Antisedan (Atipamezole Hydrochloride) Sterile inj Solution 5mg/ml By Zoetis

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 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:

Table 2: Atipamezole dosing for reversal of IM dexmedetomidine- or medetomidine-induced sedation/analgesia:

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 1-800-366-5288.

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.

ANIMAL SAFETY: Atipamezole was tolerated in healthy dogs receiving 10X the recommended dose and in dogs receiving repeated doses at 1, 3, and 5X the recommended dose, in the absence of an alpha₂-agonist. Signs were dose-related and included excitement, panting, trembling, vomiting, soft or liquid feces and scleral injection. At 10X the recommended dose, increases in creatine kinase, AST, and ALT were noted. Creatine kinase also increased in 3 (of 6) dogs in the 3X treatment group. Localized skeletal muscle injury was seen at the injection site but no associated clinical signs or complications were observed. Dogs receiving the recommended atipamezole dose in the absence of medetomidine or dexmedetomidine exhibited no adverse clinical signs. In additional safety studies, adverse events were absent up to the 3X dose of atipamezole when its administration followed medetomidine or dexmedetomidine sedation.

In a separate safety study using a crossover design, 5 dogs received atipamezole after dexmedetomidine (IV and IM). Dexmedetomidine’s effects on blood pressure, heart rate, respiratory rate, and cardiac conduction times were reversed by atipamezole. However, heart rate and cardiac conduction times did not return to predexmedetomidine values. Heart rate increases after atipamezole were closer to baseline values in dogs treated with dexmedetomidine IV (compared to IM).

STORAGE INFORMATION: Store protected from light at controlled room temperature 15°-30°C (59°-86°F).