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CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.804—Enalapril tablets.

CFR

520.804—Enalapril tablets.

(a) Specifications. Each tablet contains either 1.0, 2.5, 5.0, 10.0, or 20.0 milligrams of enalapril maleate.
(b) Sponsor. See 050604 in § 510.600(c) of this chapter.
(c) Conditions of use— (1) Dogs— 0.5 to 1.0 milligram of enalapril maleate per kilogram of body weight per day.
(ii) Indications for use. Treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs.
(iii) Limitations. Use 0.5 milligram per kilogram once daily. In the absence of adequate clinical response within a 2-week period, use may be increased to twice daily (a total of 1.0 milligram per kilogram). Enalapril maleate is administered as conjunctive therapy with furosemide and digoxin in the treatment of dilated cardiomyopathy and furosemide with or without digoxin in the treatment of chronic valvular disease. The safety of enalapril for use in breeding dogs has not been established. Use in pregnant bitches is not recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]

Code of Federal Regulations

[59 FR 17694, Apr. 14, 1994, as amended at 62 FR 63270, Nov. 28, 1997]
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