SPIRONOLACTONE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)

Beszerezhető a:

Preferred Pharmaceuticals, Inc.

INN (nemzetközi neve):

SPIRONOLACTONE

Összetétel:

SPIRONOLACTONE 25 mg

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

SPIRONOLACTONE- SPIRONOLACTONE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
SPIRONOLACTONE TABLETS, USP
WARNING
Spironolactone Tablets have been shown to be a tumorigen in chronic
toxicity studies in rats (see
_Precautions_). Spironolactone Tablets should be used only in those
conditions described under
_Indications and Usage. _Unnecessary use of this drug should be
avoided.
DESCRIPTION
Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the
aldosterone antagonist
spironolactone, USP
17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-
lactone
acetate, which has the following structural formula:
Spironolactone, USP is practically insoluble in water, soluble in
alcohol, and freely soluble in benzene
and in chloroform.
Inactive ingredients include calcium sulfate, corn starch,
croscarmellose sodium, flavor, hypromellose,
iron oxide, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene glycol,
polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin.
The 50 mg tablet also contains D&C
yellow # 10 and FD&C yellow # 6.
ACTIONS / CLINICAL PHARMACOLOGY
_Mechanism of action: _Spironolactone is a specific pharmacologic
antagonist of aldosterone, acting
primarily through competitive binding of receptors at the
aldosterone-dependent sodium-potassium
exchange site in the distal convoluted renal tubule. Spironolactone
causes increased amounts of sodium
and water to be excreted, while potassium is retained. Spironolactone
acts both as a diuretic and as an
antihypertensive drug by this mechanism. It may be given alone or with
other diuretic agents that act
more proximally in the renal tubule.
_Aldosterone antagonist activity: _Increased levels of the
mineralocorticoid, aldosterone, are present in
primary and secondary hyperaldosteronism. Edematous states in which
secondary aldosteronism is
usually involved include congestive heart failure, hepatic cirrhosis,
and the nephrotic syndrome. By
competing with aldosterone for receptor sites, spironolactone provides
effec