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

522.1452 - Nalorphine hydrochloride injection.

  (a) Specifications. Each milliliter of aqueous solution contains 5 milligrams of nalorphine hydrochloride.

  (b) Sponsor. See No. 050604 in 510.600(c) of this chapter.

  (c) Conditions of use(1) Amount. One milligram per 5 pounds; intravenously, intramuscularly, or subcutaneously.

  (2) Indications for use. Respiratory and circulatory depression in dogs resulting from overdosage of, or unusual sensitivity to, morphine and certain other narcotics. Not for depression due to any other cause.

  (3) Limitations. Successive doses of the drug gradually lose their analeptic effect and eventually induce respiratory depression equal to that of opiates. Therefore, do not exceed therapeutic dosage. Do not mix drug with meperidine solutions because the buffer will cause precipitation. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[44 FR 6707, Feb. 2, 1979, as amended at 47 FR 36418, Aug. 20, 1982; 62 FR 63271, Nov. 28, 1997]