Edenil

Furosemide and spironolactone combination is used to manage fluid retention while minimizing electrolyte imbalances.

Approved Indications:

• Edema: Associated with congestive heart failure (CHF), liver cirrhosis, nephrotic syndrome, and chronic kidney disease (CKD).
• Hypertension: Particularly in patients with fluid overload or resistant hypertension.
• Ascites: Secondary to liver cirrhosis, especially when single-agent diuretics are insufficient.
• Heart Failure: Symptomatic management to reduce pulmonary and peripheral edema while conserving potassium.

Off-label / Clinically Accepted Uses:

• Chronic edema management: In patients prone to hypokalemia with loop diuretics alone.
• Secondary hyperaldosteronism: Where aldosterone-mediated fluid retention contributes to edema.

Adults:

• Oral Formulation: Typically contains 40 mg furosemide + 25 mg spironolactone per tablet; dosing individualized based on fluid status.
• Initial: 1 tablet once daily; titrate every 3–7 days based on response and serum electrolytes.
• Max: 2 tablets daily, rarely higher under strict monitoring.

Pediatrics:

• Limited data; use only under specialist supervision with individualized dosing.

Special Populations:

• Renal Impairment: Caution; monitor serum potassium and creatinine.
• Hepatic Impairment: Adjust dose carefully due to risk of encephalopathy or fluid-electrolyte disturbances.
• Elderly: Start at lower doses; monitor closely for dehydration and hypotension.

Administration Routes:

• Oral only. Take with or after meals to reduce gastrointestinal irritation.

Furosemide is a loop diuretic that inhibits the Na⁺-K⁺-2Cl⁻ symporter in the thick ascending loop of Henle, increasing sodium, chloride, and water excretion. Spironolactone is a potassium-sparing diuretic that antagonizes aldosterone in the distal renal tubules, reducing sodium reabsorption and promoting potassium retention. The combination synergistically enhances diuresis while mitigating the risk of hypokalemia caused by furosemide alone. This dual action reduces fluid overload, lowers blood pressure, and alleviates edema without causing significant potassium loss.

Furosemide:

• Oral bioavailability: 60–70%
• Peak effect: 1–2 hours
• Half-life: 1–2 hours
• Metabolism: Minimal hepatic
• Excretion: Primarily renal

Spironolactone:

• Oral bioavailability: 60–90%
• Peak plasma concentration: 2–3 hours
• Active metabolites: Canrenone and others
• Half-life: 16–24 hours (active metabolites prolong effect)
• Metabolism: Hepatic via CYP450 enzymes
• Excretion: Urinary and fecal

Combined: Onset of diuresis typically within 1–2 hours; peak effect 2–4 hours; duration 6–24 hours depending on dose and patient renal/hepatic status.

• Pregnancy: Category C; use only if potential benefits outweigh risks. Risk of electrolyte imbalance may affect fetal development.
• Lactation: Both drugs are excreted in breast milk; caution advised, especially in premature infants. Monitor infant for electrolyte disturbances.

• Primary Class: Diuretic combination
• Subclass: Loop diuretic + potassium-sparing diuretic

• Hypersensitivity to furosemide, spironolactone, or sulfonamides
• Anuria or severe renal failure without dialysis
• Hyperkalemia (serum K⁺ >5.0 mmol/L)
• Addison’s disease or conditions with high potassium retention
• Hepatic coma or severe liver disease without monitoring

• Electrolyte Imbalances: Monitor potassium, sodium, magnesium, and chloride.
• Renal Function: Risk of acute kidney injury if over-diuresis occurs.
• Hypotension & Dehydration: Especially in elderly or volume-depleted patients.
• Hyperkalemia: Spironolactone may cause elevated potassium, particularly in renal impairment or with ACE inhibitors.
• Endocrine Effects: Spironolactone can cause gynecomastia, menstrual irregularities, or impotence.

Common:

• Increased urination, nocturia
• Dizziness, hypotension
• Headache, gastrointestinal upset
• Mild hyperkalemia

Serious / Rare:

• Severe electrolyte disturbances (hypokalemia, hyperkalemia, hyponatremia, hypomagnesemia)
• Ototoxicity (furosemide, especially IV)
• Cardiac arrhythmias secondary to electrolyte imbalance
• Allergic reactions (rash, anaphylaxis)

Timing & Dose Dependence:

• Electrolyte disturbances and hypotension are dose-dependent; effects usually appear within hours to days.

• ACE inhibitors / ARBs / Potassium supplements: Increased risk of hyperkalemia.
• Other diuretics: Additive diuretic effects; monitor electrolytes.
• NSAIDs: May reduce diuretic and antihypertensive efficacy.
• Lithium: Risk of toxicity due to altered renal clearance.
• Aminoglycosides / Cisplatin: Increased risk of nephrotoxicity or ototoxicity.

• Recommended for heart failure and cirrhotic ascites with careful monitoring of serum potassium.
• Emphasis on combining loop and potassium-sparing diuretics to prevent hypokalemia.
• Guidelines advise regular electrolyte and renal function monitoring, especially in elderly and renal-impaired patients.

• Store at 20°C to 25°C, protected from moisture and light.
• Keep in a tightly closed container.
• Protect from freezing.
• Oral solution: discard after manufacturer’s recommended period once opened.