SPIRONOLACTONE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

RedPharm Drug, Inc.

INN (International Name):

SPIRONOLACTONE

Sammensetning:

SPIRONOLACTONE 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 high

Produkt oppsummering:

Spironolactone Tablets, USP 25 mg are brown colored, round, biconvex, film-coated tablets debossed with 'TL 216' on one side and plain on the other side. Bottle of 100 Tablets NDC 59746-216-01 Bottle of 500 Tablets NDC 59746-216-05 Bottle of 1000 Tablets NDC 59746-216-10 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. Bottle of 100 Tablets NDC 59746-217-01 Bottle of 500 Tablets NDC 59746-217-05 Spironolactone Tablets, USP 100 mg are brown colored, round, biconvex, film-coated tablets debossed with 'TL 218' on one side and scored on the other side. Bottle of 100 Tablets NDC 59746-218-01 Bottle of 500 Tablets NDC 59746-218-05 For more information, call 1-800-313-4623. Protect from light. Dispense in tight, light-resistant, child resistant container as defined in the USP. 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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
BOXED WARNING
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 Structure]
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.
Spironolac