SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Prasco Laboratories

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

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