SPIRONOLACTONE- spironolactone tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

American Health Packaging

INN（国际名称）:

SPIRONOLACTONE

组成:

SPIRONOLACTONE 25 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Spironolactone is 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 is 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 this condition. Sp

產品總結:

Spironolactone Tablets, USP are available as: 25 mg: white, round, film-coated tablets, debossed "5880" on one side and debossed "V" on the reverse side, supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-206-01 50 mg: white, oval, scored, film-coated tablets, debossed "58" bisect "81" on one side and debossed "V" on the reverse side, supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-207-01 100 mg: white, round, scored, film-coated tablets, debossed "58" bisect "82" on one side and debossed "V" on the reverse side, supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-208-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

授权状态:

Abbreviated New Drug Application

产品特点

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
SPIRONOLACTONE TABLETS, USP
8020601/0815
8020601/0116OS
RX ONLY
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 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 calcium sulfate, hypromellose, magnesium
stearate, microcrystalline
cellulose, N & A mint flavor, polyethylene glycol, polysorbate 80,
povidone, pregelatinized starch,
sodium starch glycolate, talc, and titanium dioxide.
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 countera