Telazol: Product Information

TELAZOL- tiletamine hydrochloride and zolazepam hydrochloride injection, powder, for solution
Zoetis Inc.

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.