Antisedan label

Antisedan

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Side Effects & Adverse Reactions

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 1-800-366-5288.

Note to Physician

This product contains an alpha2-adrenergic antagonist.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

There is currently no usage information available for this product. We apologize for any inconvenience.

History

There is currently no drug history available for this drug.

Other Information

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:

Chemical Structure

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).

Antisedan Manufacturers

  • Orion Corporation
    Antisedan | Orion Corporation
    No Recall

    Antisedan | Orion Corporation

    Antisedan | Orion Corporation

    ANTISEDAN is administered intramuscularly 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 concentration of ANTISEDAN is formulated so that the volume of injection is the same (mL for mL) as the recommended dose of DEXDOMITOR or DOMITOR.

    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