SPIRONOLACTONE tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

NuCare Pharmaceuticals, Inc.

INN (International ime):

SPIRONOLACTONE

Sastav:

SPIRONOLACTONE 25 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 in t

Proizvod sažetak:

Spironolactone Tablets USP 25 mg tablets are Light yellow to yellow colored, round, biconvex, film coated tablets with inscription AD on one side and plain on the other side having faint odour of peppermint, supplied as: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] bottles of 30 NDC 68071-3375-3 bottles of 60 NDC 68071-3375-6 bottles of 90 NDC 68071-3375-9 bottles of 120 NDC 68071-3375-1 bottles of 180 NDC 68071-3375-8 Protect from light. Dispense in tight, Light-resistant containers. Manufactured For: Accord Healthcare, Inc., 1009 Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No 5 to 12, Pharmez, Sarkhej-Bavla, National Highway No 8-A, Near Village Matoda, Tal Sanand, Ahmedabad - 382 213, Gujarat, India 51 2267 0 700753 Issued November 2016.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

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 tablets USP, for oral administration 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 is practically insoluble in water, soluble in alcohol,
and freely soluble in benzene and in
chloroform.
Inactive ingredients include lactose monohydrate, dibasic calcium
phosphate, povidone, peppermint oil,
purified talc, pregelatinised starch, colloidal anhydrous silica,
magnesium stearate, hypromellose,
polyethylene glycol 400, titanium dioxide and iron oxide yellow. In
addition, iron oxide red (50 mg and
100 mg tablets) is included in the film coating of specific strengths.
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