spironolactone

General

**BEERS Drug**

Pronunciation:
speer-oh-no-lak-tone


Trade Name(s)

  • Aldactone
  • Carospir

Ther. Class.
diuretics
potassium-sparing diuretics

Indications

  • New York Heart Association (NYHA) class III-IV HF.
  • Hypertension.
  • Edema associated with cirrhosis and nephrotic syndrome.
  • Primary hyperaldosteronism (tablets only).

Unlabeled Use(s):

  • Acne.
  • Hormone therapy for transgender females (male-to-female).

Action

  • Causes loss of sodium bicarbonate and calcium while saving potassium and hydrogen ions by antagonizing aldosterone.
  • Directly inhibits testosterone secretion and androgen binding to the androgen receptor.

Therapeutic Effect(s):

  • Improved survival in patients with NYHA class II-IV HF.
  • Weak diuretic and antihypertensive response when compared with other diuretics.

Pharmacokinetics

Absorption: >90% absorbed. Oral suspension results in 15–37% higher serum concentrations compared to tablets. Bioavailability ↑ with food.

Distribution: Crosses the placenta; enters breast milk.

Protein Binding: >90%.

Metabolism and Excretion: Converted by the liver to its active diuretic compound (canrenone).

Half-life: 78–84 min (spironolactone); 13–24 hr (canrenone).

TIME/ACTION PROFILE (diuretic effect)

ROUTEONSETPEAKDURATION
POunknown1–3 hr2–3 days†
†Multiple doses.

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity
  • Anuria
  • Acute renal insufficiency
  • Significant renal impairment (CCr <30 mL/min); SCr >2.5 mg/dL (for patients with HF)
  • Hyperkalemia
  • Addison's disease
  • Concurrent use of eplerenone.

Use Cautiously in:

  • Hepatic dysfunction
  • Geriatric or debilitated patients or patients with diabetes mellitus (↑ risk of hyperkalemia)
  • OB:  Lactation: May cause endocrine dysfunction in infants. Is tumorigenic and should not be given to nursing mothers. Alternative method of feeding should be used if spironolactone is essential; .
  • Pedi:  Safety and effectiveness not established.

Adverse Reactions/Side Effects

CV: arrhythmias

Derm: DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, alopecia, pruritus

Endo: amenorrhea, gynecomastia (in males), breast tenderness,, deepening of voice, ↑ hair growth (in females), sexual dysfunction

F and E: hyperkalemia, hyponatremia, hyperchloremic metabolic acidosis

GI: GI irritation

GU: erectile dysfunction, dysuria

Hemat: agranulocytosis, thrombocytopenia

MS: muscle cramps

Neuro: dizziness, clumsiness, headache, sedation

Misc: hypersensitivity reactions(including anaphylaxis)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • Use with  eplerenone  ↑ risk of hyperkalemia; concurrent use contraindicated.
  • ↑ hypotension with acute ingestion of  alcohol, other   antihypertensive agents, or  nitrates.
  • Use with  ACE inhibitors,  NSAIDs,  potassium supplements,   angiotensin II receptor antagonists,  potassium-sparing diuretics,  angiotensin converting enzyme inhibitors, or   cyclosporine  ↑ risk of hyperkalemia.
  • ↓ lithium  excretion.
  • Antihypertensive and diuretic effectiveness may be ↓ by  NSAIDs.
  • May ↑ the effects of  digoxin.
  • ↓ hypoprothrombinemic effect of  oral anticoagulants.
  •  Cholestyramine  may ↑ risk of hyperkalemic metabolic acidosis.

Route/Dosage

Oral suspension is not therapeutically equivalents to tablets. If patient requires a dose >100 mg, use tablets, NOT suspension. Suspension doses >100 mg may result in higher than expected spironolactone concentrations.

HF

PO (Adults): Serum potassium ≤5 mEq/L and eGFR>50 mL/min/1.73 m2 – Tablet: 25 mg once daily; may then ↑ to 50 mg once daily; if develop hyperkalemia with 25 mg once daily, ↓ dose to 25 mg every other day. Suspension: 20 mg once daily; may then ↑ to 37.5 mg once daily; if develop hyperkalemia with 20 mg once daily, ↓ dose to 20 mg every other day.  Serum potassium ≤5 mEq/L and eGFR 30–50 mL/min/1.73 m2 – Tablets: 25 mg every other day. Suspension: 10 mg once daily.

Hypertension

PO (Adults): Tablets: 25–100 mg/day as a single dose or 2 divided doses; may titrate dose every 2 wk (max dose = 100 mg/day). Suspension: 20–75 mg/day as a single dose or 2 divided doses; may titrate dose every 2 wk (max dose = 75 mg/day).

Edema

PO (Adults): Tablets: 25–200 mg/day as a single dose or 2 divided doses. Suspension: 75 mg/day as a single dose or 2 divided doses

Primary Hyperaldosteronism

PO (Adults): 100–400 mg/day.

Acne (off-label use)

PO (Adults): 50–200 mg once daily.

Hormone Therapy for Transgender Females (off-label use)

PO (Adults): 25 mg once or twice daily. in combination with other appropriate agents. Increase at 1-week intervals based on serum testosterone levels and tolerability to a usual dose of 50–150 mg twice daily (max dose = 200 mg twice daily).

Availability (generic available)

Oral suspension (banana-flavor): 25 mg/5 mL

Tablets: 25 mg, 50 mg, 100 mg

Cost:

Generic: 25 mg $10.83/100, 50 mg $23.97/100, 100 mg $24.87/100

In Combination with: hydrochlorothiazide (Aldactazide). See combination drugs.

Assessment

  • Monitor intake and output ratios and daily weight during therapy.
  • If medication is given as an adjunct to antihypertensive therapy, evaluate BP before administering and periodically during therapy.
  • Assess patient frequently for development of hyperkalemia (fatigue, muscle weakness, paresthesia, confusion, dyspnea, cardiac arrhythmias). Patients who have diabetes mellitus or kidney disease and elderly patients are at increased risk of developing these symptoms.
  • Periodic ECGs may be recommended in patients receiving prolonged therapy.
  • Assess patient for skin rash frequently during therapy. Discontinue diuretic at first sign of rash; may be life-threatening. Stevens-Johnson syndrome or toxic epidermal necrolysis may develop. Treat symptomatically; may recur once treatment is stopped.

Lab Test Considerations:

Evaluate serum potassium levels prior to, within 1 wk of starting therapy or dose increase, and routinely during therapy. If hyperkalemia occurs, decrease dose or discontinue therapy and treat hyperkalemia.

  • Monitor BUN, serum creatinine, and electrolytes prior to and periodically during therapy. May cause ↑ serum magnesium, uric acid, BUN, creatinine, potassium, plasma renin activity, and urinary calcium excretion levels. May also cause ↓ sodium levels.
  • Discontinue potassium-sparing diuretics 3 days prior to a glucose tolerance test because of risk of severe hyperkalemia.
  • May cause false ↑ of plasma cortisol concentrations. Spironolactone should be withdrawn 4–7 days before test.

Potential Diagnoses

Implementation

  • Carospir  is not therapeutically equivalent to  Aldactone ; do not interchange.
  • PO 

    Administer in am to avoid interrupting sleep pattern.

    • Administer with food or milk to minimize gastric irritation and to increase bioavailability.
    • Oral suspension does not require dilution.

Patient/Family Teaching

  • Emphasize the importance of continuing to take this medication, even if feeling well. Instruct patient to take medication at the same time each day. Take missed doses as soon as remembered unless almost time for next dose. Do not double doses.

    • Caution patient to avoid salt substitutes and foods that contain high levels of potassium unless prescribed by health care professional.
    • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
    • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially OTC decongestants, cough or cold preparations, or appetite suppressants due to potential for increased BP.
    • Instruct patient to notify health care professional of medication regimen prior to treatment or surgery.
    • Advise patient to notify health care professional if rash, muscle weakness or cramps; fatigue; or severe nausea, vomiting, or diarrhea occurs.
    • Inform male patients that spironolactone may cause gynecomastia; may require dose decrease. Usually reversible.
    • Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
    • Emphasize the need for follow-up exams to monitor progress.
  • Hypertension:

    Reinforce need to continue additional therapies for hypertension (weight loss, restricted sodium intake, stress reduction, moderation of alcohol intake, regular exercise, and cessation of smoking). Medication helps control but does not cure hypertension.

    • Teach patient and family the correct technique for checking BP weekly.

Evaluation/Desired Outcomes

  • Improved survival in patients with NYHA class II-IV HF.
  • Increase in diuresis and decrease in edema while maintaining serum potassium level in an acceptable range.
  • Decrease in BP.
  • Prevention of hypokalemia in patients taking diuretics.
  • Treatment of hyperaldosteronism.
  • Reduced male characteristics in Male to Female transgender patients.
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