25 mg/5ml
Trade Name
Spironolactone Amarox
Oral Suspension
Request Type
New Registration
Drug Type
Generic(Multisource) Drug
Approval Date
SFDA Approved Use
Spironolactone is an antagonist of aldosterone indicated for:
·Heart Failure: Initiate treatment at 20 mg daily
·Hypertension: Initiate treatment at 20 to 75 mg daily in either single or divided doses
·Edema associated with Hepatic Cirrhosis: Initiate therapy in a hospital setting and titrate slowly. The initial recommended daily dose is 75 mg in either single or divided doses
Heart Failure
Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction in adult patients to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. Spironolactone oral suspension is usually administered in conjunction with other heart failure therapies
Hypertension
Spironolactone is indicated as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Edema caused by Cirrhosis
Spironolactone is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.
Spironolactone is an aldosterone antagonist acting primarily through competitive binding of receptors at the aldosterone-dependent sodium- potassium exchange site in the distal convoluted renal tubule, increasing sodium and water excretion, while retaining potassium. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.
·Heart Failure: Initiate treatment at 20 mg daily
·Hypertension: Initiate treatment at 20 to 75 mg daily in either single or divided doses
·Edema associated with Hepatic Cirrhosis: Initiate therapy in a hospital setting and titrate slowly. The initial recommended daily dose is 75 mg in either single or divided doses
Heart Failure
Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction in adult patients to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. Spironolactone oral suspension is usually administered in conjunction with other heart failure therapies
Hypertension
Spironolactone is indicated as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Edema caused by Cirrhosis
Spironolactone is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.
Spironolactone is an aldosterone antagonist acting primarily through competitive binding of receptors at the aldosterone-dependent sodium- potassium exchange site in the distal convoluted renal tubule, increasing sodium and water excretion, while retaining potassium. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.