TZED (TILETAMINE HYDROCHLORIDE AND ZOLAZEPAM HYDROCHLORIDE)- tiletamine and zolazepam injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tiletamine (UNII: 2YFC543249) (Tiletamine - UNII:2YFC543249), Zolazepam (UNII: G1R474U58U) (Zolazepam - UNII:G1R474U58U)

Available from:

Dechra Veterinary Products LLC

INN (International Name):

Tiletamine

Composition:

Tiletamine 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Dogs: Tzed 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.) Tzed administered intravenously is indicated in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. Cats: Tzed is indicated in cats for restraint or for anesthesia combined with muscle relaxation. The use of Tzed is contraindicated in dogs and cats with pancreatic disease. Tzed should not be used in dogs and cats with severe cardiac or pulmonary dysfunction. Because the teratogenic potential of Tzed 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 crosses the placental barrier and produces respiratory depression in the newborn; therefore, its use for Cesar

Product summary:

Tzed (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. NDC 17033-010-05: 100 mg/mL total (equivalent to 50 mg/mL tiletamine and 50 mg/mL zolazepam) when reconstituted Approved by FDA under ANADA # 200-557

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

TZED (TILETAMINE HYDROCHLORIDE AND ZOLAZEPAM HYDROCHLORIDE)-
TILETAMINE AND ZOLAZEPAM INJECTION
DECHRA VETERINARY PRODUCTS LLC
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TZED™ 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
Tzed (tiletamine and zolazepam for injection) is a nonnarcotic,
nonbarbiturate, injectable
anesthetic agent for dogs and cats. Chemically, Tzed 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: Tzed 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.)
Tzed administered
intravenously is indicated in dogs for induction of anesthesia
followed by maintenance
with an inhalant anesthetic.
CATS: Tzed 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 PROCEDUR