Code of Federal Regulations (Last Updated: November 8, 2024) |
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 |
§ 522.1258 - Lidocaine injection with epinephrine.
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(a)
Specifications. Each milliliter of the drug contains 20 milligrams (2 percent) of lidocaine hydrochloride, 0.01 milligram of epinephrine, with sodium chloride, and with methylparaben as a preservative, in water for injection.(b)
Sponsor. See No. 000402 in § 510.600(c) of this chapter.(c)
Conditions of use\1\ —(1) Amount. The drug is administered by injection as a 2 percent solution or diluted with bacteriostatic water for injection to a 0.5 percent solution for local anesthesia of large and small animals, as follows:(i) Cats: Administer approximately 2 milliliters of 2 percent solution with epinephrine by caudal injection.
(ii) Cattle: Administer 5 milliliters of 2 percent solution with epinephrine by epidural injection (standing animal). Administer 10 to 20 milliliters of 2 percent solution with epinephrine by cornural nerve block injection. For teat operations and infiltration, inject 0.5 percent solution with epinephrine to effect.
(iii) Dogs: Administer 2 to 10 milliliters of 2 percent solution with epinephrine by caudal injection. Do not give intravascularly. For infiltration, administer 0.5 percent solution with epinephrine to effect.
(iv) Horses: Administer 5 to 10 milliliters of 2 percent solution with epinephrine by volar nerve block. Administer 10 to 15 milliliters of 2 percent solution with epinephrine by epidural injection. For standing animal, apply slowly and observe individual sensitivity. For infiltration, administer 0.5 percent solution with epinephrine to effect.
(2)
Limitations. (i) The drug is contraindicated in the presence of sepsis in the region of proposed injection, shock and heart block, neurologic disease, spinal deformities, septicema, and hypertension.(ii) Do not give intravascularly.
(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.