Spironolactone

Spironolactone

DEA Class; Rx

Common Brand Names; Aldactone, CaroSpir

  • Aldosterone Antagonists, Selective; 
  • Diuretics, Potassium-Sparing
  •  

Potassium-sparing diuretic; used for edema, ascites, HTN, hypokalemia, acne vulgaris, polycystic ovary syndrome, female hirsutism, and to diagnose primary hyperaldosteronism; also improves survival and NYHA functional class, and reduces hospitalizations in NYHA Class IV heart failure.

Indicated for short-term preoperative treatment of patients with primary hyperaldosteronism

Management of edema in patients with cirrhosis of the liver when edema are unresponsive to fluid and sodium restriction or nephrotic syndrome when treatment of the underlying disease, fluid restriction and sodium intake, and the use of other diuretics produce an inadequate response

For the treatment of hypertension.
For the treatment of heart failure.
For the treatment of edema (e.g., due to nephrotic syndrome, congestive heart failure, or hepatic cirrhosis).
For the treatment of primary hyperaldosteronism.
For the treatment of pulmonary edema due to chronic lung disease (CLD).
For the treatment of symptoms of bloating and weight gain associated with premenstrual syndrome (PMS).

Hypersensitivity

Addison disease or other conditions associated with hyperkalemia

Coadministration with eplerenone

  • Gastric bleeding
  • Ulceration
  • Gastritis
  • Decreased libido
  • Inability to achieve or maintain erection
  • Postmenopausal bleeding
  • Breast and nipple pain
  • Thrombocytopenia
  • Fever
  • Urticaria
  • Maculopapular or erythematous cutaneous eruptions
  • Anaphylactic reactions
  • Vasculitis
  • Hyperkalemia
  • Electrolyte disturbances
  • Hyponatremia
  • Hypovolemia
  • Lethargy
  • Mental confusion
  • Ataxia
  • Dizziness
  • Headache
  • Drowsiness
  • Renal dysfunction (including renal failure)
  • Chloasma
  • Drowsiness
  • Lethargy
  • Headache
  • Mental confusion
  • Rash
  • Urticaria
  • Stevens-Johnson syndrome
  • Toxic epidermal necrolysis
  • Drug rash with eosinophilia and systemic symptoms (DRESS)
  • Gynecomastia
  • Impotence
  • Menstrual disorders
  • Abdominal cramping
  • Diarrhea
  • Gastritis
  • Nausea
  • Vomiting

Gynecomastia reported and usually reversible

Hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia may occur

Asymptomatic hyperuricemia can occur and rarely gout may occur; monitor serum electrolytes, uric acid, and blood glucose periodically In cirrhosis, avoid electrolyte and acid/base imbalances that might lead to hepatic encephalopathy

Hyperkalemia may occur; monitor serum potassium within 1 week of initiation or titration of spironolactone and regularly thereafter; if hyperkalemia occurs, reduce dose or discontinue treatment and treat hyperkalemia

Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs)

Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis

Not present in breastmilk

Adults

400 mg/day PO for tablets; 100 mg/day PO for oral suspension.

Geriatric

400 mg/day PO for tablets; 100 mg/day PO for oral suspension.

Adolescents

Safety and efficacy have not been established; however, doses up to 4 mg/kg/day PO (Max: 200 mg/day PO) have been used off-label for edema due to nephrotic syndrome.

Children

Safety and efficacy have not been established; however, doses up to 4 mg/kg/day PO (Max: 200 mg/day PO) have been used off-label for edema due to nephrotic syndrome.

Infants

Safety and efficacy have not been established; however, doses up to 4 mg/kg/day PO have been used off-label.

Neonates

Safety and efficacy have not been established; however, doses up to 4 mg/kg/day PO have been used off-label.

Spironolactone

tablet

  • 25mg
  • 50mg
  • 100mg

Oral suspension (CaroSpir)

  • 5mg/mL
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