Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
ATIPAMEZOLE HYDROCHLORIDE (UNII: 2W4279571X) (ATIPAMEZOLE - UNII:03N9U5JAF6)
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
INTRAMUSCULAR
PRESCRIPTION
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.
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? (855) 724-3461 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
Abbreviated New Animal Drug Application
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 # Leggi il documento completo