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ALDACTONE
CHF and arrhythmias
Edema
Electrolyte disturbances
Hypertension
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Drug Name:

ALDACTONE Rx

Generic Name and Formulations:
Spironolactone 25mg, 50mg+, 100mg+; tabs; +scored.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for ALDACTONE:

To increase survival and to reduce hospitalization for heart failure (NYHA class III–IV) when used in addition to standard of therapy.

Adult:

If serum potassium ≤5.0mEq/L and serum creatinine ≤2.5mg/dL: initially 25mg daily. May increase to 50mg daily if tolerant or decrease to 25mg every other day if intolerant.

Children:

Not established.

Contraindications:

Anuria. Renal impairment. Hyperkalemia. Addison's disease. Concomitant eplerenone.

Warnings/Precautions:

Hepatic impairment. Hyponatremia. Surgery. Monitor electrolytes (eg, potassium, magnesium, sodium, chloride); discontinue if hyperkalemia occurs. For CHF: monitor serum potassium and creatinine 1 week after initiation or dose increase, monthly for the first 3 months, then quarterly for 1 year, and then every 6 months; interrupt or discontinue if serum potassium >5mEq/L or serum creatinine >4mg/dL. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid K+ sparing diuretics, K+ supplements, K+ containing salt substitutes, lithium. Hyperkalemia more likely with ACE inhibitors, ARBs, aldosterone blockers, NSAIDs, heparin, LMWH. Hypokalemia with corticosteroids, ACTH. Reduced response to pressor amines (eg, norepinephrine). Caution with cholestyramine. Antagonized by NSAIDs. Potentiates ganglionic blockers, alcohol, barbiturates, narcotics, skeletal muscle relaxants. Digitalis toxicity.

Pharmacological Class:

Diuretic (K+ sparing).

Adverse Reactions:

Hyperkalemia, hyponatremia, gynecomastia, gastritis, diarrhea, cramping, nausea, vomiting, drowsiness, headache, rash, confusion, drug fever, ataxia, impotence, hirsutism, voice deepening, menstrual changes, gastric ulcers, agranulocytosis.

How Supplied:

Tabs—100

Indications for ALDACTONE:

Edema.

Adult:

Initially 25–200mg daily. Usual starting dosage: 100mg/day in single or divided doses. Maintain for 5 days, then retitrate.

Children:

Not established.

Contraindications:

Anuria. Renal impairment. Hyperkalemia. Addison's disease. Concomitant eplerenone.

Warnings/Precautions:

Hepatic impairment. Hyponatremia. Surgery. Monitor electrolytes (eg, potassium, magnesium, sodium, chloride); discontinue if hyperkalemia occurs. For CHF: monitor serum potassium and creatinine 1 week after initiation or dose increase, monthly for the first 3 months, then quarterly for 1 year, and then every 6 months; interrupt or discontinue if serum potassium >5mEq/L or serum creatinine >4mg/dL. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid K+ sparing diuretics, K+ supplements, K+ containing salt substitutes, lithium. Hyperkalemia more likely with ACE inhibitors, ARBs, aldosterone blockers, NSAIDs, heparin, LMWH. Hypokalemia with corticosteroids, ACTH. Reduced response to pressor amines (eg, norepinephrine). Caution with cholestyramine. Antagonized by NSAIDs. Potentiates ganglionic blockers, alcohol, barbiturates, narcotics, skeletal muscle relaxants. Digitalis toxicity.

Pharmacological Class:

Diuretic (K+ sparing).

Adverse Reactions:

Hyperkalemia, hyponatremia, gynecomastia, gastritis, diarrhea, cramping, nausea, vomiting, drowsiness, headache, rash, confusion, drug fever, ataxia, impotence, hirsutism, voice deepening, menstrual changes, gastric ulcers, agranulocytosis.

How Supplied:

Tabs—100

Indications for ALDACTONE:

Treatment of hypokalemia when other measures are inappropriate or inadequate. Prophylaxis of hypokalemia in patients taking digitalis when other measures are inappropriate or inadequate.

Adult:

25–100mg daily.

Children:

Not established.

Contraindications:

Anuria. Renal impairment. Hyperkalemia. Addison's disease. Concomitant eplerenone.

Warnings/Precautions:

Hepatic impairment. Hyponatremia. Surgery. Monitor electrolytes (eg, potassium, magnesium, sodium, chloride); discontinue if hyperkalemia occurs. For CHF: monitor serum potassium and creatinine 1 week after initiation or dose increase, monthly for the first 3 months, then quarterly for 1 year, and then every 6 months; interrupt or discontinue if serum potassium >5mEq/L or serum creatinine >4mg/dL. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid K+ sparing diuretics, K+ supplements, K+ containing salt substitutes, lithium. Hyperkalemia more likely with ACE inhibitors, ARBs, aldosterone blockers, NSAIDs, heparin, LMWH. Hypokalemia with corticosteroids, ACTH. Reduced response to pressor amines (eg, norepinephrine). Caution with cholestyramine. Antagonized by NSAIDs. Potentiates ganglionic blockers, alcohol, barbiturates, narcotics, skeletal muscle relaxants. Digitalis toxicity.

Pharmacological Class:

Diuretic (K+ sparing).

Adverse Reactions:

Hyperkalemia, hyponatremia, gynecomastia, gastritis, diarrhea, cramping, nausea, vomiting, drowsiness, headache, rash, confusion, drug fever, ataxia, impotence, hirsutism, voice deepening, menstrual changes, gastric ulcers, agranulocytosis.

How Supplied:

Tabs—100

Indications for ALDACTONE:

Adjunct in hypertension.

Adult:

Initially 50–100mg/day in single or divided doses. Titrate at 2 week intervals.

Children:

Not established.

Contraindications:

Anuria. Renal impairment. Hyperkalemia. Addison's disease. Concomitant eplerenone.

Warnings/Precautions:

Hepatic impairment. Hyponatremia. Surgery. Monitor electrolytes (eg, potassium, magnesium, sodium, chloride); discontinue if hyperkalemia occurs. For CHF: monitor serum potassium and creatinine 1 week after initiation or dose increase, monthly for the first 3 months, then quarterly for 1 year, and then every 6 months; interrupt or discontinue if serum potassium >5mEq/L or serum creatinine >4mg/dL. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid K+ sparing diuretics, K+ supplements, K+ containing salt substitutes, lithium. Hyperkalemia more likely with ACE inhibitors, ARBs, aldosterone blockers, NSAIDs, heparin, LMWH. Hypokalemia with corticosteroids, ACTH. Reduced response to pressor amines (eg, norepinephrine). Caution with cholestyramine. Antagonized by NSAIDs. Potentiates ganglionic blockers, alcohol, barbiturates, narcotics, skeletal muscle relaxants. Digitalis toxicity.

Pharmacological Class:

Diuretic (K+ sparing).

Adverse Reactions:

Hyperkalemia, hyponatremia, gynecomastia, gastritis, diarrhea, cramping, nausea, vomiting, drowsiness, headache, rash, confusion, drug fever, ataxia, impotence, hirsutism, voice deepening, menstrual changes, gastric ulcers, agranulocytosis.

How Supplied:

Tabs—100

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