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ALDACTONE®(spironolactone)

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ALDACTONE® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Heart Failure

ALDACTONE is indicated for treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival,...

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2 DOSAGE AND ADMINISTRATION

2.1 General Considerations

ALDACTONE can be taken with or without food, but should be taken consistently with respect to food...

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3 DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side.

Tablets: 50 mg oval, light orange, scored, film-coated,...

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4 CONTRAINDICATIONS

ALDACTONE is contraindicated in the patients with:

  • Hyperkalemia
  • Addison's disease
  • Concomitant use of eplerenone
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5 WARNINGS AND PRECAUTIONS

5.1 Hyperkalemia

ALDACTONE can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium...

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7 DRUG INTERACTIONS

7.1 Drugs and Supplements Increasing Serum Potassium

Concomitant administration of ALDACTONE with potassium supplementation or drugs that can...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on mechanism of action...

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10 OVERDOSAGE

The oral LD50 of ALDACTONE is greater than 1000 mg/kg in mice, rats, and rabbits.

Acute overdosage of ALDACTONE may be manifested by drowsiness, mental confusion, maculopapular or...

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11 DESCRIPTION

ALDACTONE oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

14.1 Heart Failure

The Randomized Aldactone Evaluation Study (RALES) was a placebo controlled, double-blind study of the effect of spironolactone...

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16 HOW SUPPLIED/STORAGE AND HANDLING

ALDACTONE 25 mg tablets are round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side, supplied as:

...
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17 PATIENT COUNSELING INFORMATION

Patients who receive ALDACTONE should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.

This product's label may have...

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