Brand names: Aldactone, CaroSpir
Drug class: Steroidal Mineralocorticoid Receptor Antagonists

Spironolactone (Systemic) is also contained as an ingredient in the following combinations:
Spironolactone and Hydrochlorothiazide

Medically reviewed by Drugs.com on Jun 10, 2024. Written by ASHP.

Introduction

Aldosterone antagonist; a potassium-sparing diuretic.^{256 265}

Uses for Spironolactone

Edema

Management of edema associated with excessive aldosterone, including in patients with cirrhosis of the liver, heart failure, and nephrotic syndrome.^{265 a}

Used as an adjunct to thiazide therapy when diuresis is inadequate or reduction of potassium excretion is necessary.²⁶⁵

Hypertension

Management of hypertension usually in conjunction with other classes of antihypertensive agents;^{256 265 1200} has been used for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.²⁶⁵

Not considered a preferred agent for initial management of hypertension according to current evidence-based hypertension guidelines, but may be used as add-on therapy if BP not adequately controlled with the recommended antihypertensive drug classes (i.e., ACE inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, thiazide diuretics); considered preferred add-on therapy by some experts for resistant hypertension and for hypertension associated with primary aldosteronism.^{501 502 503 504 1200}

Some experts state that spironolactone may be useful for the management of resistant hypertension in patients with type 2 diabetes mellitus when added to an existing treatment regimen consisting of a renin-angiotensin system inhibitor (e.g., ACE inhibitor, angiotensin II receptor antagonist), diuretic, and calcium-channel blocker.¹²¹⁵

Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).^{501 502 503 504 515 1200 1201}

A 2017 ACC/AHA multidisciplinary hypertension guideline classifies BP in adults into 4 categories: normal, elevated, stage 1 hypertension, and stage 2 hypertension.¹²⁰⁰ (See Table 1.)

Source: Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13-115.

Individuals with SBP and DBP in 2 different categories (e.g., elevated SBP and normal DBP) should be designated as being in the higher BP category (i.e., elevated BP).

The goal of hypertension management and prevention is to achieve and maintain optimal control of BP.¹²⁰⁰ However, the BP thresholds used to define hypertension, the optimum BP threshold at which to initiate antihypertensive drug therapy, and the ideal target BP values remain controversial.^{501 503 504 505 506 507 508 515 523 526 530 1200 1201 1207 1209 1222 1223 1229}

The 2017 ACC/AHA hypertension guideline generally recommends a target BP goal (i.e., BP to achieve with drug therapy and/or nonpharmacologic intervention) of <130/80 mm Hg in all adults, regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk.¹²⁰⁰ In addition, an SBP goal of <130 mm Hg generally is recommended for noninstitutionalized ambulatory patients ≥65 years of age with an average SBP of ≥130 mm Hg.¹²⁰⁰ These BP goals are based upon clinical studies demonstrating continuing reduction of cardiovascular risk at progressively lower levels of SBP.^{1200 1202 1210}

Other hypertension guidelines generally based target BP goals on age and comorbidities.^{501 504 536} Guidelines such as those issued by the JNC 8 expert panel generally have targeted a BP goal of <140/90 mm Hg regardless of cardiovascular risk, and have used higher BP thresholds and target BPs in elderly patients^{501 504 536} compared with those recommended by the 2017 ACC/AHA hypertension guideline.¹²⁰⁰

Some clinicians continue to support previous target BPs recommended by JNC 8 due to concerns about the lack of generalizability of data from some clinical trials (e.g., SPRINT study) used to support the 2017 ACC/AHA hypertension guideline and potential harms (e.g., adverse drug effects, costs of therapy) versus benefits of BP lowering in patients at lower risk of cardiovascular disease.^{1222 1223 1224 1229}

Consider potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs when deciding a patient's BP treatment goal.^{1200 1220 1229}

For decisions regarding when to initiate drug therapy (BP threshold), the 2017 ACC/AHA hypertension guideline incorporates underlying cardiovascular risk factors.^{1200 1207} ASCVD risk assessment is recommended by ACC/AHA for all adults with hypertension.¹²⁰⁰

ACC/AHA currently recommend initiation of antihypertensive drug therapy in addition to lifestyle/behavioral modifications at an SBP ≥140 mm Hg or DBP ≥90 mm Hg in adults who have no history of cardiovascular disease (i.e., primary prevention) and a low ASCVD risk (10-year risk <10%).¹²⁰⁰

For secondary prevention in adults with known cardiovascular disease or for primary prevention in those at higher risk for ASCVD (10-year risk ≥10%), ACC/AHA recommend initiation of antihypertensive drug therapy at an average SBP ≥130 mm Hg or an average DBP ≥80 mm Hg.¹²⁰⁰

Adults with hypertension and diabetes mellitus, chronic kidney disease (CKD), or age ≥65 years are assumed to be at high risk for cardiovascular disease; ACC/AHA state that such patients should have antihypertensive drug therapy initiated at a BP ≥130/80 mm Hg.¹²⁰⁰ Individualize drug therapy in patients with hypertension and underlying cardiovascular or other risk factors.^{502 1200}

In stage 1 hypertension, experts state that it is reasonable to initiate drug therapy using the stepped-care approach in which one drug is initiated and titrated and other drugs are added sequentially to achieve the target BP.¹²⁰⁰ Consider initiation of antihypertensive therapy with 2 first-line agents from different pharmacologic classes in patients with stage 2 hypertension and average BP >20/10 mm Hg above BP goal.¹²⁰⁰

Heart Failure

Management of severe heart failure (NYHA class III-IV) in conjunction with standard therapy, to increase survival and reduce heart failure-related hospitalization.^{265 524 700}

Management of edema and sodium retention in heart failure in patients only partially responsive to, or intolerant of, other therapeutic measures.²⁶⁵

ACCF, AHA, and the Heart Failure Society of America (HFSA) recommend the addition of an aldosterone antagonist (i.e., spironolactone or eplerenone) in selected patients with heart failure and reduced LVEF who are already receiving an agent to inhibit the renin-angiotensin-aldosterone (RAA) system (e.g., ACE inhibitor, angiotensin II receptor antagonist, angiotensin receptor-neprilysin inhibitor [ARNI]) and a β-blocker; careful patient selection required to minimize the risk of hyperkalemia and renal insufficiency.^{524 700}

Aldosterone receptor antagonists also have been used to reduce morbidity and mortality following an acute MI in patients with reduced LVEF who develop symptoms of heart failure or have a history of diabetes mellitus^{† [off-label]}.⁵²⁴

Primary Hyperaldosteronism

Short-term preoperative treatment of primary hyperaldosteronism.²⁶⁵

Long-term maintenance therapy in patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery (e.g., adrenalectomy).²⁶⁵

Long-term maintenance therapy for patients with bilateral micronodular or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).²⁶⁵

Precocious Puberty

Management of certain forms of gonadotropin releasing hormone (GnRH)-independent (peripheral) precocious puberty^{† [off-label]} (e.g., familial male precocious puberty [testotoxicosis]).^{203 204 205 206 207 208 211 213}

Hirsutism

Treatment of hirsutism^{† [off-label]} in women with polycystic ovary syndrome or idiopathic hirsutism.²¹⁰

Spironolactone Dosage and Administration

General

Monitoring and BP Treatment Goals

• Monitor BP regularly (i.e., monthly) during therapy and adjust dosage of the antihypertensive drug until BP controlled.¹²⁰⁰

• If unacceptable adverse effects occur, discontinue drug and initiate another antihypertensive agent from a different pharmacologic class.^{1200 1216}

• Assess patient's renal function and electrolytes 2–4 weeks after initiation of diuretic therapy.¹²⁰⁰

• If adequate BP response not achieved, either increase dosage of the drug or add another drug with demonstrated benefit and preferably a complementary mechanism of action (e.g., ACE inhibitor, angiotensin II receptor antagonist, calcium-channel blocker, thiazide diuretic).^{1200 1216} Many patients will require ≥2 drugs from different pharmacologic classes to achieve BP goal.^{1200 1216 1220}

Administration

Administer orally.^{256 265}

Oral Administration

Administer tablets in single or divided doses.²⁶⁵

An oral suspension (CaroSpir) currently is commercially available; however, it is not therapeutically equivalentto spironolactone tablets (e.g., Aldactone).³⁰⁰ The manufacturer of CaroSpir states that for spironolactone doses >100 mg, tablets should be used instead of the suspension because such doses of the oral suspension may result in higher than expected serum spironolactone concentrations.³⁰⁰ Administer oral suspension in single or divided doses.³⁰⁰

Extemporaneously Compounded Oral Suspension

Spironolactone tablets may be pulverized and administered as an oral suspension in cherry syrup.¹²³⁰

Standardize 4 Safety

Standardized concentrations for an extemporaneously prepared oral suspension of spironolactone have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care.¹⁹⁹ Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label.¹⁹⁹ For additional information on S4S (including updates that may be available), see [Web].¹⁹⁹

Dosage

Pediatric Patients

Edema† [off-label]

Tablets

Oral

3.3 mg/kg (up to 100 mg) daily as a single dose or in divided doses.^a

Alternatively, initial dosage of 60 mg/m² daily in divided doses.^a

Hypertension† [off-label]

Tablets

Oral

Some experts have recommended an initial dosage of 1 mg/kg daily as a single dose or in 2 divided doses.²⁶⁹ Increase dosage as necessary up to a maximum of 3.3 mg/kg (up to 100 mg) daily as a single dose or in 2 divided doses.²⁶⁹

Adults

Edema

Tablets

Oral

Initially, 100 mg daily in single or divided doses.²⁶⁵ Range: 25–200 mg daily.²⁶⁵

As monotherapy, administer usual initial dosage for ≥5 days; if response is satisfactory, titrate to optimal dosage.²⁶⁵

If response is not satisfactory after initial 5 days of therapy, add a thiazide or loop diuretic.²⁶⁵ Do not adjust spironolactone dosage during combined diuretic therapy.²⁶⁵

Oral Suspension (CaroSpir)

Oral

Initially, 75 mg daily in a single dose or divided doses for treatment of edema associated with hepatic cirrhosis.³⁰⁰ Initiate therapy in a hospital setting and titrate slowly.³⁰⁰ Administer for ≥5 days before increasing dose to obtain desired effect when given as sole diuretic agent.³⁰⁰

Spironolactone/Hydrochlorothiazide Fixed-combination Therapy

Oral

Spironolactone 100 mg daily and hydrochlorothiazide 100 mg daily as a single dose or in divided doses.²⁵⁶ Manufacturer states that optimal dosage should be established by individual titration of the drug components.²⁵⁶ Range: spironolactone 25–200 mg daily and hydrochlorothiazide 25–200 mg daily as a single dose or in divided doses.²⁵⁶ May be beneficial to administer separate tablets of either spironolactone or hydrochlorothiazide in addition to the fixed-combination of spironolactone and hydrochlorothiazide in order to provide optimal individual therapy in some instances.²⁵⁶

Hypertension

Tablets

Oral

Usual initial dosage recommended by manufacturer: 25–100 mg daily as a single dose or in divided doses.²⁶⁵ Dosage may be titrated at 2-week intervals.²⁶⁵ Dosages >100 mg daily generally do not provide additional reductions in BP.²⁶⁵

Some experts state that the usual dosage range is 25–100 mg once daily.¹²⁰⁰

Oral Suspension (CaroSpir)

Oral

Initially, 20–75 mg daily in a single dose or divided doses; may titrate dosage at 2-week intervals.³⁰⁰ Dosages >75 mg daily generally do not provide additional reductions in blood pressure.³⁰⁰

Spironolactone/Hydrochlorothiazide Fixed-combination Therapy

Oral

Spironolactone 50–100 mg daily and hydrochlorothiazide 50–100 mg daily as a single dose or in divided doses.²⁵⁶

Manufacturer states that optimal dosage should be established by individual titration of the drug components.²⁵⁶ Dosage will vary depending on the results of titration.²⁵⁶

Heart Failure

Tablets

Oral

Initially, 25 mg once daily recommended by manufacturer in patients with serum potassium concentration ≤5 mEq/L and eGFR >50 mL/minute per 1.73 m².²⁶⁵ If tolerated, may increase dosage to 50 mg once daily as clinically indicated.²⁶⁵ If 25-mg daily dosage not tolerated (i.e., hyperkalemia develops), may decrease dosage to 25 mg every other day.²⁶⁵

Alternatively, ACCF/AHA recommend 12.5–25 mg once daily initially in patients with serum potassium concentration ≤5 mEq/L and eGFR ≥50 mL/minute per 1.73 m².⁵²⁴ May increase dosage to 25 mg once or twice daily after 4 weeks if clinically indicated and if serum potassium concentration ≤5 mEq/L and eGFR ≥50 mL/minute per 1.73 m².⁵²⁴

Monitor closely for hyperkalemia and renal insufficiency.²⁶⁵ (See Hyperkalemia under Cautions.)

For management of fluid retention (e.g., edema) associated with heart failure, some experts recommend initiating spironolactone at a low dosage (e.g., 12.5–25 mg once daily) and increasing dosage until urine output increases and weight decreases, generally by 0.5–1 kg daily.⁵²⁴

ACCF/AHA recommend holding spironolactone therapy if serum potassium >5.5 mEq/L or renal function worsens; consider resuming therapy at reduced dosage following resolution (for ≥72 hours) of hyperkalemia (serum potassium <5 mEq/L) and renal insufficiency.⁵²⁴

Instruct patients to stop therapy with an aldosterone receptor antagonist if they have diarrhea or are dehydrated or if therapy with a concomitant loop diuretic is interrupted.⁵²⁴

Oral Suspension (CaroSpir)

Oral

Initially, 20 mg once daily recommended by manufacturer in patients with serum potassium concentration ≤5 mEq/L and eGFR >50 mL/minute per 1.73 m².³⁰⁰ If tolerated, may increase dosage to 37.5 mg once daily as clinically indicated.³⁰⁰ If 20-mg daily dosage results in hyperkalemia, may decrease dosage to 20 mg every other day.³⁰⁰

Primary Hyperaldosteronism

Medical Therapy Prior to Adrenalectomy

Oral

Tablets: Patients with a definitive diagnosis: 100–400 mg daily before surgery.²⁶⁵

Treatment of Primary Hyperaldosteronism

Oral

Tablets: Use lowest effective dosage for long-term maintenance therapy in patients considered unsuitable for surgery.²⁶⁵

Hirsutism†

Oral

Tablets: 50–200 mg daily.²¹⁰ Regression of hirsutism evident within 2 months, maximal within 6 months, and has been maintained for ≥16 months with continued therapy.²¹⁰

Prescribing Limits

Pediatric Patients

Hypertension†

Oral

Tablets: Maximum 3.3 mg/kg (up to 100 mg) daily.²⁶⁹

Adults

Edema

Oral

Tablets: Management of fluid retention in heart failure: ACCF/AHA recommends maximum 50 mg daily; higher dosage may be used with close monitoring.⁵²⁴

Heart Failure

Oral

Tablets: ACCF/AHA recommends maximum 50 mg daily.⁵²⁴

Special Populations

Hepatic Impairment

Patients with cirrhosis: Use lowest initial dose and titrate slowly; initiate therapy in the hospital.^{265 300}

Renal Impairment

Heart failure patients with eGFR 30–50 mL/minute per 1.73 m² (tablets): Initially, 25 mg every other day recommended by manufacturer.²⁶⁵ Alternatively, in patients with an eGFR of 30–49 mL/minute per 1.73 m², initial dosage of 12.5 mg once daily or every other day recommended by ACCF/AHA; maintenance dosage of 12.5–25 mg once daily (after 4 weeks of therapy and if serum potassium is ≤5 mEq/L).⁵²⁴

Heart failure patients with eGFR 30–50 mL/minute per 1.73 m² (oral suspension [CaroSpir]): Initially, 10 mg once daily.³⁰⁰

Heart failure patients with eGFR <30 mL/minute per 1.73 m²: ACCF/AHA states that use may be harmful because of potentially life-threatening hyperkalemia or renal insufficiency.⁵²⁴

Cautions for Spironolactone

Contraindications

• Hyperkalemia.^{265 300}

• Addison's disease.^{265 300}

• Concomitant use of eplerenone.^{265 300}

Warnings/Precautions

Warnings

Hyperkalemia

Concomitant use of potassium supplements generally not recommended.^{256 265 300} Risk of hyperkalemia increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium (e.g., ACE inhibitors, angiotensin II receptor antagonists).^{265 300} (See Specific Drugs, Foods, and Laboratory Tests under Interactions.)

Manufacturer recommends monitoring serum potassium within 1 week of initiating or titrating spironolactone therapy and regularly thereafter.^{265 300} Check serum potassium concentrations when dosages of concomitant ACE inhibitors or angiotensin II receptor antagonists are altered.^{265 300} ACCF/AHA recommend checking serum potassium and renal function within 2–3 days and again 7 days after initiation of an aldosterone antagonist; perform subsequent monitoring as needed based upon the stability of renal function and fluid status, but monitor at least monthly for the first 3 months and every 3 months thereafter.⁵²⁴

If hyperkalemia occurs, decrease the dosage of spironolactone or discontinue the drug; hyperkalemia should be treated appropriately.^{265 300}

Electrolyte and Metabolic Abnormalities

In addition to hyperkalemia, spironolactone may cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia.^{265 300} Asymptomatic hyperuricemia may occur and gout is rarely precipitated.^{265 300} Monitor serum electrolytes, uric acid, and blood glucose concentrations periodically in patients receiving spironolactone.^{265 300}

Sudden alterations of fluid and electrolyte balance may precipitate impaired neurologic function, worsening hepatic encephalopathy, and coma in patients with hepatic disease with cirrhosis and ascites.²⁶⁵ (See Hepatic Impairment under Cautions.)

Concomitant ACE Inhibitor Therapy

Combined therapy with spironolactone and an ACE inhibitor has been considered relatively contraindicated because of the potential for developing severe hyperkalemia and inhibition of aldosterone formation;^{215 217 218 222} however, clinical studies in patients with moderate or severe heart failure indicate addition of low-dose (25–50 mg daily) spironolactone to standard therapy (e.g., an ACE inhibitor and a loop diuretic with or without a cardiac glycoside) decreases mortality and hospitalization.^{218 219 246 247 251 252 253 254}

Renal Effects and Hypotension

Excessive diuresis may cause symptomatic dehydration, hypotension, and worsening renal function, especially in patients who are salt-depleted or those taking an ACE inhibitor or angiotensin II receptor antagonist.^{265 300} Worsening of renal function also may occur when spironolactone is used in conjunction with nephrotoxic drugs (e.g., aminoglycosides, cisplatin, NSAIAs).^{265 300} Monitor the patient's volume status and renal function periodically while receiving spironolactone therapy.^{265 300}

Gynecomastia

Gynecomastia reported; appears related to dosage and duration of therapy.²⁵⁶ Risk of gynecomastia may be higher than with eplerenone.¹²⁰⁰ Generally reversible upon discontinuance.²⁵⁶

Use of Fixed Combinations

When spironolactone is used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.²⁵⁶

Sensitivity Reactions

Anaphylaxis

Anaphylaxis reported.^{256 265 300}

Specific Populations

Pregnancy

Use of spironolactone during pregnancy may affect the sex differentiation of a male fetus during embryogenesis.²⁶⁵ Avoid spironolactone use during pregnancy because of the potential risk to the male fetus due to the antiandrogenic properties of the drug; advise pregnant women who receive spironolactone of the potential risk to a male fetus.^{265 300}

Lactation

Active metabolite canrenone distributed into milk.^{265 300} Consider developmental and health benefits of breastfeeding along with the mother's clinical need for spironolactone and any potential adverse effects on the breastfed child from spironolactone or from the underlying maternal condition.²⁶⁵

Pediatric Use

Safety and efficacy not established.^{265 300}

Geriatric Use

Monitor renal function.²⁶⁵

Hepatic Impairment

Use with caution in patients with impaired hepatic function; sudden alterations of fluid and electrolyte balance may precipitate impaired neurologic function, worsening hepatic encephalopathy, and coma in patients with hepatic disease and cirrhosis and ascites.²⁶⁵ Initiate spironolactone therapy in the hospital in such patients.^{265 300}

Renal Impairment

Risk of adverse reactions may be greater in patients with impaired renal function.²⁶⁵ Patients with renal impairment are at increased risk of hyperkalemia; monitor potassium closely.^{265 300} (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Most common adverse effect (incidence >5%): Gynecomastia.^{265 300}

Other adverse effects: Hyperkalemia;^{265 300} hypotension;^{265 300} worsening renal function;^{265 300} hyponatremia;^{265 300} hypomagnesemia;^{265 300} hypocalcemia;^{265 300} hypochloremic alkalosis;^{265 300} hyperglycemia;^{265 300} impaired neurologic function/coma in patients with hepatic impairment, cirrhosis and ascites.^{265 300}

Drug Interactions

Specific Drugs, Foods, and Laboratory Tests

Spironolactone Pharmacokinetics

Absorption

Well absorbed following oral administration.³⁰⁰ Peak serum concentrations of spironolactone usually attained within 2.6 or 0.5–1.5 hours with oral tablets or oral suspension (CaroSpir), respectively;^{200 201 265 300} peak serum concentrations of the principal metabolites (e.g., canrenone) usually attained within 4.3 hours (tablets)²⁶⁵ or 2.5–5 hours (oral suspension [CaroSpir]).³⁰⁰ Serum concentrations of spironolactone 15–37% higher following oral suspension (CaroSpir) than with oral tablets (Aldactone).³⁰⁰

Bioavailability

>90%.^{300 a}

Onset

Gradual; maximum diuretic effect reached on third day.^a

Spironolactone in fixed combination with hydrochlorothiazide: Diuresis usually occurs on the first day.^a

Duration

Diuresis persists for 2–3 days after discontinuance.^a

Food

Food increases peak serum concentrations and AUC.^{265 300}

Distribution

Extent

Spironolactone and its metabolites crosses the placenta.

Canrenone, a major active metabolite, is distributed into milk.^{256 300}

Plasma Protein Binding

Spironolactone and canrenone: >90%.^{265 300}

Elimination

Metabolism

Rapidly and extensively metabolized; canrenone and/or 7α-thiomethylspironolactone appear to be major active metabolites.^{200 201 256 300}

Undergoes hepatic deacetylation, thiomethylation, and hydroxylation.^{200 201 300}

Elimination Route

Excreted principally in urine as metabolites and to a lesser extent in bile.^{265 300}

Half-life

Spironolactone: 1–2 hours.^{265 300}

Metabolites: 10–35 hours depending on formulation.^{265 300}

Stability

Storage

Oral

Tablets

<25°C.^{256 265}

Suspension

CaroSpir: 20–25°C (may be exposed to 15–30°C)³⁰⁰

Actions

• Synthetic steroid mineralocorticoid receptor antagonist (aldosterone antagonist).^{215 256 265 266}

• Exhibits magnesium- and potassium-sparing,^{224 230 233} natriuretic,^{232 247} diuretic,^{224 232} and hypotensive^{215 224 225 227} effects by competitively inhibiting the physiologic effects of the adrenocortical hormone aldosterone on the distal renal tubules, myocardium,^{225 226 228 232} and vasculature.^{232 233 265}

• Androgen and progesterone receptor antagonist.^{206 208 209 210 211 215 256 265 266 267 268}

Advice to Patients

• Importance of advising patients to take the drug consistently with respect to food.³⁰⁰

• Importance of advising patient to avoid ingestion of potassium supplements, potassium-rich foods, or salt substitutes.^{256 265 300}

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{265 300} Advise a pregnant woman of the potential risk to a male fetus.³⁰⁰

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.²⁶⁵

• Importance of informing patients of other important precautionary information.²⁶⁵

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Frequently asked questions

• Winlevi vs Spironolactone: How do they compare?
• What is the strength of CaroSpir (spironolactone) oral suspension?

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