| DESCRIPTION |
Edenil® contains two active ingredients: furosemide, a short acting loop-diuretic and spironolactone, a long acting aldosterone antagonist. This combination produces a strong synergistic or additive diuretic effect. Furosemide inhibits Na+/K+/2Cl- co-transport in the ascending loop of Henle and there occur inhibition of sodium, potassium and chloride ions and water re-absorption. Spironolactone acts on collecting tubules to block the aldosterone receptors and inhibits the re-absorption of sodium and excretion of potassium at the distal tubule. So that sodium excretion is greatly favored and the excess loss of potassium induced by furosemide is reduced.
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| INDICATIONS |
Edenil® is indicated for the treatment of
Oedema (swelling due to excess fluid retention)
Congestive heart failure
Liver cirrhosis, with ascites (collection of fluid in the abdominal cavity)
Essential hypertension
Hyperaldosteronism (overproduction of aldosterone)
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| DOSAGE AND ADMINISTRATION |
1-4 tablets (20-80 mg of furosemide and 50-200 mg of spironolactone) daily according to the patients response. Edenil® is not suitable for use in children.
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| CONTRAINDICATIONS |
Furosemide & spironolactone combination is contraindicated in patients with acute renal failure, renal insufficiency (creatinine clearance: <30ml/min), anuria, hyperkalemia, hyponatremia, Addison's disease or in patients with known hypersensitivity to any of the components of this product.
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| USE IN PREGNANCY AND LACTATION |
Edenil® should be used with caution during pregnancy, only when expected benefit to the mother is greater than the possible risk to the fetus.
Edenil® passes into breast milk. It is recommended that mothers should avoid using this medicine while breastfeeding.
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| SIDE-EFFECTS |
Generally Edenil® is well tolerated. However a few side effects like fatigue, skin rashes, diarrhea, constipation, nausea, vomiting, abdominal pain, hyperglycemia, hypotension, gynecomastia, irregular menstrual cycle and impotence may occur.
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| PRECAUTION |
Caution should be taken in patients liable to electrolyte insufficiency. This combination drug should also be used with caution in diabetes, enlarged prostate, hypotension and in hypovolemia.
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| DRUG INTERACTIONS |
When taken together with ACE inhibitors or potassium salts, there is an increased risk of hyperkalemia.
Spironolactone increases the levels of cardiac glycosides such as digoxin in the blood and this may result in digitalis toxicity.
Corticosteroids may cause hypokalemia if they are used with spironolactone. The blood pressure lowering and diuretic effects of furosemide may be reduced or abolished when concomitantly used with indomethacin and other NSAIDs.
Furosemide may increase the ototoxicity of aminoglycoside antibiotics.
Simultaneous administration of sucralfate and furosemide may reduce the natriuretic and anti-hypertensive effect of furosemide.
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| OVERDOSAGE |
Symptoms of overdosage include drowsiness, mental confusion, dizziness, diarrhea and vomiting etc. due to excessive diuresis.
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| PHARMACEUTICAL PRECAUTION |
Store in a cool and dry place, protected from light. Keep out of reach of children.
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| PACKAGING |
Edenil® 20 tablet : Box containing 3 strips of 10 tablets each. Each film coated tablet contains furosemide BP 20 mg and spironolactone BP 50 mg.
Edenil® 40 tablet : Box containing 3 strips of 10 tablets each. Each film coated tablet contains furosemide BP 40 mg and spironolactone BP 50 mg.

Manufactured by:
ESKAYEF BANGLADESH LTD
GAZIPUR, BANGLADESH
® REGD.TRADEMARK |
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