Fruselac Tablet: Each tablet contains Spironolactone USP 50 mg & Furosemide USP 20 mg.
Spironolactone is a long acting potassium diuretic and furosemide is a short-acting loop diuretic. Spironolactone and Furosemide have different but complementary mechanisms and site of action. Therefore, when given together they produce synergistic or additive diuretic effects. Spironolactone is a competitive inhibitor of the binding of aldosterone to its receptors. Its most important site of action is the distal portion of renal tubules. Spironolactone acts both as a diuretic and antihypertensive drug by antagonizing the sodium retaining effects of aldosterone.
Furosemide is a potent diuretic acting primarily on the medullary portion of the ascending limb of the Loop of Henle to inhibit a Na+/K+/2Cl- co-transporter which normally mediates ionic reabsorption. Furosemide inhibits sodium and potassium reabsorption by competing for the luminal face of epithelial cells and thereby removes the stimulus of water reabsorption. It also inhibits sodium reabsorption in other nephron segment.
Fruselac is indicated in the treatment of resistant oedema where this is associated with secondary hyperaldosteronism; conditions include chronic congestive heart failure and hepatic cirrhosis. Treatment with Fruselac should be reserved for cases refractory to a diuretic alone at conventional dosage. It is also indicated in the treatment of ascites. This combination should only be used if titration with the component drugs separately indicates that this product is appropriate.
Dosage & Administration
1-4 tablets daily according to the response of patients.
Fruselac should not be given in patients with acute renal failure, renal insufficiency, anuric states, hyperkalaemia, Addison's disease or in patients hypersensitive to Spironolactone or Furosemide.
Warning & Precautions
Patients with prostatic hypertrophy or impairment of micturation have an increased risk of developing acute retention. Caution should also be exercised in the presence of liver disease as hepatic coma may be precipitated in susceptible cases. Caution should be observed in patients liable to electrolyte deficiency.
Gastrointestinal disturbances, impotence, gynaecomastia, menstrual irregularities, headache, confusion, rashes, hyponatremia, blood disorders, hyperglycemia and hypotension.
ACE inhibitors should not be used in combination with Fruselac as serum potassium levels may be increased. Certain NSAIDs have been shown to antagonise the action of Furosemide and may cause renal failure in cases of pre-existing hypovolaemia. Furosemide may sometimes potentiate the effects of salicylates, theophylline, lithium and muscle relaxants.
Use in special groups
Use in neonates: The drug is unlikely to be used in neonates.
Use in children: The drug may be used in children in appropriate doses.
Use in pregnancy: There is clinical evidence of the safety of the drug in the third trimester of human pregnancy; however, Furosemide should be used in pregnancy only if strictly indicated and for short-term treatment. Spironolactone and its metabolites may cross the placental barrier.
Fruselac Tablet: Each box contains 30's tablets in blister pack.