国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Ceva Sante Animale
ORAL
PRESCRIPTION
CARDALIS is indicated 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). Do not administer CARDALIS in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with renal insufficiency. Do not administer CARDALIS to dogs with hypoadrenocorticism (Addison’s Disease), hyperkalemia, or hyponatremia. Do not administer CARDALIS to animals with known hypersensitivity to ACE inhibitors or spironolactone.
CARDALIS chewable tablets for dogs are available in 3 sizes of oblong half scored flavored tablets: 20 mg spironolactone and 2.5 mg benazepril hydrochloride, 40 mg spironolactone and 5 mg benazepril hydrochloride, and 80 mg spironolactone and 10mg benazepril hydrochloride. Each size is available in 30-count bottles enclosed in color coded packages.
New Animal Drug Application
CARDALIS- SPIRONOLACTONE AND BENAZEPRIL HYDROCHLORIDE TABLET, CHEWABLE CEVA SANTE ANIMALE ---------- CARDALIS™ (spironolactone and benazepril hydrochloride chewable tablets) Cardiac drug for oral use in dogs only Approved by FDA under NADA # 141-538 CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: CARDALIS (spironolactone and benazepril hydrochloride chewable tablets) for dogs contains two active ingredients, spironolactone and benazepril hydrochloride, in a fixed ratio of 8:1 respectively. CARDALIS is supplied as oblong half scored flavored chewable tablets in three sizes: 20 mg spironolactone and 2.5 mg benazepril hydrochloride, 40 mg spironolactone and 5 mg benazepril hydrochloride, and 80 mg spironolactone and 10 mg benazepril hydrochloride. Benazepril belongs to the angiotensin-converting enzyme (ACE) inhibitor class of drugs. Benazepril hydrochloride empirical formula is C H N O · HCl and the molecular weight is 460.95. The chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]- 2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benazepine-1-acetic acid monohydrochloride and the structural formula is shown below: Spironolactone, and its active metabolites, act as specific aldosterone antagonists. Spironolactone empirical formula is C H O S and the molecular weight is 416.57. The chemical name is 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid y-lactone acetate and the structural formula is shown below: 24 28 2 5 24 32 4 INDICATIONS: CARDALIS is indicated 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). DOSAGE AND ADMINISTRATION: CARDALIS administration should begin after pulmonary edema is stabilized. CARDALIS should be administered orally once daily at a dose of 0.9 mg/lb (2 mg/kg) spironolactone and 0.11 mg/lb (0.25 mg/kg) benazepril hydrochloride, according to dog body we 阅读完整的文件