Names and pronunciation
(speer′on-oh-lak′tone) Aldactone, CaroSpir
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Drug reference
(speer′on-oh-lak′tone) Aldactone, CaroSpir
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Func. class.: Potassium-sparing diuretic
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Chem. class.: Aldosterone antagonist
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Do not confuse: Aldactone/Aldactazide
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ACTION: Competes with aldosterone at receptor sites in distal tubule, thereby resulting in the excretion of sodium chlo- ride and water and the retention of potas- sium and phosphate
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USES: Edema of HF, hypertension, diuretic-induced hypokalemia, primary hyperaldosteronism (diagnosis, short- term treatment, long-term treatment), edema of nephrotic syndrome, cirrhosis of liver with ascites
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Unlabeled uses: HF
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CONTRAINDICATIONS: Hyper- sensitivity, anuria, severe renal disease, hyperkalemia Precautions: Breastfeeding, dehydra- tion, hepatic disease, renal impairment, electrolyte imbalances, metabolic acido- sis, gynecomastia, pregnancy
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Black Box Warning: Secondary malig- nancy Black Box Warning: Secondary malig- nancy: assess periodically • Beers: avoid in older adults with heart- failure or CCr <30 mL/min • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; fetal harm has occurred; do not breastfeed, excreted in breast milk
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SIDE EFFECTS CNS: Headache, confusion, drowsiness, lethargy, ataxia ELECT: Hyperchloremic metabolic aci- dosis, hyperkalemia, hyponatremia ENDO: Impotence, gynecomastia, irregu- lar menses, amenorrhea, postmeno- pausal bleeding, hirsutism, deepening voice, breast pain GI: Diarrhea, cramps, bleeding, gastritis, vomiting, anorexia, nausea, hepatocel- lular toxicity HEMA: Agranulocytosis INTEG: Rash, pruritus, urticaria
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INTERACTIONS Increase: action of antihypertensives, digoxin, lithium Increase: hyperchloremic acidosis in cirrhosis—cholestyramine Increase: hyperkalemia—potassium- sparing diuretics, potassium products, ACE inhibitors, salt substitutes, angioten- sin II receptor antagonists Decrease: effect of anticoagulants, moni- tor INR/PT Decrease: effect of spironolactone— ASA, NSAIDs Drug/Food Increase: hyperkalemia—potassium- rich foods, potassium salt substitutes Drug/Herb Increase: hypotension—hawthorn, horse chestnut Decrease: antihypertensive effect— ephedra Increase: severe photosensitivity—St. John’s wort Increase: BUN, potassium Decrease: sodium, magnesium Drug/Lab Test Interference: 17-OHCS, 17-KS, radioim- munoassay, digoxin assay
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TREATMENT OF OVERDOSE: Lavage if taken orally; monitor electro- lytes, administer IV fluids, monitor hydration, renal, CV status
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DOSAGE AND ROUTES Edema/hypertension • Adult: PO 25-100 mg/day in 1-2 di- vided doses Heart failure (unlabeled) • Adult: PO 12.5-25 mg/day; max 50 mg/day Edema • Child: PO 1.5-3.3 mg/kg/day as single dose or in divided doses Hypertension • Child (unlabeled): PO 1.5-3.3 mg/kg/ day in divided doses Hypokalemia • Adult: PO 25-100 mg/day; if PO, potas- sium supplements must not be used Primary hyperaldosteronism diagnosis • Adult: PO 400 mg/day × 4 days or 4 wk depending on test, then 100-400 mg/ day maintenance Edema (nephrotic syndrome, HF, hepatic disease) • Adult: PO 100 mg/day given as single dose or in divided doses, titrate to response • Child: PO 1.5-3.3 mg/kg/day or 60 mg/ m2/day given daily or in 2-4 divided doses Renal dose • Adult: PO CCr 10-50 mL/min, give dose q12-24hr; CCr <10 mL/min, avoid use
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Available forms: Tabs 25, 50, 100 mg; oral suspension 25 mg/5 mL
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Administer: • In AM to avoid interference with sleep • With food; if nausea occurs, absorption may be decreased slightly • Effect may take 2 wk • Oral suspension: Shake well, use calibrated measuring device
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Assess: • Hypokalemia: polyuria, polydipsia; dysrhythmias, including a U wave on ECG • Hyperkalemia: weakness, fatigue, dys- pnea, dysrhythmias, confusion, fatigue • Hyponatremia: headache, weakness, lethargy, confusion, seizures, coma • Electrolytes (sodium, chloride, potas- S sium), BUN, serum creatinine, ABGs, CBC; potassium must be checked within 3 days, 1 wk, 1 mo × 3, then q3mo; recheck after starting products that alter potassium • HF assessment daily: weight, I&O to determine fluid loss; effect of product may be decreased if used daily; ECG peri- odically with long-term therapy, breath sounds, edema, B/P • Signs of metabolic acidosis: drowsi- ness, restlessness • Confusion, especially in geriatric pa- tients; take safety precautions if needed • Hydration: skin turgor, thirst, dry mu- cous membranes
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Evaluate: • Therapeutic response: improvement in edema of feet, legs, sacral area daily if medication is being used in HF
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To avoid foods with high potassium content: oranges, bananas, salt substi- tutes, dried apricots, dates; to avoid po- tassium salt substitutes • That drowsiness, ataxia, mental confu- sion may occur; to observe caution when driving • To notify prescriber of cramps, diar- rhea, lethargy, thirst, headache, skin rash, menstrual abnormalities, deepen- ing voice, breast enlargement • To take in AM to prevent sleeplessness • To avoid hazardous activities until re- action is known • To notify prescriber if pregnancy is planned or suspected; not to breastfeed
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PHARMACOKINETICS Onset 24-48 hr, peak 48-72 hr, metabo- lized in liver, excreted in urine, crosses placenta, protein binding >90%, termi- nal half-life 10-35 hr
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• Adult: PO 25-100 mg/day in 1-2 di- vided doses Heart failure (unlabeled)
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• Adult: PO 12.5-25 mg/day; max 50 mg/day Edema
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• Adult: PO 25-100 mg/day; if PO, potas- sium supplements must not be used Primary hyperaldosteronism diagnosis
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• Adult: PO 400 mg/day × 4 days or 4 wk depending on test, then 100-400 mg/ day maintenance Edema (nephrotic syndrome, HF, hepatic disease)
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• Adult: PO 100 mg/day given as single dose or in divided doses, titrate to response
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• Adult: PO CCr 10-50 mL/min, give dose q12-24hr; CCr <10 mL/min, avoid use
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