SPIRONOLACTONE tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Physicians Total Care, Inc.

ИНН (Международная Имя):

SPIRONOLACTONE

состав:

SPIRONOLACTONE 25 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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: Spironolactone levels may be exceptionally high in

Обзор продуктов:

Spironolactone Tablets, USP are available as follows: 25 mg ― Each white to off-white, round, film coated tablet, imprinted with on one side and 803 on the other side contains 25 mg of Spironolactone, USP.  Tablets are supplied in 50 mg — Each white to off-white, oval, film coated tablet, imprinted with and 672 on one side and partial bisect on the other side contains 50 mg of Spironolactone, USP. Tablets are supplied in 100 mg — Each white to off-white, round, film coated tablet, imprinted with and 673 on one side and bisect on the other side contains 100 mg of Spironolactone, USP. Tablets are supplied in Pharmacist: Dispense in a tight, light-resistant, child-resistant container. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 07207 USA 40-9048 Revised — October 2011 Relabeling and Repackaging by; Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

SPIRONOLACTONE - SPIRONOLACTONE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
SPIRONOLACTONE TABLETS, USP
40-9048
Revised – October 2011
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, 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 (-
lactone acetate. The molecular formula is C
H 0 S and is represented by 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, corn starch,
crospovidone, dextrose,
hypromellose, magnesium stearate, maltodextrin, natural peppermint
flavor, polydextrose, polyethylene
glycol, povidone, silicon dioxide, titanium dioxide, triacetin.
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
24
32
4
usually involved include congestive heart failure, hepatic cirrhosis,
and nephrotic syndrome. By
competing with aldosterone for receptor sites, spironolactone provides
effective