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  • Fusid
    / Teva


    Active Ingredient
    Furosemide 40 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    30 x 40 mg

    full basket chart 84637 6442

    Tablets

    50 x 40 mg

    full basket chart 20739

    Related information


    Dosage

    Adults Edema: The usual initial dose is 20-80 mg/day administered as a single dose. Usually, prompt diuresis ensues. Depending on the response, a second dose should be administered 6-8 hours later. If the diuretic response is unsatisfactory, the dose should be increased by increments of 20 or 40 mg, no sooner than 6-8 hours after previous dose, until the desired diuretic effect has been obtained. This individuallydetermined dose should then be administered 1-2 times a day. In patients with severe edema, dosage may be titrated up to 600 mg/day. Mobilization of edema may be most efficiently and safely accomplished with an intermittent dosage schedule. Furosemide should be administered on 2-4 consecutive days, each week. With doses exceeding 80 mg/day, clinical and laboratory observations are recommended.
    Hypertension: The usual initial dosage is 40 mg, twice a day. Dosage should be adjusted according to response. If a patient does not respond, other antihypertensive agents should be added. Blood pressure changes should be observed when used with other antihypertensives, especially during initial therapy. The dosage of other agents should be reduced by at least 50% as soon as furosemide is added, to prevent excessive drop in blood pressure. As blood pressure falls, either the dose should be reduced or the other antihypertensives discontinued.
    Infants and Children: The usual initial dose of furosemide in infants and children is 2 mg/kg body weight. If diuretic response after the initial dose is unsatisfactory, dosage may be increased by 1-2 mg/kg body weight, but no sooner than 6-8 hours after the first dose. Doses greater than 6 mg/kg are not recommended. For maintenance therapy, the dose should be adjusted to the minimum effective level.


    Indications

    Edema associated with congestive cardiac failure, hepatic cirrhosis, renal failure, hypertension.


    Contra-Indications

    Known hypersensitivity to furosemide or to sulfonamides. Electrolyte deficiency (e.g: Severe hypokalaemia, severe hyponatraemia). Hypovolaemia, dehydration Renal failure due to nephrotoxic or hepatotoxic agents. Renal failure associated with hepatic coma. Pre-comatose and comatose states associated with hepatic encephalopahty/liver cirrhosis. Anuria or renal failure with anuria not responding to furosemide. Breastfeeding. As furosemide may be capable of displacing bilirubin from albumin at least “in vitro”, it should not be administered to jaundiced newborn infants or to infants suffering from diseases (e.g. Rh incompatibility, familial non-hemolytic jaundice, etc.) with the potential of causing hyperbilirubinemia and possibly kernicterus.
    For full details see prescribing information.


    Special Precautions

    FUROSEMIDE IS A POTENT DIURETIC WHICH IF GIVEN IN EXCESSIVE AMOUNTS CAN LEAD TO A PROFOUND DIURESIS WITH WATER AND ELECTROLYTE DEPLETION. THEREFORE, CAREFUL MEDICAL SUPERVISION IS REQUIRED, AND DOSE AND DOSE SCHEDULE HAVE TO BE ADJUSTED TO THE INDIVIDUAL PATIENT’S NEEDS.
    Note: Steps should be taken to correct hypotension or hypovolemia before commencing therapy. In patients with hepatic cirrhosis and ascites, initiation of therapy with furosemide is best carried out in a hospital. In hepatic coma and states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma. Therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist, are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, the drug should be discontinued. Patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention.
    Where indicated, steps should be taken to correct hypotension or hypovolemia before commencing therapy. Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse, together with the possibility of vascular thrombosis and embolism, particularly in elderly patients. Electrolyte depletion may occur during therapy, especially in patients receiving higher doses and a restricted salt intake. Frequent serum electrolyte, CO2 and BUN determinations should be performed during the first few months of therapy and periodically thereafter, in order to correct abnormalities or if necessary, withdraw the drug temporarily. Furosemide may lower serum calcium levels, and rare cases of tetany have been reported. Accordingly, periodic serum calcium levels should be obtained. Hypokalemia may develop with furosemide especially with brisk diuresis, inadequate oral electrolyte intake, concomitant abuse of laxatives, when liver cirrhosis is present, or during concomitant use of corticosteroids or ACTH. Digitalis therapy may exaggerate metabolic effects of hypokalemia, especially myocardial effects. All patients receiving furosemide therapy should be observed for the following signs and symptoms of fluid or electrolyte imbalance (hyponatremia, hypochloremic alkalosis, hypokalemia, hypomagnesemia or hypocalcemia): dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, patients who are at risk from a pronounced fall in blood pressure, oliguria, tachycardia, arrhythmia, or gastrointestinal disturbances such as nausea and vomiting. Increases in blood glucose and alterations in glucose tolerance tests (with abnormalities of the fasting and 2-hour postprandial sugar) have been observed, and rarely, precipitation of diabetes mellitus has been reported. In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. Thus, these patients require careful monitoring, especially during the initial stages of treatment. In patients at high risk for radiocontrast nephropathy furosemide can lead to a higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast. In patients with hypoproteinemia (e.g., associated with nephrotic syndrome) the effect of furosemide may be weakened and its ototoxicity potentiated. Asymptomatic hyperuricemia can occur, and gout may rarely be precipitated. Patients allergic to sulfonamides may also be allergic to furosemide. The possibility exists of exacerbation or activation of systemic lupus erythematosus. Serum cholesterol and triglyceride levels may rise during furosemide treatment. During long- term therapy they will usually return to normal within 6 months.
    Careful monitoring is also necessary in:
    – patients with hypotension.
    – patients who are at risk from a pronounced fall in blood pressure.
    – patients where latent diabetes may become manifest or the insulin requirements of diabetic patients may increase.
    – patients with gout.
    – patients with hepatorenal syndrome -patients with hypoproteinaemia, e.g. associated with nephritic syndrome (the effect of furosemide may be weakened and its ototoxicity potentiated). Cautious dose titration is required.
    – premature infants (possible development nephrocalcinosis/nephrolithiasis; renal function must be monitored and renal ultrasonography performed). As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver damage, or other idiosyncratic reactions. In patients who are at high risk for radiocontrast nephropathy, furosemide is not recommended to be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy.
    For full details see prescribing information.


    Side Effects

    Anorexia, oral and gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, intrahepatic cholestatic jaundice, pancreatitis, dizziness, vertigo, paresthesias, headache, xanthopsia, blurred vision, tinnitus, hearing loss, anemia, leukopenia, thrombocytopenia, agranulocytosis (rare), aplastic anemia (rare). Purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), exfoliative dermatitis, erythema multiforme, pruritus, thrombophlebitis, orthostatic hypotension, hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, urinary bladder spasm.
    For full details see prescribing information.


    Drug interactions

    Furosemide/Other Antihypertensive Drugs: Furosemide may intensify the therapeutic effect of other antihypertensive drugs. Concurrent administration requires dosage adjustment.
    Furosemide/Salicylates in High Doses: Furosemide and salicylates have competitive renal excretory sites. Therefore patients receiving high doses of salicylates concomitantly administered with furosemide, such as in rheumatic diseases, may experience salicylate toxicity a lower furosemide doses than usual. Therefore, caution should be exercised when administering this combination.
    Furosemide/Ototoxic and/or Nephrotoxic Medications: Concurrent and/or sequential administration of furosemide with ototoxic and /or nephrotoxic medications such as parenteral amphotericin B, aminoglycoside antibiotics, the cephalosporin antibiotics cephaloridine and cephalothin, parenteral amphotericin, cisplatin, should be avoided because of the potential for these toxicities being increased. This is especially important in patients presenting with renal function impairment. Impairment of renal function may develop in patients receiving concurrent treatment with furosemide and high doses of certain cephalosporins
    Furosemide/Cardiac Glycosides: Concurrent use may increase the possibility of digitalis toxicity associated with hypokalemia.
    Furosemide/Risperidone: Caution should be exercised and the risks and benefits of the combination or co-treatment with furosemide or with other potent diuretics should be considered prior to the decision to use. In risperidone placebo controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone when compared to patients treated with risperidone alone or furosemide alone. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings. No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed Cautions should be exercised and the risks and benefits of this combination or co-treatment should be considered prior to the decision to use. Dehydration should be avoided.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: Safety of use in pregnancy has not been established. Furosemide should be used during pregnancy only if the potential benefit to the mother outweighs the possible risk to the fetus. Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher birth weights. Furosemide has been shown to cause unexplained matemal deaths and abortions in rabblts at 2, 4 and 8 times the maximal recommended human dose.
    Lactation: Furosemide appears in breast milk. Therefore, having taken into account the importance of the drug to the mother, either nursing or the drug should be discontinued. Furosemide may inhibit lactation.
    For full details see prescribing information.


    Overdose

    Manifestations: The principal signs and symptoms are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of the diuretic action. The acute toxicity of furosemide has been determined in mice, rats, and dogs. In all three, the oral LD 50 exceeded 1000 mg/kg body weight while the intravenous LD 50 ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats. The concentration of furosemide in biological fluid associated with toxicity or death is not known.
    TreatmentTreatment of overdose is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy). Hemodialysis does not accelerate furosemide elimination.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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