Revertidine (Atipamezole Hydrochloride) Sterile Injectable Solution

Description

Revertidine is indicated for the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride, and medetomidine hydrochloride in dogs.

Directions

Revertidine is administered intramuscularly (IM) for reversal of sedation and analgesia regardless of the route used for dexmedetomidine or medetomidine. The atipamezole dose for the reversal of IV dexmedetomidine or medetomidine is 3750 mcg/m2.

• The atipamezole dose for the reversal of IM dexmedetomid.i ne or medetomidine is 5000 mcg/m2.
• The dosage of REVERTIDINE is calculated based on body surface area. Use the following tables to determine the correct injection volume or the correct REVERTIDINE dosage on the basis of kilograms of body weight.
• Note that the mcg/kg dosage decreases as body weight increases.

Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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 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 1-888-590-9839

Note to Physician

This product contains an alpha2-adrenergic antagonist

Precautions

Handling

REVERTIDINE can produce an abrupt reversal of sedation; therefore, dogs that have recently received REVERTIDINE 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.

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 alpha2-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.

Analgesia reversal

Atipamezole reverses analgesic effects as well as sedative effects. Additional procedures for the control of pain may be required.

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 2 -antagonists (as well as alpha -agonists). Dogs with abnormalities associated with the cardiovascular system are especially at risk.

Breeding dogs

REVERTIDINE 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.

Minimum age and weight

REVERTIDINE has not been evaluated in dogs less than four months of age or in dogs weighing less than 4.4 lbs (2 kg)

Storage

Store between 20-25°C (68-77°F) with excursion permitted between 15-30°C (59-86°F). Discard unused product after 28 days of first broaching the vial.