Telazol

Description

TELAZOL (tiletamine and zolazepam for injection) is a nonnarcotic, nonbarbiturate injectable anesthetic agent indicated for use in dogs and cats. It is formulated as a sterile solution containing equal parts by weight of tiletamine hydrochloride (2-ethylamino-2-2-thienyl-cyclohexanone hydrochloride) and zolazepam hydrochloride (4-o-fluorophenyl-6, 8-dihydro-1,3,8-trimethylpyrazolo 3, 4-e diazepin-7 1H-1-hydrochloride). Tiletamine is classified as an arylaminocycloalkanone dissociative anesthetic, while zolazepam is a nonphenothiazine diazepinone with minor tranquilizing properties.

The product is supplied in vials, and upon the addition of 5 mL of diluent, it yields a solution containing 50 mg of tiletamine base, 50 mg of zolazepam base, and 57.7 mg of mannitol per milliliter. The resulting solution has a pH range of 2 to 3.5 and is intended for deep intramuscular injection.

Uses and Indications

This drug is indicated for use in dogs and cats for various procedures requiring sedation and analgesia.

In dogs, TELAZOL is indicated for restraint and minor procedures of short duration, averaging 30 minutes, that require mild to moderate analgesia. Such minor surgical procedures include laceration repair, draining of abscesses, castrations, and other interventions necessitating mild to moderate analgesia. Additionally, TELAZOL, when administered intravenously, is indicated for the induction of anesthesia, which may be followed by maintenance with an inhalant anesthetic.

In cats, TELAZOL is indicated for restraint or for anesthesia in conjunction with muscle relaxation.

Limitations of use have not been specified; however, it is essential to consider the individual health status and specific needs of each patient when administering TELAZOL.

Dosage and Administration

For dogs, TELAZOL may be administered intramuscularly (IM) for restraint and minor procedures. The initial dosage for diagnostic purposes is 3 to 4.5 mg/lb (6.6 to 9.9 mg/kg). For minor procedures, the dosage should be increased to 4.5 to 6 mg/lb (9.9 to 13.2 mg/kg). The total dose, including both initial and supplemental doses, must not exceed 12 mg/lb (26.4 mg/kg), with a maximum safe dose of 13.6 mg/lb (29.92 mg/kg).

For the induction of anesthesia in dogs, TELAZOL should be administered intravenously (IV) at a dosage of 1-2 mg/lb (2.2-4.4 mg/kg) body weight. The administration should be performed slowly over a period of 30-45 seconds. After 30-60 seconds, the clinician should assess the level of consciousness, muscle relaxation, and jaw tone. The total IV dose must not exceed 2 mg/lb (4.4 mg/kg) body weight.

In cats, TELAZOL can also be administered intramuscularly (IM). The initial dosage for procedures such as dentistry and abscess treatment is 4.4 to 5.4 mg/lb (9.7 to 11.9 mg/kg). For minor procedures, the recommended dosage is 4.8 to 5.7 mg/lb (10.6 to 12.5 mg/kg). For more invasive procedures such as ovariohysterectomy and onychectomy, the dosage should be increased to 6.5 to 7.2 mg/lb (14.3 to 15.8 mg/kg). The total dose, including both initial and supplemental doses, must not exceed 32.7 mg/lb (72 mg/kg).

Contraindications

The use of TELAZOL is contraindicated in dogs and cats with pancreatic disease due to the potential for exacerbating the condition. Additionally, TELAZOL should not be administered to dogs and cats with severe cardiac or pulmonary dysfunction, as it may worsen these conditions.

In pregnant bitches or queens, TELAZOL is contraindicated at any stage of pregnancy because of its unknown teratogenic potential. Furthermore, its use during Cesarean sections is contraindicated, as TELAZOL crosses the placental barrier and can lead to respiratory depression in the newborn.

Warnings and Precautions

The use of TELAZOL is restricted to dogs and cats only. When administering TELAZOL for the induction of anesthesia, it is imperative that patients are continuously monitored throughout the procedure. Facilities must be equipped to maintain a patent airway, provide artificial ventilation, and offer oxygen supplementation as necessary.

Particular caution should be exercised in cats, as pulmonary edema has been reported following the use of TELAZOL. Clinicians should be vigilant for signs and symptoms indicative of this condition, which may include dyspnea, lethargy, anorexia, and abnormal behavior. In severely affected individuals, fatalities have been documented. Close observation is essential to identify any early signs of pulmonary edema, allowing for timely intervention and appropriate therapy.

TELAZOL is contraindicated in cats with renal insufficiency. Preexisting renal pathology or impairment may lead to an extended duration of anesthesia, necessitating careful consideration of the patient's renal function prior to administration.

The concomitant use of TELAZOL with phenothiazine-derivative drugs at the indicated dosages for intramuscular (IM) injection is not recommended, as this combination can result in significant respiratory and myocardial depression, hypotension, and hypothermia.

The safety of TELAZOL in pregnant animals or its effects on reproduction have not been established. It is important to note that TELAZOL crosses the placental barrier and may induce respiratory depression in neonates. Therefore, caution is advised when considering its use in pregnant patients.

Side Effects

Respiratory depression is a serious adverse reaction that may occur following the administration of high doses of TELAZOL. In cases where respiration becomes excessively depressed and the patient exhibits cyanosis, prompt resuscitative measures should be instituted. Other serious adverse reactions include cardiac arrest, pulmonary edema, and convulsions, which have been reported during surgical procedures and in various patient populations.

Common adverse reactions observed in clinical settings include emesis, excessive salivation, vocalization, erratic recovery, prolonged recovery, and transient apnea. In a study involving intravenous induction of anesthesia followed by maintenance with inhalant anesthesia in dogs, emesis was reported in 4 occurrences, while post-induction apnea was observed in 49.3% of dogs, with a mean duration of one minute. Additionally, tachycardia frequently occurs, particularly in dogs, typically lasting about 30 minutes.

Other notable reactions include excessive tracheal and bronchial secretions, which were reported when atropine sulfate was not administered prior to anesthesia. Involuntary muscular twitching, hypertonicity, and central nervous system stimulation have also been documented as adverse reactions. Patients may experience variations in blood pressure, with hypertension or hypotension possible, and insufficient anesthesia has been reported in dogs.

In terms of specific clinical trial findings, 16 dogs experienced oxygen saturation levels (SpO2) ≤90 mmHg, while 59 dogs had mean blood pressure readings ≤60 mmHg. Temperature fluctuations were noted, with 25 dogs experiencing temperatures ≥103°F and 27 dogs having temperatures ≤96°F at one or more time points. Ventricular premature depolarizations and transient ST depression were also observed in select patient groups.

Postmarketing experiences have indicated that death has occurred in both dogs and cats following TELAZOL administration, particularly in those with preexisting pulmonary or renal disease. Additionally, renal insufficiency is a contraindication for the use of TELAZOL in cats. Other reactions such as nystagmus, diarrhea, hypersalivation, urticarial, anorexia, hyperthermia, and lethargy have been reported, albeit less frequently. It is important to note that athetoid movement and copious salivation may occur during TELAZOL anesthesia and should not be mistaken for inadequate anesthesia or analgesia. Vomiting and retching may also occur due to exaggerated swallowing and accumulation of saliva.

Drug Interactions

The concurrent administration of chloramphenicol is associated with an extended duration of anesthesia in cats. This interaction should be considered when planning anesthetic protocols, as prolonged effects may necessitate adjustments in monitoring and recovery times.

Phenothiazine-derivative drugs are contraindicated for use with TELAZOL at the dosages recommended for intramuscular (IM) injection. The combination of these agents can lead to significant adverse effects, including respiratory and myocardial depression, hypotension, and hypothermia. Caution is advised, and alternative preanesthetic agents should be considered to avoid these potentially severe complications.

Preanesthetic treatment with high-dose acepromazine, as well as both high and low doses of dexmedetomidine, has been shown to substantially elevate plasma concentrations of tiletamine and zolazepam at the time of intubation. Specifically, the plasma concentration of tiletamine was approximately doubled with high-dose acepromazine and increased by 2.7 to 4.5 times with low and high doses of dexmedetomidine, respectively, compared to saline controls. Similarly, zolazepam plasma concentrations were found to be 1.5 times higher with high-dose acepromazine and increased by 1.8 to 2.8 times with low and high doses of dexmedetomidine, respectively, compared to saline. These findings indicate that careful monitoring of anesthetic depth and potential dose adjustments may be necessary when using these preanesthetic agents in conjunction with tiletamine and zolazepam.

Packaging & NDC

The table below lists each NDC Code for Telazol (tiletamine hydrochloride and zolazepam hydrochloride) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The use of TELAZOL is contraindicated in pediatric patients with pancreatic disease. Its safety during pregnancy and effects on reproduction have not been established. TELAZOL crosses the placental barrier and may cause respiratory depression in neonates.

Dosing considerations for TELAZOL vary by age and physical condition. In healthy cats, an initial intramuscular dosage of 4.4 to 5.4 mg/lb (9.7 to 11.9 mg/kg) is recommended for procedures such as dentistry and abscess treatment, while initial dosages of 6.5 to 7.2 mg/lb (14.3 to 15.8 mg/kg) are suggested for ovariohysterectomy and onychectomy. For dogs, TELAZOL should be administered intravenously at 1-2 mg/lb (2.2-4.4 mg/kg) for induction of anesthesia. The total dose, including any supplemental doses, must not exceed the maximum allowable safe dose of 13.6 mg/lb (29.92 mg/kg) for dogs and 32.7 mg/lb (72 mg/kg) for cats.

Monitoring of body temperature is essential, as cats and smaller dogs are at risk of heat loss during TELAZOL anesthesia, necessitating protective measures against hypothermia. Recovery from anesthesia may vary based on the age and physical condition of the animal, as well as the dose administered. Following a single, deep intramuscular injection, the onset of anesthetic effect typically occurs within 5 to 12 minutes. The quality of anesthesia is improved when the entire dose is administered as a single injection rather than divided into multiple doses.

Due to the principal route of excretion being renal in cats, TELAZOL is not recommended for use in those with renal insufficiency. Caution is advised, as death has been reported in both cats and dogs following intramuscular administration of TELAZOL.

Geriatric Use

Elderly patients, specifically those aged 65 and older, may require dosage adjustments when receiving TELAZOL. It is recommended that the dosage be reduced in geriatric patients, as well as in those who are in a debilitated condition or have impaired renal function.

The recovery process in geriatric patients can vary significantly based on age, physical condition, and the dosage of TELAZOL administered. Notably, recovery may be prolonged with higher doses or multiple injections, particularly in cats.

Healthcare providers should exercise caution when administering TELAZOL to elderly patients, especially those with preexisting conditions. Cases of death following intramuscular administration of TELAZOL have been associated with preexisting pulmonary disease, renal disease, and shock, as identified during necropsy in both cats and dogs. Therefore, careful monitoring and consideration of the patient's overall health status are essential when treating geriatric patients with this medication.

Pregnancy

The use of TELAZOL is contraindicated in pregnant bitches or queens at any stage of pregnancy due to its unknown teratogenic potential. TELAZOL crosses the placental barrier and has been associated with respiratory depression in newborns, which further contraindicates its use during Cesarean sections. Currently, the safety of TELAZOL in pregnant animals or its effects on reproduction have not been established. Healthcare professionals should exercise caution and avoid administering TELAZOL to pregnant patients to mitigate potential risks to fetal outcomes.

Lactation

The safe use of TELAZOL in lactating mothers has not been established. There is a potential for excretion of TELAZOL in breast milk, and caution should be exercised when administering this medication to nursing mothers. Given the known risks associated with TELAZOL, including its ability to cross the placental barrier and produce respiratory depression in newborns, healthcare professionals should carefully consider the benefits and risks before prescribing TELAZOL to lactating patients.

Renal Impairment

Patients with renal impairment should be closely monitored when considering the use of TELAZOL, as it is predominantly excreted by the kidneys. In cats suffering from renal insufficiency, the use of TELAZOL is not recommended due to the potential for prolonged duration of anesthesia associated with preexisting renal pathology or impairment of renal function. Dosing adjustments may be necessary, and careful assessment of renal function is advised to mitigate risks associated with its use in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

The teratogenic potential of TELAZOL is currently unknown; therefore, its use in pregnant bitches or queens at any stage of pregnancy is contraindicated. TELAZOL is capable of crossing the placental barrier and has been associated with respiratory depression in newborns, further supporting the recommendation against its use for Cesarean sections. The safety of TELAZOL in pregnant animals or its effects on reproduction have not been established.

In terms of animal pharmacology and toxicology, TELAZOL demonstrates a wider margin of safety in cats compared to dogs. Dogs have tolerated repeated intramuscular (IM) dosages of 13.6 mg/lb (30 mg/kg) for eight consecutive days without adverse effects. In contrast, cats have survived IM dosages of up to 32.7 mg/lb (72 mg/kg) on alternate days for seven episodes. The duration of effect of zolazepam in cats exceeds that of tiletamine, resulting in a greater degree of tranquilization than anesthetization during recovery.

In cats, a slight decrease in blood pressure is observed during the first hour post-injection. Conversely, in dogs, the duration of effect of tiletamine surpasses that of zolazepam, leading to a lesser degree of tranquilization compared to anesthetization. Following TELAZOL administration in dogs, a marked and persistent tachycardia is noted within two minutes after IM injection of either 4.5 or 9 mg/lb (10 or 20 mg/kg). At the 4.5 mg/lb (10 mg/kg) dose, stroke volume decreases in proportion to the increased heart rate, with minimal change in net cardiac output. An initial increase in systolic blood pressure is followed by a slight decrease within five minutes, with systolic pressure remaining at this lower level throughout the anesthetic effect, while diastolic pressure continues to rise.

After administering a 9 mg/lb (20 mg/kg) dose of TELAZOL in dogs, the relationship between stroke volume and heart rate becomes disproportionate, leading to a significant reduction in cardiac output. This is accompanied by decreased contractility and mean blood pressure, indicating direct myocardial depression. During surgical procedures, tachycardia and hypertension may occur, potentially triggered by sympathetic responses to painful stimuli. TELAZOL anesthesia enhances the assurance of a patent airway by preserving pharyngeal-laryngeal reflexes.

Notably, during the first 15 minutes following IM administration of 9 mg/lb (20 mg/kg) of TELAZOL, the respiratory rate doubles while tidal volume decreases to less than half of control values. Arterial pO2 levels may decline, which can manifest as hypoxemia and cyanosis; however, pulmonary function typically returns to normal within 35 minutes post-administration.

Postmarketing Experience

Pulmonary edema has been reported in cats following the administration of TELAZOL, with associated signs and symptoms including dyspnea, lethargy, anorexia, and abnormal behavior. Occasionally, fatalities have been noted in severely affected individuals. It is recommended that cats be closely monitored for any signs indicative of pulmonary edema to facilitate timely therapeutic intervention.

Deaths have occurred in both cats and dogs after intramuscular administration of TELAZOL. While preexisting pulmonary disease, renal disease, and shock were identified as contributing factors at necropsy, at least one case of death was deemed drug-attributable in one dog (out of 1072) and one cat (out of 1095).

Adverse reactions reported include emesis during emergence, excessive salivation, transient apnea, vocalization, erratic and prolonged recovery, excessive tracheal and bronchial secretions (notably when atropine sulfate was not administered prior to 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 documented. Tachycardia is frequently observed, particularly in dogs, typically lasting about 30 minutes. Both hypertension and hypotension may occur.

In a field study evaluating the safety and effectiveness of TELAZOL administered intravenously at doses of 1-2 mg/lb (2.2-4.4 mg/kg) for anesthesia induction followed by inhalant anesthesia maintenance in dogs, 16 adverse reactions were recorded: nystagmus (5 cases), emesis (4 cases), diarrhea (2 cases), and one case each of hypersalivation, urticaria, anorexia, hyperthermia, and lethargy. All adverse reactions resolved by the conclusion of the study.

Post-induction apnea, defined as a duration of 30 seconds or more from induction to the first inspiration, was observed in 49.3% of dogs across all treatment groups, with a mean duration of one minute. The highest frequency and duration of post-induction apnea were noted in the alpha2-agonist + opioid groups.

Sixteen dogs exhibited oxygen saturation (SpO2) levels of 90 mmHg or lower, with 7 cases in the alpha2-agonist + opioid groups, 6 in the phenothiazine + opioid groups, and 3 in the opioid-only groups. Additionally, 27 dogs experienced temperatures of 96°F or lower at one or more time points, with most receiving supplemental heat during surgery.

Mean blood pressure (BP) values of 60 mmHg or lower were recorded in 59 dogs, distributed across all treatment groups. No adverse reactions related to hypotension or hypertension were reported in any dose groups, and any elevated or low BP values were transient.

Ventricular premature depolarizations were observed in 3 dogs within the alpha2-agonist + opioid group, a transient rhythm disturbance not uncommon in dogs receiving alpha2-agonists or inhalant anesthetics. One dog in the phenothiazine + opioid group exhibited transient ST depression, potentially attributable to cardiac hypoxia. All dogs involved in these observations recovered normally.

Patient Counseling

Healthcare providers should inform patients that federal law restricts the use of this drug to administration by or on the order of a licensed veterinarian. It is important to advise patients that fasting prior to the induction of general anesthesia with TELAZOL is not essential; however, for elective surgery, it is recommended to withhold food for at least 12 hours before administration.

Patients should be made aware that recovery from TELAZOL anesthesia can vary based on the age and physical condition of the animal, as well as the dose administered. It is also crucial to communicate that there may be pain associated with the injection, particularly in cats.

Healthcare providers should explain that following a single, deep intramuscular injection of TELAZOL in cats and dogs, the onset of anesthetic effect typically occurs within 5 to 12 minutes. Muscle relaxation is optimal for approximately the first 20 to 25 minutes after administration, after which it diminishes. The quality of anesthesia is enhanced and more predictable when the entire dose is given as a single injection rather than divided into multiple doses.

Monitoring the patient for deliberate conscious responses to nociceptive stimuli is the best method for evaluating the depth of anesthesia. If the recommended dosage does not produce adequate anesthesia, supplemental anesthesia or an alternative agent should be considered.

Patients should be informed that the eyes usually remain open with dilated pupils, and the application of a bland ophthalmic ointment is advisable to protect the corneas from drying out. Additionally, copious salivation may occur during anesthesia, which can be managed in dogs and cats by administering atropine sulfate, USP, at a dosage of 0.02 mg/lb (0.04 mg/kg) body weight via IV, IM, or SC routes.

Healthcare providers should also discuss the potential for exaggerated swallowing, reflex actions, and saliva accumulation, which may lead to vomiting and retching. Continuous monitoring of the patient during TELAZOL anesthesia is essential, and facilities for maintaining a patent airway, artificial ventilation, and oxygen supplementation should be readily available.

Cats should be closely observed for any signs of pulmonary edema, allowing for timely intervention if necessary. The stimulation of surgical procedures can assist in maintaining adequate ventilation. It is imperative that the anesthetized patient is monitored throughout the procedure, and if any cardiopulmonary issues arise, measures must be taken to ensure that alveolar ventilation and cardiovascular functions are supported.

Finally, healthcare providers should emphasize that if respiration becomes excessively depressed and the animal exhibits cyanosis, prompt resuscitative measures should be initiated, with adequate pulmonary ventilation using either oxygen or room air recommended as a resuscitative action.

Storage and Handling

The product is supplied in a clear solution, which may vary in color from colorless to light amber. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Unused solution must be discarded after 7 days when stored at room temperature. If the solution is kept refrigerated, it should be discarded after 56 days. It is important to ensure that only clear solutions are utilized.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This document includes the full labeling information for Telazol, as submitted by Zoetis Inc. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)