| FRUSELAC
Spironolactone & Furosemide
Composition:
Fruselac Tablet:
Each tablet contains Spironolactone USP 50 mg & Furosemide
USP 20 mg.
Fruselac-Plus
Tablet: Each tablet contains Spironolactone USP 50 mg &
Furosemide USP 40 mg.
Pharmacology:
Fruselac
contains a long acting potassium sparing diuretic, Spironolactone
and a short-acting loop diuretic, furosemide. Spironolactone
and Frusemide 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, and in part by inhibiting the adrenocortical
biosynthesis 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.
Indications:
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. The dosage
of Fruselac in the management of essential hypertension
should be restricted to patients with demonstrated hyperaldosteronism.
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 and administration:
1 - 4 tablets daily
according to the response of patients.
Contraindications:
Fruselac
should not be given in patients with acute renal failure, renal
insufficiency, anuric states, hyperkalaeamia, Addison’s disease
or in patients hypersensitive to Spironolactone, Furosemide
or Sulfonamides.
Side-effects:
Gastrointestinal
disturbances, impotence, gynaecomastia, menstrual irregularities,
headache, confusion, rashes, hyponatremia, blood disorders,
hyperglycemia and hypotension.
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.
Drug Interactions:
ACE inhibitors
should not be used in combination with Fruselac as serum
potassium levels may be increased. The toxic effects of nephrotoxic
anbiotics may be potentiated by concurrent administration of
Furosemide. 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 attenuate
the effects of antidiabetics and pressor amines and sometimes
potentiate the effects of salicylates, theophylline, lithium
and curare-type muscle relaxants. Salicylates may attenuate
the effects of spironolactone. Concomitant glucocorticoid medication
or abuse of laxatives may lead to potassium deficiency. In the
presence of potassium deficiency the effect of cardiac glycosides
may be enhanced.
Use in special
groups:
Neonates: The
drug is unlikely to be used in neonates.
Children:
The drug may be used in children in appropriate doses.
Pregnancy and
lactation: Result of animal works, in general, shows no
hazardous effect of Furosemide 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.
Storage:
Store in a cool
and dry place. Keep out of the reach of the children.
Packing:
Fruselac Tablet: Each
box contains 3×10’s tablets in blister pack.
Fruselac-Plus Tablet: Each
box contains 3×10’s tablets in blister pack. |
