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:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Nama Internasional):

SPIRONOLACTONE

Komposisi:

SPIRONOLACTONE 25 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Spironolactone tablets 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 tablets are 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 tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. For nephrotic patient

Ringkasan produk:

Spironolactone Tablets, USP are available containing 25 mg, 50 mg or 100 mg of spironolactone, USP. The 25 mg tablet is a white, film-coated, round, unscored tablet debossed with M over 146 on one side of the tablet and blank on the other side. They are available as follows: NDC 0615-1535-39 blisterpacks of 30 tablets NDC 0615-1535-31 blisterpacks of 31 tablets NDC 0615-1535-05 blisterpacks of 15 tablets The 50 mg tablet is a white, film-coated, round tablet debossed with M over 243 on one side of the tablet and scored on the other side. They are available as follows: NDC 0615-5592-39 blisterpacks of 30 tablets The 100 mg tablet is a white, film-coated, round tablet debossed with M over 437 on one side of the tablet and scored on the other side. They are available as follows: NDC 0615-6591-39 blisterpacks of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED APRIL 2009 SP:R19

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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SPIRONOLACTONE
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, molecular formula, and
molecular weight:
C
H O S M.W.=416.59
Spironolactone, USP is practically insoluble in water, soluble in
alcohol, and freely soluble in benzene
and in chloroform.
Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of
spironolactone, USP and the
following inactive ingredients: calcium sulfate dihydrate, colloidal
silicon dioxide, croscarmellose
sodium, crospovidone, hypromellose, lactose monohydrate, magnesium
stearate, peppermint flavor,
polydextrose, polyethethylene glycol, povidone, pregelatinized starch,
sodium lauryl sulfate, 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 which act more proximally
24
32
4
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 fa