SPIRONOLACTONE- spironolactone tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Sandoz Inc

INN (Nama Internasional):

SPIRONOLACTONE

Komposisi:

SPIRONOLACTONE 25 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Spironolactone tablets, USP are indicated in the management of: 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). 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. Aldosterone levels may be exceptionally high in this condition. Spironolactone is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. For nephrotic patients when treatm

Ringkasan produk:

Spironolactone tablets, USP, 25 mg are round, scored, film-coated, white tablets debossed GG85 on one side and plain on the reverse side. They are available for oral administration and supplied as: NDC 0781-1599-01 bottles of 100 NDC 0781-1599-05 bottles of 500 NDC 0781-1599-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
SANDOZ 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 tablets, USP for oral administration contain 25 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.
Inactive ingredients include calcium sulfate, hypromellose, magnesium
stearate, polyethylene glycol,
polysorbate 80, povidone, starch (corn), titanium dioxide, and
peppermint.
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 nephrotic syndrome.
By competing with aldosterone for
receptor sites, spironolactone provides effective therapy for the
edema and ascites in those conditions.
Spironolactone counteracts secondary aldosteronism induced by the
volume depletion and associated
sodium loss caused by active diuretic therapy.