Edemide 20 mg+50 mg

Indications
The combination of Frusemide & Spironolactone is indicated for the treatment of the following conditions:

• Essential hypertension
• Chronic congestive heart failure
• Hepatic cirrhosis, particularly with the accumulation of fluid in the abdominal cavity (ascites)
• Swelling caused by fluid retention (edema)
• Hyperaldosteronism
• Resistant edema associated with secondary hyperaldosteronism

Use this medication under the guidance of a registered healthcare professional.

Pharmacology
Spironolactone, a potassium-sparing diuretic, and Furosemide, a loop diuretic, work through different but complementary mechanisms and sites of action. When combined, they produce an additive or synergistic diuretic effect.
Furosemide works by inhibiting the Na+/K+/2Cl- co-transporter in the ascending Loop of Henle, preventing the reabsorption of sodium, potassium, and chloride ions. This increases the excretion of sodium and water in the urine, typically resulting in potassium loss.
Spironolactone acts by blocking aldosterone at the distal tubule, which reduces sodium reabsorption in exchange for potassium. This process favors sodium excretion and helps counteract the potassium loss caused by Furosemide.

Dosage & Administration

• Furosemide 20 mg and Spironolactone 50 mg: Typically, 1 to 4 tablets daily, corresponding to 20 to 80 mg of Furosemide and 50 to 200 mg of Spironolactone, depending on the patient’s response.
• Furosemide 40 mg and Spironolactone 50 mg: This formulation is for patients who are stabilized but require a higher dose of Furosemide and Spironolactone. It can be taken as 1 to 2 tablets daily (Furosemide 40 to 80 mg and Spironolactone 50 to 100 mg).

This medication is not suitable for use in children.
Both Spironolactone and Furosemide may be excreted more slowly in elderly patients.
Always consult a registered healthcare professional before use.

Interactions

• When used with ACE inhibitors or potassium salts, there is an increased risk of hyperkalemia.
• Spironolactone can elevate the levels of cardiac glycosides, like digoxin, in the blood, potentially leading to digitalis toxicity.
• The use of corticosteroids with Spironolactone can cause hypokalemia.
• The diuretic and blood pressure-lowering effects of Furosemide may be diminished when used with indomethacin or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Furosemide may enhance the ototoxicity of aminoglycoside antibiotics.
• Co-administration of Furosemide with sucralfate may reduce its natriuretic and anti-hypertensive effects.

Contraindications
This medication should not be used in patients who have:

• Anuria
• Acute renal insufficiency
• Rapidly worsening or severe renal impairment (creatinine clearance <30 ml/min)
• Hyperkalemia
• Addison’s disease
• Hypersensitivity to Spironolactone, Furosemide, or sulphonamides

Side Effects

• Spironolactone may cause headache, drowsiness, and gastrointestinal discomfort, including cramps and diarrhea.
• Ataxia, mental confusion, and skin rashes have been reported.
• Gynaecomastia (enlarged breast tissue in males) may occur, and in rare cases, it can persist.
• Other endocrine effects like hirsutism, voice deepening, menstrual irregularities, and impotence may occur.
• A temporary rise in blood urea nitrogen levels and mild acidosis have been observed.
• Spironolactone may result in hyponatremia and hyperkalemia.
• Excessive diuresis may lead to dehydration, reduced blood volume, and circulatory collapse, with the potential for vascular thrombosis and embolism, especially in the elderly.
• Severe depletion of potassium and magnesium may cause cardiac arrhythmias.

Pregnancy & Lactation

• Pregnancy: Spironolactone and its metabolites can cross the placental barrier. Its use during pregnancy should only occur when the benefits outweigh the risks to both the mother and the fetus. Animal studies suggest that Furosemide may cause fetal abnormalities, so it should only be used in women of childbearing age if effective contraception is employed, or if the benefits justify the potential risks to the fetus.
• Lactation: Spironolactone metabolites are present in breast milk. If it is necessary to use Spironolactone, an alternative infant feeding method should be considered. Furosemide is also excreted in breast milk, so breastfeeding should be discontinued if treatment is essential.

Precautions & Warnings

• Use with caution in patients at risk for electrolyte imbalances.
• Caution is also advised in individuals with diabetes, enlarged prostate, low blood pressure (hypotension), and hypovolemia.

Therapeutic Class

• Potassium-sparing diuretics
• Potassium-sparing diuretics & Aldosterone antagonists

Storage Conditions
Store below 30°C, away from light and moisture. Keep out of the reach of children.

Packaging
Edemide 20 mg Tablet

Use this medication under the guidance of a registered healthcare professional.