SPIRONOLACTONE- spironolactone tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

SPIRONOLACTONE

Composition:

SPIRONOLACTONE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Spironolactone tablets are 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 tablets are 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 hi

Product summary:

Spironolactone Tablets, USP 50 mg are brown colored, round, biconvex, film-coated tablets debossed with 'TL 217' on one side and scored on the other side. NDC 68071-4073-3 Bottles of 30 Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Rx Only Manufactured by: Jubilant Generics Limited Roorkee - 247661, India Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Revised: February/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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SPIRONOLACTONE TABLETS, USP
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 USP is freely soluble in benzene and chloroform;
soluble in ethyl acetate and in
alcohol, slightly soluble in ether, in methanol and in fixed oils and
practically insoluble in water.
Inactive ingredients include calcium sulfate dihydrate, corn starch,
peppermint, hypromellose,
magnesium stearate, polyethylene glycol, povidone, titanium dioxide,
iron oxide red, iron oxide yellow
and iron oxide black.
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 nephrotic syndrome. By
competing with aldosterone for receptor sites, spironolactone provides
effective therapy for the edema
and ascites in those conditions. Spiron