Spironolactone 50 mg/1
Spironolactone · TABLET, COATED · A-S Medication Solutions
Spironolactone is a tablet, coated containing spironolactone at 50 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Spironolactone
- Generic Name
- Spironolactone
- NDC Code (Product)
50090-6600- Manufacturer
- A-S Medication Solutions
- Strength
- 50 mg/1
- Dosage Form
- TABLET, COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040750
- Drug Class
- Aldosterone Antagonist [EPC]
- Marketing Start
- 01/04/2021
Recall History
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
SUN PHARMACEUTICAL INDUSTRIES INC
Presence of foreign substance: identified as aluminum.
Health Innovations Pharmacy, Inc
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
MasterPharm LLC
Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.
Greenstone Llc
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Pfizer Us Pharmaceutical Group
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
Prescription Labs Inc dba Greenpark
Lack of Assurance of Sterility
MasterPharm LLC
Lack of Processing Controls (lack of assurance of conformity to specifications).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3 ). Treatment of primary hyperaldosteronism for: ( 1.4 ) Short-term preoperative treatment Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia 1.1 Heart Failure Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejec…
Dosage & Administration
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 determined for the individual patient ( 2.5 ). 2.1 General Considerations Spironolactone can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3) ] . 2.2 Treatment of Heart Failure In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m², initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions (5.1) ] . In patients with an eGFR between 30 and 50 mL/min/1.73 m 2 , consider initiating…
Contraindications
4 CONTRAINDICATIONS Spironolactone is contraindicated in the patients with: Hyperkalemia Addison’s disease Concomitant use of eplerenone Spironolactone is contraindicated in patients with ( 4 ): Hyperkalemia Addison’s disease Concomitant use of eplerenone
Drug Interactions
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 may reduce the efficacy of spironolactone ( 7.6 ) Abiraterone: May increase prostate-specific antigen (PSA) levels ( 7.7 ). 7.1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia. In general, discontinue potassium supplementation in heart failure patients who start spironolactone [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Check serum potassium levels when ACE inhibitor or ARB therapy is altered in patients receiving spironolactone. Examples of drugs that can increase potassium include: ACE inhibitors angiotensin receptor b…
Adverse Reactions
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 Populations (8.7) ] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain. Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, …
Frequently Asked Questions
What is Spironolactone used for?
Spironolactone contains Spironolactone. It is a tablet, coated taken oral. Consult your doctor for specific uses.
Is Spironolactone a controlled substance?
Spironolactone is not classified as a controlled substance by the DEA.
What is the generic name for Spironolactone?
The generic name for Spironolactone is Spironolactone. There are 9 other brand versions of Spironolactone.
What is the NDC code for Spironolactone 50 mg/1?
The NDC (National Drug Code) for Spironolactone 50 mg/1 is 50090-6600, listed by A-S Medication Solutions.
Other Spironolactone Dosages
Other Spironolactone Brands
See all →- SPIRONOLACTONE25 mg/172162-1624
- spironolactone50 mg/131722-095
- spironolactone100 mg/151655-153
- SPIRONOLACTONE50 mg/163629-1066
- Spironolactone and Hydrochlorothiazide25 mg/163629-1069
- SPIRONOLACTONE50 mg/163629-5341
- SPIRONOLACTONE25 mg/171335-2301
- Spironolactone and Hydrochlorothiazide25 mg/171335-2674
- SPIRONOLACTONE25 mg/171610-742
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)