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Spironolactone

Generic Name
Spironolactone
Brand Names
Aldactazide, Aldactone, Carospir, Qaialdo
Drug Type
Small Molecule
Chemical Formula
C24H32O4S
CAS Number
52-01-7
Unique Ingredient Identifier
27O7W4T232

Overview

Spironolactone is a potassium-sparing diuretic. It binds to mineralocorticoid receptors and functions as aldosterone antagonists. It promotes sodium and water excretion and potassium retention. Spironolactone was originally developed purely for this ability before other pharmacodynamic properties of the drug were discovered. It is indicated to treat several conditions, including heart failure, edema, hyperaldosteronism, and hypertension. Off-label uses of spironolactone include hirsutism, female pattern hair loss, and adult acne vulgaris. Spironolactone was developed in 1957, marketed in 1959, and approved by the FDA on January 21, 1960.

Background

Spironolactone is a potassium-sparing diuretic. It binds to mineralocorticoid receptors and functions as aldosterone antagonists. It promotes sodium and water excretion and potassium retention. Spironolactone was originally developed purely for this ability before other pharmacodynamic properties of the drug were discovered. It is indicated to treat several conditions, including heart failure, edema, hyperaldosteronism, and hypertension. Off-label uses of spironolactone include hirsutism, female pattern hair loss, and adult acne vulgaris. Spironolactone was developed in 1957, marketed in 1959, and approved by the FDA on January 21, 1960.

Indication

Spironolactone is indicated for the treatment of the following conditions: As spironolactone has antiandrogenic activity, its off-label uses include the treatment of hirsutism, female pattern hair loss, and adult acne vulgaris.

Associated Conditions

  • Edema
  • Hypertension
  • Primary Aldosteronism
  • Primary Hyperaldosteronism
  • Secondary hyperaldosteronism
  • Chronic heart failure with reduced ejection fraction (NYHA Class III)
  • Chronic heart failure with reduced ejection fraction (NYHA Class IV)
  • Idiopathic hyperaldosteronism
  • Refractory Edema

Clinical Trials

FDA Approved Products

SPIRONOLACTONE
Manufacturer:RPK Pharmaceuticals, Inc.
Route:ORAL
Strength:25 mg in 1 1
Approved: 2023/01/20
NDC:53002-4721
SPIRONOLACTONE
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:100 mg in 1 1
Approved: 2023/01/20
NDC:71335-2203
SPIRONOLACTONE
Manufacturer:NuCare Pharmaceuticals,Inc.
Route:ORAL
Strength:25 mg in 1 1
Approved: 2023/09/18
NDC:68071-2989
Spironolactone
Manufacturer:Direct_Rx
Route:ORAL
Strength:100 mg in 1 1
Approved: 2023/07/05
NDC:72189-495
SPIRONOLACTONE
Manufacturer:Aurobindo Pharma Limited
Route:ORAL
Strength:25 mg in 1 1
Approved: 2023/08/28
NDC:59651-426

Singapore Approved Products

SPIRIDON TABLETS 50MG
Manufacturer:Orion Corporation, Orion Pharma (primary and secondary packager), Orion Corporation, Orion Pharma
Form:TABLET
Strength:50.0mg
Online:Yes
Approved: 2023/02/23
Approval:SIN16710P
URACTONUM TABLET 25 mg
Manufacturer:MEDOCHEMIE LTD
Form:TABLET
Strength:25 mg
Online:Yes
Approved: 1988/05/03
Approval:SIN00664P
SPIRIDON TABLETS 25MG
Manufacturer:Orion Corporation, Orion Pharma (primary and secondary packager), Orion Corporation, Orion Pharma
Form:TABLET
Strength:25.0mg
Online:Yes
Approved: 2023/02/23
Approval:SIN16711P
SPIROLON 100 TABLET 100 mg
Manufacturer:REMEDICA LTD
Form:TABLET, FILM COATED
Strength:100 mg
Online:Yes
Approved: 1988/06/27
Approval:SIN02168P
SPIRIDON TABLETS 100MG
Manufacturer:Orion Corporation, Orion Pharma (primary and secondary packager), Orion Corporation, Orion Pharma
Form:TABLET
Strength:100.0mg
Online:Yes
Approved: 2023/02/23
Approval:SIN16709P

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