Tiletamine-zolazepam Recall

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Questions & Answers

Side Effects & Adverse Reactions

FOR USE IN DOGS AND CATS ONLY. The principal route of excretion of both components in the cat is the urine; therefore, Tiletamine-Zolazepam 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.

The safety of the use of Tiletamine-Zolazepam (tiletamine HCl and zolazepam HCl) in pregnant animals or on reproduction has not been established. Tiletamine HCI and zolazepam HCI crosses the placental barrier and causes respiratory depression in the neonate. Phenothiazine-derivative drugs should not be used with Tiletamine-Zolazepam because the combination produces respiratory and myocardial depression, hypotension and hypothermia. Pulmonary edema has been reported to occur in cats with the use of Tiletamine-Zolazepam. 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.

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Manufacturer Warnings

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FDA Labeling Changes

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Other Information

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.

Tiletamine-zolazepam Manufacturers

  • Putney, Inc.
    Tiletamine-zolazepam (Tiletamine Hydrochloride And Zolazepam Hydrochloride) Injection, Powder, For Solution [Putney, Inc.]

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