国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)
NuCare Pharmaceuticals, Inc.
SPIRONOLACTONE
SPIRONOLACTONE 25 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED NUCARE PHARMACEUTICALS, INC. ---------- 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 完全なドキュメントを読む