Aldactone 25mg Tablets

Manufacturer PFIZER Active Ingredient Spironolactone Tablets(speer on oh LAK tone) Pronunciation speer-on-oh-LAK-tone
It is used to get rid of extra fluid. It is used to treat heart failure (weak heart).It is used to treat high blood pressure.It is used to treat some people with high aldosterone levels.It is used to treat some kidney problems.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Diuretic, Antihypertensive
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Pharmacologic Class
Aldosterone Antagonist, Potassium-Sparing Diuretic
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Pregnancy Category
Not available
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FDA Approved
Aug 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Spironolactone is a 'water pill' (diuretic) that helps your body get rid of extra salt and water, but unlike some other water pills, it helps your body keep potassium. It's used to treat high blood pressure, swelling (edema) caused by heart failure, liver disease, or kidney disease, and low potassium levels. It also blocks a hormone called aldosterone, which can be helpful in certain heart conditions.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but it's essential to take it the same way each time. Choose to take it either always with food or always on an empty stomach to maintain consistency.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well. Be aware that this medication may increase your urine production, so try to avoid taking it too close to bedtime to minimize sleep disturbances.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms and areas prone to moisture. Keep all medications in a safe and secure location, out of reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for safe and responsible disposal.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Avoid potassium supplements and salt substitutes that contain potassium, unless specifically instructed by your doctor.
  • Limit high-potassium foods (e.g., bananas, oranges, potatoes, leafy greens) if advised by your doctor, especially if you have kidney problems or are taking other medications that increase potassium.
  • Stay hydrated, but do not over-hydrate unless advised by your doctor.
  • Monitor your blood pressure regularly at home if advised.
  • Take with food to increase absorption and reduce stomach upset.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication, typically 25-100 mg once daily or in divided doses.
Dose Range: 12.5 - 400 mg

Condition-Specific Dosing:

Hypertension: 25-100 mg/day, usually initiated at 25-50 mg/day.
Edema (CHF, Cirrhosis, Nephrotic Syndrome): Initial 25-100 mg/day, can be adjusted to 25-200 mg/day in 1-2 divided doses.
Severe Heart Failure (NYHA Class III-IV, LVEF ≤35%): Initial 12.5-25 mg once daily, may be increased to 50 mg once daily or decreased to 12.5 mg every other day based on potassium levels and tolerability.
Hypokalemia: 25-100 mg/day.
Primary Aldosteronism (Diagnosis): 100-400 mg/day for 3-4 weeks.
Primary Aldosteronism (Preoperative): 100-400 mg/day.
Primary Aldosteronism (Long-term Management): 100-400 mg/day.
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Pediatric Dosing

Neonatal: Not established for routine use, consult specialist.
Infant: 1-3 mg/kg/day in 1-2 divided doses for edema/ascites.
Child: 1-3 mg/kg/day in 1-2 divided doses for edema/ascites.
Adolescent: 1-3 mg/kg/day in 1-2 divided doses for edema/ascites, or adult dosing for hypertension/heart failure if appropriate weight/size.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution, monitor potassium and renal function closely.
Moderate: Reduce dose, monitor potassium and renal function frequently. Generally avoid if CrCl < 50 mL/min.
Severe: Contraindicated if CrCl < 30 mL/min due to high risk of hyperkalemia.
Dialysis: Not recommended. Spironolactone is not significantly removed by dialysis. Contraindicated in anuric patients.

Hepatic Impairment:

Mild: Use with caution, monitor for electrolyte imbalances and hepatic encephalopathy.
Moderate: Use with caution, consider lower initial doses and careful titration. Monitor for hepatic encephalopathy.
Severe: Use with extreme caution, may precipitate hepatic coma. Contraindicated in severe liver disease with anuria.

Pharmacology

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Mechanism of Action

Spironolactone is a competitive antagonist of aldosterone at mineralocorticoid receptors in the distal renal tubules. This action leads to increased excretion of sodium and water, while conserving potassium and hydrogen ions. It also has anti-androgenic and weak progestational effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 90% (variable), increased by food.
Tmax: 1-2 hours for spironolactone; 2-4 hours for active metabolites (e.g., canrenone).
FoodEffect: Food increases the extent of absorption (AUC) by 90-100%.

Distribution:

Vd: Approximately 0.05 L/kg (for spironolactone); larger for metabolites.
ProteinBinding: >90% (primarily to albumin and alpha-1 acid glycoprotein).
CnssPenetration: Limited

Elimination:

HalfLife: Spironolactone: 1.4 hours; Canrenone: 16.5 hours; 7-alpha-thiomethylspironolactone: 3-9 hours; 6-beta-hydroxy-7-alpha-thiomethylspironolactone: 10-35 hours.
Clearance: Not readily quantifiable for parent drug due to rapid metabolism; overall clearance is dependent on metabolite elimination.
ExcretionRoute: Primarily renal (metabolites), with some biliary/fecal excretion.
Unchanged: <1% (parent drug)
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Pharmacodynamics

OnsetOfAction: Diuretic effect typically begins within 2-3 days.
PeakEffect: Full therapeutic effect may take 2-3 days.
DurationOfAction: Effects persist for 2-3 days after discontinuation due to long half-lives of active metabolites.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of fluid and electrolyte problems, such as:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
+ Increased thirst or seizures
+ Feeling very tired or weak
+ Decreased appetite
+ Unable to pass urine or changes in urine production
+ Dry mouth, dry eyes, or severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Unable to pass urine or changes in urine production
+ Blood in the urine or significant weight gain
Severe dizziness or passing out
Confusion or changes in balance
Decreased interest in sex or erectile dysfunction
Fever, chills, or sore throat
Unexplained bruising or bleeding
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Changes in menstrual periods
Breast pain or enlarged breasts in males
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting or yellow skin and eyes (one reported death)
Severe skin reactions, including Stevens-Johnson syndrome (SJS), which can be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever, chills, body aches, or shortness of breath
+ Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness or drowsiness
Headache
Diarrhea, upset stomach, or vomiting
Stomach cramps
* Hair loss

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of high potassium (hyperkalemia): unusual tiredness, muscle weakness, slow or irregular heartbeat, numbness or tingling.
  • Signs of low sodium (hyponatremia): headache, confusion, nausea, vomiting, seizures.
  • Signs of dehydration: excessive thirst, dry mouth, decreased urination, dizziness, lightheadedness.
  • Breast enlargement or tenderness in men (gynecomastia).
  • Menstrual irregularities or deepening of voice in women.
  • Severe stomach pain, dark urine, yellowing of skin or eyes (signs of liver problems).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Certain health conditions, including Addison's disease or high potassium levels, as these may affect your ability to take this medication safely.
If you are currently taking any of the following medications: Abiraterone, amiloride, eplerenone, or triamterene, as these may interact with this drug.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to disclose all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

Your doctor and pharmacist need this information to assess the safety of taking this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, undergo blood tests as scheduled by your doctor and discuss the results with them.

Be aware that this medication may impact certain laboratory test results. Therefore, notify all your healthcare providers and laboratory personnel that you are taking this drug.

If you are following a low-salt or salt-free diet, consult with your doctor to ensure safe management of your condition.

This medication may cause an increase in potassium levels in the blood, which can be life-threatening if left untreated. Individuals with diabetes, kidney disease, severe illness, or older adults are at a higher risk. Your doctor will closely monitor you and adjust the dosage as needed to minimize this risk.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor to avoid potential interactions.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Confusion
  • Nausea
  • Vomiting
  • Diarrhea
  • Rash
  • Dehydration
  • Electrolyte imbalances (especially hyperkalemia, hyponatremia)
  • Hypotension (low blood pressure)

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is supportive and symptomatic, focusing on correcting fluid and electrolyte imbalances.

Drug Interactions

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Contraindicated Interactions

  • Eplerenone (increased risk of hyperkalemia)
  • Amiloride (increased risk of hyperkalemia)
  • Triamterene (increased risk of hyperkalemia)
  • Potassium supplements (increased risk of hyperkalemia)
  • Potassium-containing salt substitutes (increased risk of hyperkalemia)
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Major Interactions

  • ACE inhibitors (e.g., Lisinopril, Enalapril) - increased risk of hyperkalemia
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan) - increased risk of hyperkalemia
  • NSAIDs (e.g., Ibuprofen, Naproxen) - may reduce diuretic/antihypertensive effect and increase hyperkalemia risk, especially in renal impairment
  • Trimethoprim/Sulfamethoxazole (Bactrim) - increased risk of severe hyperkalemia
  • Lithium - spironolactone may reduce renal clearance of lithium, leading to increased lithium levels and toxicity
  • Digoxin - spironolactone may interfere with digoxin radioimmunoassays and may increase digoxin levels
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Moderate Interactions

  • Corticosteroids (e.g., Prednisone) - additive natriuretic effect, may increase risk of electrolyte imbalance
  • Cholestyramine - may induce hyperchloremic metabolic acidosis in patients receiving spironolactone
  • Heparin/Low Molecular Weight Heparin - increased risk of hyperkalemia
  • Abiraterone - increased risk of hyperkalemia (spironolactone is often used to manage hypokalemia caused by abiraterone, but careful monitoring is needed)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Serum Potassium (K+)

Rationale: To establish baseline and identify pre-existing hyperkalemia or hypokalemia.

Timing: Before initiation of therapy.

Serum Sodium (Na+)

Rationale: To establish baseline and identify pre-existing hyponatremia.

Timing: Before initiation of therapy.

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess kidney function, as spironolactone is contraindicated in severe renal impairment and dose adjustments are needed.

Timing: Before initiation of therapy.

Blood Pressure (BP)

Rationale: To establish baseline and monitor therapeutic effect.

Timing: Before initiation of therapy.

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Routine Monitoring

Serum Potassium (K+)

Frequency: Within 1 week of initiation or dose adjustment, then monthly for the first 3 months, then quarterly or as clinically indicated.

Target: 3.5-5.0 mEq/L (adjust based on clinical context, especially in heart failure)

Action Threshold: >5.5 mEq/L (consider dose reduction or discontinuation); >6.0 mEq/L (urgent intervention)

Renal Function (Serum Creatinine, eGFR)

Frequency: Within 1 week of initiation or dose adjustment, then monthly for the first 3 months, then quarterly or as clinically indicated.

Target: Stable or improving

Action Threshold: Significant increase in creatinine (>30% from baseline) or eGFR <30 mL/min (consider dose reduction or discontinuation)

Serum Sodium (Na+)

Frequency: Periodically, especially if signs of hyponatremia develop.

Target: 135-145 mEq/L

Action Threshold: <130 mEq/L (investigate cause, consider dose adjustment)

Blood Pressure (BP)

Frequency: Regularly, as clinically indicated.

Target: Individualized target (e.g., <130/80 mmHg for hypertension)

Action Threshold: Persistent uncontrolled hypertension or symptomatic hypotension

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Symptom Monitoring

  • Signs of hyperkalemia (fatigue, muscle weakness, bradycardia, paresthesias)
  • Signs of hyponatremia (nausea, headache, confusion, lethargy, seizures)
  • Signs of dehydration (dry mouth, thirst, decreased urination, dizziness)
  • Gynecomastia (breast enlargement in males), breast tenderness
  • Menstrual irregularities or postmenopausal bleeding in females
  • Deepening of voice or hirsutism in females
  • Gastric upset, diarrhea, cramping

Special Patient Groups

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Pregnancy

Generally not recommended during pregnancy due to potential anti-androgenic effects on the developing male fetus. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for endocrine disruption in male fetus.
Second Trimester: Potential for endocrine disruption in male fetus.
Third Trimester: Potential for endocrine disruption in male fetus; may cause electrolyte disturbances in the mother.
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Lactation

Spironolactone and its active metabolites are excreted in breast milk in small amounts. Use with caution. Monitor breastfed infant for adverse effects (e.g., dehydration, electrolyte imbalance). Consider alternative if possible, especially in preterm or neonates.

Infant Risk: L3 (Moderately Safe) - Low risk of adverse effects, but monitor for dehydration, electrolyte imbalance, and potential endocrine effects.
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Pediatric Use

Dosing is weight-based for edema/ascites. Use with caution, especially in infants and young children, due to higher risk of electrolyte imbalances. Close monitoring of electrolytes and renal function is essential.

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Geriatric Use

Increased risk of hyperkalemia, hyponatremia, and renal impairment due to age-related decline in renal function and polypharmacy. Start with lower doses and titrate slowly. Close monitoring of electrolytes and renal function is crucial.

Clinical Information

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Clinical Pearls

  • Spironolactone is a key medication in the management of heart failure with reduced ejection fraction (HFrEF) due to its mortality benefit, even at low doses.
  • It is the drug of choice for primary aldosteronism.
  • Gynecomastia is a common and dose-dependent side effect in males, often leading to discontinuation. Eplerenone is an alternative aldosterone antagonist with less anti-androgenic activity.
  • Always counsel patients to avoid potassium supplements and potassium-containing salt substitutes due to the high risk of hyperkalemia.
  • Take with food to improve absorption and reduce gastrointestinal upset.
  • Full diuretic and antihypertensive effects may take several days to develop.
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Alternative Therapies

  • Eplerenone (another selective aldosterone antagonist, less anti-androgenic effects)
  • Loop diuretics (e.g., Furosemide, Bumetanide - for more potent diuresis, but potassium-wasting)
  • Thiazide diuretics (e.g., Hydrochlorothiazide, Chlorthalidone - for hypertension, but potassium-wasting)
  • Other potassium-sparing diuretics (e.g., Amiloride, Triamterene - generally less potent than spironolactone)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (25mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic), Tier 2-3 (Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.