Aldactone 25mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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).
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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)
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
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)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline and identify pre-existing hyperkalemia or hypokalemia.
Timing: Before initiation of therapy.
Rationale: To establish baseline and identify pre-existing hyponatremia.
Timing: Before initiation of therapy.
Rationale: To assess kidney function, as spironolactone is contraindicated in severe renal impairment and dose adjustments are needed.
Timing: Before initiation of therapy.
Rationale: To establish baseline and monitor therapeutic effect.
Timing: Before initiation of therapy.
Routine Monitoring
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)
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)
Frequency: Periodically, especially if signs of hyponatremia develop.
Target: 135-145 mEq/L
Action Threshold: <130 mEq/L (investigate cause, consider dose adjustment)
Frequency: Regularly, as clinically indicated.
Target: Individualized target (e.g., <130/80 mmHg for hypertension)
Action Threshold: Persistent uncontrolled hypertension or symptomatic hypotension
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
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:
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.
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.
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
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.
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)