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Aldactone, Novo-Spiroton (CA)
Pharmacologic class: Aldosterone inhibitor
Therapeutic class: Potassium-sparing diuretic
Pregnancy risk category D
FDA Box Warning
• Drug induced tumors in chronic toxicity studies in rats. Use only in conditions listed under "Indications and dosages." Avoid unnecessary use.
Inhibits aldosterone effects in distal renal tubule, promoting sodium and water excretion and potassium retention
Tablets: 25 mg, 50 mg, 100 mg
⊘Indications and dosages
➣ Edema caused by heart failure, hepatic cirrhosis, or nephrotic syndrome
Adults: As sole diuretic, initially 100 mg/day P.O. (range of 25 to 200 mg) in single or divided doses, continued for 5 or more days and then adjusted to optimal therapeutic level
Children: 1 to 3 mg/kg/day P.O. as a single dose or in divided doses
➣ Essential hypertension
Adults: Initially, 50 to 100 mg/day P.O. as a single dose or in divided doses, continued for at least 2 weeks
Children: 1 to 2 mg/kg P.O. b.i.d.
Adults: 25 to 100 mg/day P.O.
➣ Diagnosis and treatment of primary hyperaldosteronism
Adults: For diagnosis, 400 mg/day P.O. for 4 days in short test or for 3 to 4 weeks in long test. Resolution of hypokalemia and hypertension confirm diagnosis of primary hyperaldosteronism. Dosages of 100 to 400 mg/day P.O. may be used as a bridge to surgical therapy; in patients unsuitable for this therapy, lowest effective dosage may be used for long-term maintenance.
• Acne vulgaris
• Familial male precocious puberty (given with other drugs)
• Premenstrual syndrome
• Anuria, acute renal insufficiency, significant impairment of renal excretory function
Use cautiously in:
• hepatic dysfunction, diabetes mellitus, fluid and electrolyte imbalances, severe heart failure
• concurrent use of other potassium-sparing diuretics, such as amiloride and triamterene (avoid use)
• concurrent use of potassium supplements (avoid use with serum potassium level greater than 3.5 mEq/L)
• concurrent use of ACE inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs) (use with extreme caution)
• concurrent use of lithium (generally avoid use)
• elderly or debilitated patients
• pregnant or breastfeeding patients
• children (safety not established).
• Give single daily dose with breakfast. If two daily doses are prescribed, give second dose with food in mid-afternoon.
CNS: headache, drowsiness, lethargy, ataxia, confusion
GI: vomiting, diarrhea, cramping, gastritis, GI ulcers, GI bleeding
GU: gynecomastia, irregular menses or amenorrhea, postmenopausal bleeding, erectile dysfunction, breast cancer
Metabolic: hyponatremia, hyperchloremic metabolic acidosis, hyperkalemia
Skin: rash, pruritus, hirsutism, drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson Syndrome, toxic epidermal necrolysis
Other: deepening of voice, drug fever, hypersensitivity (including vasculitis, anaphylactic reactions)
Drug-drug.Angiotensin-converting enzyme inhibitors, NSAIDs, potassium-sparing diuretics, potassium supplements, other potassium-containing drugs: increased risk of hyperkalemia
Anticoagulants, heparin: reduced hypoprothrombinemic effects of these drugs
Digoxin: increased digoxin blood level
Lithium: reduced lithium renal clearance and increased risk of lithium toxicity
Salicylates: decreased diuretic effect
Drug-diagnostic tests.Blood urea nitrogen, potassium: increased levels
Digoxin assays: false digoxin elevation
Granulocytes: decreased count
Drug-food.Potassium-containing salt substitutes, potassium-rich diet: increased risk of hyperkalemia
Drug-herbs.Licorice: potassium loss
☞ Monitor electrolyte levels (especially potassium), particularly in patients with severe heart failure. Watch for signs and symptoms of imbalances and metabolic acidosis. Interrupt or discontinue treatment for serum potassium level greater than 5 mEq/L or serum creatinine greater than 4 mg/dl.
• Monitor weight and fluid intake and output. Stay alert for indications of fluid imbalance.
• Monitor CBC with white cell differential.
• Tell patient to take daily dose with breakfast. If two daily doses are prescribed, advise him to take second dose with food in mid-afternoon.
• Advise patient to restrict intake of high-potassium foods and to avoid licorice and salt substitutes containing potassium.
• Tell male patient drug may cause breast enlargement.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.