Spironolactone

Spironolactone
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions). Spironolactone tablets should be used only in those conditions described under Indications and Usage. Unnecessary use of this drug should be avoided.

Overview

Spironolactone is {{{aOrAn}}} Aldosterone antagonist that is FDA approved for the {{{indicationType}}} of Primary hyperaldosteronism,edematous conditions of congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include gynecomastia, diarrhea, nausea and vomiting,[somnolence]],disorder of menstruation, impotence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

<h4>Condition 1</h4>

• Dosing Information

(Dosage)

Off-Label Use and Dosage (Adult)

Non–Guideline-Supported Use

Acne vulgaris

• Dosing information

• 50-200 mg PO
• optimal dosage: 150-200 mg PO

Ascites of patients in cirrhosis of liver

• Dosing information

• 100-400 mg/day (300-600 mg/day satisfies 50%-90% patients)
• recommended initial dosage: 100-200 mg PO qd
• 225 mg/day

Proteinuria in Chronic renal failure

• Dosing information

• 25 mg/day

Proteinuria in diabetic nephropathy

• Dosing information

• 25 mg in addition to an ACE inhibitor or angiotensin II receptor antagonist

Hirsutism

• Dosing information

• spironolactone plus cyproterone/ethinyl estradiol or flutamide alone were both significantly effective for the treatment of women with moderate to severe hirsutism in a prospective, randomized, clinical trial

Idiopathic edema

• Dosing information

• spironolactone 50-200 mg every morning or hydrochlorothiazide 25 mg every morning

Myocardial infarction

• Dosing information

• 25 mg/day

Prophylaxis of osteopenia; - Polycystic ovary syndrome

• Dosing information

• 100 mg PO qd

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Spironolactone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Non–Guideline-Supported Use

Primary aldosteronism

• Dosing information

• initial dosage: 400 mg/day with gradual reduction to 200 mg/day

Contraindications

Spironolactone tablets are contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hypercalcemia, hyperkalemia, Addison's disease or other conditions associated with hyperkalemia,and with concomitant use of eplerenone.

Warnings

WARNING See full prescribing information for complete Boxed Warning. Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions). Spironolactone tablets should be used only in those conditions described under Indications and Usage. Unnecessary use of this drug should be avoided.

Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with ALDACTAZIDE therapy. Excessive potassium intake may cause hyperkalemia in patients receiving ALDACTAZIDE (see Precautions: General).

Concomitant administration of ALDACTAZIDE with the following drugs or potassium sources may lead to severe hyperkalemia:

• other potassium-sparing [[diuretics]]
• ACE inhibitors
• angiotensin II receptor antagonists
• aldosterone blockers
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin
• heparin and low molecular weight heparin
• other drugs known to cause hyperkalemia
• potassium supplements
• diet rich in potassium
• salt substitutes containing potassium

Spironolactone tablets should not be administered concurrently with other potassium-sparing diuretics. Spironolactone tablets, when used with ACE inhibitors or indomethacin, even in the presence of a diuretic, have been associated with severe hyperkalemia. Extreme caution should be exercised when spironolactone tablets are given concomitantly with these drugs. Hyperkalemia in patients with severe heart failure Hyperkalemia may be fatal. It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Avoid using other potassium-sparing diuretics. Avoid using oral potassium supplements in patients with serum potassium > 3.5 mEq/L. RALES excluded patients with a serum creatinine > 2.5 mg/dL or a recent increase in serum creatinine > 25%. The recommended monitoring for potassium and creatinine is one week after initiation or increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months. Discontinue or interrupt treatment for serum potassium > 5 mEq/L or for serum creatinine > 4 mg/dL. (See Clinical Studies: Severe heart failure, and Dosage and Administration: Severe heart failure.) Spironolactone tablets should be used with caution in patients with impaired hepatic function because minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Lithium generally should not be given with diuretics (see Precautions: Drug interactions). PRECAUTIONS General All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance, e.g., hypomagnesemia, hyponatremia, hypochloremic alkalosis, and hyperkalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting. Hyperkalemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities, which may be fatal. Consequently, no potassium supplement should ordinarily be given with spironolactone tablets. If hyperkalemia is suspected (warning signs include paresthesia, muscle weakness, fatigue, flaccid paralysis of the extremities, bradycardia, and shock), an electrocardiogram (ECG) should be obtained. However, it is important to monitor serum potassium levels because mild hyperkalemia may not be associated with ECG changes. If hyperkalemia is present, spironolactone tablets should be discontinued immediately. With severe hyperkalemia, the clinical situation dictates the procedures to be employed. These may include the intravenous administration of calcium chloride solution, sodium bicarbonate solution and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation. These are temporary measures to be repeated as required. Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis. Reversible hyperchloremic metabolic acidosis, usually in association with hyperkalemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function. Dilutional hyponatremia, manifested by dryness of the mouth, thirst, lethargy, and drowsiness, and confirmed by a low serum sodium level, may be caused or aggravated, especially when spironolactone tablets are administered in combination with other diuretics, and dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than administration of sodium, except in rare instances when the hyponatremia is life-threatening. Spironolactone therapy may cause a transient elevation of BUN, especially in patients with pre-existing renal impairment. Spironolactone tablets may cause mild acidosis. Gynecomastia may develop in association with the use of spironolactone; physicians should be alert to its possible onset. The development of gynecomastia appears to be related to both dosage level and duration of therapy and is normally reversible when spironolactone tablets are discontinued. In rare instances some breast enlargement may persist when spironolactone tablets are discontinued. Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.

Adverse Reactions

Clinical Trials Experience

• Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.
  
• Reproductive: Gynecomastia (see Precautions), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast pain. Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established.
  
• Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.
  
• Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions,
  anaphylactic reactions, vasculitis.
• Metabolism: Hyperkalemia, electrolyte disturbances (see Warnings and Precautions).
  
• Musculoskeletal: Leg cramps.
  
• Nervous system/psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.
  
• Liver/biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.
  
• Renal: Renal dysfunction (including renal failure).
  
• Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritus.
  

Postmarketing Experience

There is limited information regarding Spironolactone Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Spironolactone Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Spironolactone in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Spironolactone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Spironolactone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Spironolactone in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Spironolactone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Spironolactone in geriatric settings.

Gender

There is no FDA guidance on the use of Spironolactone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Spironolactone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Spironolactone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Spironolactone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Spironolactone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Spironolactone in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Spironolactone Administration in the drug label.

Monitoring

There is limited information regarding Spironolactone Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Spironolactone and IV administrations.

Overdosage

There is limited information regarding Spironolactone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Spironolactone Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Spironolactone Mechanism of Action in the drug label.

Structure

There is limited information regarding Spironolactone Structure in the drug label.

Pharmacodynamics

There is limited information regarding Spironolactone Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Spironolactone Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Spironolactone Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Spironolactone Clinical Studies in the drug label.

How Supplied

There is limited information regarding Spironolactone How Supplied in the drug label.

Storage

There is limited information regarding Spironolactone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Spironolactone Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Spironolactone interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Spironolactone Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Spironolactone Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.