SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Bryant Ranch Prepack

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

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