[Title 21 CFR 522.1503] [Code of Federal Regulations (annual edition) - April 1, 1996 Edition] [Title 21 - FOOD AND DRUGS] [Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)] [Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS] [Part 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS] [Sec. 522.1503 - Neostigmine methylsulfate injection.] [From the U.S. Government Publishing Office]21 FOOD AND DRUGS 6 1996-04-01 1996-04-01 false Neostigmine methylsulfate injection. 522.1503 Sec. 522.1503 FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Sec. 522.1503 Neostigmine methylsulfate injection. (a) Specifications. Neostigmine methylsulfate injection contains two milligrams of neostigmine methylsulfate in each milliliter of sterile aqueous solution. (b) Sponsor. See No. 011716 in Sec. 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is intended for use for treating rumen atony; initiating peristalsis which causes evacuation of the bowel; emptying the urinary bladder; and stimulating skeletal muscle contractions. It is a curare antagonist. (2) It is administered to cattle and horses at a dosage level of 1 milligram per 100 pounds of body weight subcutaneously. It is administered to sheep at a dosage level of 1 to 1\1/2\ milligrams per 100 pounds body weight subcutaneously. It is administered to swine at a dosage level of 2 to 3 milligrams per 100 pounds body weight intramuscularly. These doses may be repeated as indicated. (3) The drug is contraindicated in mechanical, intestinal or urinary obstruction, late pregnancy, and in animals treated with other cholinesterase inhibitors. (4) Not for use in animals producing milk, since this use will result in contamination of the milk. (5) Federal law restricts this drug to use by or on the order of a licensed veterinarian.