국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for: Edematous conditions for patients with: - For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures; - The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate; - The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate. - Aldosterone levels may be exceptionally high in this condition. Spironolactone and hydrochlorothiazide tablets are indicated for maintenance t
Spironolactone and hydrochlorothiazide tablets, USP are supplied as follows: Spironolactone and hydrochlorothiazide tablets, 25 mg/25 mg are buff, round, unscored, debossed MP 40. Bottles of 30 NDC 63629-1071-1 Bottles of 60 NDC 63629-1071-2 Bottles of 1000 NDC 63629-1071-3 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE- SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET BRYANT RANCH PREPACK ---------- RX ONLY SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLETS USP 25 MG / 25 MG DESCRIPTION Spironolactone and hydrochlorothiazide oral tablets contain: spironolactone . . . . . . . . . . . . . . . . 25 mg hydrochlorothiazide . . . . . . . . . . . . 25 mg Spironolactone, an aldosterone antagonist, is 17-hydroxy-7α-mercapto-3-oxo-17α- pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Hydrochlorothiazide, a diuretic and antihypertensive, is 6-chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula: Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, D&C yellow #10 lake, docusate sodium, FD&C yellow #6 lake, magnesium stearate, microcrystalline cellulose, peppermint flavor, povidone, sodium benzoate, and sodium starch glycolate. ACTIONS / CLINICAL PHARMACOLOGY MECHANISM OF ACTION: Spironolactone and hydrochlorothiazide tablets are a combination of two diuretic agents with different but complementary mechanisms and sites of action, thereby providing additive diuretic and antihypertensive effects. Additionally, the spironolactone component helps to minimize the potassium loss characteristically induced by the thiazide component. The diuretic effect of spironolactone is mediated through its action as a specific pharmacologic antagonist of aldosterone, primarily by competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Hydrochlorothiazide promotes the excretion of sodium and water primarily by inhibiting their reabsorption in the cortical diluting segment of the distal renal tubule. Spironolactone and 전체 문서 읽기