SPIRONOLACTONE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

Spironolactone (UNII: 27O7W4T232) (Spironolactone - UNII:27O7W4T232)

Tillgänglig från:

Rebel Distributors Corp

INN (International namn):

Spironolactone

Sammansättning:

Spironolactone 25 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Spironolactone is indicated in the management of: Primary hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with: Congestive heart failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Spironolactone is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Cirrhosis of the liver accompanied by edema and/or ascites: Aldosterone levels may be exceptionally high in this condition. Spi

Produktsammanfattning:

Spironolactone tablets, USP are supplied as follows: Spironolactone tablets 25 mg, white, round, unscored, debossed MP 35 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

SPIRONOLACTONE- SPIRONOLACTONE TABLET
REBEL DISTRIBUTORS CORP
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SPIRONOLACTONE TABLETS USP
Spironolactone has been shown to be a tumorigen in chronic toxicity
studies in rats (see
_Precautions_). Spironolactone 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,
17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid
γ-lactone acetate,
which has the following structural formula:
Spironolactone is practically insoluble in water, soluble in alcohol,
and freely soluble in benzene and in
chloroform.
Spironolactone tablets, 25 mg contain the following inactive
ingredients: anhydrous lactose, colloidal
silicon dioxide, crospovidone, docusate sodium 85%/sodium benzoate
15%, entrapped peppermint
flavor, magnesium stearate, microcrystalline cellulose, and sodium
starch glycolate.
Spironolactone tablets, 50 mg and 100 mg contain the following
inactive ingredients: anhydrous lactose,
carnauba wax, colloidal silicon dioxide, docusate sodium 85%/sodium
benzoate 15%, entrapped
peppermint flavor, hydroxypropyl methylcellulose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, povidone, sodium starch glycolate,
titanium dioxide, and triacetin.
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
sodiumpotassium 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 which act more proximally
in the renal tubule.
ALDOSTERONE ANTAGONIST ACTIVITY
Increased levels of the mineralocorticoid, aldos