Label: TORBUGESIC- butorphanol tartrate solution

  • NDC Code(s): 54771-2033-1, 54771-2033-2
  • Packager: Zoetis Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated October 16, 2018

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  • SPL UNCLASSIFIED SECTION

    NADA 135-780, Approved by FDA

    Torbugesic®

    (butorphanol tartrate injection)

  • CAUTION

    Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

  • DESCRIPTION

    TORBUGESIC (butorphanol tartrate injection) is a totally synthetic, centrally acting, narcotic agonist-antagonist analgesic with potent antitussive activity. It is a member of the phenanthrene series. The chemical name is Morphinan-3, 14-diol, 17-(cyclobutylmethyl)-, (-)-, (S- (R*, R*))-2,3-dihydroxybutanedioate (1:1) (salt). It is a white, crystalline, water soluble substance having a molecular weight of 477.55; its molecular formula is C21H29NO2•C4H6O6.

    Chemical Structure

    Chemical Structure

     

     

    Each mL of TORBUGESIC contains 10 mg butorphanol base (as butorphanol tartrate), 3.3 mg citric acid, USP, 6.4 mg sodium citrate, 4.7 mg sodium chloride, and 0.1 mg benzethonium chloride, q.s. with water for injection.

  • CLINICAL PHARMACOLOGY

    Comparative Pharmacology

    In animals, butorphanol has been demonstrated to be 4 to 30 times more potent than morphine and pentazocine (Talwin®-V) respectively.1

    In humans, butorphanol has been shown to have 5 to 7 times the analgesic activity of morphine and 20 times that of pentazocine.2,3

    Butorphanol has 15 to 20 times the oral antitussive activity of codeine or dextromethorphan in dogs and guinea pigs.4

    As an antagonist, butorphanol is approximately equivalent to nalorphine and 30 times more potent than pentazocine.1

    Cardiopulmonary depressant effects are minimal after treatment with butorphanol as demonstrated in dogs5, humans6,7 and horses.8

    Unlike classical narcotic agonist analgesics which are associated with decreases in blood pressure, reduction in heart rate and concomitant release of histamine, butorphanol does not cause histamine release.1

    Furthermore, the cardiopulmonary effects of butorphanol are not distinctly dosage-related but rather reach a ceiling effect beyond which further
    dosage increases result in relatively lesser effects.

    Reproduction: Studies performed in mice and rabbits revealed no evidence of impaired fertility or harm to the fetus due to butorphanol tartrate. In the female rat, parenteral administration was associated with increased nervousness and decreased care for the newborn, resulting in a decreased survival rate of the newborn. This nervousness was seen only in the rat species.

    Equine Pharmacology

    Following intravenous injection in horses, butorphanol is largely eliminated from the blood within 3 to 4 hours. The drug is extensively metabolized in the liver and excreted in the urine. In ponies, butorphanol given intramuscularly at a dosage of 0.22 mg/kg, was shown to alleviate experimentally induced visceral pain for about 4 hours.9

    In horses, intravenous dosages of butorphanol ranging from 0.05 to 0.4 mg/kg were shown to be effective in alleviating visceral and superficial pain for at least 4 hours, as illustrated in the following figure:

    Analgesic Effects of Butorphanol Given at
    Various Dosages in Horses with Abdominal Pain
     *Pain threshold in butorphanol-treated colicky horses relative to placebo controls.
     Figure

    A definite dosage-response relationship was detected in that butorphanol dosage of 0.1 mg/kg was more effective than 0.05 mg/kg but not different from 0.2 mg/kg in alleviating deep abdominal pain.

    Acute Equine Studies

    Rapid intravenous administration of butorphanol at a dosage of 2 mg/kg (20 times the recommended dosage) to a previously unmedicated horse resulted in a brief episode of inability to stand, muscle fasciculation, a convulsive seizure of 6 seconds duration and recovery within three minutes. The same dosage administered after 10 successive daily 1 mg/kg dosages of butorphanol resulted only in transient sedative effects. During the 10-day course of administration at 1 mg/kg (10 times the recommended use level) in two horses, the only detectable drug effects were transient behavioral changes typical of narcotic agonist activity. These included muscle fasciculation about the head and neck, dysphoria, lateral nystagmus, ataxia and salivation.

    Repeated administration of butorphanol at 1 mg/kg (10 times the recommended dose) every four hours for 48 hours caused constipation in one of two horses.

    Subacute Equine Studies

    Horses were found to tolerate butorphanol given intravenously at dosages of 0.1, 0.3 and 0.5 mg/kg every 4 hours for 48 hours followed by once daily injections for a total of 21 days. The only detectable drug effects were slight transient ataxia observed occasionally in the high dosage group. No clinical, laboratory, or gross or histopathologic evidence of any butorphanol-related toxicity was encountered in the horses.

  • INDICATIONS

    TORBUGESIC (butorphanol tartrate injection) is indicated for the relief of pain associated with colic in adult horses and yearlings. Clinical studies in the horse have shown that TORBUGESIC alleviates abdominal pain associated with torsion, impaction, intussusception, spasmodic and tympanic colic and postpartum pain.

  • WARNINGS

    DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUMPTION. NOT FOR HUMAN USE.

  • CAUTION

    TORBUGESIC, a potent analgesic, should be used with caution with other sedative or analgesic drugs as these are likely to produce additive effects. There are no well-controlled studies using butorphanol in breeding horses, weanlings and foals. Therefore, the drug should not be used in these groups.

  • ADVERSE REACTIONS

    In clinical trials in horses, the most commonly observed side effect was slight ataxia which lasted 3 to 10 minutes.

    Marked ataxia was reported in 1.5% of the 327 horses treated. Mild sedation was reported in 9% of the horses.

  • DOSAGE

    The recommended dosage in the horse is 0.1 mg of butorphanol per kilogram of body weight (0.05 mg/lb) by intravenous injection. This is equivalent to 5 mL of TORBUGESIC for each 1000 lbs body weight.

    The dose may be repeated within 3 to 4 hours but treatment should not exceed 48 hours.

    Use contents within 4 months of first puncture. Pre-clinical model studies and clinical field trials in horses demonstrate that the analgesic effects of TORBUGESIC are seen within 15 minutes following injection and persist for about 4 hours.

  • HOW SUPPLIED

    50 mL vials TORBUGESIC (butorphanol tartrate injection) Veterinary Injection, 10 mg base activity per mL.

    10 mL vials TORBUGESIC (butorphanol tartrate injection) Veterinary Injection, 10 mg base activity per mL.

    Store at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F).

  • REFERENCES

    REFERENCES

    1. Pircio, A.W. et al: “The Pharmacology of Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2): 231–257, 1976.

    2. Dobkin, A.B. et al: “Butorphanol and Pentazocinein Patients with Severe Postoperative Pain,” Clin. Pharmacol. Ther.     18: 547–553, 1975.

    3. Gilbert, M.S. et al: “Intramuscular Butorphanol and Meperidine in Postoperative Pain,” Clin. Pharmacol. Ther. 20: 359     –364, 1976.

    4. Cavanagh, R.L. et al: “Antitussive Properties of Butorphanol,” Arch. Int. Pharmacodyn. Ther. 220 (2):258–268, 1976.

    5. Schurig, J.E. et al: “Eff ect of Butorphanol and Morphine on Pulmonary Mechanics, Arterial Blood Pressure, and     Venous Plasma Histamine in the Anesthetized Dog,” Arch. Int. Pharmacodyn. Ther. 233: 296–304, 1978.

    6. Nagashmina, H. et al: “Respiratory and Circulatory Effects of Intravenous Butorphanol and Morphine,” Clin. Pharmacol.     Ther. 19:735–745, 1976.

    7. Popio, K.A. et al: “Hemodynamic and Respiratory Effects of Morphine and Butorphanol,” Clin. Pharmacol. Ther. 23:     281–287, 1978.
    8. Robertson, J.T. and Muir, W.W.: “Cardiopulmonary Effects of Butorphanol Tartrate in Horses,” Am. J. Vet. Res. 42:     41–44, 1981.
    9. Kalpravidh, M. et al: “Effects of Butorphanol, Flunixin, Levorphanol, Morphine, Pentazocine zine  in Ponies,” Am. J.     Vet. Res.  45:217–223, 1984.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Made in Spain

    Revised: April 2018

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

    Torbugesic®

    (butorphanol tartrate injection)

    contains 10 mg butorphanol base per mL as butorphanol tartrate

    CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

    NADA 135-780, Approved by FDA

    10 mL

    40022903

    Zoetis

    10 mL bottle label

    10 mL bottle label

  • PRINCIPAL DISPLAY PANEL - 50 mL Carton Label

    Torbugesic®

    (butorphanol tartrate injection)

    contains 10 mg butorphanol base per mL as butorphanol tartrate

    CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed

    veterinarian.

    NADA 135-780, Approved by FDA

    50 mL

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Made in Spain

    40022907

    50 mL carton label

    50 mL carton label

  • INGREDIENTS AND APPEARANCE
    TORBUGESIC 
    butorphanol tartrate solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-2033
    Route of AdministrationINTRAVENOUSDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (BUTORPHANOL - UNII:QV897JC36D) BUTORPHANOL TARTRATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 3.3 mg  in 1 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-2033-21 in 1 CARTON
    150 mL in 1 VIAL
    2NDC:54771-2033-110 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA13578006/11/1985
    Labeler - Zoetis Inc. (828851555)