21 C.F.R. § 522.62   Aminopentamide hydrogen sulfate injection.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 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 §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....................................................         0.111 to 20....................................................         0.221 to 50....................................................         0.351 to 100...................................................         0.4Over 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

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