ZOLETIL- tiletamine and zolazepam for injection injection, powder, lyophilized, 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:

Jurox Pty. Limited

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Dogs Zoletil for Injection 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 a laceration repair, draining of abscesses, castrations and other procedures requiring mild to moderate analgesia. (See Dogs under Dosage and Administration.) Cats Zoletil for Injection is indicated in cats for restraint or for anesthesia combined with muscle relaxation. The use of Zoletil for Injection is contraindicated in dogs and cats with pancreatic disease. Zoletil for Injection should not be used in dogs and cats with severe cardiac or pulmonary dysfunction. Because the teratogenic potential of Zoletil for Injection is unknown, it should not be used in pregnant bitches or queens at any stage of pregnancy. Also, a study has shown that tiletamine and zolazepam injection crosses the placental barrier and produces respiratory depression in the newborn; therefore, its use for Cesarean section is contraindicated.

Product summary:

Zoletil for Injection (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. 5 mL vial – 100 mg/mL total (equivalent to 50 mg/mL tiletamine and 50 mg/mL zolazepam) when reconstituted.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ZOLETIL- TILETAMINE AND ZOLAZEPAM FOR INJECTION INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
JUROX PTY. LIMITED
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ZOLETIL FOR INJECTION (TILETAMINE AND ZOLAZEPAM FOR INJECTION)
CIII
100 MG/ML TOTAL (EQUIVALENT TO 50 MG/ML TILETAMINE AND 50 MG/ML
ZOLAZEPAM)
FOR INTRAMUSCULAR USE IN DOGS AND CATS ONLY
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Zoletil for Injection (tiletamine and zolazepam for injection) is a
nonnarcotic, nonbarbiturate, injectable
anesthetic agent for dogs and cats. Chemically, Zoletil for Injection
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
non-phenothiazine 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
Zoletil for Injection 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 a laceration repair,
draining of abscesses, castrations and other procedures requiring mild
to moderate analgesia. (See
Dogs under Dosage and Administration.)
CATS
Zoletil for Injection 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