Label: TORBUGESIC SA- butorphanol tartrate solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated February 13, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    NADA 141-047, Approved by FDA

    Torbugesic-SA®

    (butorphanol tartrate injection)

    CIV

  • CAUTION

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

  • DESCRIPTION

    Butorphanol tartrate,  is a synthetic, centrally acting, narcotic agonist-antagonist analgesic with potent antitussive activity. The results from laboratory and clinical studies suggest the existence of several distinct types of receptors that are responsible for the activity of opioid and opioid-like drugs. When activated, the μ(mu)-receptors are involved in analgesia, respiratory depression, miosis, physical dependence and feelings of well-being (euphoria). When activated, the κ(kappa)-receptors are involved in analgesia, as well as less intense (as compared to μ-receptors) miosis and respiratory depression. Butorphanol is considered to be a weak antagonist at the μ-receptor, but a strong agonist at the κ-receptor. Thus, butorphanol provides analgesia with a lower incidence and/or intensity of adverse reactions (e.g., miosis and respiratory depression) than traditional opioids.

    Butorphanol tartrate 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-SA contains 2 mg butorphanol base (as butorphanol tartrate, USP); 3.3 mg citric acid, USP; 6.4 mg sodium citrate, USP; 4.7 mg sodium chloride; and 0.1 mg benzethonium chloride; q.s. with water for injection.

  • CLINICAL PHARMACOLOGY

    Feline Pharmacology

    The magnitude and duration of analgesic activity of butorphanol were studied in cats under controlled laboratory conditions using both a visceral pain model and a somatic pain model.1,2 Subcutaneous butorphanol dosages of 0.4 mg/kg produced analgesia significantly (p<0.05) greater than the placebo for up to two hours in the somatic pain model. At the label dose (0.4 mg/kg), cardiopulmonary depressant effects were minimal after treatment with butorphanol as demonstrated in cats.1,2

    Clinical studies confirmed the analgesic effect of butorphanol administered subcutaneously in the cat. In field trials the overall analgesic effect was rated as satisfactory in approximately 75% of butorphanol treated cats. The duration of activity in cats responding to butorphanol ranged from 15 minutes to 8 hours. However, in 70% of responding cats the duration of activity was 3 to 6 hours following subcutaneous administration

    Safety Studies in Cats

    Daily subcutaneous injections of butorphanol in cats, beginning at a dosage of 2 mg/kg the first week and doubling each week to a final dosage of 16 mg/kg on the fourth week, resulted in no deaths. No evidence of toxicity was observed during the first three weeks of the experiment, other than pain on injection. During the fourth week, transient incoordination, salivation, or mild seizures were observed within the first hour in the cats following the 16 mg/kg dosage (40 times the recommended clinical dosage). No other clinical, serum chemistry, or gross necropsy evidence of drug toxicity was encountered in any of the cats.

    In subacute safety studies, butorphanol was injected subcutaneously to each of six cats at dosages of 0 (saline), 0.4, 1.2 or 2.0 mg/kg, every six hours for six days and continued once daily for a total of 21 days. The only adverse clinical effect observed was pain on injection. Histopathologic changes indicative of minimal to slight irritation were noted at the injection sites in 3 of 6 cats in the low dose group, 4 of 6 cats in the middle dose group and 6 of 6 cats in the high dose group. Histopathologic changes of focal renal tubular dilation were noted in half of the cats in the high dose group.

  • INDICATIONS

    TORBUGESIC-SA (butorphanol tartrate injection) is indicated for the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.

  • WARNINGS

    NOT FOR HUMAN USE.

  • PRECAUTIONS

    TORBUGESIC-SA, a potent analgesic, should be used with caution with other sedative or analgesic drugs as these are likely to produce additive effects.

    Safety for use in pregnant female cats, breeding male cats or kittens less than 4 months of age has not been determined. Use of TORBUGESIC-SA can therefore not be recommended in these groups.

  • ADVERSE REACTIONS

    In clinical trials in cats, pain on injection, mydriasis, disorientation, swallowing/licking and sedation were reported.

  • DOSAGE

    The recommended dosage in cats is 0.4 mg of butorphanol per kilogram body weight (0.2 mg/lb) given by subcutaneous injection. This is equivalent to 1.0 mL of TORBUGESIC-SA per 10 lbs of body weight.

    Pre-clinical model studies and clinical field trials in cats demonstrated that the analgesic effects of TORBUGESIC-SA are seen within 20 minutes and persist in the majority of responding cats for 3 to 6 hours following subcutaneous injection (see Feline Pharmacology). The dose may be repeated up to 4 times per day for up to 2 days.

    Use contents within 4 months of first puncture.

  • HOW SUPPLIED

    10 mL vials TORBUGESIC-SA (butorphanol tartrate injection) Veterinary Injection, 2 mg base

    activity per mL.

    10 mL —vials

    Store at controlled room temperature 20°-

    25°C (68°-77°F) with excursions between 15°-

    30°C (59°-86°F).

  • References

    1. Sawyer, D.C. and Rech, R.H. “Analgesia and Behavioral Effects of Butorphanol, Nalbuphine and Pentazocine in the Cat,” J. Amer. Hosp.    Assoc. 23: 438–446, 1987.

    2. Mandsager, R.E. and Raffe, M.R. “Evaluation of Periosteal Nociception in the Cat,” PVN 2(4): 237–242, 1991.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Revised: August 2016

    Made in Spain

    40014911

  • PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

    Torbugesic -SA®

    (butorphanol tartrate injection)

    contains 2 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 141-047, Approved by FDA

    10 mL

    40014909

    Zoetis

    Torbugesic SA Label
  • INGREDIENTS AND APPEARANCE
    TORBUGESIC  SA
    butorphanol tartrate solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-4531
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BUTORPHANOL TARTRATE (UNII: 2L7I72RUHN) (BUTORPHANOL - UNII:QV897JC36D) BUTORPHANOL TARTRATE2 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:54771-4531-110 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14104706/11/1985
    Labeler - Zoetis Inc. (828851555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teva Czech Industries s.r.o643896244API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Zoetis Manufacturing & Research Spain, S.L.460052343MANUFACTURE