Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Prasco Laboratories
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: Congestive heart failure: Cirrhosis of the liver accompanied by edema and/or ascites: The nephrotic syndrome: Essential hypertension: Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Progr
Spironolactone and hydrochlorothiazide tablets containing 25 mg of spironolactone and 25 mg of hydrochlorothiazide are round, tan, film coated, with G debossed on one side and 5014 on the other side, supplied as: 66993-188-02 bottle of 100 Store below 77°F (25°C). To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
New Drug Application Authorized Generic
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE- SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED PRASCO LABORATORIES ---------- SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLETS 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 calcium sulfate, corn starch, flavor, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide. 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 hydrochlorothiazide is effective in significantly lowering the systolic and diastolic blood pressure in many patients with essential hyp Aqra d-dokument sħiħ