CONTRASED- 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:

MWI Animal Health

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

ContraSed™ 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:

ContraSed™ is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL. Approved by FDA under ANADA # 200-753 Distributed by: MWI www.VetOne.net Boise, ID 83705 For technical assistance, call 1-844-227-6687 Made in India Rev. 08/2023

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

CONTRASED- ATIPAMEZOLE HYDROCHLORIDE INJECTION, SOLUTION
MWI ANIMAL HEALTH
----------
CONTRASED™
(ATIPAMEZOLE HYDROCHLORIDE)
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
ContraSed™ (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 ContraSed™ contains 5.0 mg atipamezole hydrochloride, 1.0
mg
methylparaben (NF), 8.5 mg sodium chloride (USP), and water for
injection (USP).
INDICATIONS
ContraSed™ is indicated for the reversal of the sedative and
analgesic effects of
dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
DOSAGE AND ADMINISTRATION
ContraSed™ 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
atipamezole dose for
the reversal of IM dexmedetomidine hydrochloride or medetomidine
hydrochloride is
5000 mcg/m .
2
14
16
2
2
2
The dosage of ContraSed™ is calculated based on body surface area.
Use the following
tables to determine the correct injection volume or the correct
ContraSed™ 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 CONTRASED™ (3750 MCG/M ) WHEN DEXMEDETOMIDINE OR
MEDETOMIDINE IS GIVEN IV
FOR # LBS
FOR # KG
DOSE = MCG/KG
VOLUME = ML CONTRASED™
4-7
2-3
300
0.1
7-9
3-4
250
0.15
9-11
4-5
230
0.2
11-22
5-10
200
0.3
22-33
10-15
170
0.4
33-44
15-20
150
0.5
44-55
20-25
140
0.6
55-