Classes
DEA Class; Rx
Common Brand Names; Aldactone, CaroSpir
- Aldosterone Antagonists, Selective;
- Diuretics, Potassium-Sparing
Description
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.
Indications
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
Contraindications
Hypersensitivity
Addison disease or other conditions associated with hyperkalemia
Coadministration with eplerenone
Adverse Effects
- 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
Warnings
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)
Pregnancy and Lactation
Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis
Not present in breastmilk
Maximum Dosage
400 mg/day PO for tablets; 100 mg/day PO for oral suspension.
400 mg/day PO for tablets; 100 mg/day PO for oral suspension.
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.
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.
Safety and efficacy have not been established; however, doses up to 4 mg/kg/day PO have been used off-label.
Safety and efficacy have not been established; however, doses up to 4 mg/kg/day PO have been used off-label.
How supplied
Spironolactone
tablet
- 25mg
- 50mg
- 100mg
Oral suspension (CaroSpir)
- 5mg/mL