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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TILETAMINE HYDROCHLORIDE (UNII: 99TAQ2QWJI) (TILETAMINE - UNII:2YFC543249), ZOLAZEPAM HYDROCHLORIDE (UNII: 45SJ093Q1N) (ZOLAZEPAM - UNII:G1R474U58U)

Available from:

Zoetis Inc.

INN (International Name):

TILETAMINE HYDROCHLORIDE

Composition:

TILETAMINE 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic 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. 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 q

Product summary:

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

Authorization status:

New Animal Drug Application

Summary of Product characteristics

TELAZOL- TILETAMINE HYDROCHLORIDE AND ZOLAZEPAM HYDROCHLORIDE
INJECTION,
POWDER, FOR SOLUTION
ZOETIS INC.
----------
TELAZOL CIII
(TILETAMINE AND ZOLAZEPAM FOR INJECTION)
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 O