CROPAMEZOLE- 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:

Cronus Pharma LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Cropamezole™ 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:

Cropamezole™ is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL. Approved by FDA under ANADA # 200-753 Cropamezole™ is the trademark of Cronus Pharma LLC Manufactured for: Cronus Pharma LLC, East Brunswick, NJ 08816. Contact No: 1-844-227-6687 (1-844-2-CRONUS) Made in India July 2023

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

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