic evidence of injection and persist for about 4 hours. any butorphanol-related toxicity was encountered in the horses. HOW SUPPLIED Distributed by: 50 mL vials TORBUGESIC (butorphanol tartrate Zoetis Inc. INDICATIONS injection) Veterinary Injection, 10 mg base activity Kalamazoo, MI 49007 TORBUGESIC (butorphanol tartrate injection) is per mL. indicated for the relief of pain associated with colic 10 mL vials TORBUGESIC (butorphanol tartrate Made in Spain in adult horses and yearlings. Clinical studies in injection) Veterinary Injection, 10 mg base activity the horse have shown that TORBUGESIC alleviates per mL. Revised: April 2018 abdominal pain associated with torsion, impaction, *Pain threshold in butorphanol-treated colicky horses relative intussusception, spasmodic and tympanic colic and Store at controlled room temperature 20°-25°C to placebo controls. postpartum pain. (68°-77°F) with excursions between 15°-30°C (59°- 86°F). A defi nite dosage-response relationship was WARNINGS detected in that butorphanol dosage of 0.1 mg/kg DO NOT USE IN HORSES INTENDED FOR HUMAN REFERENCES was more eff ective than 0.05 mg/kg but not CONSUMPTION. NOT FOR HUMAN USE. 1. Pircio, A.W. et al: “The Pharmacology of diff erent from 0.2 mg/kg in alleviating deep Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): abdominal pain. CAUTION 231–257, 1976. TORBUGESIC, a potent analgesic, should be used 2. Dobkin, A.B. et al: “Butorphanol and Pentazocine Acute Equine Studies with caution with other sedative or analgesic drugs in Patients with Severe Postoperative Pain,” Clin. Rapid intravenous administration of butorphanol at as these are likely to produce additive eff ects. Pharmacol. Ther. 18: 547–553, 1975. a dosage of 2 mg/kg (20 times the recommended There are no well-controlled studies using 3. Gilbert, M.S. et al: “Intramuscular Butorphanol dosage) to a previously unmedicated horse resulted butorphanol in breeding horses, weanlings and and Meperidine in Postoperative Pain,” Clin. in a brief episode of inability to stand, muscle Pharmacol. Ther. 20: 359–364, 1976. CLINICAL PHARMACOLOGY foals. Therefore, the drug should not be used in fasciculation, a convulsive seizure of 6 seconds 4. Cavanagh, R.L. et al: “Antitussive Properties of Comparative Pharmacology these groups. duration and recovery within three minutes. Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): In animals, butorphanol has been demonstrated to NADA 135-780, Approved by FDA The same dosage administered after 10 successive 258–268, 1976. be 4 toIn 30 horses, times moreintravenous potent thandosages morphine of butorphanol and Repeated administrationADVERSE of butorphanol REACTIONS at 1 mg/kg DOSAGE daily 1 mg/kg dosages of butorphanol resulted 5. Schurig, J.E. et al: “Eff ect of Butorphanol and pentazocineranging (Talwin®-V) from 0.05 respectively.to 0.4 mg/kg1 were shown to be (10 timesIn clinicalthe recommended trials in horses, dose) everythe most four hourscommonly The recommended dosage in the horse is 0.1 mg 7. Popio, K.A. et al: “Hemodynamic and Respiratory only in transient sedative eff ects. During the 10-day Morphine on Pulmonary Mechanics, Arterial In humans,eff ective butorphanol in alleviating has visceralbeen shown and superfi to have cial pain for 48observed hours caused side eff constipation ect was slight in ataxia one ofwhich two lasted of butorphanol per kilogram of body weight Eff ects of Morphine and Butorphanol,” Clin. Torbugesic® course of administration at 1 mg/kg (10 times the Blood Pressure, and Venous Plasma Histamine in 5 to 7 timesfor at theleast analgesic 4 hours, activity as illustrated of morphine in the and following horses.3 to 10 minutes. (0.05 mg/lb) by intravenous injection. This is Pharmacol. Ther. 23: 281–287, 1978. recommended use level) in two horses, the only the Anesthetized Dog,” Arch. Int. Pharmacodyn. (butorphanol tartrate 20 timesfi gure: that of pentazocine.2,3 equivalent to 5 mL of TORBUGESIC for each 1000 lbs 8. Robertson, J.T. and Muir, W.W.: “Cardiopulmonary detectable drug eff ects were transient behavioral Ther. 233: 296–304, 1978. Butorphanol has 15 to 20 times the oral antitussive SubacuteMarked Equine ataxia Studies was reported in 1.5% of the body weight. Eff ects of Butorphanol Tartrate in Horses,” Am. J. changes typical of narcotic agonist activity. These 6. Nagashmina, H. et al: “Respiratory and injection) activity of Analgesiccodeine or Eff dextromethorphanects of Butorphanol in Given dogs at Horses327 were horses found treated. to tolerate Mild sedationbutorphanol was reportedgiven in The dose may be repeated within 3 to 4 hours but Vet. Res. 42: 41–44, 1981. included muscle fasciculation about the head and Circulatory Eff ects of Intravenous Butorphanol and guineaVarious pigs. Dosages4 in Horses with Abdominal Pain intravenously9% of the at horses.dosages of 0.1, 0.3 and 0.5 mg/kg treatment should not exceed 48 hours. 9. Kalpravidh, M. et al: “Eff ects of Butorphanol, CAUTION neck, dysphoria, lateral nystagmus, ataxia and and Morphine,” Clin. Pharmacol. Ther. 19: As an antagonist, butorphanol is approximately every 4 hours for 48 hours followed by once daily Use contents within 4 months of fi rst puncture. Flunixin, Levorphanol, Morphine, Pentazocine FederalIn (USA) horses, law restrictsintravenous this drugdosages to use of by butorphanol or on Repeatedsalivation. administration of butorphanol at 1 mg/kg injections for a total of 21 days.DOSAGE The only detectable Pre-clinical735–745, model studies1976. and clinical fi eld trials in and Xylazine in Ponies,” Am. J. Vet. Res. 45: equivalent(10 times to nalorphine the recommended and 30 times dose) more every potent four hours the orderranging of a licensed from 0.05 veterinarian. to 0.4 mg/kg were shown to be 1 drug effThe ects recommended were slight transientdosage inataxia the horseobserved is 0.1 mg 7.horses Popio, demonstrate K.A. et al: “Hemodynamic that the analgesic and Respiratory eff ects of 217–223, 1984. eff ective in alleviating visceral and superfi cial painthan pentazocine.for 48 hours caused constipation in one of two of butorphanol per kilogram of body weight Eff ects of Morphine and Butorphanol,” Clin. Cardiopulmonary depressant eff ects are minimal occasionally in the high dosage group. No clinical, TORBUGESIC are seen within 15 minutes following for at least 4DESCRIPTION hours, as illustrated in the following horses. laboratory,(0.05 ormg/lb) gross orby histopathologic intravenous evidenceinjection. ofThis is injectionPharmacol. and persistTher. 23: for 281– about287, 4 1978. hours. TORBUGESICfi gure: (butorphanol tartrate injection) is a after treatment with butorphanol as demonstrated equivalent to 5 mL of TORBUGESIC for each 1000 lbs 8. Robertson, J.T. and Muir, W.W.: “Cardiopulmonary in dogs5, humans6,7 and horses.8 any butorphanol-related toxicity was encountered totally synthetic, centrally acting, narcotic agonist- Subacute Equine Studies body weight. Eff ects of ButorphanolHOW SUPPLIED Tartrate in Horses,” Am. J. Unlike classical narcotic agonist analgesics which in the horses. Distributed by: antagonist Analgesicanalgesic Eff ectswith of Butorphanolpotent antitussive Given at Horses were found to tolerate butorphanol given The dose may be repeated within 3 to 4 hours but 50 Vet.mL Re vialss. 42: TORBUGESIC41–44, 1981. (butorphanol tartrate are associated with decreases in blood pressure, Zoetis Inc. activity.Various It is aDosages member in Horsesof the with phenanthrene Abdominal Pain intravenously at dosages of 0.1, 0.3 and 0.5 mg/kg treatment should not exceed 48 hours. 9.injection)Kalpravidh, Veterinary M. et Injection,al: “Eff ects 10 mgof Butorphanolbase activity, reduction in heart rate and concomitant release of INDICATIONS Kalamazoo, MI 49007 series. The chemical name is Morphinan-3, 14- every 4 hours for 48 hours followed by once daily Use contents within 4 months of fi rst puncture. perF mL.lunixin, Levorphanol, Morphine, Pentazocine histamine, butorphanol does not cause histamine TORBUGESIC (butorphanol tartrate injection) is diol, 17-(cyclobutylmethyl)-, (-)-, (S- (R*, R*))-2,3- injections for a total of 21 days. The only detectable Pre-clinical model studies and clinical fi eld trials in 10 andmL Xylazinevials TORBUGESIC in Ponies,” (butorphanol Am. J. Vet. Res.tartrate 45: release.1 indicated for the relief of pain associated with colic Made in Spain dihydroxybutanedioate (1:1) (salt). It is a white, drug eff ects were slight transient ataxia observed horses demonstrate that the analgesic eff ects of injection)217–223, Veterinary 1984. Injection, 10 mg base activity Furthermore, the cardiopulmonary eff ects of in adult horses and yearlings. Clinical studies in crystalline, water soluble substance having a occasionally in the high dosage group. No clinical, the horseTORBUGESIC have shown are thatseen TORBUGESIC within 15 minutes alleviates following per mL. Revised: April 2018 molecular weight of 477.55; its molecular formula is butorphanollaboratory, are notor gross distinctly or histopathologic dosage-related evidence but of injection and persist for about 4 hours. rather reach a ceiling eff ect beyond which further abdominal pain associated with torsion, impaction, C21H29NO2•C4H6O6. any*Pain butorphanol-related threshold in butorphanol-treated toxicity colickywas encountered horses relative Store at controlled room temperature 20°-25°C dosage increases result in relatively lesser eff ects. intussusception, spasmodic and tympanic colic and into theplacebo horses. controls. postpartum pain. HOW SUPPLIED Distributed(68°-77°F) with by: excursions between 15°-30°C (59°- Chemical Structure Reproduction: Studies performed in mice and 50 mL vials TORBUGESIC (butorphanol tartrate Zoetis86°F). Inc. rabbits revealed no evidence of impaired fertility or A defi nite dosage-responseINDICATIONS relationship was injection) VeterinaryWARNINGS Injection, 10 mg base activity Kalamazoo, MI 49007 harm toTORBUGESICdetected the fetus in due that (butorphanol to butorphanol butorphanol tartrate dosage tartrate. ofinjection) In 0.1 the mg/kg is per mL. REFERENCES female rat, parenteral administration was associated DO NOT USE IN HORSES INTENDED FOR HUMAN indicatedwas more for eff the ective relief thanof pain 0.05 associated mg/kg withbut colicnot CONSUMPTION.10 mL vials NOT TORBUGESICFOR HUMAN USE.(butorphanol tartrate Made1. Pircio, in Spain A.W. et al: “The Pharmacology of with increasedindiff adulterent nervousnesshorsesfrom and0.2 mg/kgyearlings.and decreased in Clinicalalleviating care studies for deep in injection) Veterinary Injection, 10 mg base activity Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): the newborn,theabdominal horse resulting have pain. shown in a decreased that TORBUGESIC survival ratealleviates per mL. Revised:231–257, April 1976. 2018 of the newborn. This nervousness was seen only in CAUTION abdominal pain associated with torsion, impaction, TORBUGESIC, a potent analgesic, should be used 2. Dobkin, A.B. et al: “Butorphanol and Pentazocine the rat species. Store at controlled room temperature 20°-25°C *Pain threshold in butorphanol-treated colicky horses relative intussusception,Acute Equine Studies spasmodic and tympanic colic and with caution with other sedative or analgesic drugs in Patients with Severe Postoperative Pain,” Clin. to placebo controls. (68°-77°F) with excursions between 15°-30°C (59°- postpartumRapid intravenous pain. administration of butorphanol at as these are likely to produce additive eff ects. Pharmacol. Ther. 18: 547–553, 1975. Equine Pharmacology 86°F). a dosage of 2 mg/kg (20 times the recommended There are no well-controlled studies using 3. Gilbert, M.S. et al: “Intramuscular Butorphanol A defi nite dosage-response relationship wasFollowing intravenous injection in horses, dosage) to a previouslyWARNINGS unmedicated horse resulted butorphanol in breeding horses, weanlings and and Meperidine in Postoperative Pain,” Clin. Each detectedmL of inTORBUGESIC that butorphanol contains dosage 10 of 0.1mg mg/kg butorphanol DOin aNOT brief isUSE episodelargely IN HORSES ofeliminated inability INTENDED tofrom stand,FOR the HUMANmuscle REFERENCES Pharmacol. Ther. 20: 359–364, 1976. foals. Therefore, the drug should not be used in CLINICAL PHARMACOLOGY butorphanolwas more base eff(as ective butorphanol than 0.05tartrate), mg/kg 3.3 mgbut notblood CONSUMPTION.fasciculation,within 3 to 4 ahours. NOTconvulsive FORThe HUMANdrug seizure is extensivelyUSE. of 6 seconds 1. Pircio, A.W. et al: “The Pharmacology of 4. Cavanagh, R.L. et al: “Antitussive Properties of these groups. Comparative Pharmacology citric acid,diff erent 6.4 mgfrom sodium 0.2 mg/kgcitrate, 4.7in mgalleviating sodium deepmetabolized duration in theand liver recovery and excreted within in thethree urine. minutes. Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): In animals, butorphanol has been demonstrated to chloride,abdominal and 0.1 pain.mg benzethonium chloride, q.s. In ponies,The samebutorphanol dosage administeredgivenCAUTION intramuscularly after 10 successive at 231–257, 1976. 258–268, 1976. NADA 135-780, Approved by FDA ADVERSE REACTIONS be 4 to 30 times more potent than morphine and with water for injection. a dosageTORBUGESIC,daily of 1 0.22mg/kg mg/kg, a potentdosages was analgesic, shownof butorphanol to should alleviate beresulted used 2. Dobkin, A.B. et al: “Butorphanol and Pentazocine 5. Schurig, J.E. et al: “Eff ect of Butorphanol and In clinical trials in horses, the most commonly pentazocine (Talwin®-V) respectively.1 Acute Equine Studies experimentallywithonly cautionin transient induced with sedative other visceral sedative eff ects.pain orDuring for analgesic about the 10-day drugs in Patients with Severe Postoperative Pain,” Clin. Morphine on Pulmonary Mechanics, Arterial 9 observed side eff ect was slight ataxia which lasted In humans, butorphanol has been shown to have Rapid intravenousCLINICAL PHARMACOLOGY administration of butorphanol at4 hours.ascourse these of are administration likely to produce at 1 additivemg/kg (10 eff ects.times the Pharmacol. Ther. 18: 547–553, 1975. Blood Pressure,Torbugesic® and Venous Plasma Histamine in 3 to 10 minutes. 5 to 7 times the analgesic activity of morphine and Comparativea dosage Pharmacology of 2 mg/kg (20 times the recommended Thererecommended are no use well-controlled level) in two horses,studies the using only 3. Gilbert, M.S. et al: “Intramuscular Butorphanol the Anesthetized Dog,” Arch. Int. Pharmacodyn. (butorphanol tartrate 20 times that of pentazocine.2,3 In animals,dosage) butorphanol to a previously has beenunmedicated demonstrated horse resultedto butorphanoldetectable drug in breedingeff ects were horses, transient weanlings behavioral and and Meperidine in Postoperative Pain,” Clin. Ther. 233: 296–304, 1978. NADA 135-780, Approved by FDA Marked ataxia was reported in 1.5% of the Butorphanol has 15 to 20 times the oral antitussive be 4 toin 30a brieftimes episodemore potent of inability than morphine to stand, and muscle foals.changes Therefore, typical ofthe narcotic drug should agonist not activity. be used These in Pharmacol. Ther. 20: 359–364, 1976. 6. Nagashmina, H. injection)et al: “Respiratory and 40022905 1 327 horses treated. Mild sedation was reported in activity of codeine or dextromethorphan in dogs pentazocinefasciculation, (Talwin®-V) a convulsive respectively. seizure of 6 seconds theseincluded groups. muscle fasciculation about the head and 4. Cavanagh, R.L. et al: “Antitussive Properties of Circulatory Eff ects of Intravenous Butorphanol 9% of the horses. and guinea pigs.4 Torbugesic® In humans,duration butorphanol and recovery has been within shown three to haveminutes. neck, dysphoria, lateral nystagmus, ataxia and Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): and Morphine,” Clin. CAUTIONPharmacol. Ther. 19: As an antagonist, butorphanol is approximately 5 to 7The times same the dosageanalgesic administered activity of morphine after 10 successive and salivation. ADVERSE REACTIONS 258–268, 1976. 735–745,Federal 1976. (USA) law restricts this drug to use by or on (butorphanol tartrate 20 timesdaily that 1 ofmg/kg pentazocine. dosages2,3 of butorphanol resulted 5. Schurig, J.E. et al: “Eff ect of Butorphanol and equivalent to nalorphine and 30 times more potent In horses, intravenous dosages of butorphanol InRepeated clinical administrationtrials in horses, of butorphanol the most commonlyat 1 mg/kg DOSAGE the order of a licensed veterinarian. 1 Butorphanolonly in transienthas 15 to sedative 20 times eff the ects. oral During antitussive the 10-day Morphine on Pulmonary Mechanics, Arterial than pentazocine. ranging from 0.05 to 0.4 mg/kg were shown to be observed(10 times sidethe recommended eff ect was slight dose) ataxia every which four lasted hours The recommended dosage in the horse is 0.1 mg 7. Popio, K.A. et al: “Hemodynamic and Respiratory injection) activitycourse of codeine of administration or dextromethorphan at 1 mg/kg (10in dogstimes the Blood Pressure, and Venous Plasma Histamine in Cardiopulmonary depressant eff ects are minimal eff ective in alleviating visceral and superfi cial pain 3for to 1048 minutes.hours caused constipation in one of two of butorphanol per kilogram of body weight Eff ects of Morphine DESCRIPTIONand Butorphanol,” Clin. and guinearecommended pigs.4 use level) in two horses, the only the Anesthetized Dog,” Arch. Int. Pharmacodyn. after treatment with butorphanol as demonstrated CAUTION for at least 4 hours, as illustrated in the following horses. (0.05 mg/lb) by intravenous injection. This is Pharmacol.TORBUGESIC Ther. 23:(butorphanol 281–287, 1978. tartrate injection) is a 5 6,7 8 As andetectable antagonist, drug butorphanol eff ects were is transientapproximately behavioral Ther. 233: 296–304, 1978. in dogs , humans and horses. Federal (USA) law restricts this drug to use by or on fi gure: Marked ataxia was reported in 1.5% of the equivalent to 5 mL of TORBUGESIC for each 1000 lbs 8. Robertson,totally synthetic, J.T. and Muir, centrally W.W.: “Cardiopulmonaryacting, narcotic agonist- equivalentchanges to nalorphinetypical of andnarcotic 30 times agonist more activity. potent These 6. Nagashmina, H. et al: “Respiratory and Unlike classical narcotic agonist analgesics which the order of a licensed veterinarian. 327Subacute horses Equine treated. Studies Mild sedation was reported in body weight. Eff ectsantagonist of Butorphanol analgesic Tartrate with in Horses,”potent Am.antitussive J. than pentazocine.included muscle1 fasciculation about the head and Circulatory Eff ects of Intravenous Butorphanol are associated with decreases in blood pressure, Analgesic Eff ects of Butorphanol Given at 9%Horses of the were horses. found to tolerate butorphanol given The dose may be repeated within 3 to 4 hours but Vet.activity. Res. 42: 41–44,It is 1981.a member of the phenanthrene Cardiopulmonaryneck, dysphoria, depressant lateral effnystagmus, ects are minimal ataxia and and Morphine,” Clin. Pharmacol. Ther. 19: reduction in heart rate and concomitant release of DESCRIPTION Various Dosages in Horses with Abdominal Pain intravenously at dosages of 0.1, 0.3 and 0.5 mg/kg treatment should not exceed 48 hours. 9. Kalpravidh,series. The M. chemicalet al: “Eff nameects of is ButorphanolMorphinan-3,, 14- In horses, intravenous dosages of butorphanolafter treatmentsalivation.Repeated administrationwith butorphanol of butorphanol as demonstrated at 1 mg/kg DOSAGE 735–745, 1976. histamine, butorphanol does not cause histamine TORBUGESIC (butorphanol tartrate injection) is a every 4 hours for 48 hours followed by once daily Use contents within 4 months of fi rst puncture. Flunixin,diol, 17-(cyclobutylmethyl)-,Levorphanol, Morphine, (-)-, Pentaz (S- (R*,ocine R*))-2,3- 1 in dogs5, humans6,7 and horses.8 release. totallyranging synthetic, from centrally 0.05 to acting,0.4 mg/kg narcotic were agonist- shown to be (10 times the recommended dose) every four hours injectionsThe forrecommended a total of 21 days.dosage The in only the detectablehorse is 0.1 mg 7.Pre-clinical Popio, K.A. model et al : studies“Hemodynamic and clinical and fi Respiratoryeld trials in anddihydroxybutanedioate Xylazine in Ponies,” Am.(1:1) J.(salt). Vet. Res.It is 45:a white, Unlike classical narcotic agonist analgesics which Furthermore, the cardiopulmonary eff ects of antagonisteff ective analgesic in alleviating with visceral potent and antitussivesuperfi cial pain for 48 hours caused constipation in one of two drug effof ects butorphanol were slight pertransient kilogram ataxia of observed body weight horsesEff ects demonstrate of Morphine that andthe analgesicButorphanol,” eff ects Clin. of 217–223,crystalline, 1984. water soluble substance having a are associated with decreases in blood pressure, butorphanol are not distinctly dosage-related but activity.for Itat leastis a 4member hours, asof illustrated the phenanthrene in the following horses. occasionally(0.05 inmg/lb) the high by dosageintravenous group. injection. No clinical, This is TORBUGESICPharmacol. areTher. seen 23: 281–within287, 15 1978.minutes following molecular weight of 477.55; its molecular formula is reduction in heart rate and concomitant release of rather reach a ceiling eff ect beyond which further series.fi gure:The chemical name is Morphinan-3, 14- laboratory,equivalent or gross to 5or mL histopathologic of TORBUGESIC evidence for each of1000 lbs 8.injection Robertson, and persistJ.T. and forMuir, about W.W.: 4 “Cardiopulmonaryhours. C21H29NO2•C4H6O6. histamine, butorphanol does not cause histamine dosage increases result in relatively lesser eff ects. diol, 17-(cyclobutylmethyl)-, (-)-, (S- (R*, R*))-2,3- Subacute Equine Studies any butorphanol-relatedbody weight. toxicity was encountered Eff ects of Butorphanol Tartrate in Horses,” Am. J. release.1 Reproduction: Studies performed in mice and dihydroxybutanedioateAnalgesic Eff ects(1:1) of (salt).Butorphanol It is a Given white, at Horses were found to tolerate butorphanol given in the horses.The dose may be repeated within 3 to 4 hours but Vet. Res. 42: 41–44,HOW 1981. SUPPLIED DistributedChemical by: Structure Furthermore, the cardiopulmonary eff ects of rabbits revealed no evidence of impaired fertility or crystalline,Various water Dosages soluble in Horses substance with Abdominal having a Pain intravenously at dosages of 0.1, 0.3 and 0.5 mg/kg treatment should not exceed 48 hours. 9.50 Kalpravidh,mL vials TORBUGESICM. et al: “Eff (butorphanolects of Butorphanol tartrate, Zoetis Inc. butorphanol are not distinctly dosage-related but harm to the fetus due to butorphanol tartrate. In the molecular weight of 477.55; its molecular formula is every 4 hours for 48 hours followed by once daily Use contentsINDICATIONS within 4 months of fi rst puncture. injection)Flunixin, Veterinary Levorphanol, Injection, Morphine, 10 mg basePentaz activityocine Kalamazoo, MI 49007 rather reach a ceiling eff ect beyond which further female rat, parenteral administration was associated C21H29NO2•C4H6O6. injections for a total of 21 days. The only detectable TORBUGESICPre-clinical (butorphanol model studies tartrate and clinicalinjection) fi eld istrials in perand mL. Xylazine in Ponies,” Am. J. Vet. Res. 45: dosage increases result in relatively lesser eff ects. with increased nervousness and decreased care for drug eff ects were slight transient ataxia observed indicatedhorses for thedemonstrate relief of pain that associated the analgesic with colic eff ects of 10 217–223,mL vials 1984. TORBUGESIC (butorphanol tartrate Made in Spain Reproduction: Studies performed in mice and the newborn, resulting in a decreased survival rate Chemical Structure occasionally in the high dosage group. No clinical, in adultTORBUGESIC horses and are yearlings. seen within Clinical 15 minutes studies following in injection) Veterinary Injection, 10 mg base activity rabbits revealed no evidence of impaired fertility or of the newborn. This nervousness was seen only in laboratory, or gross or histopathologic evidence of the horseinjection have andshown persist that forTORBUGESIC about 4 hours. alleviates per mL. Revised: April 2018 harm to the fetus due to butorphanol tartrate. In the the rat species. any butorphanol-related toxicity was encountered abdominal pain associated with torsion, impaction, femalein rat, the parenter horses. al administration was associated HOW SUPPLIED DistributedStore at controlled by: room temperature 20°-25°C *Pain threshold in butorphanol-treated colicky horses relative intussusception, spasmodic and tympanic colic and Equine Pharmacology with increasedto placebo nervousnesscontrols. and decreased care for 50 mL vials TORBUGESIC (butorphanol tartrate Zoetis(68°-77°F) Inc. with excursions between 15°-30°C (59°- postpartum pain. Following intravenous injection in horses, the newborn, resulting inINDICATIONS a decreased survival rate injection) Veterinary Injection, 10 mg base activity Kalamazoo,86°F). MI 49007 butorphanol is largely eliminated from the of theTORBUGESICA newborn. defi nite This dosage-response(butorphanol nervousness wastartrate seenrelationship injection)only in was is per mL. Each mL of TORBUGESIC contains 10 mg WARNINGS blood within 3 to 4 hours. The drug is extensively the ratindicateddetected species. forin that the reliefbutorphanol of pain dosageassociated of 0.1with mg/kg colic 10 mL vials TORBUGESIC (butorphanol tartrate MadeREFERENCES in Spain butorphanol base (as butorphanol tartrate), 3.3 mg DO NOT USE IN HORSES INTENDED FOR HUMAN metabolized in the liver and excreted in the urine. inwas adult more horses eff ective and yearlings.than 0.05 Clinical mg/kg studies but not in injection) Veterinary Injection, 10 mg base activity 1. Pircio, A.W. et al: “The Pharmacology of citric acid, 6.4 mg sodium citrate, 4.7 mg sodium CONSUMPTION. NOT FOR HUMAN USE. In ponies, butorphanol given intramuscularly at Equinethediff Pharmacology erenthorse havefrom shown0.2 mg/kg that TORBUGESIC in alleviating alleviates deep per mL. Revised:Butorphanol,” April 2018 Arch. Int. Pharmacodyn. Ther. 220 (2): chloride, and 0.1 mg benzethonium chloride, q.s. Following intravenous injection in horses, a dosage of 0.22 mg/kg, was shown to alleviate abdominalabdominal painpain. associated with torsion, impaction, CAUTION 231–257, 1976. with water for injection. *Pain threshold in butorphanol-treated colicky horses relativebutorphanol intussusception, is largely spasmodic eliminated and tympanic from thecolic and Store at controlled room temperature 20°-25°C experimentally induced visceral pain for about Each mL of TORBUGESIC contains 10 mg TORBUGESIC, a potent analgesic, should be used 2. Dobkin, A.B. et al: “Butorphanol and Pentazocine 9 to placebo controls. blood within 3 to 4 hours. The drug is extensively (68°-77°F) with excursions between 15°-30°C (59°- 4 hours. butorphanol base (as butorphanol tartrate), 3.3 mg postpartumAcute Equine pain. Studies with caution with other sedative or analgesic drugs in Patients with Severe Postoperative Pain,” Clin. metabolized in the liver and excreted in the urine. 86°F). citric acid, 6.4 mg sodium citrate, 4.7 mg sodium Rapid intravenous administration of butorphanol at as these are likely to produce additive eff ects. Pharmacol. Ther. 18: 547–553, 1975. A defi nite dosage-response relationship wasIn ponies, butorphanol given intramuscularly at chloride, and 0.1 mg benzethonium chloride, q.s. a dosage of 2 mg/kgWARNINGS (20 times the recommended There are no well-controlled studies using 3. Gilbert, M.S. et al: “Intramuscular Butorphanol detected in that butorphanol dosage of 0.1 mg/kga dosage of 0.22 mg/kg, was shown to alleviate REFERENCES with water for injection. DOdosage) NOT toUSE a previously IN HORSES unmedicated INTENDED horseFOR HUMANresulted butorphanol in breeding horses, weanlings and and Meperidine in Postoperative Pain,”40022905 Clin. was more eff ective than 0.05 mg/kg but notexperimentally induced visceral pain for about 1. Pircio, A.W. et al: “The Pharmacology of CONSUMPTION.in a brief episode NOT FORof inability HUMAN toUSE. stand, muscle foals. Therefore, the drug should not be used in Pharmacol. Ther. 20: 359–364, 1976. diff erent from 0.2 mg/kg in alleviating deep4 hours.9 Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): fasciculation, a convulsive seizure of 6 seconds these groups. 4. Cavanagh, R.L. et al: “Antitussive Properties of abdominal pain. duration and recoveryCAUTION within three minutes. 231–257, 1976. Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): 2. 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