Spironolactone 100mg Tablets

Spironolactone is a competitive antagonist of aldosterone at the mineralocorticoid receptor in the distal renal tubules, collecting ducts, and other target tissues. By blocking aldosterone, it increases sodium and water excretion while conserving potassium and hydrogen ions. This action reduces blood volume, lowers blood pressure, and mitigates aldosterone-induced cardiac and vascular remodeling.

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: 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 (rarely, liver problems have been reported with this medication, including one death).
Severe skin reactions, including Stevens-Johnson syndrome (SJS): 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 (these reactions can be life-threatening and may affect internal organs).

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

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 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.

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. 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 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 your condition and adjust the dosage as necessary.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, discuss this with 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.

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.

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

• 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 risk of hyperkalemia and renal impairment
• Trimethoprim/Sulfamethoxazole (Bactrim) - increased risk of severe hyperkalemia
• Digoxin - Spironolactone may increase digoxin half-life and serum levels
• Lithium - Spironolactone may reduce renal clearance of lithium, leading to increased lithium toxicity
• Cholestyramine - may cause hyperchloremic metabolic acidosis

• Corticosteroids - may enhance electrolyte depletion (hypokalemia)
• Non-depolarizing muscle relaxants (e.g., Vecuronium) - Spironolactone may prolong the effect
• Anticoagulants (oral) - Spironolactone may decrease anticoagulant effect
• Alcohol, Barbiturates, Narcotics - may potentiate orthostatic hypotension

• Not available

• Signs of hyperkalemia (muscle weakness, fatigue, bradycardia, paresthesias, irregular heartbeat)
• Signs of hyponatremia (nausea, headache, confusion, lethargy, seizures)
• Signs of dehydration/hypovolemia (dizziness, lightheadedness, dry mouth, decreased urination)
• Gynecomastia or breast tenderness (in males)
• Menstrual irregularities or hirsutism (in females)
• Gastric upset (nausea, vomiting, diarrhea)

Generally not recommended during pregnancy, especially in the first trimester, due to potential anti-androgenic effects on male fetuses. Use only if the potential benefit justifies the potential risk to the fetus.

Spironolactone and its active metabolite (canrenone) are excreted into breast milk. While the amount is generally low, caution is advised. Monitor the infant for potential adverse effects such as dehydration, electrolyte imbalance, or endocrine effects. Consider alternative agents or temporary discontinuation of breastfeeding, especially in preterm or neonates.

Use in pediatric patients is generally off-label for conditions like heart failure or edema, with dosing based on weight. Close monitoring of electrolytes (especially potassium) and renal function is crucial due to increased susceptibility to imbalances. Gynecomastia can occur in males.

Elderly patients are at increased risk of hyperkalemia, dehydration, and renal impairment due to age-related decline in kidney function and polypharmacy. Initiate with lower doses and monitor serum potassium and renal function more frequently. Increased risk of falls due to orthostatic hypotension.

• Spironolactone is a potassium-sparing diuretic; therefore, avoid concomitant use with potassium supplements, potassium-containing salt substitutes, or other potassium-sparing diuretics (e.g., eplerenone, amiloride, triamterene) unless specifically directed and closely monitored by a physician.
• Hyperkalemia is the most serious adverse effect; educate patients on symptoms and the importance of regular blood tests.
• Food significantly increases spironolactone absorption; advise patients to take it consistently with food to maintain stable drug levels.
• Gynecomastia is a common dose-dependent side effect in males, which may be irreversible in some cases. Discuss this with male patients.
• Spironolactone has a slow onset of action for its diuretic and antihypertensive effects, often taking days to weeks to achieve full therapeutic benefit.
• It is a cornerstone therapy in heart failure with reduced ejection fraction (HFrEF) due to its mortality and morbidity benefits, independent of its diuretic effect.

• Eplerenone (selective aldosterone antagonist)
• Loop diuretics (e.g., Furosemide, Torsemide) - for more potent diuresis, but are potassium-wasting
• Thiazide diuretics (e.g., Hydrochlorothiazide, Chlorthalidone) - for hypertension and mild edema, but are potassium-wasting
• Other potassium-sparing diuretics (e.g., Amiloride, Triamterene) - generally less potent and used in combination with thiazides/loops to prevent hypokalemia

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.