21 C.F.R. § 520.1921 Prochlorperazine, isopropamide, with neomycin sustained-release capsules.
Title 21 - Food and Drugs
(a) Specifications. Each capsule contains either: (1) Capsule No. 1: 3.33 milligrams of prochlorperazine (as the dimaleate), 1.67 milligrams of isopropamide (as the iodide), and 25 milligrams of neomycin base (as the sulfate); or (2) Capsule No. 3: 10 milligrams of prochlorperazine (as the dimaleate), 5 milligrams of isopropamide (as the iodide), and 75 milligrams of neomycin base (as the sulfate). (b) Sponsor. See No. 000069 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Administer capsules orally twice daily to dogs as follows: (2) Indications for use. For treatment of dogs in which infectious bacterial gastroenteritis is associated with emotional stress. (3) Limitations. Do not continue medication longer than 5 days. Overdosage or prolonged administration may produce nephrotoxicity as manifested by albuminuria, presence of granular casts and depressed urinary output. If it is desirable to administer a vasoconstrictor, norepinephrine is the drug of choice. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [49 FR 14103, Apr. 10, 1984, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1921 Prochlorperazine, isopropamide, with neomycin sustained-release capsules.
------------------------------------------------------------------------ Number of capsules per dose Animal weight (pounds) ------------------- Capsule Capsule No. 1 No. 3------------------------------------------------------------------------10 to 20............................................ 120 to 30............................................ 2Over 30............................................. 3 1Over 60............................................. 2------------------------------------------------------------------------
