Spironolactone and benazepril.

21 C.F.R. § 520.2138
in effectEffective: 2024-07-01
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(a) Specifications. Each chewable tablet contains 20 milligrams (mg) spironolactone and 2.5 mg benazepril hydrochloride, 40 mg spironolactone and 5 mg benazepril hydrochloride, or 80 mg spironolactone and 10 mg benazepril hydrochloride. (b) Sponsor. See No. 013744 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer orally once daily, with food, at a dose of 0.9 mg per pound (lb) (2 mg per kilogram (kg)) spironolactone and 0.11 mg/lb (0.25 mg/kg) benazepril hydrochloride, according to dog body weight using a suitable combination of whole and/or half tablets. (2) Indications for use. With concurrent therapy (e.g., furosemide, etc.) for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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