[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.62]

[Page 216]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 522.62  Aminopentamide hydrogen sulfate injection.

    (a) Chemical name. 4-(Dimethylamino)-2,2-diphenylvaleramide hydrogen 
sulfate.
    (b) Specifications. It is sterile and each milliliter of aqueous 
solution contains 0.5 milligram of the drug.
    (c) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) It is intended for use in dogs and cats 
only for the treatment of vomiting and/or diarrhea, nausea, acute 
abdominal visceral spasm, pylorospasm, or hypertrophic gastritis.
    Note: Not for use in animals with glaucoma because of the occurrence 
of mydriasis.
    (2) Dosage is administered by subcutaneous or intramuscular 
injection every 8 to 12 hours, as follows:

------------------------------------------------------------------------
                                                               Dosage in
                 Weight of animal in pounds                   milligrams
------------------------------------------------------------------------
Up to 10....................................................         0.1
11 to 20....................................................         0.2
21 to 50....................................................         0.3
51 to 100...................................................         0.4
Over 100....................................................         0.5
------------------------------------------------------------------------


Dosage may be gradually increased up to a maximum of five times the 
suggested dosage. Following parenteral use dosage may be continued by 
oral administration of tablets.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988