Aldace-50mg Tab
Manufactured By
Omnica Laboratories P. Ltd.: Life Remedies
Spironolactone
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Spironolactone
Action Indications Contraindications Route/Dosage Interactions Lab Test Interferences Adverse Reactions Precautions Patient Care Considerations Administration/Storage Assessment/Interventions Patient/Family Education
(SPEER-oh-no-LAK-tone) Aldactone, Spironolactone, Novo-Spiroton, Novo-Spirozine Class: Potassium-sparing diuretic
Action Competitively inhibits aldosterone in distal tubules, resulting in increased excretion of sodium and water and decreased excretion of potassium.
Indications Short-term preoperative treatment of primary hyperaldosteronism; long-term maintenance therapy for idiopathic hyperaldosteronism; management of edematous conditions in CHF, cirrhosis of liver and nephrotic syndrome; management of essential hypertension; treatment of hypokalemia. Unlabeled use(s): Treatment of hirsutism; relief of PMS symptoms; short-term treatment of familial male precocious puberty; and short-term treatment of acne vulgaris.
Contraindications Anuria; acute renal insufficiency; impaired renal excretory function; hyperkalemia.
Route/Dosage
Diagnosis of Primary Hyperaldosteronism
ADULTS: PO 400 mg/day for 4 days (short test) or 3 to 4 wk (long test).
Maintenance Therapy for Hyperaldosteronism
ADULTS: PO 100 to 400 mg daily in single or divided doses.
Edema
ADULTS: PO 25 to 200 mg/day in single or divided doses. CHILDREN: PO 3.3 mg/kg/day in single or divided doses.
Essential Hypertension
ADULTS: PO 50 to 100 mg/day in single or divided doses. CHILDREN: PO 1 to 2 mg/kg bid.
Diuretic-Induced Hypokalemia
ADULTS: PO 25 to 100 mg/day when oral potassium or other potassium-sparing regimens are inappropriate.
Interactions
ACE inhibitors: May result in severely elevated serum potassium levels. Digitalis glycosides: May decrease digoxin clearance, resulting in increased serum digoxin levels and toxicity; may attenuate inotropic action of digoxin. Mitotane: May decrease therapeutic response to mitotane. Potassium preparations: May severely increase serum potassium levels, possibly resulting in cardiac arrhythmias or cardiac arrest. Do not take with potassium preparations. Salicylates: May result in decreased diuretic effect.
Lab Test Interferences Drug may cause falsely elevated serum digoxin values with radioimmunoassay (assay specific) for measuring digoxin.
Adverse Reactions
CNS: Drowsiness; lethargy; headache; mental confusion; ataxia. DERM: Maculopapular or erythematous cutaneous eruptions; urticaria. GI: Cramping; diarrhea; gastric bleeding; gastric ulceration; gastritis; vomiting. GU: Inability to achieve or maintain erection. HEMA: Agranulocytosis. META: Hyperchloremic metabolic acidosis in decompensated hepatic cirrhosis. OTHER: Gynecomastia; irregular menses or amenorrhea; postmenopausal bleeding; hirsutism; deepening of voice; drug fever; carcinoma of breast.
Precautions
Pregnancy: Category D. Lactation: Excreted in breast milk. Electrolyte imbalances and BUN increase: Hyperkalemia (serum potassium > 5.5 mEq/L), hyponatremia, hypochloremia and increases in BUN may occur.
PATIENT CARE CONSIDERATIONS
Administration/Storage
If single dose is prescribed, administer in morning.
Take medication with food.
May crush tablets and administer as suspension.
Suspension is stable for 30 days under refrigeration. Protect from light.
Store tablets at room temperature.
Assessment/Interventions
Obtain patient history, including drug history and any known allergies.
Assess fluid and electrolyte status prior to therapy.
Monitor potassium levels. If level is > 5.5 mEq/L, withhold medication and notify physician.
Monitor serum electrolytes, I&O, weight and BP daily.
Monitor ABGs, liver and renal function studies.
If deep rapid respirations or headaches develop, notify physician.
Assess urinary status. If patient develops frequency, dysuria, edema or reduced urinary output, notify physician.
Assess for any changes in hepatic status. If patient appears jaundiced and mentally confused, notify physician.
If nausea, vomiting, distention, diarrhea or anorexia occur, notify physician.
Note any changes in neurologic status. If drowsiness, ataxia, lethargy, confusion or headache occurs, notify physician.
OVERDOSAGE: SIGNS & SYMPTOMS Electrolyte imbalance
Patient/Family Education
Explain that medication's full diuretic effect may not be achieved for 1 to 2 wk.
Instruct patient to avoid large quantities of potassium-rich foods or potassium salt substitutes.
For patient being treated for hypertension, explain that patient may feel tired for several wks because body needs to adjust to lowered BP.
Instruct patient to take drug with food to minimize GI irritation.
Tell patient to weigh self twice wkly and to notify physician of any increase.
Instruct patient to notify physician if new symptoms develop.
Tell patient to report these symptoms to physician: GI cramping, diarrhea, lethargy, thirst, headache, skin rash, menstrual abnormalities, deepening of voice and breast enlargement in men.
Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
Instruct patient not to take prescription or otc medications without consulting physician.
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Copyright © 2003 Facts and Comparisons
David S. Tatro
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