Generic equivalent of SPIRONOLACTONE
12 SKUs available · In stock · NABP accredited · DSCSA compliant
Spironolactone is the generic equivalent of the brand-name drug SPIRONOLACTONE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Spironolactone through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Spironolactone is an aldosterone antagonist indicated for: The treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2 ). The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, re…
12.1 Mechanism of Action Spironolactone and its active metabolites are specific pharmacologic antagonists 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.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Spironolactone and its active metabolites are specific pharmacologic antagonists 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. 12.2 Pharmacodynamics Aldosterone antagonist activity: Increased levels of the mineralocorticoid, aldos…
4 CONTRAINDICATIONS Spironolactone tablets are contraindicated in the patients with: Hyperkalemia Addison's disease Concomitant use of eplerenone Spironolactone tablets are contraindicated in patients with ( 4 ): Hyperkalemia Addison's disease Concomitant use of eplerenone
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Hypotension and Worsening Renal Function [see Warnings and Precautions (5.2) ] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.3) ] Gynecomastia [see Warnings and Precautions (5.4 ] Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populatio…
7 DRUG INTERACTIONS Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( 5.1 , 7.1 ). Lithium: Increased risk of lithium toxicity ( 7.2 ). NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone ( 7.3 ). Digoxin: spironolactone can interfere with radioimmunologic assays of digoxin exposure ( 7.4 ). Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( 7.5 ). Acetylsalicylic Acid (ASA): ASA m…
2 DOSAGE AND ADMINISTRATION Heart Failure: Initiate treatment at 25 mg once daily ( 2.2 ). Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses ( 2.3 ). Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses ( 2.4 ). Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage deter…
17 PATIENT COUNSELING INFORMATION Patients who receive spironolactone tablets should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes. Manufactured For: Accord Healthcare, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No 5 to 14, Pharmez, Near Village Matoda, Sarkhej-Bavla Highway, No. 8-A, Taluka Sanand, Ahmedabad, Gujarat 382213, India. 51 2946 4 733371 Issued October 2023
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| SPIRONOLACTONE 100MG 100TAB | In Stock |
| SPIRONOLACTONE 100MG 500 TAB Accord Healthcare, Inc. | 2-Day |
| SPIRONOLACTONE 100MG 500 TABLETS | 2-Day |
| SPIRONOLACTONE 25 MG 100 TAB | 2-Day |
| SPIRONOLACTONE 25 MG 500 TAB | 2-Day |
| SPIRONOLACTONE 25MG 100 TAB | 2-Day |
| SPIRONOLACTONE 25MG 1000 TAB Accord Healthcare, Inc. | 2-Day |
| SPIRONOLACTONE 25MG 100TABLETS | 2-Day |
| SPIRONOLACTONE 25MG 500 TAB | 2-Day |
| SPIRONOLACTONE TABLETS, USP 25MG, 500CT | 2-Day |
| SPIRONOLACTONE 50MG 500 TAB Accord Healthcare, Inc. | 2-Day |
| SPIRONOLACTONE 50MG 100TAB | 2-Day |
Premier Pharma stocks 12 Spironolactone SKUs — 1 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Spironolactone is the generic equivalent of SPIRONOLACTONE. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Spironolactone in 100 mg/1, 100MG, 25 mg/1, 50 mg/1, 50MG and TABLET, TABLET, COATED, TABLET, FILM COATED. Available from manufacturers including Accord Healthcare, Inc..
Spironolactone carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
12.1 Mechanism of Action Spironolactone and its active metabolites are specific pharmacologic antagonists 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.
Create a free Premier Pharma account to unlock live wholesale pricing, place orders, and track shipments — approval typically takes minutes for licensed pharmacies, clinics, doctor's offices, and veterinary practices.