Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
atipamezole hydrochloride (UNII: 2W4279571X) (atipamezole - UNII:03N9U5JAF6)
Zoetis Inc.
atipamezole hydrochloride
atipamezole hydrochloride 5 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION
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.
ANTISEDAN is supplied in 10-mL, multidose vials containing 5.0 mg of atipamezole hydrochloride per mL.
New Animal Drug Application
ANTISEDAN- ATIPAMEZOLE HYDROCHLORIDE INJECTION, SOLUTION ZOETIS INC. ---------- 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 Prečítajte si celý dokument