Rx Item-Spironolactone-HCTZ 25Mg/25Mg Tab 100 By Caraco Pharma gen Aldactazide

Clinical Information
Gen. Code and Des.
6813 spironolact/hydrochlorothiazid ORAL TABLET 25 MG-25MG
GCN and Des.
82330 spironolact/hydrochlorothiazid ORAL TABLET 25 MG-25MG
Strength
25-25 MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24322000 MINERALOCORTICOID (ALDOSTERONE) ANTAGNTS
40281600 POTASSIUM-SPARING DIURETICS
24082420 THIAZIDE DIURETICS(HYPOTENSIVE AGENTS)
40282000 THIAZIDE DIURETICS
24084420 MINERALOCORTICOID(ALDOSTER.)ANTAG(HYPOT)
24082416 POTASSIUM-SPARING DIURETICS (HYPOTEN)
Active Ingredients
2211 spironolactone 52017
2294 hydrochlorothiazide 58935
Inactive Ingredients
10143 yellow dye
2432 lactose 64044515
2537 povidone 9003398
7989 peppermint


ALDACTAZIDE- spironolactone and hydrochlorothiazide tablet, film coated
G.D. Searle LLC Division of Pfizer Inc
WARNING

Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions). ALDACTAZIDE should be used only in those conditions described under Indications and Usage. Unnecessary use of this drug should be avoided.

Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension. Edema or hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant.
DESCRIPTION

ALDACTAZIDE oral tablets contain:

spironolactone . . . . . . . . . . . . . . . . . . . . 25 mg
hydrochlorothiazide . . . . . . . . . . . . . . . . 25 mg

or

spironolactone . . . . . . . . . . . . . . . . . . . . 50 mghydrochlorothiazide . . . . . . . . . . . . . . . . 50 mg

Spironolactone (ALDACTONE�), an aldosterone antagonist, is 17-hydroxy-7?-mercapto-3-oxo-17?-pregn-4-ene-21-carboxylic acid ?-lactone acetate
Hydrochlorothiazide, a diuretic and antihypertensive, is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide
ACTIONS / CLINICAL PHARMACOLOGY
Mechanism of action

ALDACTAZIDE is 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.

ALDACTAZIDE is effective in significantly lowering the systolic and diastolic blood pressure in many patients with essential hypertension, even when aldosterone secretion is within normal limits.

Both spironolactone and hydrochlorothiazide reduce exchangeable sodium, plasma volume, body weight, and blood pressure. The diuretic and antihypertensive effects of the individual components are potentiated when spironolactone and hydrochlorothiazide are given concurrently.
INDICATIONS AND USAGE

Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). ALDACTAZIDE should be used only in those conditions described below. Unnecessary use of this drug should be avoided.

Spironolactone-HCTZ 25Mg/25Mg
Spironolactone-HCTZ 25Mg/25Mg Tab 100 By Caraco Pharma gen Aldactazide NDC 53489-0144-01 UPC/GTIN No.3-53489-14401-8 Mfg.Part No.14401

RX ITEM-Spironolactone-HCTZ 25Mg/25Mg Ta
NDC 53489-0144-01 UPC/GTIN No.3-53489-14401-8 Mfg.Part No.14401

Spironolactone-HCTZ 25Mg/25Mg Tab 100 By
BRAND: SPIRONOLACTONE-HCTZ NDC: 53489-0144-01,53489014401 UPC: 3-53489-14401-8,353489144018

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