Dexdomitor: Product Information (Page 7 of 7)

Feline acute tolerance study

IM DEXDOMITOR was administered once at 10X (400 mcg/kg) the recommended dose of 40 mcg/kg to 3 female and 3 male 7 month old cats. No mortality was observed. Sedation was observed within 15 minutes of dosing and lasted for at least 4 hours with full recovery noted between 8 and 24 hours after dosing. Transient observations of corneal dehydration and opacity, miosis, pale skin and gingiva, salivation, and watery ocular discharge were observed in some animals. Vomiting was observed 7 to 11 hours after dosing in all but one animal. Decreases in heart rate accompanied by prolonged PQ and QT intervals were most pronounced 2 to 4 hours after dosing. No atrioventricular (AV) blocks or escape rhythms were noted. In one cat, incidental and reversible premature junctional complexes were seen at 1 and 2 hours after dosing which were considered secondary to bradycardia. Slightly lower respiratory rate and reduced rectal temperature were observed 4 to 8 hours after dosing. Observations had returned to normal by 24 hours after dosing. Mild inflammatory lesions observed histologically at the injection site were representative of the IM injection procedure. No treatment related changes were observed in hematology. Mild elevations in some clinical ALT, AST, and CK, were observed 24 hours after dosing, with a trend towards recovery by 48 hours. Total protein, albumin and globulin levels were slightly lowered in one cat 48 hours after dosing.

STORAGE INFORMATION

Store at controlled room temperature 15-30°C (59-86°F). Protect from freezing. In use shelf life: 90 days at 25°C (77°F).

HOW SUPPLIED

DEXDOMITOR 0.1 mg/mL is supplied in 20-mL multidose vials with filling volume of 15 mL containing 0.1 mg of dexmedetomidine hydrochloride per mL.

DEXDOMITOR 0.5 mg/mL is supplied in 10-mL, multidose vials containing 0.5 mg of dexmedetomidine hydrochloride per mL.

REFERENCES

(1) Ko JCH, Fox SMF, Mandsager RE. Effects of preemptive atropine administration on incidence of medetomidine-induced bradycardia in dogs. J Am Vet Med Assoc 2001; 218:52-58.
(2) Alibhai HIK, Clarke KW, Lee YH, et al. Cardiopulmonary effects of combinations of medetomidine hydrochloride and atropine sulphate in dogs. Vet Rec 1996; 138:11-13.
(3) Short, CE. Effects of anticholinergic treatment on the cardiac and respiratory systems in dogs sedated with medetomidine. Vet Rec 1991; 129:310-313.
(4) Hikasa Y, Akiba T, Iino Y et al. Cen tral alpha-adrenoceptor subtypes involved in the emetic pathway in cats. Eur J Pharmacol 1992; 229:241-251.

U.S. Patent No. 4,910,214
DEXDOMITOR® is a trademark of Orion Corporation.

Approved by FDA under NADA # 141-267

Mfd by:
Orion Pharma
Orion Corporation
Espoo, Finland
Dist by:
zoetis
Zoetis Inc.
Kalamazoo, MI 49007
Revised: December 2022
144440-3122691-7

PRINCIPAL DISPLAY PANEL — 10 mL Vial Carton

PRINCIPAL DISPLAY PANEL — 15 mL Vial Carton

DEXDOMITOR dexmedetomidine hydrochloride injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2805 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength dexmedetomidine hydrochloride (dexmedetomidine) dexmedetomidine 0.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength methylparaben 1.6 mg in 1 mL propylparaben 0.2 mg in 1 mL sodium chloride 9 mg in 1 mL water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54771-2805-1 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 1 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (54771-2805-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141267 12/01/2006

DEXDOMITOR dexmedetomidine hydrochloride injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2806 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength dexmedetomidine hydrochloride (dexmedetomidine) dexmedetomidine 0.1 mg in 1 mL

Inactive Ingredients Ingredient Name Strength methylparaben 0.2 mg in 1 mL propylparaben 0.2 mg in 1 mL sodium chloride 9 mg in 1 mL water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54771-2806-1 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE 1 15 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (54771-2806-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141267 12/01/2006

Labeler — Zoetis Inc. (828851555)

Revised: 03/2023 Zoetis Inc.