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Side Effects & Adverse Reactions
HUMAN WARNINGS: Not for human use. Keep out of reach of children.
Atipamezole hydrochloride can be absorbed and may cause irritation following direct exposure to skin, eyes, or mouth. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing.
If irritation or other adverse reaction occurs (for example, increased heart rate, tremor, muscle cramps), seek medical attention.
In case of accidental oral exposure or injection, seek medical attention. Caution should be used while handling and using filled syringes. Users with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product.
The material safety data sheet (MSDS) contains more detailed occupational safety information.
To report adverse reactions in users or to obtain a copy of the MSDS for this product call 1-888-963-8471.
Note to Physician: This product contains an alpha2-adrenergic antagonist.
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History
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Other Information
DESCRIPTION: ANTISEDAN (atipamezole hydrochloride) is a synthetic α2-adrenergic antagonist.
The chemical name is 4-(2-ethyl-2,3-dihydro-1H-inden-2-yl)-1H-imidazole hydrochloride.
The molecular formula is C14H16N2 • 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).
Sources
Sapphire 30 Special Order Manufacturers
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Uriel Pharmacy Inc.
Sapphire 30 Special Order | Zoetis Inc.
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/m2. The atipamezole dose for the reversal of IM DEXDOMITOR or DOMITOR is 5000 mcg/m2.
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 sedation/analgesia: Dose table for ANTISEDAN (3750 mcg/m2) 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 1.2 143-165 65-75 93 1.3 165-176 75-80 91 1.4 >176 >80 90 1.5 Table 2: Atipamezole dosing for reversal of IM dexmedetomidine- or medetomidine-induced sedation/analgesia: Dose table for ANTISEDAN (5000 mcg/m2) when dexmedetomidine or medetomidine is given IM For # lbs For # kg dose = mcg/kg volume = mL ANTISEDAN 4-7 2-3 400 0.15 7-9 3-4 350 0.2 9-11 4-5 300 0.3 11-22 5-10 250 0.4 22-29 10-13 230 0.5 29-33 13-15 210 0.6 33-44 15-20 200 0.7 44-55 20-25 180 0.8 55-66 25-30 170 0.9 66-73 30-33 160 1.0 73-81 33-37 150 1.1 81-99 37-45 145 1.2 99-110 45-50 140 1.3 110-121 50-55 135 1.4 121-132 55-60 130 1.5 132-143 60-65 128 1.6 143-154 65-70 125 1.7 154-176 70-80 123 1.8 >176 >80 120 1.9
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