TILETAMINE-ZOLAZEPAM- 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:

Putney, Inc.

INN (International Name):

tiletamine hydrochloride

Composition:

tiletamine 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Tiletamine-Zolazepam is indicated in cats for restraint or for anesthesia combined with muscle relaxation and 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 ADMINISTRATION AND DOSAGE.) The use of Tiletamine-Zolazepam is contraindicated in dogs and cats with pancreatic disease. Tiletamine-Zolazepam is excreted predominantly by the kidneys. Preexistent renal pathology or impairment of renal function may be expected to result in prolonged duration of anesthesia. Tiletamine-Zolazepam should not be used in dogs and cats with severe cardiac or pulmonary dysfunction. Because the teratogenic potential of Tiletamine-Zolazepam is unknown, it should not be used in pregnant bitches or queens at any stage of pregnancy. Also, a study has shown that tiletamine HCl and zolazepam HCl crosses the plac

Product summary:

Tiletamine-Zolazepam (tiletamine HCl and zolazepam HCl) 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 26637-131-05: 5 mL vial – 100 mg/mL (when reconstituted). Store at controlled room temperature 68-77°F (20-25°C).

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

TILETAMINE-ZOLAZEPAM- TILETAMINE HYDROCHLORIDE AND ZOLAZEPAM
HYDROCHLORIDE INJECTION,
POWDER, FOR SOLUTION
PUTNEY, INC.
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TILETAMINE-ZOLAZEPAM (TILETAMINE HCL AND ZOLAZEPAM HCL) CIII
FOR INTRAMUSCULAR USE IN DOGS AND CATS ONLY
ANADA# 200-557, APPROVED BY FDA
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Tiletamine-Zolazepam (tiletamine HCl and zolazepam HCl) is a
nonnarcotic, nonbarbiturate, injectable
anesthetic agent for dogs and cats. Chemically, Tiletamine-Zolazepam
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.
ACTIONS
Tiletamine-Zolazepam is a rapid-acting anesthetic combination of
tiletamine hydrochloride and
zolazepam hydrochloride. Tiletamine hydrochloride is a dissociative
anesthetic agent whose
pharmacologic action is characterized by profound analgesia, normal
pharyngeal-laryngeal reflexes and
cataleptoid anesthesia. The anesthetic state produced does not fit
into the conventional classification of
stages of anesthesia, but instead Tiletamine-Zolazepam produces a
state of unconsciousness which has
been termed "dissociative" anesthesia in that it appears to
selectively interrupt association pathways to
the brain before producing somesthetic sensory blockade.
Cranial nerve and spinal reflexes remain active; however, these
reflexes must not be confused with
inadequate anesthesia. Analgesia results from appare