REVERTASED- atipamezole hydrochloride injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

ASPEN VETERINARY RESOURCES®, LTD

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION

Käyttöaiheet:

Revertased™ 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.

Tuoteyhteenveto:

Revertased™ is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL. Approved by FDA under ANADA # 200-753 Manufactured for: Aspen Veterinary Resources®, LTD. Liberty, MO 64068 pivetalvet.com [e-mail]

Valtuutuksen tilan:

Abbreviated New Animal Drug Application

Valmisteyhteenveto

REVERTASED- ATIPAMEZOLE HYDROCHLORIDE INJECTION, SOLUTION
ASPEN VETERINARY RESOURCES®, LTD
----------
REVERTASED™
(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
Revertased™ (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 Revertased™ contains 5.0 mg atipamezole hydrochloride,
1.0 mg
methylparaben (NF), 8.5 mg sodium chloride (USP), and water for
injection (USP).
INDICATIONS
Revertased™ is indicated for the reversal of the sedative and
analgesic effects of
dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.
DOSAGE AND ADMINISTRATION
Revertased™ 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 Revertased™ is calculated based on body surface area.
Use the following
tables to determine the correct injection volume or the correct
Revertased™ 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 REVERTASED™ (3750 MCG/M ) WHEN DEXMEDETOMIDINE OR
MEDETOMIDINE IS GIVEN IV
FOR # LBS
FOR # KG
DOSE = MCG/KG
VOLUME = ML REVERTASED™
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