SPIRONOLACTONE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Blenheim Pharmacal, Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Spironolactone tablets, USP are indicated in the management of: Primary hyperaldosteronism for: - Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. - Short-term preoperative treatment of patients with primary hyperaldosteronism. 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 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). Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edema

Produktu pārskats:

Spironolactone Tablets, USP 25 mg are white, film-coated, round tablets, debossed “AN” above “511” on one side and plain on other side. They are available as follows: Bottles of 30:        NDC 53746-511-30 Bottles of 60:        NDC 53746-511-60 Bottles of 90:        NDC 53746-511-90 Bottles of 100:      NDC 53746-511-01 Bottles of 500:      NDC 53746-511-05 Bottles of 1000:    NDC 53746-511-10 Spironolactone Tablets, USP 50 mg are yellow, film-coated, round tablets, debossed “AN” bisect “514” on one side and plain on other side. They are available as follows: Bottles of 30:        NDC 53746-514-30 Bottles of 60:        NDC 53746-514-60 Bottles of 90:        NDC 53746-514-90 Bottles of 100:      NDC 53746-514-01 Bottles of 500:      NDC 53746-514-05 Bottles of 1000:    NDC 53746-514-10 Spironolactone Tablets, USP 100 mg are beige, film-coated, round tablets, debossed “AN” on above bisect and “515” below bisect on one side and plain on other side. They are available as follows: Bottles of 30:        NDC 53746-515-30 Bottles of 60:        NDC 53746-515-60 Bottles of 90:        NDC 53746-515-90 Bottles of 100:      NDC 53746-515-01 Bottles of 500:      NDC 53746-515-05 Bottles of 1000:    NDC 53746-515-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured by: Amneal Pharmaceuticals Co. (I) Pvt. Ltd. Ahmedabad, INDIA  382220 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 10-2014-00

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

SPIRONOLACTONE- SPIRONOLACTONE TABLET
BLENHEIM PHARMACAL, INC.
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SPIRONOLACTONE TABLETS, USP
WARNING
Spironolactone Tablets have been shown to be a tumorigen in chronic
toxicity studies in rats (see
_Precautions_). Spironolactone Tablets should be used only in those
conditions described under
_Indications and Usage. _Unnecessary use of this drug should be
avoided.
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 the 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.
Spironolactone is effective in lowering the systolic and diastolic
blood pressure in patients with
primary hyperaldosteronism. It is also effective in most cases of
essential hypertension, despite the fact
that aldosterone secretion may be within normal limits in benign
essential hypertension.
Through its action in antagonizing the effect of aldosterone,
spironolactone inhibits the exchange of
sodium for potassium in the distal renal tubule and helps to prevent
potassium loss.
Spironolactone has not been demo