Label: TELAZOL- tiletamine hydrochloride and zolazepam hydrochloride injection, powder, for solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated May 5, 2020

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  • SPL UNCLASSIFIED SECTION

    100 mg/mL total
    (equivalent to 50 mg/mL tiletamine and 50 mg/mL zolazepam)
    For Intramuscular and Intravenous injection in Dogs
    For Intramuscular injection only in Cats

  • CAUTION

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

  • DESCRIPTION

    TELAZOL (tiletamine and zolazepam for injection) is a nonnarcotic, nonbarbiturate, injectable anesthetic agent for dogs and cats. Chemically, TELAZOL is a combination of equal parts by weight of base of tiletamine hydrochloride (2-[ethylamino]-2-[2-thienyl]-cyclohexanone hydrochloride), an arylaminocycloalkanone dissociative anesthetic, and zolazepam hydrochloride (4-[o-fluorophenyl]-6, 8-dihydro-1,3,8- trimethylpyrazolo [3, 4-e][1,4] diazepin-7 [1H]-1- hydrochloride), a nonphenothiazine diazepinone having minor tranquilizing properties. The product is supplied sterile in vials. The addition of 5 mL diluent produces a solution containing the equivalent of 50 mg tiletamine base, 50 mg zolazepam base and 57.7 mg mannitol per milliliter. This solution has a pH of 2 to 3.5 and is recommended for deep intramuscular injection.

  • INDICATIONS

    Dogs
    TELAZOL is indicated in dogs for restraint and minor procedures of short duration (30 min. avg.) requiring mild to moderate analgesia. Minor surgery is considered to be laceration repair, draining of abscesses, castrations and other procedures requiring mild to moderate analgesia. (See Dogs under Dosage and Administration.) TELAZOL administered intravenously is indicated in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic.

    Cats
    TELAZOL is indicated in cats for restraint or for anesthesia combined with muscle relaxation.

  • DOSAGE AND ADMINISTRATION

    The dose is determined by the total combined concentration of 100 mg/mL (see HOW SUPPLIED)

    Dogs

    Intramuscular (IM) For Restraint and Minor
    Procedures of Short Duration Requiring Mild to
    Moderate Analgesia:

    In healthy dogs, an initial intramuscular
    dosage of 3 to 4.5 mg/lb (6.6 to 9.9 mg/kg)
    TELAZOL is recommended for diagnostic
    purposes; 4.5 to 6 mg/lb (9.9 to 13.2 mg/
    kg) for minor procedures of short duration,
    such as treatment of lacerations and wounds,
    castrations and other procedures requiring mild
    to moderate analgesia. When supplemental
    doses of TELAZOL are required, such individual
    supplemental doses should be less than the
    initial dose, and the total dose given (initial
    dose plus supplemental dose or doses)
    should not exceed 12 mg/lb (26.4 mg/kg). The
    maximum safe dose is 13.6 mg/lb (29.92 mg/
    kg). (See Animal Safety.) Results from TELAZOL
    anesthesia in dogs will be more satisfactory
    if the procedures are completed within one
    hour and if the procedures can be completed
    following single dose administration. In order to
    maintain at least a 2X margin of safety in dogs,
    the use of this product is limited to procedures
    that call for low doses (see Indications). Studies
    show that there is variation in response to
    different dosages of TELAZOL and that low
    doses do not give adequate levels of anesthesia,
    and in some instances do not give adequate
    analgesia, for extensive procedures.


    Intravenous (IV) For Induction of Anesthesia
    Followed by Maintenance with an Inhalant
    Anesthetic:

    In dogs, for induction of anesthesia, administer
    TELAZOL intravenously at 1-2 mg/lb (2.2-4.4 mg/
    kg) body weight to effect. TELAZOL should be
    administered slowly, over 30-45 seconds; after
    approximately 30-60 seconds, the dog’s level
    of consciousness, muscle relaxation, and jaw
    tone should be assessed to determine the
    ability to intubate. If after waiting 60 seconds
    the dog’s level of anesthesia is not sufficient for
    successful intubation, additional TELAZOL may be
    administered; the total dose should not exceed
    2 mg/lb (4.4 mg/kg) body weight.

    Cats

    In healthy cats, an initial TELAZOL dosage of 4.4 to
    5.4 mg/lb (9.7 to 11.9 mg/kg) IM is recommended
    for such procedures as dentistry, treatment of
    abscesses, foreign body removal and related
    types of surgery; 4.8 to 5.7 mg/lb (10.6 to
    12.5 mg/kg) for minor procedures requiring
    mild to moderate analgesia, such as repair of
    lacerations, castrations and other procedures of
    short duration. Initial dosages of 6.5 to 7.2 mg/
    lb (14.3 to 15.8 mg/kg) are recommended for
    ovario hysterectomy and onychectomy. When
    supplemental doses of TELAZOL are required,
    such individual supplemental doses should be
    given in increments that are less than the initial
    dose, and the total dose given (initial dose plus
    supplemental doses) should not exceed the
    maximum allowable safe dose of 32.7 mg/lb
    (72 mg/kg). (See Animal Safety.)

    General Dosing Information

    Fasting prior to induction of general anesthesia with
    TELAZOL is not essential; however, when preparing
    for elective surgery, it is advisable to withhold food
    for at least 12 hours prior to TELAZOL administration.
    As with other injectable anesthetic agents, the
    individual response to TELAZOL is somewhat
    varied, depending upon the dose, general physical
    condition and age of the patient, duration of the
    surgical procedure, and any preanesthetics used.
    Therefore, recommendations for dosage regimens
    cannot be fixed absolutely. Specific dosage
    requirements must be determined by evaluation
    of the health status and condition of the patient
    and of the procedure to be performed.
    Recovery varies with the age and physical
    condition of the animal and the dose of TELAZOL
    administered. Recovery is extended with high
    dose or multiple injections, particularly in cats.


    Intramuscular injection in dogs and cats:
    There may be pain on injection. This is especially
    prevalent in cats.
    Following a single, deep intramuscular injection
    of TELAZOL in cats and dogs, onset of anesthetic
    effect usually occurs within 5 to 12 minutes.
    Muscle relaxation is optimum for approximately
    the first 20 to 25 minutes after TELAZOL is
    administered, and then diminishes.
    Repeated doses increase the duration of the
    effect of TELAZOL but may not further diminish
    muscle tone. The quality of anesthesia with
    repeated doses varies because the ratio of the two
    components within the animal’s body changes
    with each injection. This is due to the difference
    in the rates of metabolism and elimination of the
    two components. The quality of anesthesia will
    be improved and more predictable if the entire
    dose is given as a single injection rather than in
    several doses. The best method of evaluating
    the depth of TELAZOL anesthesia is to monitor
    the patient for deliberate conscious response to
    nociceptive stimuli.
    If adequate anesthesia is not produced by the
    recommended dosage regimen, supplemental
    anesthesia or another agent is indicated. This
    includes the use of barbiturates and volatile
    anesthetics. When used concurrently with TELAZOL
    the dosage of these agents should be reduced.

  • PREPARATION OF SOLUTION FOR ADMINISTRATION

    To each vial add 5 mL sterile water for injection,
    USP. Slight agitation will facilitate complete
    reconstitution. The resultant solution will contain
    100 mg total TELAZOL per one milliliter (50 mg
    tiletamine and 50 mg zolazepam per mL).
    Discard unused solution after 7 days when stored
    at room temperature or after 56 days when kept
    refrigerated. Only use clear solution. Color of
    solution may vary from colorless to light amber.

  • CONTRAINDICATIONS

    The use of TELAZOL is contraindicated in dogs and cats with pancreatic disease. TELAZOL is excreted predominantly by the kidneys. Preexistent renal pathology or impairment of renal function may be expected to result in prolonged duration of anesthesia. TELAZOL should not be used in dogs and cats with severe cardiac or pulmonary dysfunction. Because the teratogenic potential of TELAZOL is unknown, it should not be used in pregnant bitches or queens at any stage of pregnancy. Also, a study has shown that TELAZOL crosses the placental barrier and produces respiratory depression in the newborn; therefore, its use for Cesarean section is contraindicated.

  • WARNINGS

    FOR USE IN DOGS AND CATS ONLY. 

    When using TELAZOL for induction of anesthesia,
    patients should be continuously monitored.
    Facilities for the maintenance of a patent airway,
    artificial ventilation and oxygen supplementation
    should be available.
    Pulmonary edema has been reported to occur in
    cats with the use of TELAZOL. Signs and symptoms
    include dyspnea, lethargy, anorexia and abnormal
    behavior. Deaths have been reported occasionally
    in severely affected individuals. Cats should be
    observed closely for any signs and symptoms
    which may suggest pulmonary edema so that
    appropriate therapy may be instituted.
    The principal route of excretion of both
    components in the cat is the urine; therefore,
    TELAZOL is not recommended for use in cats
    suffering from renal insufficiency.
    Balance studies in dogs indicated extensive
    biotransformation of both components with less
    than 4% of the dose excreted unchanged in the
    urine.
    TELAZOL is excreted predominantly by the
    kidneys. Preexistent renal pathology or
    impairment of renal function may be expected to
    result in prolonged duration of anesthesia.
    Phenothiazine-derivative drugs should not
    be used with TELAZOL at dosages indicated
    for intramuscular (IM) injection because the
    combination produces respiratory and myocardial
    depression, hypotension and hypothermia.
    The safe use of TELAZOL in pregnant animals
    or on reproduction has not been established.
    TELAZOL crosses the placental barrier and causes
    respiratory depression in the neonate.

  • PRECAUTIONS

    The dosage of TELAZOL should be reduced in
    geriatric dogs and cats, in animals in debilitated
    condition and in animals with impairment of
    renal function. Death has occurred in both cats
    and dogs following intramuscular TELAZOL
    administration. Preexisting pulmonary disease,
    renal disease (see Contraindications and
    Warnings) and shock were causally implicated at
    necropsy; however, death was drug attributable
    in at least one dog (of 1072) and one cat (of 1095).
    Intravenous TELAZOL has been demonstrated
    to be safe in a field study in dogs when used in
    conjunction with phenothiazine-derivative drugs
    (acepromazine) administered at dosages from
    0.04-0.06 mg/kg IM.
    Cats and smaller dogs with small body masses
    in relation to large body surfaces should be
    protected from heat loss during TELAZOL
    anesthesia. Body temperature should be
    monitored, and supplemental heat may be
    required to control hypothermia. As with
    other anesthetics, it is prudent to provide for
    hemostasis during any surgical procedure.
    During TELAZOL anesthesia, athetoid movement
    may occur. This athetosis should not be mistaken
    for lack of anesthesia nor is it indicative of lack
    of analgesia. Do not give additional anesthesia
    in an attempt to abolish the athetoid movement.
    Efforts to eliminate athetoid movement with
    additional doses of TELAZOL can result in
    anesthetic overdosage.
    TELAZOL does not abolish laryngeal, pharyngeal,
    pinnal, palpebral, and pedal reflexes, and may
    not be adequate as the sole anesthetic for
    surgical procedures in these areas. Endotracheal
    tubes are not well tolerated in connection with TELAZOL anesthesia in the cat and their use may
    result in impaired respiration. After removal of
    the tube, normal respiration should resume.
    The stimulation of surgical procedures aids in
    maintaining adequate ventilation. The anesthetized
    patient must be monitored throughout the
    procedure, and if cardiopulmonary problems do
    occur, measures must be taken to assure that
    alveolar ventilation and cardiovascular functions are
    maintained.
    The eyes normally remain open with the pupils
    dilated. The use of a bland ophthalmic ointment is
    advisable to protect the corneas from desiccation.
    The concurrent use of chloramphenicol will
    prolong the duration of anesthesia in cats.
    Copious salivation may occur during TELAZOL
    anesthesia. Ptyalism may be controlled in dogs
    and cats by administering atropine sulfate, USP,
    0.02 mg/lb (0.04 mg/kg) body weight (IV, IM,
    or SC) as concurrent medication. Exaggerated
    swallowing, reflex action and accumulation of
    saliva may give rise to vomiting and retching.

  • ADVERSE REACTIONS

    For Restraint and Minor Procedures of Short
    Duration Requiring Mild to Moderate
    Analgesia

    Respiratory depression may occur following
    administration of high doses of TELAZOL. If at any
    time respiration becomes excessively depressed
    and the animal becomes cyanotic, resuscitative
    measures should be instituted promptly. Adequate
    pulmonary ventilation using either oxygen or room
    air is recommended as a resuscitative measure.
    Adverse reactions reported include emesis during
    emergence, excessive salivation, transient apnea,
    vocalization, erratic recovery and prolonged
    recovery, excessive tracheal and bronchial
    secretions when atropine sulfate, was not given
    before anesthesia, involuntary muscular twitching,
    hypertonicity, cyanosis, cardiac arrest, pulmonary
    edema and muscle rigidity during surgical
    procedures. Central nervous system stimulation and
    convulsions have also been reported. Tachycardia
    frequently occurs, particularly in the dog. This rise
    in heart rate usually lasts about 30 minutes. Either
    hypertension or hypotension may also occur.
    Insufficient anesthesia has been reported in dogs.
    Death has been reported in dogs and cats following
    TELAZOL administration.

    Intravenous Induction of Anesthesia followed by
    Maintenance with Inhalant Anesthesia in Dogs

    In a field study to assess the effectiveness and
    safety of TELAZOL administered intravenously
    at 1-2 mg/lb (2.2-4.4 mg/kg) for the induction of
    anesthesia followed by maintenance with inhalant
    anesthesia in dogs, 144 dogs were intravenously
    administered TELAZOL (See Effectiveness).
    Sixteen adverse reactions occurred during the
    study: nystagmus (5), emesis (4), diarrhea (2), and
    one occurrence each of hypersalivation, urticarial,
    anorexia, hyperthermia, and lethargy. All adverse
    reactions resolved by the end of the study.
    Physiologic abnormalities related to general
    anesthesia were transient and not severe.
    Post-induction apnea (time from induction to
    first inspiration ≥30 seconds) was observed in
    49.3% of dogs across all treatment groups with a
    mean duration of one minute. The highest overall
    frequency and duration of post-induction apnea
    was in the alpha2-agonist + opioid groups.
    Overall, 36 dogs received assisted ventilation.
    Assisted ventilation was needed most frequently
    early in the procedure (at procedure start,
    possibly after an apneic period) then decreased
    in frequency as the procedure continued.
    Sixteen dogs experienced oxygen saturation
    (SpO2) ≤90 mmHg: 7 in the alpha2-agonist +
    opioid groups, 6 in the phenothiazine + opioid
    groups, and 3 in the opioid alone groups.
    Twenty-five dogs had a temperature ≥103°F
    during the study, with 12 of these occurring
    prior to preanesthetic administration only. Of the
    remaining 13 dogs, 7 were in the alpha2-agonist +
    opioid groups, 5 were in the opioid alone groups,
    and 1 in the phenothiazine + opioid groups.
    One dog was reported with hyperthermia as an
    adverse reaction in the alpha2-agonist + opioid
    treatment groups. The dog became excitable
    during recovery and its temperature elevated to
    105.7°F. Hyperthermia resolved with treatment
    of IV fluids and cooling.

    Twenty-seven dogs experienced temperatures
    ≤96°F at one or more timepoints. Most dogs
    received supplemental heat during surgery.
    Fifty-nine dogs had mean blood pressure
    (BP) values ≤60 mmHg. These values are
    spread among all treatment groups. No dogs
    were reported with adverse reactions due to
    hypotension or hypertension in any dose groups.
    Elevated or low BP values were transient.
    Ventricular premature depolarizations were
    noted in 3 dogs in the alpha2-agonist + opioid
    group. This transient rhythm disturbance is
    not uncommon in dogs receiving alpha2-
    agonists or inhalant anesthetics. One dog in the
    phenothiazine + opioid group showed transient
    ST depression that could have been due to
    cardiac hypoxia. All dogs recovered normally.
    For a copy of the Safety Data Sheet (SDS) or
    to report adverse reactions call Zoetis Inc. at
    1-888-963-8471. Additional information can be
    found at www. Zoetis.US.com.
    For additional information about adverse drug
    experience reporting for animal drugs, contact
    FDA at 1-888-FDA-VETS or http://www.fda.gov/
    AnimalVeterinary/SafetyHealth.

  • CLINICAL PHARMACOLOGY

    Mechanism of Action

    TELAZOL is a rapid-acting anesthetic combination
    of tiletamine hydrochloride and zolazepam
    hydrochloride. Tiletamine hydrochloride is a
    dissociative anesthetic agent whose pharmacologic
    action is characterized by profound analgesia,
    normal pharyngeal-laryngeal reflexes and
    cataleptoid anesthesia. The anesthetic state
    produced does not fit into the conventional
    classification of stages of anesthesia, but instead
    TELAZOL produces a state of unconsciousness
    which has been termed “dissociative’’ anesthesia in
    that it appears to selectively interrupt association
    pathways to the brain before producing somesthetic
    sensory blockade.
    Cranial nerve and spinal reflexes remain active;
    however, these reflexes must not be confused
    with inadequate anesthesia. Analgesia results
    from apparent selective interruption of sensory
    inputs to the brain and usually persists after the
    anesthetic effect has subsided.
    Protective reflexes, such as coughing and
    swallowing, are maintained under tiletamine
    anesthesia. Other reflexes, e.g., corneal, pedal,
    are maintained during tiletamine anesthesia,
    and should not be used as criteria for judging
    depth of anesthesia. The eyes normally remain
    open with the pupil dilated. It is suggested that
    a bland ophthalmic ointment be applied to the
    cornea if anesthesia is to be prolonged.
    Used alone, tiletamine hydrochloride does
    not provide adequate muscle relaxation for
    abdominal surgical procedures. When combined
    with zolazepam hydrochloride, good muscle
    relaxation is generally attained during the phase
    of deep surgical anesthesia.


    Pharmacokinetics
    The pharmacokinetics of TELAZOL injectable
    solution was evaluated in 12 healthy adult
    Beagle dogs, following a single intravenous (IV)
    administration of 2.2 mg/kg bodyweight, which
    is equivalent to 1.1 mg/kg for both tiletamine
    hydrochloride and zolazepam hydrochloride.
    After administration of 2.2 mg/kg TELAZOL IV,
    the initial mean concentration of tiletamine (C0)
    was 1018 ng/mL, the systemic clearance (CL)
    was 6223 mL/kg/h, the area under the curve to
    the last measured concentration (AUC 0-last) was
    178 ng*hr/mL, and steady state volume of
    distribution (Vss) was 3250 mL/kg. The mean
    elimination half-life of tiletamine was 0.87 hours.
    For zolazepam, the mean C0 was 2594 ng/mL, CL
    was 1993 mL/kg/h and Vss was 604 mL/kg. The mean
    elimination half-life of zolazepam was 0.41 hours.
    The mean C0 and AUC0-t(last) were approximately
    2.5 and 3 times, respectively, greater for zolazepam
    than for tiletamine. However, the mean half-life
    (T1/2) of tiletamine was approximately 2.5 times
    longer than for zolazepam, resulting in quantifiable
    plasma concentrations up to 2 hours longer.
    Pretreatment with an alpha-2 agonist or
    phenothiazine followed by inhalant isoflurane
    has been shown to increase in the initial
    concentration of both tiletamine and zolazepam.

  • EFFECTIVENESS

    Dogs
    Preanesthesia

    In a field study conducted at 6 veterinary hospitals,
    144 dogs of various breeds, ranging in age from
    4 months to 14 years (mean age 5 years) and
    body weights from 1.2- 85.5 kg, were enrolled for
    completion of a veterinary procedure requiring
    anesthesia. Dogs were preanesthetized with a
    phenothiazine + opioid, an opioid alone, or an
    alpha2-agonist + opioid at the study Investigator’s
    discretion based on individual patient needs.
    Approximately 20 minutes later, dogs were
    intravenously administered TELAZOL at 1-2 mg/lb
    (2.2-4.4 mg/kg) ‘to effect’ of anesthesia and
    were intubated. After induction, dogs received
    either isoflurane or sevoflurane for anesthetic
    maintenance for at least 30 minutes. Procedures
    conducted included dental prophylaxis with or
    without extractions (64), ovariohysterectomy
    (31), castration (18), and mass removal (14).
    Upon completion of the procedure, dogs were
    monitored in recovery for 4 hours, then followed at
    home for 2-4 days, monitoring for the presence of
    abnormal clinical signs.
    Of 144 dogs enrolled in the study, 142 (98.6%)
    were successfully intubated after intravenous
    administration of TELAZOL at a mean dosage of
    1.2 mg/lb (2.7 mg/kg). The mean dosage range was
    lowest in the alpha2-agonist + opioid preanesthetic
    treatment group (0.9 mg/lb; 2 mg/kg) and highest
    in the opioid alone preanesthetic group (1.8 mg/lb;
    3.9 mg/kg).
    Overall induction quality evaluated on a scale
    of acceptable, intermediate, or unacceptable
    was acceptable in 131/142 (91.6%) dogs and
    intermediate in 12/143(8.4%) dogs. On a scale of
    good, fair, or poor, study participants rated the
    quality of recovery from anesthesia as good in
    75% of dogs (118/144) and fair in 18.1% (26/144).
    In an overall assessment of anesthesia, considering
    induction, maintenance, and recovery, was scored
    as excellent or good in 128/144 (88.9%) of dogs.
    Three dogs (2.1%) were rated with an overall
    assessment of anesthesia as poor, and for these
    dogs, recovery was also rated poor. Physiologic
    measurements of heart rate, respiratory rate,
    body temperature, oxygen saturation, and blood
    pressure during anesthetic induction, maintenance,
    and recovery showed that the administration of
    TELAZOL did not severely impact these variables.
    A variety of concomitant treatments were used
    during the study including intravenous fluid
    solutions, non-steroidal anti-inflammatory
    medications, antimicrobials, and antiparasitics that
    were consistent with routine canine practice.

  • ANIMAL SAFETY

    TELAZOL has a wider margin of safety in cats
    than in dogs. Dogs have survived repeated
    IM dosage regimens of 13.6 mg/lb (30 mg/kg)
    (maximum safe dose) for eight successive days.
    This is approximately two times the maximum
    recommended therapeutic dose. Cats have
    survived IM dosage regimens of up to 32.7 mg/
    lb (72 mg/kg) (maximum safe dose) on alternate
    days for seven episodes. This is 4.6 times the
    maximum recommended therapeutic dose for
    cats. However, these reports should not obviate
    prudent anesthetic practices. Some degree of
    tolerance has been reported. This tolerance
    appears to be species-variable.

    Cats

    In cats, the duration of effect of zolazepam exceeds
    that of tiletamine so that as the animal recovers
    there is a greater degree of tranquilization than
    anesthetization. There is a slight lowering of blood
    pressure during the first hour after injection.
    Heart rate and electrocardiogram readings are
    unaffected by TELAZOL (tiletamine and zolazepam
    for injection). Arterial pO2 levels are decreased
    three minutes after injection but usually return to
    normal within 15 to 35 minutes.


    Dogs
    In dogs, the duration of effect of tiletamine
    exceeds that of zolazepam so there is a lesser
    degree of tranquilization than anesthetization in
    this species. The total effect of TELAZOL in dogs is
    of shorter duration than in cats.
    Following administration of TELAZOL in dogs, a
    marked, persistent tachycardia occurs within two
    minutes following either 4.5 or 9 mg/lb (10 or
    20 mg/kg) TELAZOL intramuscularly. Stroke volume
    decreases proportionately to the increased rate
    at the 4.5 mg/lb (10 mg/kg) dose, with little
    change in net cardiac output. There is an initial
    increase in systolic blood pressure, with a slight
    drop in pressure within five minutes. The systolic
    blood pressure remains at this decreased level
    throughout the duration of the anesthetic effect.
    Diastolic pressure increases throughout this same
    period. Following a 9 mg/lb (20 mg/kg) dose
    of TELAZOL in dogs, the relationship between
    stroke volume and heart rate is disproportionate,
    with a resultant substantial decrease in cardiac
    output. Contractility and mean blood pressure are
    decreased, indicating direct myocardial depression.
    Ventricular function is adequate. During surgical
    manipulations, tachycardia and hypertension may
    be observed, and may be brought on by sympathetic
    reaction to painful stimuli. Epinephrine is markedly
    less arrhythmogenic in animals under TELAZOL
    anesthesia than in those under halothane anesthesia.
    During TELAZOL anesthesia, the assurance of
    a patent airway is greatly enhanced by virtue
    of maintaining pharyngeal-laryngeal reflexes.
    During the first 15 minutes after intramuscular
    administration of 9 mg/lb (20 mg/kg) of TELAZOL,
    the respiratory rate is doubled while the tidal
    volume is decreased to less than one-half of control
    values. Arterial pO2 levels also decrease. This may
    be evidenced by hypoxemia and cyanosis. The
    pulmonary function usually returns to normal within
    35 minutes after the administration of TELAZOL.


    Preanesthetic Compatibility Study in Dogs
    Six healthy Beagle dogs (3 males and 3 females),
    at least 8 months of age, ranging in body
    weight between 5.6 and 9.4 kg, were fitted
    with a telemetry device that captured systemic
    arterial blood pressures, electrocardiogram, and
    body temperature. Each dog received a total of
    6 treatments with at least a 7-day washout between
    periods. During each period, dogs received
    1 of the following 6 preanesthetics prior to the
    TELAZOL administration: placebo (0.9% saline),
    acepromazine low dose (0.1 mg/kg body weight
    [BW]), acepromazine high dose (1.1 mg/kg BW),
    dexmedetomidine low dose (125 mcg/m2 body
    surface area [BSA]), dexmedetomidine high dose
    (375 mcg/m2 BSA), or butorphanol (0.4 mg/kg BW).
    Blood samples were collected at intubation, end
    of isoflurane administration, and after anesthesia
    when the dogs were able to walk. Plasma
    concentrations of tiletamine and zolazepam were
    measured using a validated method. Preanesthetic
    treatment with high dose acepromazine and both
    high and low doses of dexmedetomidine resulted
    in substantial increases in plasma concentrations
    of tiletamine and zolazepam at intubation. The
    increase in the tiletamine plasma concentrations
    was approximately 2X higher for the high dose of
    acepromazine and 2.7 to 4.5X higher for the low
    and high doses of dexmedetomidine, respectively,
    compared to saline. The increase in zolazepam
    plasma concentrations was 1.5X higher for the
    high dose acepromazine, and 1.8 to 2.8X higher
    for the low and high doses of dexmedetomidine,
    respectively, compared to saline.
    No information on the dose-sparing of TELAZOL
    was obtained during the study because the dogs
    were given the full initial half-dose (2.2 mg/kg) and
    not actually administered TELAZOL ‘to effect’. The
    average total dose of test article administered to
    the dogs was 2.6 mg/kg for the saline group and
    2.2 mg/kg for the other treatment groups. One
    dog (saline group) required more than the initial
    2.2 mg/kg bolus to achieve intubation at the first
    attempt.
    Without preanesthesia (saline group), dogs
    retained a strong cough reflex, chewing motions,
    tachycardia and increased muscle tone during
    intubation. With preanesthesia, half of the dogs
    in the high dose dexmedetomidine group had
    no laryngeal reflex response to intubation and
    all experienced post-intubation apnea. The postintubation
    apnea suggests that the 2.2 mg/kg dose
    of TELAZOL was higher than necessary in some
    groups.
    All dogs in all treatment groups achieved successful
    anesthetic plane following TELAZOL administration
    and were intubated and induced to isoflurane
    anesthesia uneventfully. The quality of intubation,
    and occurrence and severity of adverse reactions
    (e.g., apnea and bradypnea) following TELAZOL
    administration and intubation revealed differences
    among preanesthetic treatment groups. The
    cardiovascular and respiratory changes observed
    were typical of each preanesthetic medication used
    in combination with TELAZOL. Acepromazine and
    isoflurane administration decreased arterial blood
    pressure. Dexmedetomidine decreased heart rate.
    Intubation transiently increased heart rate and/or
    blood pressure (sympathetic stimulations). Mild to
    severe respiratory depression was observed after
    TELAZOL administration and each preanesthetic
    agent. Adverse reactions were manageable with
    appropriate care.

  • STORAGE CONDITIONS

    Store at controlled room temperature 20° to 25°C (68° to 77°F). Discard unused solution after 7 days when stored at room temperature or after 56 days when kept refrigerated. Only use clear solution. Color of solution may vary from colorless to light amber.

  • HOW SUPPLIED

    TELAZOL (tiletamine and zolazepam for injection) is available in individual vials of 5 mL solution when reconstituted. The addition of 5 mL diluent produces a solution containing the equivalent of 50 mg tiletamine base, 50 mg zolazepam base and 57.7 mg mannitol per milliliter.

    10 mL vial -100 mg/mL total (equivalent to 50 mg/mL tiletamine and 50 mg/mL zolazepam) when reconstituted

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA # 106-111

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Revised: June 2019

    40027682

  • PRINCIPAL DISPLAY PANEL - 5 mL Bottle Label

    5 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TELAZOL 
    tiletamine hydrochloride and zolazepam hydrochloride injection, powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:54771-9050
    Route of AdministrationINTRAMUSCULARDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TILETAMINE HYDROCHLORIDE (UNII: 99TAQ2QWJI) (TILETAMINE - UNII:2YFC543249) TILETAMINE50 mg  in 1 mL
    ZOLAZEPAM HYDROCHLORIDE (UNII: 45SJ093Q1N) (ZOLAZEPAM - UNII:G1R474U58U) ZOLAZEPAM50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A) 57.7 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-9050-11 in 1 CARTON
    15 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA10611104/09/1982
    Labeler - Zoetis Inc. (828851555)