Aldactone 100mg Tablets
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.
Drug Class
Diuretic; Antihypertensive; Aldosterone Antagonist
Pharmacologic Class
Aldosterone Antagonist; Potassium-sparing Diuretic
Pregnancy Category
Category D
FDA Approved
Aug 1960
DEA Schedule
Not Controlled
Overview
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 conditions like heart failure or liver disease, and a condition where your body makes too much of a hormone called aldosterone.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, but be consistent in how you take it each time - either always with food or always on an empty stomach.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're 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 disruptions.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture. Keep all medications in a secure location, out of the 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 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 a safe and environmentally responsible way to dispose of your medications.
What to Do If You Miss 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 adverse effects.
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, but be consistent in how you take it each time - either always with food or always on an empty stomach.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're 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 disruptions.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms and areas prone to moisture. Keep all medications in a secure location, out of the 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 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 a safe and environmentally responsible way to dispose of your medications.
What to Do If You Miss 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 adverse effects.
Lifestyle & Tips
- Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
- Limit high-potassium foods (e.g., bananas, oranges, potatoes, leafy greens, tomatoes) if advised by your doctor, especially if you have kidney problems or are taking other medications that increase potassium.
- Stay hydrated, especially in hot weather or during exercise, to prevent dehydration.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness from low blood pressure.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For hypertension, typically 50-100 mg once daily or in divided doses. For edema, 25-200 mg daily. For heart failure (NYHA Class III-IV), 12.5-25 mg once daily.
Dose Range:
12.5 - 400 mg
Condition-Specific Dosing:
Hypertension:
50-100 mg/day, once daily or in divided doses. May be titrated up to 100 mg/day.
Edema (CHF, Cirrhosis, Nephrotic Syndrome):
Initial 25-200 mg/day, once daily or in divided doses. Maintenance adjusted based on response.
Severe Heart Failure (NYHA Class III-IV):
Initial 12.5-25 mg once daily. May increase to 50 mg once daily if tolerated and needed, or decrease to 12.5 mg every other day if hyperkalemia occurs.
Primary Aldosteronism (Diagnosis):
100-400 mg/day for 3-4 days (short test) or 3-4 weeks (long test).
Primary Aldosteronism (Preoperative):
100-400 mg/day in divided doses.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution, often off-label for specific conditions like ascites or heart failure).
Infant:
Not established (off-label use for edema/ascites: 1-3 mg/kg/day in divided doses).
Child:
Not established (off-label use for edema/ascites: 1-3 mg/kg/day in divided doses, max 100 mg/day).
Adolescent:
Dosing similar to adult for specific indications, often off-label.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor potassium and renal function closely.
Moderate:
CrCl 30-50 mL/min: Consider dose reduction (e.g., 12.5 mg/day or every other day) and frequent monitoring of potassium and renal function. Avoid if possible.
Severe:
CrCl < 30 mL/min: Contraindicated due to high risk of severe hyperkalemia.
Dialysis:
Not recommended; spironolactone is not significantly removed by dialysis. Contraindicated in anuric renal failure.
Hepatic Impairment:
Mild:
Use with caution; monitor for electrolyte imbalances and hepatic encephalopathy.
Moderate:
Use with caution; dose adjustment may be necessary. Monitor closely for adverse effects and electrolyte disturbances.
Severe:
Use with extreme caution; may precipitate hepatic coma. Consider lower initial doses and close monitoring.
Pharmacology
Mechanism of Action
Spironolactone is a competitive antagonist of aldosterone at the mineralocorticoid receptors in the distal renal tubules, increasing the excretion of sodium and water while conserving potassium and hydrogen ions. It also has antiandrogenic and progestational effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
Spironolactone: 1-2 hours; Canrenone (active metabolite): 2.5-4 hours
FoodEffect:
Food increases absorption significantly (by 90-100%).
Distribution:
Vd:
Approximately 0.2 L/kg
ProteinBinding:
>90% (primarily to albumin and alpha-1 acid glycoprotein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Spironolactone: 1.3 hours; Canrenone: 13-24 hours (terminal half-life)
Clearance:
Not readily quantifiable for parent drug due to rapid metabolism; Canrenone clearance is primarily renal.
ExcretionRoute:
Urine (primarily metabolites), Feces
Unchanged:
<1% (spironolactone)
Pharmacodynamics
OnsetOfAction:
Diuretic effect is delayed, typically 2-3 days for maximal effect.
PeakEffect:
2-3 days
DurationOfAction:
2-3 days after discontinuation due to active metabolites.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, 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: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Severe dizziness or fainting, confusion, or changes in balance.
Sexual problems: decreased interest in sex, or difficulty getting or maintaining an erection.
Fever, chills, or sore throat.
Unexplained bruising or bleeding, black, tarry, or bloody stools, or vomiting blood or coffee ground-like material.
Menstrual changes, breast pain, or enlarged breasts in males.
Signs of liver problems: dark urine, tiredness, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. (Note: One reported case of liver problems resulted in 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; shortness of breath; or swollen glands.
Other Possible Side Effects
Most people taking this medication will not experience severe side effects. However, some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness or drowsiness
Headache
Diarrhea, stomach upset, or vomiting
Stomach cramps
* Hair loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, 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: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Severe dizziness or fainting, confusion, or changes in balance.
Sexual problems: decreased interest in sex, or difficulty getting or maintaining an erection.
Fever, chills, or sore throat.
Unexplained bruising or bleeding, black, tarry, or bloody stools, or vomiting blood or coffee ground-like material.
Menstrual changes, breast pain, or enlarged breasts in males.
Signs of liver problems: dark urine, tiredness, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. (Note: One reported case of liver problems resulted in 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; shortness of breath; or swollen glands.
Other Possible Side Effects
Most people taking this medication will not experience severe side effects. However, some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Dizziness or drowsiness
Headache
Diarrhea, stomach upset, or vomiting
Stomach cramps
* Hair loss
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Unusual tiredness or weakness
- Slow or irregular heartbeat
- Muscle cramps or pain
- Numbness or tingling in hands or feet
- Dizziness or lightheadedness, especially when standing up
- Nausea, vomiting, or diarrhea
- Breast enlargement or tenderness (in men and women)
- Menstrual irregularities (in women)
- Deepening of voice (in women)
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.
Certain health conditions, including Addison's disease or high potassium levels.
* If you are currently taking any of the following medications: Abiraterone, amiloride, eplerenone, or triamterene. Please note that this is not an exhaustive list of interacting drugs.
To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist. This will enable them to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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.
Certain health conditions, including Addison's disease or high potassium levels.
* If you are currently taking any of the following medications: Abiraterone, amiloride, eplerenone, or triamterene. Please note that this is not an exhaustive list of interacting drugs.
To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist. This will enable them to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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, and undergo blood tests as scheduled by your doctor. Discuss any concerns or questions with your doctor.
Be aware that this medication may interfere with certain laboratory tests. Therefore, inform 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 your condition and adjust the dosage as needed.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor.
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.
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Regularly monitor your blood pressure as directed by your healthcare provider, and undergo blood tests as scheduled by your doctor. Discuss any concerns or questions with your doctor.
Be aware that this medication may interfere with certain laboratory tests. Therefore, inform 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 your condition and adjust the dosage as needed.
If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with your doctor.
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.
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Confusion
- Skin rash
- Nausea, vomiting, diarrhea
- Dehydration
- Electrolyte imbalances (especially hyperkalemia, hyponatremia)
- Hypotension (low blood pressure)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, focusing on correcting fluid and electrolyte imbalances. Hyperkalemia may require urgent treatment.
Drug Interactions
Contraindicated Interactions
- Eplerenone (increased risk of hyperkalemia)
- Potassium supplements (increased risk of hyperkalemia)
- Amiloride, Triamterene (other potassium-sparing diuretics, increased risk of hyperkalemia)
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
- Trimethoprim/sulfamethoxazole (Bactrim) - significantly increased risk of severe hyperkalemia
- Lithium - spironolactone may reduce renal clearance of lithium, leading to increased lithium toxicity
- Digoxin - spironolactone may interfere with digoxin radioimmunoassays and may increase digoxin half-life
Moderate Interactions
- Other antihypertensives - additive hypotensive effects
- Loop diuretics (e.g., furosemide) - synergistic diuretic effect, but monitor electrolytes closely
- Corticosteroids, ACTH - may intensify electrolyte depletion (especially hypokalemia) with other diuretics, but spironolactone counteracts potassium loss
- Norepinephrine - spironolactone may reduce vascular responsiveness to norepinephrine
Minor Interactions
- Alcohol, barbiturates, narcotics - may potentiate orthostatic hypotension
Monitoring
Baseline Monitoring
Serum Potassium (K+)
Rationale: To establish baseline and identify pre-existing hyperkalemia, a major risk.
Timing: Prior to initiation of therapy.
Serum Sodium (Na+)
Rationale: To establish baseline and identify pre-existing hyponatremia.
Timing: Prior to initiation of therapy.
Renal Function (BUN, Serum Creatinine, eGFR)
Rationale: To assess kidney function, as impaired renal function increases hyperkalemia risk and is a contraindication in severe cases.
Timing: Prior to initiation of therapy.
Blood Pressure
Rationale: To establish baseline and guide therapy for hypertension.
Timing: Prior to initiation of therapy.
Routine Monitoring
Serum Potassium (K+)
Frequency: Within 1 week of initiation or dose change, then monthly for the first 3 months, then quarterly or as clinically indicated.
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L (consider dose reduction/discontinuation), >6.0 mEq/L (urgent intervention, discontinue drug).
Renal Function (BUN, Serum Creatinine, eGFR)
Frequency: Within 1 week of initiation or dose change, then monthly for the first 3 months, then quarterly or as clinically indicated.
Target: Stable, within patient's baseline
Action Threshold: Significant increase in creatinine or decrease in eGFR (e.g., >30% from baseline) may require dose adjustment or discontinuation.
Blood Pressure
Frequency: Regularly, as clinically indicated for hypertension management.
Target: Individualized based on patient guidelines (e.g., <130/80 mmHg)
Action Threshold: Persistent hypotension or uncontrolled hypertension.
Fluid Status/Weight
Frequency: Daily or as clinically indicated for edema/heart failure management.
Target: Stable weight, absence of edema
Action Threshold: Significant weight gain/loss, worsening edema, or signs of dehydration.
Symptom Monitoring
- Muscle weakness
- Fatigue
- Bradycardia (slow heart rate)
- Palpitations
- Numbness or tingling (paresthesias)
- Dizziness or lightheadedness (orthostatic hypotension)
- Nausea, vomiting, diarrhea
- Breast tenderness or enlargement (gynecomastia in males)
- Menstrual irregularities (in females)
- Deepening of voice (in females)
Special Patient Groups
Pregnancy
Category D (older classification). Spironolactone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a theoretical risk of feminization of a male fetus due to its antiandrogenic activity.
Trimester-Specific Risks:
First Trimester:
Theoretical risk of feminization of male fetus due to antiandrogenic effects during critical periods of sexual differentiation.
Second Trimester:
Continued theoretical risk of endocrine disruption.
Third Trimester:
Risk of electrolyte imbalance in the mother and fetus. Neonatal jaundice, thrombocytopenia, and altered carbohydrate metabolism have been reported with thiazide diuretics, which may be relevant.
Lactation
Spironolactone's active metabolite, canrenone, is excreted in human breast milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. L3 (Moderately safe).
Infant Risk:
Potential for electrolyte disturbances (e.g., hyperkalemia), endocrine effects (antiandrogenic), and other adverse effects. Monitor infant for signs of dehydration, lethargy, or electrolyte imbalance.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established by controlled clinical trials. Use in pediatric patients is generally off-label for conditions like heart failure, ascites, or hypertension, with dosing based on weight. Close monitoring for hyperkalemia and other adverse effects is crucial.
Geriatric Use
Elderly patients are at increased risk of hyperkalemia, dehydration, and renal impairment. Start with lower doses and titrate slowly. Monitor serum potassium and renal function more frequently. Use with caution in patients with pre-existing renal or hepatic impairment.
Clinical Information
Clinical Pearls
- Spironolactone is a cornerstone therapy for heart failure with reduced ejection fraction (HFrEF) due to its mortality and morbidity benefits, even at low doses (12.5-25 mg).
- It is the drug of choice for primary aldosteronism.
- Always monitor serum potassium and renal function closely, especially when initiating therapy, increasing dose, or adding interacting medications (e.g., ACE inhibitors, ARBs, NSAIDs, trimethoprim/sulfamethoxazole).
- Advise patients to avoid potassium supplements and potassium-containing salt substitutes.
- Gynecomastia is a common dose-dependent side effect in males, which may lead to non-adherence. Eplerenone is an alternative with less risk of gynecomastia but is more expensive.
- Take with food to enhance absorption and reduce gastrointestinal upset.
Alternative Therapies
- Eplerenone (selective aldosterone antagonist, less antiandrogenic side effects)
- Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone for hypertension, edema)
- Loop diuretics (e.g., furosemide, torsemide for significant edema, heart failure)
- ACE inhibitors (e.g., lisinopril, enalapril for hypertension, heart failure)
- Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan for hypertension, heart failure)
- Beta-blockers (e.g., metoprolol, carvedilol for hypertension, heart failure)
- Calcium channel blockers (e.g., amlodipine, diltiazem for hypertension)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for generic 100mg per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2 (Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the medication, including the amount taken and the time it happened.