SPIRONOLACTONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Contract Pharmacy Services-PA

INN (International Name):

SPIRONOLACTONE

Composition:

SPIRONOLACTONE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Spironolactone tablets, USP are indicated in the management of: Primary hyperaldosteronism for: - Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. - Short-term preoperative treatment of patients with primary hyperaldosteronism. 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 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). Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edema

Product summary:

Spironolactone Tablets, USP 25 mg are white, film-coated, round tablets, debossed “AN” above “511” on one side and plain on other side. They are available as follows: Blisterpacks of 30: NDC 67046-717-30

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SPIRONOLACTONE- SPIRONOLACTONE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
SPIRONOLACTONE TABLETS, USP 717
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
eff