ANTISEDAN- 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:

Zoetis Inc.

INN (International Name):

atipamezole hydrochloride

Composition:

atipamezole hydrochloride 5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

ANTISEDAN is indicated for the reversal of the sedative and analgesic effects of DEXDOMITOR (dexmedetomidine hydrochloride), and DOMITOR (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:

ANTISEDAN is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ANTISEDAN- ATIPAMEZOLE HYDROCHLORIDE INJECTION, SOLUTION
ZOETIS INC.
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ANTISEDAN
(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
ANTISEDAN (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 ANTISEDAN contains 5.0 mg atipamezole hydrochloride, 1.0 mg
methylparaben (NF), 8.5
mg sodium chloride (USP), and water for injection (USP).
INDICATIONS
ANTISEDAN is indicated for the reversal of the sedative and analgesic
effects of DEXDOMITOR
(dexmedetomidine hydrochloride), and DOMITOR (medetomidine
hydrochloride) in dogs.
DOSAGE AND ADMINISTRATION
ANTISEDAN is administered intramuscularly (IM) for reversal of
sedation and analgesia regardless of
the route used for DEXDOMITOR or DOMITOR. The atipamezole dose for the
reversal of IV
DEXDOMITOR or DOMITOR is 3750 mcg/m . The atipamezole dose for the
reversal of IM
DEXDOMITOR or DOMITOR is 5000 mcg/m .
®
2
14
16
2
2
2
The dosage of ANTISEDAN is calculated based on body surface area. Use
the following tables to
determine the correct injection volume or the correct ANTISEDAN 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
S EDATION/ANALGES IA:
DOSE TABLE FOR ANTISEDAN (3750 MCG/M ) WHEN DEXMEDETOMIDINE OR
MEDETOMIDINE IS GIVEN
IV
FOR # LBS
FOR # KG
DOSE = MCG/KG
VOLUME = ML ANTISEDAN
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
55-66
25-30
130
0.7
66-81
30-37
120
0.8
81-99
37-45
110
0.9
99-110
45-50
105
1.0
110-132
50-60
100
1.1
132-143
60-65
95