21 C.F.R. § 522.246 Butorphanol tartrate injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of aqueous solution contains either 0.5, 2 or 10 milligrams of butorphanol (as butorphanol tartrate). (b) Sponsors. Approval to firms identified in §510.600(c) of this chapter for use as indicated: (1) See Nos. 057926 and 059130 for use as in paragraph (c)(2) of this section. (2) See No. 000856 for use as in paragraphs (c)(1), (c)(2), and (c)(3) of this section. (c) Conditions of use—(1) Dogs—(i) Amount. 0.025 milligram of butorphanol base activity per pound of body weight (equivalent to 0.5 milliliter per 10 pounds), using 0.5 milligram per milliliter solution. (ii) Indications for use. For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract. (iii) Limitations. For subcutaneous injection in dogs only. Repeat at intervals of 6 to 12 hours as required. If necessary, increase dose to maximum of 0.05 milligram per pound of body weight. Treatment should not normally be required for longer than 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses—(i) Amount. 0.05 milligram of butorphanol base activity per pound of body weight (0.1 milligram/kilogram) using 10 milligrams per milliliter solution. (ii) Indications for use. For the relief of pain associated with colic and postpartum pain in adult horses and yearlings. (iii) Limitations. For intravenous use in horses only. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Cats—(i) Amount. 0.2 milligram of butorphanol base activity per pound of body weight (0.4 milligram/kilogram), using 2 milligrams per milliliter solution. (ii) Indications for use. For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures. (iii) Limitations. For subcutaneous injection in cats only. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days. Safety for use in pregnant female cats, breeding male cats or kittens less than 4 months of age has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [45 FR 29276, May 2, 1980, as amended at 50 FR 24508, June 11, 1985; 53 FR 27851, July 25, 1988; 59 FR 41665, Aug. 15, 1994; 63 FR 66432, Dec. 2, 1998; 68 FR 22594, Apr. 29, 2003]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.246 Butorphanol tartrate injection.
