TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

522.2474 - Tolazoline hydrochloride injection.

  (a) Specifications. Each milliliter of sterile aqueous solution contains tolazoline hydrochloride equivalent to 100 milligrams of base activity.

  (b) Sponsor. See No. 061690 in 510.600(c) of this chapter.

  (c) Conditions of use. It is used as follows: (1) Horses(i) Amount. Administer slowly by intravenous injection 4 milligrams per kilogram of body weight or 1.8 milligrams per pound (4 milliliters per 100 kilograms or 4 milliliters per 220 pounds).

  (ii) Indications for use. For use in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.

  (iii) Limitations. The safety of TolazineTM has not been established in pregnant mares, lactating mares, horses intended for breeding, foals, or horses with metabolically unstable conditions. The safety of TolazineTM has not been evaluated for reversing xylazine used as a preanesthetic to a general anesthetic. This drug is for use in horses only and not for use in food-producing animals. Users with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid accidental exposure to this product.

Accidental spillage on the skin should be washed off immediately with soap and water. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  (2) [Reserved] [61 FR 25785, May 23, 1996]