Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)
Preferred Pharmaceuticals, Inc
SPIRONOLACTONE
SPIRONOLACTONE 25 mg
ORAL
PRESCRIPTION DRUG
Spironolactone tablets, USP 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, USP 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 exceptiona
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: bottles of 30 NDC 68788-9124-3 bottles of 60 NDC 68788-9124-6 bottles of 90 NDC 68788-9124-9 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 Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9174 Revised — March 2015: Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
SPIRONOLACTONE- SPIRONOLACTONE TABLET PREFERRED PHARMACEUTICALS, INC ---------- SPIRONOLACTONE TABLETS, USP 40-9174 Revised – March 2015 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 γ- lactone acetate. The molecular formula is C H 0 S and is represented by the following structural formula: Spironolactone, USP 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 and 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 24 32 4 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 Belgenin tamamını okuyun