SPIRONOLACTONE- spironolactone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

SPIRONOLACTONE

Composition:

SPIRONOLACTONE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Product: 50436-9973 NDC: 50436-9973-1 30 TABLET in a BOTTLE NDC: 50436-9973-3 90 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SPIRONOLACTONE- SPIRONOLACTONE TABLET
UNIT DOSE SERVICES
----------
SPIRONOLACTONE TABLETS USP
RX ONLY
WARNING
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, hypromellose, 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 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, aldos