Atipamezole

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 2 . The atipamezole dose for the reversal of IM dexmedetomidine hydrochloride or medetomidine hydrochloride is 5000 mcg/m 2 . 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 2 ) when dexmedetomidine or medetomidine is given IV For # lbs For # kg dose = mcg/kg volume = mL Atipamezole Hydrochloride Injection 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 Atipamezole Hydrochloride Injection (5000 mcg/m 2 ) when dexmedetomidine or medetomidine is given IM For # lbs For # kg dose = mcg/kg volume = mL Atipamezole Hydrochloride Injection 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

Contraindications

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. 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 safety data sheet (SDS) contains more detailed occupational safety information. Note to Physician This product contains an alpha 2 -adrenergic antagonist

Precautions

1. Handling Atipamezole Hydrochloride Injection can produce an abrupt reversal of sedation; therefore, dogs that have recently received Atipamezole Hydrochloride Injection should be handled with caution. The potential for apprehensive or aggressive behavior should be considered in the handling of dogs emerging from sedation, especially in dogs predisposed to nervousness or fright. Also, avoid situations where a dog might fall. 2. Sedation relapse While atipamezole does reverse the clinical signs associated with medetomidine or dexmedetomidine sedation, complete physiologic return to pretreatment status may not be immediate or may be temporary, and dogs should be monitored for sedation relapse. Sedation relapse is more likely to occur in dogs that receive an alpha 2 -agonist by the IV route, compared to dogs that are sedated using the IM route. Animals should be monitored closely for persistent hypothermia, bradycardia, and depressed respiration, until signs of recovery persist. 3. Analgesia reversal Atipamezole reverses analgesic effects as well as sedative effects. Additional procedures for the control of pain may be required. 4. Debilitated dogs The safety of atipamezole has not been evaluated in dogs with compromised health. Geriatric, debilitated, and ill dogs are more likely to experience adverse reactions associated with the administration of alpha -antagonists (as well as alpha -agonists). Dogs with abnormalities associated with the cardiovascular system are especially at risk. 5. Breeding dogs Atipamezole Hydrochloride Injection has not been evaluated in breeding dogs; therefore, the drug is not recommended for use in pregnant or lactating dogs, or in dogs intended for breeding. 6. Minimum age and weight Atipamezole Hydrochloride Injection has not been evaluated in dogs less than four months of age or in dogs weighing less than 4.4 lbs (2 kg).

Adverse Reactions

Occasional vomiting may occur. At times, a period of excitement or apprehensiveness may be seen in dogs treated with atipamezole. Other effects of atipamezole include hypersalivation, diarrhea, and tremors.

Description

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 C 14 H 16 N 2 • 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). structure

Storage

Store at USP controlled room temperature 20° to 25°C (68°-77°F), with excursions permitted to 15° to 30°C (59°-86°F). Use within 90 days of first puncture.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• Atipamezole Hydrochloride Injection Sterile Injectable Solution - 5.0 mg/mL, BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA. Set id 0eecca64-53f0-4c54-9368-08c5d072051b.
• VETONE ® Inversedine® (atipamezole hydrochloride) 5.0 mg/mL Sterile Injectable Solution Dexmedetomidine and Medetomidine Reversing Agent, MWI Veterinary Supply. Set id f13cd2f0-bc17-4274-bfca-4e68c805b946.
• VETONE ® CONTRASED™ (atipamezole hydrochloride) 5.0 mg/mL Sterile Injectable Solution Dexmedetomidine and Medetomidine Reversing Agent, MWI Veterinary Supply. Set id 2cd688a6-e0f9-4bb9-897e-33489960bf3b.
• CONTRASED™ (atipamezole hydrochloride) 5.0 mg/mL Sterile Injectable Solution Dexmedetomidine and Medetomidine Reversing Agent, Parnell Technologies Pty Ltd. Set id e6c1f710-04b5-4515-8971-b60211182041.
• Cropamezole™ (atipamezole hydrochloride) Sterile Injectable Solution - 5.0 mg/mL, Cronus Pharma LLC. Set id 47429f8e-8dfa-4e00-b5ab-fc7c0e31c9eb.
• Inversedine™ (atipamezole hydrochloride) Sterile Injectable Solution - 5.0 mg/mL, MWI Animal Health. Set id 262b470a-4eb4-4f25-9842-22cce90bab0a.
• Revertased™ (atipamezole hydrochloride) Sterile Injectable Solution - 5.0 mg/mL, ASPEN VETERINARY RESOURCES®, LTD. Set id 51410acc-da0c-4831-9e4e-01cb98c7b933.
• ANTISEDAN ® (atipamezole hydrochloride), Zoetis Inc.. Set id 403065e1-4c1a-433c-bb1b-6a2951946297.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming atipamezole as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.