Spironolactone is an aldosterone antagonist sold in the U.S. under 2 brand and generic names, for ascites, edema and heart failure. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Carospir (application NDA209478). Other spironolactone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Spironolactone oral suspension is not therapeutically equivalent to Aldactone ( 2.1 ) • Heart Failure: Initiate treatment at 20 mg once daily. ( 2.2 ) • Hypertension: Initiate treatment at 20 to 75 mg daily in either single or divided doses ( 2.3 ) • 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 ( 2.4 ) 2.1 General Considerations Spironolactone oral suspension is not therapeutically equivalent to Aldactone. Follow dosing instructions given here. In patients requiring a dose greater than 100 mg, use another formulation. Doses of the suspension greater than 100 mg may result in spironolactone concentrations higher than expected [see Clinical Pharmacology ( 12.3 )] . Spironolactone oral suspension 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/1.73m 2 , initiate treatment at 20 mg (4 mL) once daily. Patients who tolerate 20 mg (4 mL) once daily may have their dosage increased to 37.5 mg (7.5 mL) once daily as clinically indicated. Patients who develop hyperkalemia on 20 mg (4 mL) once daily may have their dosage reduced to 20 mg (4 mL) every other…
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: Gynecomastia [see Warnings and Precautions ( 5.4 )] , 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, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Metabolism: Hyperkalemia, electrolyte disturbances…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Suspension | Generic | $3 | View → | |
| 2 | Not yet rated | Prescription | Suspension | Generic | $3 | View → |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| MP;35 | 25 mg | white | round | — |
| MP;303 | 100 mg | white | oval | — |
| AN;515 | 100 mg | brown | round | — |
| 852;O | 25 mg | white | round | — |
| TL218 | 100 mg | brown | round | — |
| 852;O | 25 mg | white |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Spironolactone oral suspension is contraindicated for patients with the following conditions: • Hyperkalemia • Addison’s disease • Concomitant use of eplerenone Spironolactone oral suspension is contraindicated in patients with ( 4 ): • Hyperkalemia • Addison’s disease • Concomitant use of eplerenone
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 oral suspension ( 7.3 ) • Digoxin: Spironolactone oral suspension 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 ) 7.1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone oral suspension 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 oral suspension [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 oral suspension. Examples of drugs that can increase potassium include: • ACE inhibitors • angiotensin receptor blockers • aldosterone blockers • non-steroidal anti-inflammatory drugs (NSAIDs) • heparin and low molecular weight heparin • trimethoprim 7.2 Lithium Like other diuretics,…
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| M;41 | 25 mg / 25 mg | white | round | — |
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| MP;40 | 25 mg / 25 mg | white | round | — |
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| M;41 | 25 mg / 25 mg | white | round | — |
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| MP;40 | 25 mg / 25 mg | white | round | — |
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| MP;40 | 25 mg / 25 mg | white | round | — |
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| MP;542 | 50 mg | white | round | — |
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