Spironolactone (Lexi-Drugs)

Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

Pronunciation

(speer on oh LAK tone)

Brand Names: US

Aldactone; CaroSpir

Brand Names: Canada

Aldactone; TEVA-Spironolactone

Dosing: Adult

Note: Suspension is NOT therapeutically equivalent to tablets. In patients requiring >100 mg/dose, use tablets (>100 mg/dose of suspension may result in spironolactone concentration higher than expected).

Edema: Note: When used as the sole agent for diuresis, administer ≥5 days before increasing dose to obtain desired effect.

Tablet: Oral: Initial: 100 mg daily in single or divided doses; dosage range: 25 to 200 mg daily in single or divided doses.

Suspension: Oral: Initial: 75 mg daily in single or divided doses. Titrate slowly.

Heart failure:

Tablet:

Severe (NYHA class III to IV): Oral: Initial: 12.5 to 25 mg once daily; maximum: 50 mg/day. If 25 mg once daily not tolerated, may reduce to 25 mg every other day (ACC/AHA [Yancy 2013]).

NYHA class II; LVEF ≤35% (off-label use): Oral: 12.5 to 25 mg once daily; maximum: 50 mg/day (ACC/AHA [Yancy 2013]).

Post myocardial infarction; LVEF ≤40% (off-label use): Oral: 12.5 to 25 mg once daily; maximum: 50 mg/day (ACC/AHA [Yancy 2013]).

Note: Withhold treatment if potassium >5.5 mEq/L or renal function worsens; hold doses until potassium is <5 mEq/L and consider restarting with a reduced dose after confirming resolution of hyperkalemia/renal insufficiency for at least 72 hours (ACC/AHA [Yancy 2013]).

Suspension: Serum potassium ≤5 mEq/L: Initial: 20 mg once daily. May titrate to 37.5 mg once daily or decrease to 20 mg every other day as clinically indicated.

Hypertension (alternative agent): Oral: Initial:

Tablet: 25 to 50 mg daily in 1 or 2 divided doses; may titrate every 2 weeks as needed based on patient response up to 100 mg daily (ACC/AHA [Whelton 2017]).

Suspension: 20 to 100 mg daily in 1 or 2 divided doses; may titrate at 2-week intervals (ACC/AHA [Whelton 2017]). Note: Doses >75 mg/day generally do not provide additional reductions in blood pressure.

Primary aldosteronism: Oral: Tablet:

Manufacturer’s labeling:

Maintenance until surgical correction: 100 to 400 mg once daily.

Alternate recommendations:

Treatment of bilateral adrenal hypersecretion, or unilateral hypersecretion in patients unwilling or unable to undergo surgery: Initial: 12.5 to 25 mg once daily; gradually titrate upward if necessary to the lowest effective dose (maximum: 100 mg/day) (Funder 2016).

Acne vulgaris (females) (off-label use): Oral: 50 to 200 mg once daily (AAD [Zaenglein 2016]; Goodfellow 1984; Muhlemann 1986).

Ascites, due to cirrhosis (off-label dose): Initial: 100 mg once daily; titrate every 3 to 5 days as clinically indicated (usual maximum: 400 mg once daily); a spironolactone to furosemide dosing ratio of 100 mg (spironolactone) to 40 mg (furosemide) should be maintained (AASLD [Runyon 2012]).

Hirsutism (off-label use): Females: Oral: Usual therapeutic dose: 100 to 200 mg/day in 2 divided doses; assess response at 6-month intervals before adjusting dose, adding additional agents, or switching to alternative therapy (Endocrine Society [Martin 2018])

Hormone therapy for transgender females (male-to-female) (adjunct) (off-label use): Oral: Initial: 25 mg twice daily in combination with other appropriate agents; increase each week based on response and tolerability to a usual dose of 100 to 300 mg/day. Adjust dose with a goal of suppressing serum testosterone levels into the normal range for females (ie, <50 ng/dL). Maximum: 200 mg twice daily (Deutsch 2016; ES [Hembree 2017]; Prior 1989).

Dosing: Geriatric

Heart failure: Oral: Avoid use of tablets >25 mg/day (ACC/AHA [Yancy 2013]).

Hypertension: Oral: No initial dosage adjustment necessary (Aronow 2011).

Dosing: Renal Impairment: Adult

Manufacturer’s labeling:

Tablet:

Edema, hypertension, primary aldosteronism: There are no specific dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.

Heart failure:

eGFR >50 mL/minute/1.73 m2: No initial dosage adjustment necessary.

eGFR 30 to 50 mL/minute/1.73 m2: Initial: 25 mg every other day.

eGFR <30 mL/minute/1.73 m2: There are no specific dosage adjustments provided in the manufacturer’s labeling.

Suspension:

Edema, hypertension: There are no dosage adjustments provided in the manufacturer’s labeling; spironolactone is substantially excreted by the kidney; use with caution.

Heart failure:

eGFR >50 mL/minute/1.73 m2: No initial dosage adjustment necessary.

eGFR 30 to 50 mL/minute/1.73 m2: Initial: 10 mg once daily.

eGFR <30 mL/minute/1.73 m2: There are no specific dosage adjustments provided in the manufacturer’s labeling.

Alternate recommendations: Tablet:

Heart failure (ACC/AHA [Yancy 2013]):

eGFR ≥50 mL/minute/1.73 m2: Initial dose: 12.5 to 25 mg once daily; Maintenance dose (after 4 weeks of treatment with potassium ≤5 mEq/L): 25 mg once or twice daily.

eGFR 30 to 49 mL/minute/1.73 m2: Initial dose: 12.5 mg once daily or every other day; Maintenance dose (after 4 weeks of treatment with potassium ≤5 mEq/L): 12.5 to 25 mg once daily.

eGFR <30 mL/minute/1.73 m2: Not recommended.

Patients ≥65 years: CrCl <30 mL/minute (regardless of indication): Avoid use due to risk of hyperkalemia (Beers Criteria [AGS 2015]).

Dosing: Hepatic Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer’s labeling; initiate with low dose and titrate slowly (cirrhosis). Use with caution; minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Dosing: Pediatric

Note: Although spironolactone is commercially available in a suspension, it is NOT therapeutically equivalent to the tablets; commercially available suspension results in 15% to 37% higher serum concentration compared to the tablet; pediatric dosing is based on experience with tablets and extemporaneously compounded suspension. Multiple concentrations of oral suspension exist; use extra precaution and prescribe in mg (not mL).

Bronchopulmonary dysplasia (BPD): Limited data available; efficacy results variable. Although the benefits of diuretic therapy in the management of BPD are variable (eg, optimal duration of therapy, impact on pulmonary endpoints), diuretics continue to be used in clinical practice (Slaughter 2013). Infants: Oral: 1.5 mg/kg/dose every 12 hours (Albersheim 1989; Engelhardt 1989; Hoffman 2000; Stewart 2011).

Edema (diuresis): Limited data available: Infants, Children, and Adolescents: Oral: Initial: 1 to 3 mg/kg/day divided every 6 to 24 hours; titrate as needed; reported maximum daily dose range: 4 to 6 mg/kg/day in divided doses every 6 to 12 hours or 400 mg/day, whichever is less (Giefer 2011; Kliegman 2016; Sabri 2003; van der Vorst 2006)

Hypertension: Limited data available: Infants, Children, and Adolescents: Oral: Initial: 1 mg/kg/day divided every 12 to 24 hours; titrate as needed up to a maximum daily dose: 3.3 mg/kg/day or 100 mg/day, whichever is less (NHBPEP 2004; Park 2014)

Primary aldosteronism (caused by adrenal hyperplasia), treatment: Limited data available: Infants, Children, and Adolescents: Oral: 1 to 3 mg/kg/day; maximum daily dose: 100 mg/day (Kliegman 2016)

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; spironolactone is substantially excreted by the kidney; use with caution; monitor serum potassium closely. The following recommendations have been suggested: In pediatric patients with mild to moderate failure, consider extended dosing interval (eg, every 12 to 24 hours) and avoid use in severe renal impairment (van der Vorst 2006).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Use: Labeled Indications

Edema: Management of edema for cirrhosis of liver when unresponsive to fluid and sodium restriction

Tablet only: Management of edema for nephrotic syndrome when unresponsive to treatment of underlying disease, restriction of fluid and sodium intake, and use of other diuretics; may be useful for treatment of edema when other diuretics have caused hypokalemia.

Heart failure: To increase survival, manage edema and reduce hospitalization for heart failure in patients with New York Heart Association (NYHA) class III to IV and reduced ejection fraction; usually administered in conjunction with other heart failure therapies

Guideline recommendations: The American College of Cardiology/American Heart Association (ACC/AHA) 2013 heart failure guidelines recommend the use of aldosterone antagonists, along with other guideline-directed medical therapies, to reduce morbidity and mortality in patients with heart failure (NYHA class III to IV) with left ventricular ejection fraction (LVEF) 35% or less.

Hypertension: Management of hypertension unresponsive to other therapies. Note: Not recommended for the initial treatment of hypertension (ACC/AHA [Whelton 2017]).

Primary hyperaldosteronism (tablet only): Short-term preoperative treatment of primary hyperaldosteronism; long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery; long-term maintenance therapy for bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).

Use: Off-Label: Adult

  Acne vulgaris (females)Level of Evidence [C, G]

Data from a limited number of patients in a small number of randomized, placebo-controlled trials suggest that spironolactone may be beneficial in the treatment of moderate to severe acne in women. Additional trials may be necessary to further define the role of spironolactone in this condition.

Based on the American Academy of Dermatology guidelines of care for the management of acne vulgaris, spironolactone may be beneficial as therapy for the treatment of acne in select females. Access Full Off-Label Monograph

  Heart failure (NYHA class II; LVEF ≤35%)Level of Evidence [G]

Based on the American College of Cardiology/American Heart Association guidelines for the management of heart failure, spironolactone (along with other guideline directed medical therapies) is effective and recommended to reduce morbidity and mortality in patients with heart failure (NYHA class II-IV) with a left ventricular ejection fraction ≤35%.

  Heart failure (post-myocardial infarction; LVEF ≤40%):Level of Evidence [G]

According to the 2013 ACC/AHA guidelines for the management of ST-elevation myocardial infarction (STEMI) and the 2014 ACC/AHA guidelines for the management of non-ST-Elevation Acute Coronary Syndromes (NSTE-ACS), an aldosterone antagonist should be given to post-MI patients (without significant renal dysfunction) who are already on an ACE inhibitor and beta-blocker, who have an LVEF ≤40% and either symptomatic heart failure or diabetes mellitus.

  HirsutismLevel of Evidence [B, G]

Data from a systematic review and network meta-analysis of published randomized trials of adult females with hirsutism (including idiopathic hirsutism and hirsutism in women with polycystic ovary syndrome or nonclassic congenital adrenal hyperplasia) support the use of spironolactone in the treatment of hirsutism Ref. Additional trials may be necessary to further define the role of spironolactone in this condition.

Based on the Evaluation and Treatment of Hirsutism in Premenopausal Women: An Endocrine Society Clinical Practice guideline, spironolactone is effective and may be considered among other antiandrogens in the management of this condition. Spironolactone may be considered for initial therapy, either as monotherapy in women who are not at risk for becoming pregnant, or in combination with an oral contraceptive in select women with severe hirsutism causing distress and/or a prior history of inadequate response to oral contraceptive therapy. Spironolactone may also be considered for add-on therapy in women who fail to achieve a satisfactory response to initial oral contraceptive monotherapy Ref.

  Hormone therapy for transgender females (male-to-female)Level of Evidence [G]

Based on the Endocrine Society guidelines for the endocrine treatment of gender dysphoric/gender incongruent persons, spironolactone is effective when used in combination with estrogen to block androgens in transgender females, thereby reducing testosterone levels into the normal range for females. The result is decreased hair growth, muscle mass, sexual desire, sperm production, spontaneous erections, and testicular volume, as well as breast growth, male sexual dysfunction, redistribution of body fat, and skin and voice changes Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Acne:

American Academy of Dermatology, “Guidelines of care for the management of acne vulgaris,” May 2016

Ascites:

AASLD Practice Guidelines: “Management of Adult Patients with Ascites Due to Cirrhosis: Update 2012,” 2012

Heart Failure:

ACC/AHA, “2013 ACC/AHA Guideline for the Management of Heart Failure,” June 2013

ACC/AHA/HFSA, “2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure,” May 2016

Canadian Cardiovascular Society, “2012 Heart Failure Management Guidelines Update: Focus on Acute and Chronic Heart Failure,” 2012

“HFSA 2010 Comprehensive Heart Failure Practice Guideline,” July 2010

Hirsutism:

Endocrine Society, “Evaluation and Treatment of Hirsutism in Premenopausal Women: An Endocrine Society Clinical Practice Guideline,” March 2018

Hormone Therapy for Transgender Females:

Endocrine Society, “Endocrine treatment of gender-dysphoric/gender-incongruent persons: An Endocrine Society clinical practice guideline,” December 2017

The World Professional Association for Transgender Health, “Standards of care for the health of transsexual, transgender and gender nonconforming people, Version 7,” 2011

Hypertension:

“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,” November 2017.

“ACC/AHA Expert Consensus Document on Hypertension in the Elderly,” 2011

AHA/ACC/CDC, “AHA/ACC/CDC Science Advisory: An Effective Approach to High Blood Pressure Control” November 2013

ASH/ISH “Clinical Practice Guidelines for the Management of Hypertension in the Community: A Statement by the American Society of Hypertension and the International Society of Hypertension,” January 2014

Eighth Joint National Committee (JNC 8), “2014 Evidence-based Guideline for the Management of High Blood Pressure in Adults,” December 2013

“National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents,” May 2005

Ischemic Heart Disease:

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes,” September 2014.

ACC/AHA, “2013 ACC/AHA Guideline for the Management of ST-Elevation Myocardial Infarction,” December 2012

Prevention:

“AHA/ACC Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2011 Update,” November 2011

Primary Aldosteronsim:

Endocrine Society, “The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment,” March 2016

Administration: Oral

Tablet: Administer with or without food; however, administer consistently with respect to food.

Suspension: Shake well before administering dose. Administer with or without food; however, administer consistently with respect to food.

Administration: Pediatric

Oral: May be taken with or without food; however, consistent administration with or without food is preferred to minimize fluctuations in drug exposure.

Dietary Considerations

Administration with food increases the bioavailability of spironolactone. Excessive potassium intake (eg, salt substitutes, low-salt foods, bananas, nuts) should be avoided.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.

NIOSH recommends single gloving for administration of intact tablets or capsules. If manipulating tablets/capsules (eg, to prepare an oral suspension), NIOSH recommends double gloving, a protective gown, and preparation in a controlled device; if not prepared in a controlled device, respiratory and eye/face protection as well as ventilated engineering controls are recommended. NIOSH recommends double gloving, a protective gown, and (if there is a potential for vomit or spit up) eye/face protection for administration of an oral liquid/feeding tube administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Storage/Stability

Tablet: Store below 25°C (77°F).

Suspension: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Extemporaneously Prepared

5 mg/mL Oral Suspension (ASHP Standard Concentration) (ASHP 2017)

A 5 mg/mL oral suspension may be made with tablets. Crush twelve 50 mg tablets in a mortar and reduce to a fine powder. Add small portions of distilled water and mix to a uniform paste; mix while adding cherry syrup to almost 120 mL; transfer to a calibrated glass bottle, rinse mortar with cherry syrup, and add quantity of cherry syrup sufficient to make 120 mL. Label “shake well” and “refrigerate.” Stable for 28 days at room temperature or refrigerated (Mathur 1989).

Mathur LK, Wickman A. Stability of extemporaneously compounded spironolactone suspensions. Am J Hosp Pharm. 1989;46(10):2040-2042.[PubMed 2816959]

1 mg/mL Oral Suspension

A 1 mg/mL oral suspension may be made with tablets. Crush ten 25 mg tablets in a mortar and reduce to a fine powder. Add a small amount of purified water and soak for 5 minutes; add 50 mL 1.5% carboxymethylcellulose, 100 mL syrup NF, and mix to a uniform paste; mix while adding purified water in incremental proportions to almost 250 mL; transfer to a calibrated bottle, rinse mortar with purified water, and add quantity of purified water sufficient to make 250 mL. Label “shake well.” Stable for 3 months at room temperature or refrigerated (Nahata 1993).

Nahata MC, Morosco RS, and Hipple TF, “Stability of Spironolactone in an Extemporaneously Prepared Suspension at Two Temperatures,” Ann Pharmacother. 1993, 27(10):1198-9.[PubMed 8251687]

25 mg/mL Oral Suspension

A 25 mg/mL oral suspension may be made with tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus. Crush one-hundred-twenty 25 mg tablets in a mortar and reduce to a fine powder. Add small portions of chosen vehicle and mix to a uniform paste; mix while adding vehicle in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 120 mL. Store in amber bottles; label “shake well” and “refrigerate.” Stable for 60 days refrigerated (Allen 1996).

Allen LV Jr and Erickson MA 3rd, “Stability of Ketoconazole, Metolazone, Metronidazole, Procainamide Hydrochloride, and Spironolactone in Extemporaneously Compounded Oral Liquids,” Am J Health Syst Pharm. 1996, 53(17):2073-8.[PubMed 8870895]

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, fatigue, headache, hair loss, nausea, vomiting, or abdominal cramps. Have patient report immediately to prescriber signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, dizziness, passing out, tachycardia, increased thirst, seizures, loss of strength and energy, lack of appetite, urinary retention or change in amount of urine passed, dry mouth, dry eyes, nausea, or vomiting), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe bleeding or persistent bleeding), severe dizziness, passing out, confusion, change in balance, decreased libido, sexual dysfunction, chills, pharyngitis, menstrual changes, breast pain, or enlarged breasts (males) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
  International issues:
Contraindications

Hyperkalemia; Addison disease; concomitant use with eplerenone.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to spironolactone or any component of the formulation; concomitant use with heparin or low molecular weight heparin; pregnancy; breastfeeding.

Warnings/Precautions

Concerns related to adverse effects:

• Fluid/electrolyte imbalance: Fluid and electrolyte imbalance (eg, hypomagnesemia, hyponatremia, hypocalcemia, hypochloremic alkalosis, hyperglycemia, hyperkalemia) may occur. Patients with heart failure, renal disease, or cirrhosis may be particularly susceptible. Monitor and correct electrolyte disturbances; adjust dose to avoid dehydration.

• Gout: Asymptomatic hyperuricemia may occur and gout may be precipitated (rare).

• Gynecomastia: May occur; risk increases based on dose and onset is variable (after 1 to 2 months to over a year of therapy); usually reversible following discontinuation of therapy.

• Hyperkalemia: Hyperkalemia may occur; risk of hyperkalemia is increased with renal impairment, excessive potassium intake, and patients taking certain drugs (eg, ACE inhibitors, angiotensin receptor blockers, NSAIDs). Monitor serum potassium closely. The concurrent use of larger doses of ACE inhibitors (eg, ≥ lisinopril 10 mg daily in adults) also increases the risk of hyperkalemia (ACC/AHA [Yancy 2013]). Dose reduction or interruption of therapy may be necessary with development of hyperkalemia. Use is contraindicated in patients with hyperkalemia; use caution in conditions known to cause hyperkalemia.

• Tumorigenic: Shown to be a tumorigen in chronic toxicity animal studies. Avoid unnecessary use.

Disease-related concerns:

• Adrenal vein catheterization: Discontinue use prior to adrenal vein catheterization.

• Heart failure: When evaluating a heart failure patient for spironolactone treatment, eGFR should be >30 mL/minute/1.73 m2 or creatinine should be ≤2.5 mg/dL (men) or ≤2 mg/dL (women) with no recent worsening and potassium <5 mEq/L with no history of severe hyperkalemia (ACC/AHA [Yancy 2013]). Serum potassium levels require close monitoring and management if elevated. ACC/AHA recommends considering discontinuation upon the development of serum potassium >5.5 mEq/L or worsening renal function with careful evaluation of the entire medical regimen. Avoid routine triple therapy with the combined use of an ACE inhibitor, ARB, and spironolactone. Instruct patients with heart failure to discontinue use during an episode of diarrhea or dehydration or when loop diuretic therapy is interrupted (ACC/AHA [Yancy 2013]).

• Hepatic impairment: Use with caution in patients with hepatic impairment; minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

• Renal impairment: Risk of hyperkalemia is increased with declining renal function and with the concurrent use of larger doses of ACE inhibitors (eg, ≥ lisinopril 10 mg daily in adults) (ACC/AHA [Yancy 2013]). Use with caution in patients with renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Avoid use of tablets >25 mg/day in elderly patients with heart failure or with reduced renal function (eg, CrCl <30 mL/minute or eGFR ≤30 mL/minute/1.73 m2 [ACC/AHA (Yancy 2013)]).

Other warnings/precautions:

• Suspension: Suspension is NOT therapeutically equivalent to tablets. In patients requiring >100 mg/dose, use tablets (>100 mg/dose of suspension may result in spironolactone concentration higher than expected).

Geriatric Considerations

When used in combination with ACE inhibitors or ARBs, monitor patient for increased risk of hyperkalemia.

Avoid in patients with a creatinine clearance <30mL/minute.

Warnings: Additional Pediatric Considerations

Due to pharmacologic properties (aldosterone antagonist and some androgen receptor blocking), spironolactone may cause endocrine-related adverse effects including gynecomastia; an ovarian cyst has been reported in a premature neonate following spironolactone use (Vachharajani 2001); long-term effects have not been described in pediatric patients. When used with a thiazide diuretic, may cause hypercalcuria; in neonates, monitor calcium and ensure adequate supplementation with use.

Pregnancy Considerations

Spironolactone crosses the placenta (Regitz-Zagrosek 2011).

Use of diuretics to treat edema during normal pregnancies is not appropriate; use may be considered when edema is due to pathologic causes (as in the nonpregnant patient); monitor. The treatment of heart failure is generally the same in pregnant and nonpregnant women; however, spironolactone should be avoided in the first trimester due to its antiandrogenic effects (Regitz-Zagrosek 2011). The use of mineralocorticoid receptor antagonists is not recommended to treat chronic uncomplicated hypertension in pregnant women and should generally be avoided in women of reproductive potential. When treatment for hypertension in pregnancy is needed, other agents are preferred (ACOG 2013)

Breast-Feeding Considerations

The active metabolite of spironolactone (canrenone) is present in breast milk.

Information is available from a case report following maternal use of spironolactone 25 mg twice daily throughout pregnancy, then 4 times daily after delivery. Milk and maternal serum samples were obtained 17 days after birth. Two hours after the maternal dose, canrenone concentrations were ~144 ng/mL (serum) and ~104 ng/mL (milk). When measured 14.5 hours after the dose, canrenone concentrations were ~92 ng/mL (serum) and ~47 ng/mL (milk). The authors calculated the estimated maximum amount of canrenone to the nursing infant to be ~0.2% of the maternal dose of spironolactone (Phelps 1977). Effects to humans are not known; however, this metabolite was found to be carcinogenic in rats. Diuretics have the potential to decrease milk volume and suppress lactation. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother; if use of spironolactone is essential, an alternative method of feeding should be used.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%:

Endocrine & metabolic: Gynecomastia (9%)

Frequency not defined.

Cardiovascular: Vasculitis

Central nervous system: Ataxia, confusion, dizziness, drowsiness, headache, lethargy, nipple pain

Dermatologic: Alopecia, chloasma, erythematous maculopapular rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Endocrine & metabolic: Amenorrhea, asymptomatic hyperuricemia, decreased libido, electrolyte disorder, gout, hyperglycemia, hyperkalemia, hyperuricemia, hypocalcemia, hypochloremic alkalosis, hypomagnesemia, hyponatremia, hypovolemia

Gastrointestinal: Abdominal cramps, diarrhea, gastritis, gastrointestinal hemorrhage, gastrointestinal ulcer, nausea, vomiting

Genitourinary: Erectile dysfunction, irregular menses, mastalgia, postmenopausal bleeding

Hematologic & oncologic: Agranulocytosis, leukopenia, thrombocytopenia

Hepatic: Hepatotoxicity

Hypersensitivity: Anaphylaxis

Immunologic: DRESS syndrome

Neuromuscular & skeletal: Lower limb cramp

Renal: Renal failure syndrome, renal insufficiency

Miscellaneous: Fever

Metabolism/Transport Effects

None known.

Drug Interactions 

Abiraterone Acetate: Spironolactone may diminish the therapeutic effect of Abiraterone Acetate. Risk C: Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Alpha-/Beta-Agonists: Spironolactone may diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification

AMILoride: May enhance the hyperkalemic effect of Spironolactone. Risk X: Avoid combination

Ammonium Chloride: Potassium-Sparing Diuretics may enhance the adverse/toxic effect of Ammonium Chloride. Specifically the risk of systemic acidosis. Risk D: Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Angiotensin II Receptor Blockers: May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Potassium-Sparing Diuretics may enhance the hyperkalemic effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]).Risk C: Monitor therapy

Aspirin: May diminish the therapeutic effect of Spironolactone. Risk C: Monitor therapy

AtorvaSTATin: May enhance the adverse/toxic effect of Spironolactone. Specifically, there is a theoretical potential for enhanced effects on reducing endogenous steroid activity. Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Risk X: Avoid combination

Cardiac Glycosides: Potassium-Sparing Diuretics may diminish the therapeutic effect of Cardiac Glycosides. In particular, the inotropic effects of digoxin appear to be diminished. Potassium-Sparing Diuretics may increase the serum concentration of Cardiac Glycosides. This particular effect may be unique to Spironolactone. Risk C: Monitor therapy

Cholestyramine Resin: May enhance the adverse/toxic effect of Spironolactone. Specifically, the risks of developing metabolic acidosis and hyperkalemia may be elevated with this combination. Risk C: Monitor therapy

Ciprofloxacin (Systemic): Spironolactone may enhance the arrhythmogenic effect of Ciprofloxacin (Systemic). Risk C: Monitor therapy

Cosyntropin: Spironolactone may diminish the diagnostic effect of Cosyntropin. Management: Patients receiving spironolactone should omit their pre-test dose on the day selected for cosyntropin testing. Risk D: Consider therapy modification

CycloSPORINE (Systemic): Potassium-Sparing Diuretics may enhance the hyperkalemic effect of CycloSPORINE (Systemic). Risk X: Avoid combination

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diacerein: May enhance the therapeutic effect of Diuretics. Specifically, the risk for dehydration or hypokalemia may be increased. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Digoxin: Spironolactone may increase the serum concentration of Digoxin. Spironolactone (and/or its metabolites) may also interfere with the assays used to determine Digoxin concentrations, falsely increasing or decreasing Digoxin concentrations. Risk C: Monitor therapy

Drospirenone: May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Eplerenone: May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Management: This combination is contraindicated in patients receiving eplerenone for treatment of hypertension. Risk D: Consider therapy modification

Heparin: May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Management: Monitor serum potassium concentrations closely. The spironolactone Canadian product monograph lists its combination with heparin or low molecular weight heparins as contraindicated. Risk C: Monitor therapy

Heparins (Low Molecular Weight): May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Management: Monitor serum potassium concentrations closely. The spironolactone Canadian product monograph lists its combination with heparin or low molecular weight heparins as contraindicated. Risk C: Monitor therapy

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Mitotane: Spironolactone may diminish the therapeutic effect of Mitotane. Management: Consideration should be given to discontinuing spironolactone prior to initiating mitotane in order to eliminate the risk of therapeutic failure of the mitotane. Risk D: Consider therapy modification

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Spironolactone may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May diminish the antihypertensive effect of Potassium-Sparing Diuretics. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Opioid Agonists: May enhance the adverse/toxic effect of Diuretics. Opioid Agonists may diminish the therapeutic effect of Diuretics. Risk C: Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Potassium Salts: May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk D: Consider therapy modification

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

QuiNIDine: Potassium-Sparing Diuretics may diminish the therapeutic effect of QuiNIDine. Risk C: Monitor therapy

Sodium Phosphates: Diuretics may enhance the nephrotoxic effect of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Management: Consider avoiding this combination by temporarily suspending treatment with diuretics, or seeking alternatives to oral sodium phosphate bowel preparation. If the combination cannot be avoided, hydrate adequately and monitor fluid and renal status. Risk D: Consider therapy modification

Tacrolimus (Systemic): Potassium-Sparing Diuretics may enhance the hyperkalemic effect of Tacrolimus (Systemic). Risk X: Avoid combination

Tolvaptan: May enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

Triamterene: May enhance the hyperkalemic effect of Spironolactone. Risk X: Avoid combination

Trimethoprim: May enhance the hyperkalemic effect of Spironolactone. Risk C: Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Food Interactions

Food increases the bioavailability of unmetabolized spironolactone by ~90% to 95%.

Test Interactions

May interfere with the radioimmunoassay for digoxin; may lead to false negative aldosterone/renin ratio (ARR) (Funder 2016; Mulatero 2002)

Monitoring Parameters

Blood pressure, serum electrolytes (potassium [within 1 week of initiation or dose titration and regularly thereafter], sodium), uric acid, glucose, renal function, volume status

Heart failure: Serum potassium and renal function should be checked in 3 days after initiation, at 1 week after initiation, at least monthly for the first 3 months of therapy, and every 3 months thereafter. If adding or increasing the dose of concomitant ACE inhibitors or ARBs, a new cycle of monitoring should be done. If serum potassium increases to >5.5 mEq/L or renal function worsens, hold doses until potassium is <5 mEq/L and consider restarting with a reduced dose after confirming resolution of hyperkalemia/renal insufficiency for at least 72 hours (ACC/AHA [Yancy 2013]).

Transgender hormone therapy: Serum testosterone levels (goal: <50 ng/dL) every 3 months during the first year and then annually or biannually; serum electrolytes every 3 months for the first year then annually; routine cancer and laboratory screening as in non-transgender individuals for all tissues present (ES [Hembree 2017]).

Advanced Practitioners Physical Assessment/Monitoring

Diuretic effect may be delayed 2 to 3 days. Assess serum electrolytes on a regular basis. Assess fluid status and monitor for CNS changes (drowsiness, headache, confusion), rash, gynecomastia, dehydration, and hyperkalemia during therapy.

Nursing Physical Assessment/Monitoring

Diuretic effect may be delayed 2 to 3 days. Monitor serum electrolytes on a regular basis during therapy. Assess fluid status and monitor for CNS changes (drowsiness, headache, confusion), rash, gynecomastia, and hyperkalemia during therapy.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Oral:

CaroSpir: 25 mg/5 mL (118 mL, 473 mL) [contains saccharin sodium; banana flavor]

Tablet, Oral:

Aldactone: 25 mg

Aldactone: 50 mg, 100 mg [scored]

Generic: 25 mg, 50 mg, 100 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Aldactone: 25 mg, 100 mg

Generic: 25 mg, 100 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C03DA01
Generic Available (US)

May be product dependent

Pricing: US

Suspension (CaroSpir Oral)

25 mg/5 mL (per mL): $2.99

Tablets (Aldactone Oral)

25 mg (per each): $3.05

50 mg (per each): $5.35

100 mg (per each): $8.98

Tablets (Spironolactone Oral)

25 mg (per each): $0.43 – $0.46

50 mg (per each): $0.81 – $0.88

100 mg (per each): $1.42 – $1.48

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Competes with aldosterone for receptor sites in the distal renal tubules, increasing sodium chloride and water excretion while conserving potassium and hydrogen ions; may block the effect of aldosterone on arteriolar smooth muscle as well

Pharmacodynamics/Kinetics

Note: Suspension results in 15% to 37% higher serum concentration compared to the tablet; doses of suspension >100 mg may result in higher spironolactone concentrations than expected.

Duration: Tablet: 2 to 3 days

Bioavailability: High-fat/-calorie meal increased the bioavailability of spironolactone ~90%.

Protein binding: >90%

Metabolism: Rapid and extensive; hepatic to multiple metabolites, including active metabolites canrenone, 7-alpha-spirolactone, and 6-beta-hydroxy-7-alpha

Half-life elimination:

Tablet: Spironolactone: 1.4 hours; Canrenone: 16.5 hours (terminal); 7-alpha-spirolactone: 13.8 hours (terminal)

Suspension: Spironolactone: 1 to 2 hours; Canrenone, 7-alpha-spirolactone, and 6-beta-hydroxy-7-alpha: 10 to 35 hours.

Time to peak, serum:

Tablet: 2.6 to 4.3 hours (primarily as active metabolites)

Suspension: Spironolactone: 0.5 to 1.5 hours; Canrenone: 2.5 to 5 hours

Excretion: Urine (primarily as metabolites) and bile (secondary)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: Terminal half-life is increased in patients with cirrhotic ascites.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date
January 21, 1960
References

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Brand Names: International

Aldactin (TW); Aldacton (TR); Aldactone (AE, AT, AU, BB, BD, BE, BF, BH, BJ, BR, CH, CI, CO, CR, CY, CZ, DE, EC, EE, ES, ET, FI, FR, GB, GH, GM, GN, GR, HK, HR, HU, IE, IL, IN, IQ, IR, IS, IT, JO, KE, KR, KW, LB, LK, LR, LU, LY, MA, ML, MR, MT, MU, MW, MX, NE, NG, NO, OM, PA, PE, PH, PK, PL, PT, QA, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, SY, TH, TN, TW, TZ, UG, VE, YE, ZA, ZM, ZW); Aldactone A (AR, BM, BS, BZ, EC, GY, JM, SR, TT, UY); Aldoxol (PY); Alizar (CL); Alspiron (RO); Altone (TH); Antagerone (EG); Belactone (LK); Diulactone (PH, VN); Epilactone (EG); Flumach (FR); Huma-Spiroton (HU); Hyles (TH); Indurit (PY); Lactone (PH); Noractone (AE, JO); Osiren (AT); Osyrol (DE, JP); Pondactone (TH); S-Tone (TH); Skyton (TW); Spectone (EG); Spilac (LK); Spinolac (VN); Spiractin (AU, ZA); Spiretic (BD); Spirix (DK, FI, NO); Spiroctan (FR, LU); Spirofar (PH); Spirola (ID); Spirolacton (ID); Spirolon (BF, BJ, CI, EC, ET, GH, GM, GN, KE, LR, MA, ML, MR, MT, MU, MW, MY, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Spiron (DK, HU); Spirone (PE); Spirono-Isis (DE); Spironolacton-ratiopharm (LU); Spironolactone-Eurogenerics (LU); Spironolactone-Searle (LU); Spiros (PH); Spirotone (NZ, TW); Unilactone (AE, BH, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Uractone (LU); Uractonum (SG, TR); Verospiron (BD, BG, CZ, EE, HN, HU, LT, SK, UA); Vivitar (CR, DO, GT, HN, MX, NI, PA, SV); Xenalon Lactabs (DO)

Spironolactone (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(speer on oh LAK tone)

Brand Names: US

Aldactone; CaroSpir

Brand Names: Canada

Aldactone

What is this drug used for?
  • It is used to get rid of extra fluid.
  • It is used to raise potassium stores in the body.
  • It is used to treat heart failure (weak heart).
  • It is used to treat high blood pressure.
  • It is used to treat some people with high aldosterone levels.
  • It is used to treat some kidney problems.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to spironolactone or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Addison’s disease or high potassium levels.
  • If you are taking any of these drugs: Amiloride, eplerenone, or triamterene.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • Sometimes elements (potassium) in the blood may be raised with this drug. This can be deadly if it is not treated. The chance is greatest in people with high blood sugar (diabetes), kidney disease, very bad illness, and/or in older adults. Your doctor will follow you closely to change the dose to match your body’s needs.
  • If you are taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your doctor.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Change in balance.
  • Lowered interest in sex.
  • Not able to get or keep an erection.
  • Fever or chills.
  • Sore throat.
  • Any unexplained bruising or bleeding.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Period (menstrual) changes.
  • Breast pain.
  • For males, enlarged breasts.
  • Liver problems have rarely happened with this drug. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Diarrhea.
  • Feeling sleepy.
  • Dizziness.
  • Headache.
  • Upset stomach or throwing up.
  • Stomach cramps.
  • Hair loss.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take with or without food but take the same way each time. Always take with food or always take on an empty stomach.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • This drug may cause you to pass urine more often. To keep from having sleep problems, try to take before 6 pm.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Spironolactone (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(speer on oh LAK tone)

Brand Names: US

Aldactone; CaroSpir

Brand Names: Canada

Aldactone

What is this drug used for?
  • It is used to get rid of extra fluid.
  • It is used to treat high blood pressure.
  • It is used to treat some people with high aldosterone levels.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: Addison’s disease or high potassium levels.
  • If your child is taking any of these drugs: Amiloride, eplerenone, or triamterene.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Have your child’s blood pressure checked often. Talk with your child’s doctor.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • If your child is on a low-salt or salt-free diet, talk with your child’s doctor.
  • Sometimes elements (potassium) in the blood may be raised with this drug. This can be deadly if it is not treated. The chance is greatest in people with high blood sugar (diabetes), kidney disease, very bad illness, and/or in older adults. Your child’s doctor will follow your child closely to change the dose to match the body’s needs.
  • If your child is taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your child’s doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Change in balance.
  • Fever or chills.
  • Sore throat.
  • Any unexplained bruising or bleeding.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Breast pain.
  • For males, enlarged breasts.
  • Liver problems have rarely happened with this drug. Sometimes, this has been deadly. Call your child’s doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • If your child has menstrual periods:
  • Period (menstrual) changes.
  • If your child is or may be sexually active:
  • Not able to get or keep an erection.
  • Lowered interest in sex.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Diarrhea.
  • Feeling sleepy.
  • Dizziness.
  • Headache.
  • Upset stomach or throwing up.
  • Stomach cramps.
  • Hair loss.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug with or without food but give it the same way each time. Always give with food or always give on an empty stomach.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • This drug may cause your child to pass urine more often. To keep your child from having sleep problems, try to give this drug before 6 PM.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.