Aldactone 100mg

Spironolactone 100 mg

Black Box Warnings
Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats; use only for specified indications

All formulations
  • Hypersensitivity
  • Addison disease or other conditions associated with hyperkalemia
  • Coadministration with eplerenone
Tablet only
  • Anuria
  • Severe renal impairment, acute renal insufficiency
Use caution in diabetes mellitus, diabetic nephropathy, fluid and electrolyte imbalance, hepatic disease, or metabolic acidosis
Discontinue use prior to adrenal vein catheterization
Risk of orthostasis may occur with concurrent ethanol use
Risk of gynecomastia and male sexual dysfunction
Not recommended for pregnancy-induced hypertension
Somnolence may occur; caution when operating heavy machinery

Electrolyte imbalance
  • In cirrhosis, avoid electrolyte and acid/base imbalances that might lead to hepatic encephalopathy
  • PO suspension
  1. Hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia may occur
  2. Asymptomatic hyperuricemia can occur and rarely gout may occur; monitor serum electrolytes, uric acid, and blood glucose periodically
  • Concomitant use with K+-sparing diuretics or ACE inhibitors
  • Risk of hyperkalemia increases with declining renal function
  • If used for edema alone, maintain initial dose for at least 5 days before adjustments
  • Avoid potassium-rich diet or supplements
  • Discontinue if hyperkalemia develops; monitor serum potassium; severe hyperkalemia may occur with concomitant use with other potassium-sparing diuretics or ACE inhibitors, angiotensin II antagonists, NSAIDs, heparin, low molecular weight heparin, potassium supplements, salt substitutes, or other drugs known to cause hyperkalemia
  • Risk of potentially fatal hyperkalemia in severe heart failure patients
  • Discontinue or interrupt therapy if serum potassium >5m mEq/L or serum creatinine >4 mg/L
  • Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine
  • For PO suspension: Monitor serum potassium ≥1 week of initiation, titration, and regularly thereafter; closer monitoring may be required with coadministration of drugs that cause hyperkalemia or in renally impaired patients
Excessive diuresis
  • Excess amounts of electrolyte loss can result in profound diuresis; adjust to avoid dehydration; correct electrolyte disturbances resulting from therapy
  • Excessive diuresis may cause symptomatic dehydration, hypotension, and worsening renal function, particularly in salt-depleted patients or those taking ACE inhibitors and ARBs
  • Risk of worsening of renal function can also occur with concomitant use of nephrotoxic drugs (eg, aminoglycosides, cisplatin, NSAIDs); monitor volume status and renal function periodically
Drug interactions with PO suspension
  • Coadministration of PO suspension and lithium reduces the renal clearance of lithium, inducing a high risk of lithium toxicity
  • Reported that of coadministration of PO suspension and an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing, and thiazide diuretics
  • Acetylsalicylic acid: Reported that single dose of 600 mg of acetylsalicylic acid inhibited the natriuretic effect of spironolactone, which was hypothesized be due to inhibition of tubular secretion of canrenone, causing decreased effectiveness of spironolactone
  • Drugs/supplements increasing serum potassium: Concomitant administration of PO formulation with potassium supplementation, salt substitutes containing potassium, a diet rich in potassium, or drugs that can increase potassium, including ACE inhibitors, ARBs, NSAIDs, heparin and low molecular weight heparin, may lead to severe hyperkalemia

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