ATIPAMEZOLE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATIPAMEZOLE HYDROCHLORIDE (UNII: 2W4279571X) (ATIPAMEZOLE - UNII:03N9U5JAF6)

Available from:

BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Atipamezole hydrochloride injection is indicated for the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs. Since atipamezole is always used concomitantly with dexmedetomidine or medetomidine, it should not be used in dogs with the following conditions: cardiac disease, respiratory disorders, liver or kidney diseases, dogs in shock, severely debilitated dogs, or dogs stressed due to extreme heat, cold or fatigue. Administration of atipamezole is contraindicated in dogs with a known hypersensitivity to the drug.

Product summary:

Atipamezole hydrochloride injection is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL. Approved by FDA under ANADA # 200-753 Questions? [phone] Distributed by: Covetrus® North America 400 Metro Place North Dublin, OH 43017 covetrus.com Reorder #082124 Made in India AH-AtipamezolePI-01 REV: 0823 © 2023 Covetrus®, Inc. All rights reserved. No copying without consent. PC70201-00

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ATIPAMEZOLE HYDROCHLORIDE- ATIPAMEZOLE HYDROCHLORIDE INJECTION,
SOLUTION
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
----------
ATIPAMEZOLE HYDROCHLORIDE INJECTION
STERILE INJECTABLE SOLUTION - 5.0 MG/ML
_Dexmedetomidine and Medetomidine Reversing Agent_
_For intramuscular use in dogs only_
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Atipamezole hydrochloride is a synthetic α -adrenergic antagonist.
The chemical name is
4-(2-ethyl-2,3-dihydro-1H-inden-2-yl)-1H-imidazole hydrochloride.
The molecular formula is C
H
N • HCl and structural formula is:
Each mL of Atipamezole hydrochloride injection contains 5.0 mg
atipamezole
hydrochloride, 1.0 mg methylparaben (NF), 8.5 mg sodium chloride
(USP), and water for
injection (USP).
INDICATIONS
Atipamezole hydrochloride injection is indicated for the reversal of
the sedative and
analgesic effects of dexmedetomidine hydrochloride, and medetomidine
hydrochloride in
dogs.
DOSAGE AND ADMINISTRATION
Atipamezole hydrochloride injection is administered intramuscularly
(IM) for reversal of
sedation and analgesia regardless of the route used for
dexmedetomidine hydrochloride
or medetomidine hydrochloride. The atipamezole dose for the reversal
of IV
dexmedetomidine hydrochloride or medetomidine hydrochloride is 3750
mcg/m . The
2
14
16
2
2
atipamezole dose for the reversal of IM dexmedetomidine hydrochloride
or
medetomidine hydrochloride is 5000 mcg/m .
The dosage of Atipamezole hydrochloride injection is calculated based
on body surface
area. Use the following tables to determine the correct injection
volume or the
correct Atipamezole hydrochloride injection dosage on the basis of
kilograms of body
weight.
NOTE THAT THE MCG/KG DOSAGE DECREASES AS BODY WEIGHT INCREASES.
TABLE 1: ATIPAMEZOLE DOSING FOR REVERSAL OF IV DEXMEDETOMIDINE- OR
MEDETOMIDINE-INDUCED SEDATION/ANALGESIA: DOSE TABLE FOR ATIPAMEZOLE HYDROCHLORIDE INJECTION (3750 MCG/M ) WHEN
DEXMEDETOMIDINE OR MEDETOMIDINE IS GIVEN IV
FOR # LBS FOR #