Aldactone 50mg Tablets

Spironolactone is a competitive antagonist of aldosterone at the mineralocorticoid receptors in the distal renal tubules, collecting ducts, and other target tissues. This antagonism leads to increased excretion of sodium and water, while decreasing the excretion of potassium and hydrogen ions, thereby conserving potassium and hydrogen.

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 medical attention immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of fluid and electrolyte problems, such as:
+ 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
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or passing out
Feeling confused
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, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (one reported death has been associated with this medication)
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 skin
+ Fever
+ Chills
+ Body aches
+ Shortness of breath
+ Swollen glands

Other Possible Side Effects

Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following symptoms, contact your doctor or seek medical attention:

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

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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.

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 health problems you may have. Your doctor and pharmacist need this information to determine whether it is safe for you 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 all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid driving and other activities that require alertness.

Regularly check 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.

This medication may interfere with certain laboratory tests, so it is crucial to 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 use of this medication.

Be aware that this drug may increase potassium levels in the blood, which can be life-threatening if left untreated. This risk is higher in individuals with diabetes, kidney disease, severe illness, and older adults. Your doctor will closely monitor you 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 essential to closely monitor your blood sugar levels while taking this medication.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Eplerenone (increased risk of hyperkalemia)
• Amiloride, Triamterene (other potassium-sparing diuretics - severe hyperkalemia risk)
• Potassium supplements (severe hyperkalemia risk)
• Potassium-containing salt substitutes (severe hyperkalemia risk)

• 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 - reduced diuretic/antihypertensive effect, increased risk of hyperkalemia and renal dysfunction)
• Trimethoprim/Sulfamethoxazole (increased risk of hyperkalemia)
• Digoxin (spironolactone may increase digoxin half-life, leading to toxicity)
• Lithium (reduced renal clearance of lithium, leading to toxicity)
• Abiraterone (increased exposure of abiraterone, leading to toxicity)

• Heparin/Low Molecular Weight Heparins (increased risk of hyperkalemia)
• Cyclosporine, Tacrolimus (increased risk of hyperkalemia)
• Cholestyramine (may cause hyperchloremic metabolic acidosis)
• Corticosteroids, ACTH (enhanced electrolyte depletion, particularly hypokalemia)
• Norepinephrine (reduced vascular responsiveness to norepinephrine)
• Alcohol, Barbiturates, Narcotics (orthostatic hypotension may be potentiated)

• Anticoagulants (may decrease anticoagulant effect)
• Carbenoxolone (may antagonize spironolactone's effect)

• Signs of hyperkalemia (fatigue, muscle weakness, paresthesias, bradycardia, irregular heartbeat)
• Signs of hypotension (dizziness, lightheadedness, syncope)
• Signs of dehydration (excessive thirst, dry mouth, decreased urination)
• Gynecomastia or breast tenderness (in males)
• Menstrual irregularities or postmenopausal bleeding (in females)
• GI upset (nausea, vomiting, diarrhea)
• Rash or allergic reactions

Generally not recommended for routine use in pregnancy due to potential endocrine effects on the fetus (e.g., feminization of male fetuses). Use only if clearly needed and benefits outweigh risks.

Spironolactone and its metabolites are excreted in breast milk. Due to potential for adverse effects on the infant (e.g., electrolyte imbalance, endocrine effects) and reduction in milk production, use with caution or consider an alternative. Monitor infant for adverse effects.

Use with caution. Dosing is weight-based and requires careful titration. Risk of hyperkalemia is significant, especially in neonates and infants. Long-term effects on growth and development, particularly endocrine, are not fully established.

Increased risk of hyperkalemia, dehydration, and renal impairment. Start with lower doses and titrate slowly. Monitor renal function and serum potassium more frequently. More susceptible to orthostatic hypotension.

• Always check serum potassium and renal function before initiating spironolactone and regularly thereafter, especially when co-prescribing with ACE inhibitors, ARBs, or NSAIDs.
• Advise patients to avoid potassium supplements and potassium-containing salt substitutes.
• Gynecomastia is a common and often dose-dependent side effect in males, which may be irreversible in some cases. Counsel patients about this possibility.
• Take spironolactone with food to enhance absorption and reduce GI upset.
• The full diuretic and antihypertensive effects may take several days to weeks to manifest, so dose adjustments should be made gradually.
• Spironolactone is particularly useful in heart failure with reduced ejection fraction (HFrEF) for its mortality and morbidity benefits, even at low doses (12.5-25 mg/day), independent of its diuretic effect.

• Loop diuretics (e.g., Furosemide, Torsemide - for edema, but cause potassium loss)
• Thiazide diuretics (e.g., Hydrochlorothiazide, Chlorthalidone - for hypertension, but cause potassium loss)
• ACE inhibitors/ARBs (for hypertension, heart failure, renal protection)
• Beta-blockers (for hypertension, heart failure)
• Calcium channel blockers (for hypertension)

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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.