Spironolactone 25mg/5ml Oral Susp
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 may be given to you for other reasons. Talk with the doctor.
Drug Class
Diuretic; Antihypertensive; Aldosterone Antagonist
Pharmacologic Class
Potassium-sparing diuretic; Mineralocorticoid receptor antagonist
Pregnancy Category
C
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), and heart failure. It works by blocking a natural hormone called aldosterone.
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. This means either always taking it with food or always taking it on an empty stomach.
Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose carefully using the measuring device that comes with the medication. If you don't have a measuring device, ask your pharmacist for one.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. Be aware that this medication may increase the frequency of urination. To minimize sleep disturbances, try to avoid taking it too close to bedtime.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, ask your pharmacist. You may also want to check if there are any drug take-back programs in your area.
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 dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
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. This means either always taking it with food or always taking it on an empty stomach.
Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose carefully using the measuring device that comes with the medication. If you don't have a measuring device, ask your pharmacist for one.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. Be aware that this medication may increase the frequency of urination. To minimize sleep disturbances, try to avoid taking it too close to bedtime.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, ask your pharmacist. You may also want to check if there are any drug take-back programs in your area.
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 dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Avoid potassium supplements and salt substitutes containing 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.
- Stay hydrated as advised by your doctor, especially in hot weather or during exercise, to prevent dehydration.
- Monitor your blood pressure and weight regularly as instructed.
- Report any unusual symptoms, especially muscle weakness, fatigue, or irregular heartbeat, which could indicate high potassium levels.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For edema/ascites: 25-100 mg/day orally in single or divided doses. For hypertension: 25-100 mg/day orally in single or divided doses. For heart failure (NYHA Class III-IV): 12.5-25 mg once daily.
Dose Range:
12.5 - 400 mg
Condition-Specific Dosing:
Edema/Ascites:
25-100 mg/day initially, adjusted to 25-200 mg/day.
Hypertension:
25-100 mg/day, usually as add-on therapy.
Heart Failure (NYHA Class III-IV):
12.5-25 mg once daily, target 25 mg once daily.
Primary Hyperaldosteronism:
100-400 mg/day in single or divided doses.
Pediatric Dosing
Neonatal:
Not established for routine use; specific conditions may warrant off-label use under specialist guidance (e.g., 1-3 mg/kg/day in divided doses for refractory edema).
Infant:
1-3 mg/kg/day orally in single or divided doses for edema/ascites.
Child:
1-3 mg/kg/day orally in single or divided doses for edema/ascites; max 100 mg/day. For hypertension: 1-2 mg/kg/day once daily or divided, max 100 mg/day.
Adolescent:
Dosing similar to adult for specific indications, typically 25-100 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor renal function and potassium closely.
Moderate:
Use with caution. Consider lower initial doses (e.g., 12.5 mg/day) and monitor potassium and renal function frequently. Avoid if GFR < 30 mL/min/1.73m².
Severe:
Contraindicated or not recommended due to high risk of hyperkalemia (GFR < 30 mL/min/1.73m²).
Dialysis:
Not recommended in patients on dialysis due to risk of hyperkalemia and lack of significant removal by dialysis. Avoid use.
Hepatic Impairment:
Mild:
No specific adjustment, but monitor for electrolyte imbalances and adverse effects.
Moderate:
Use with caution. May require lower doses due to altered metabolism and increased risk of adverse effects. Monitor closely.
Severe:
Use with extreme caution; may exacerbate hepatic encephalopathy. Consider lower doses and close monitoring. Contraindicated in severe hepatic dysfunction if associated with hyperkalemia.
Pharmacology
Mechanism of Action
Spironolactone is a competitive antagonist of aldosterone at mineralocorticoid receptors in the distal renal tubules, collecting ducts, and other target organs. By blocking aldosterone, it increases sodium and water excretion while conserving potassium and hydrogen ions. This action contributes to its diuretic and antihypertensive effects, and its beneficial effects in heart failure by reducing aldosterone-mediated cardiac remodeling and fibrosis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-90% (variable)
Tmax:
1-2 hours for parent drug; 2-4 hours for active metabolites (canrenone)
FoodEffect:
Increased absorption with food (up to 90%)
Distribution:
Vd:
Not precisely determined, but extensively distributed; approximately 0.2 L/kg for canrenone.
ProteinBinding:
Approximately 90% (spironolactone and canrenone)
CnssPenetration:
Limited
Elimination:
HalfLife:
Spironolactone: 1.3 hours; Canrenone: 13-24 hours; 7-alpha-thiomethylspironolactone: 3-12 hours
Clearance:
Not precisely quantified, but primarily hepatic
ExcretionRoute:
Primarily renal (approximately 50%) and biliary/fecal (approximately 35-40%)
Unchanged:
< 1% (parent drug)
Pharmacodynamics
OnsetOfAction:
Diuretic effect: 2-3 days; Antihypertensive effect: 2-3 weeks
PeakEffect:
Diuretic effect: 3-5 days; Antihypertensive effect: 4-6 weeks
DurationOfAction:
2-3 days (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 passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or vomiting.
Signs of kidney problems: unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
Severe dizziness or passing out
Confusion
Change in balance
Decreased interest in sex
Erectile dysfunction
Fever, chills, or sore throat
Unexplained bruising or bleeding
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Menstrual changes
Breast pain
Enlarged breasts (in males)
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes. Note: Rarely, liver problems have been reported with this medication, including one 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 your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or 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, contact your doctor or seek medical attention if they bother you or persist:
Dizziness or drowsiness
Headache
Diarrhea, upset stomach, or vomiting
Stomach cramps
Hair loss
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
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 passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or vomiting.
Signs of kidney problems: unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
Severe dizziness or passing out
Confusion
Change in balance
Decreased interest in sex
Erectile dysfunction
Fever, chills, or sore throat
Unexplained bruising or bleeding
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Menstrual changes
Breast pain
Enlarged breasts (in males)
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes. Note: Rarely, liver problems have been reported with this medication, including one 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 your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or 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, contact your doctor or seek medical attention if they bother you or persist:
Dizziness or drowsiness
Headache
Diarrhea, upset stomach, or vomiting
Stomach cramps
Hair loss
Reporting Side Effects
This list is not exhaustive, and you may experience other 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, severe weakness, seizures.
- Signs of dehydration: extreme thirst, dry mouth, decreased urination, dizziness, lightheadedness.
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, persistent nausea/vomiting, severe stomach pain.
- Breast enlargement or tenderness (gynecomastia) in men, or breast tenderness/menstrual changes 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 help determine whether it is safe to take this medication in conjunction with your other treatments. 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 help determine whether it is safe to take this medication in conjunction with your other treatments. 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 instructed by your healthcare provider. Additionally, undergo blood tests as directed by your doctor and discuss the results with them.
Be aware that this medication may interfere with certain laboratory tests. 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 necessary 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, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Regularly monitor your blood pressure as instructed by your healthcare provider. Additionally, undergo blood tests as directed by your doctor and discuss the results with them.
Be aware that this medication may interfere with certain laboratory tests. 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 necessary 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, planning to become pregnant, or 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
- 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. Treatment is supportive and symptomatic, focusing on correcting fluid and electrolyte imbalances, particularly hyperkalemia.
Drug Interactions
Contraindicated Interactions
- Eplerenone (increased risk of hyperkalemia)
- Amiloride, triamterene (other potassium-sparing diuretics - severe hyperkalemia risk)
- Potassium supplements (severe hyperkalemia risk)
Major Interactions
- ACE inhibitors (e.g., lisinopril, enalapril - increased hyperkalemia risk)
- Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan - increased hyperkalemia risk)
- NSAIDs (e.g., ibuprofen, naproxen - reduced diuretic/antihypertensive effect, increased hyperkalemia and renal impairment risk)
- Trimethoprim/sulfamethoxazole (increased hyperkalemia risk)
- Digoxin (spironolactone may increase digoxin levels)
- Lithium (spironolactone may reduce lithium clearance, leading to toxicity)
- Heparin/low molecular weight heparins (increased hyperkalemia risk)
Moderate Interactions
- Corticosteroids (may reduce spironolactone's effect)
- Barbiturates (may reduce spironolactone's effect)
- Cholestyramine (may increase hyperkalemia risk)
- Tacrolimus, cyclosporine (increased hyperkalemia risk)
- Abiraterone (increased spironolactone exposure)
Minor Interactions
- Alcohol (additive hypotensive effect)
- Licorice (may antagonize spironolactone's effects)
Monitoring
Baseline Monitoring
Serum Potassium (K+)
Rationale: Risk of hyperkalemia, especially with renal impairment or concomitant medications.
Timing: Before initiation
Serum Sodium (Na+)
Rationale: Risk of hyponatremia.
Timing: Before initiation
Renal Function (BUN, Serum Creatinine, eGFR)
Rationale: Renal impairment increases risk of hyperkalemia and affects drug clearance.
Timing: Before initiation
Blood Pressure
Rationale: To assess baseline and monitor therapeutic effect.
Timing: Before initiation
Routine Monitoring
Serum Potassium (K+)
Frequency: Within 1 week of initiation or dose change, then monthly for first 3 months, then quarterly or as clinically indicated.
Target: 3.5-5.0 mEq/L (adjust based on clinical context, e.g., HF patients may tolerate slightly higher)
Action Threshold: >5.5 mEq/L (consider dose reduction/discontinuation); >6.0 mEq/L (urgent intervention)
Renal Function (Serum Creatinine, eGFR)
Frequency: Within 1 week of initiation or dose change, then monthly for first 3 months, then quarterly or as clinically indicated.
Target: Stable, within patient's baseline
Action Threshold: Increase in creatinine >30% from baseline or eGFR <30 mL/min/1.73m² (consider dose reduction/discontinuation)
Blood Pressure
Frequency: Regularly, as per hypertension/heart failure guidelines.
Target: Individualized based on indication and patient comorbidities
Action Threshold: Persistent hypotension or uncontrolled hypertension
Weight and Fluid Status
Frequency: Daily (for edema/HF) or as clinically indicated.
Target: Stable weight, reduced edema
Action Threshold: Significant weight gain/loss, worsening edema, signs of dehydration
Symptom Monitoring
- Signs of hyperkalemia (muscle weakness, fatigue, bradycardia, irregular heartbeat, paresthesias)
- Signs of hyponatremia (nausea, headache, confusion, lethargy, seizures)
- Signs of dehydration (dry mouth, thirst, decreased urination, dizziness)
- Gynecomastia or breast tenderness (in males and females)
- Menstrual irregularities (in females)
- Erectile dysfunction (in males)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. Spironolactone crosses the placenta. Category C.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show potential for feminization of male fetuses at high doses.
Second Trimester:
Risk of electrolyte imbalance in the mother and fetus.
Third Trimester:
Risk of electrolyte imbalance in the mother and fetus; potential for feminization of male fetuses.
Lactation
Use with caution. Spironolactone and its metabolites are excreted in breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but some sources suggest monitoring for adverse effects in the infant. Lactation Risk Category L3 (Moderately Safe).
Infant Risk:
Potential for electrolyte disturbances (hyperkalemia, hyponatremia), dehydration, and endocrine effects in the infant. Monitor infant for signs of dehydration, poor feeding, and electrolyte imbalance.
Pediatric Use
Dosing is weight-based. Use with caution, especially in neonates and infants, due to higher risk of electrolyte imbalances. Close monitoring of electrolytes and renal function is crucial. Oral suspension formulation is beneficial for pediatric dosing.
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. Frequent monitoring of electrolytes and renal function is essential. More susceptible to orthostatic hypotension.
Clinical Information
Clinical Pearls
- Spironolactone is a potassium-sparing diuretic; emphasize avoiding potassium supplements and salt substitutes unless directed by a physician.
- Onset of diuretic effect is delayed (2-3 days), and full antihypertensive effect may take 2-3 weeks. Counsel patients on this delay.
- Monitor serum potassium and renal function closely, especially during initiation, dose changes, and with concomitant medications (e.g., ACEIs, ARBs, NSAIDs).
- Gynecomastia is a common and often dose-dependent side effect in males, which may be irreversible. Counsel patients about this possibility.
- Administer with food to increase absorption and reduce gastrointestinal upset.
- The oral suspension (CaroSpir) provides a more precise dosing option for patients who cannot swallow tablets or require lower doses.
Alternative Therapies
- Loop diuretics (e.g., Furosemide, Torsemide for edema/HF)
- Thiazide diuretics (e.g., Hydrochlorothiazide for hypertension/edema)
- ACE inhibitors (e.g., Lisinopril for hypertension/HF)
- Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan for hypertension/HF)
- Beta-blockers (e.g., Metoprolol for hypertension/HF)
- Calcium channel blockers (e.g., Amlodipine for hypertension)
Cost & Coverage
Average Cost:
$15 - $50 per 120ml (25mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.