Generic Demadex

LOOP DIURETICS
Demadex

Indications
Edema: Edema associated with CHF, hepatic cirrhosis, and renal disease, including the nephrotic syndrome. Particularly useful when greater diuretic potential is desired. Parenteral administration is indicated when a rapid onset of diuresis is desired (e.g., acute pulmonary edema), when GI absorption is impaired or when oral use is not practical for any reason. As soon as it is practical, replace with oral therapy.
Hypertension (furosemide, oral; torsemide (Demadex), oral): Alone or in combination with other antihypertensive drugs.
Ethacrynic acid:
Ascites - Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.
Congenital heart disease, nephrotic syndrome - Short-term management of hospitalized pediatric patients, other than infants.
Pulmonary edema, acute - Adjunctive therapy.

Administration and Dosage
Bumetanide:
Oral - 0.5 to 2 mg/day, given as a single dose. If diuretic response is not adequate, give a second or third dose at 4- to 5 -hour intervals, up to a maximum daily dose of 10 mg. An intermittent dose schedule, given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is the safest and most effective method for the continued control of edema. In patients with hepatic failure, keep the dose to a minimum, and if necessary, increase the dose carefully.
Parenteral - Initially, 0.5 to 1 mg IV or IM. Administer IV over a period of 1 to 2 minutes. If the initial response is insufficient, give a second or third dose at intervals of 2 to 3 hours; do not exceed a daily dosage of 10 mg. End parenteral treatment and start oral treatment as soon as possible.
Renal function impairment - In patients with severe chronic renal insufficiency, a continuous infusion of bumetanide (12 mg over 12 hours) may be more effective and less toxic than intermittent bolus therapy.
Ethacrynic acid:
Oral-
Initial therapy: Give minimally effective dose (usually, 50 to 200 mg/day) on a continuous or intermittent dosage schedule to produce gradual weight loss of 2.2 to 4-4 kg/day (1 to 2 lb/day). Adjust dose in 25 to 50 mg increments. Higher doses, up to 200 mg twice daily, achieved gradually, are most often required in patients with severe, refractory edema.
Children: Initial dose is 25 mg. Make careful increments of 25 mg to achieve maintenance. Dosage for infants has not been established.
Maintenance therapy: Administer intermittently after an effective diuresis is obtained using an alternate daily schedule or more prolonged periods of diuretic therapy interspersed with rest periods.
Parenteral - Do not give SC or IM because of local pain and irritation. The usual IV dose for the average adult is 50 mg, or 0.5 to 1 mg/kg. Give slowly through the tubing of a running infusion or by direct IV injection over several minutes. Usually, only 1 dose is necessary; occasionally, a second dose may be required; use a new injection site to avoid thrombophlebitis. A single IV dose, not exceeding 100 mg, has been used. Insufficient pediatric experience precludes recommendation for this age group.
Furosemide:
Oral-
Edema: 20 to 80 mg/day as a single dose. Depending on response, administer a second dose 6 to 8 hours later. If response is not satisfactory, increase by increments of 20 or 40 mg, no sooner than 6 to 8 hours after previous dose, until desired diuresis occurs. This dose should then be given once or twice daily (e.g., at 8 am and 2 pm). Dosage may be titrated up to 600 mg/day in patients with severe edema.
Mobilization of edema may be most efficiently and safely accomplished with an intermittent dosage schedule; the drug is given 2 to 4 consecutive days each week. With doses > 80 mg/day, clinical and laboratory observations are advisable.
Hypertension; 40 mg twice a day; adjust according to response. If the patient does not respond, add other antihypertensive agents. Reduce dosage of other agents by at least 50% as soon as furosemide is added to prevent excessive drop in blood pressure.
Infants and children: 2 mg/kg. If diuresis is unsatisfactory, increase by 1 or 2 mg/kg, no sooner than 6 to 8 hours after previous dose. Doses > 6 mg/kg are not recommended. For maintenance therapy, adjust dose to the minimum effective level. A dose range of 0.5 to 2 mg/kg twice daily has also been recommended.
CHF and chronic renal failure: It has been suggested that doses as high as 2 to 2.5 g/ day or more are well tolerated and effective in these patients.
Parenteral -
Edema: Initial dose: 20 to 40 mg IM or IV. Give the IV injection slowly (1 to 2 minutes). If needed, another dose may be given in the same manner 2 hours later. The dose may be raised by 20 mg and given no sooner than 2 hours after previous dose, until desired diuretic effect is obtained. This dose should then be given once or twice daily. Administer high-dose parenteral therapy as a controlled infusion at a rate Acute pulmonary edema: The usual initial dose is 40 mg IV (over 1 to 2 minutes). If response is not satisfactory within 1 hour, increase to 80 mg IV (over 1 to 2 minutes).
Infants and children: 1 mg/kg IV or IM given slowly under close supervision. If diuretic response after the initial dose is not satisfactory, increase the dosage by 1 mg/kg, no sooner than 2 hours after previous dose, until desired effect is obtained. Doses > 6 mg/kg are not recommended.
CHF and chronic renal failure: It has been suggested that doses as high as 2 to 2.5 g/ day or more are well tolerated and effective in these patients. For IV bolus injections, the maximum should not exceed 1 g/day given over 30 minutes.
Torsemide: Torsemide may be given at any time in relation to a meal.
Because of high bioavailability, oral and IV doses are therapeutically equivalent, so patients may be switched to and from the IV form with no change in dose. Administer the IV injection slowly over a period of 2 minutes.
Congestive heart failure/chronic renal failure -The usual initial dose is 10 or 20 mg once daily oral or IV. If the diuretic response is inadequate, titrate the dose upward by approximately doubling until the desired diuretic response is obtained. Single doses > 200 mg have not been adequately studied.
Hepatic cirrhosis -The usual initial dose is 5 or 10 mg once daily oral or IV, administered together with an aldosterone antagonist or a potassium-sparing diuretic. If the diuretic response is inadequate, titrate the dose upward by approximately doubling until the desired diuretic response is obtained. Single doses > 40 mg have not been adequately studied.
Hypertension - The usual initial dose is 5 mg once daily. If the 5 mg dose does not provide adequate reduction in blood pressure within 4 to á weeks, the dose may be increased to 10 mg once daily.
Actions
Pharmacology: Furosemide and ethacrynic acid inhibit primarily re-absorption of sodium and chloride, not only in proximal and distal tubules, but also the loop of Henle. In contrast, bumetanide is more chloruretic than natriuretic and may have an additional action in the proximal tubule; it does not appear to act on the distal tubule. Torsemide acts from within the lumen of the thick ascending portion of the loop of Henle, where it inhibits the Na+/K+/2Cl-carrier system.
Pharmacokinetics: These agents are metabolized and excreted primarily through the urine. Protein binding of these agents exceeds 90%. Furosemide is metabolized 30% to 40%, and its urinary excretion is 60% to 70%. Oral administration of bumetanide revealed that 81% was excreted in urine, 45% of it as unchanged drug. Torsemide is cleared from the circulation by both hepatic metabolism (about 80% of total clearance) and excretion into the urine (about 20% of total clearance).

Contraindications
Anuria; hypersensitivity to these compounds or to sulfonylureas; infants (ethacrynic acid); patients with hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected (bumetanide).

Warnings
Dehydration: Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse and the possibility of vascular thrombosis and embolism, particularly in elderly patients.
Hepatic cirrhosis and ascites: In these patients, sudden alterations of electrolyte balance may precipitate hepatic encephalopathy and coma. Do not institute therapy until the basic condition is improved.
Ototoxicity: Tinnitus, reversible and irreversible hearing impairment, deafness, and vertigo with a sense of fullness in the ears have been reported. Deafness is usually reversible and of short duration (1 to 24 hours); however, irreversible hearing impairment has occurred. Usually, ototoxicity is associated with rapid injection, with severe renal impairment, with doses several times the usual dose, and with concurrent use with other ototoxic drugs.
Systemic lupus erythematosus: Systemic lupus erythematosus may be exacerbated or activated.
Thrombocytopenia: Because there have been rare spontaneous reports of thrombocytopenia with bumetanide, observe regularly for possible occurrence.
Hypersensitivity reactions: Patients with known sulfonamide sensitivity may show allergic reactions to furosemide, torsemide, or bumetanide. Bumetanide use following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
Renal function impairment: If increasing azotemia, oliguria, or reversible increases in BUN or creatinine occur during treatment of severe progressive renal disease, discontinue therapy.
Pregnancy: Category  (ethacrynic acid, torsemide); Category Ñ (furosemide, bumetanide). Since furosemide may increase the incidence of patent ductus arteriosus in preterm infants with respiratory-distress syndrome, use caution when administering before delivery.
Lactation: Furosemide appears in breast milk.
Children: Safety and efficacy for use of torsemide in children, bumetanide in children Furosemide - Furosemide stimulates renal synthesis of prostaglandin E2 and may increase the incidence of patent ductus arteriosus when given in the first few weeks of life, to premature infants with respiratory-distress syndrome.

Precautions
Monitoring: Observe for blood dyscrasias, liver or kidney damage, or idiosyncratic reactions. Perform frequent serum electrolyte, calcium, glucose, uric acid, CO2, creatinine, and BUN determinations during the first few months of therapy and periodically thereafter.
Cardiovascular effects: Too vigorous a diuresis, as evidenced by rapid and excessive weight loss, may induce an acute hypotensive episode. In elderly cardiac patients, avoid rapid contraction of plasma volume and the resultant hemoconcentration to prevent thromboembolic episodes, such as cerebral vascular thromboses and pulmonary emboli.
Electrolyte imbalance: Electrolyte imbalance may occur, especially in patients receiving high doses with restricted salt intake. Perform periodic determinations of serum electrolytes.
Hypokalemia - Hypokalemia prevention requires particular attention to the following: Patients receiving digitalis and diuretics for CHF, hepatic cirrhosis, and ascites; in aldosterone excess with normal renal function; potassium-losing nephropathy; certain diarrheal states; or where hypokalemia is an added risk to the patient (e.g., history of ventricular arrhythmias).
Hypomagnesemia - Loop diuretics increase the urinary excretion of magnesium.
Hypocalcemia - Serum calcium levels may be lowered (rare cases of tetany have occurred).
Hyperuricemia: Asymptomatic hyperuricemia can occur, and rarely, gout may be precipitated.
Glucose: Increases in blood glucose and alterations in glucose tolerance tests (fasting and 2 hour postprandial sugar) have been observed.
Lipids: Increases in LDL and total cholesterol and triglycerides with minor decreases in HDL cholesterol may occur.
Photosensitivity: Photosensitization (photo-allergy or photo-toxicity) may occur.

Drug Interactions
Loop diuretics may affect the following drugs: Aminoglycosides; anticoagulants; chloral hydrate; digitalis glycosides; lithium; non-depolarizing neuromuscular blockers; propranolol; sulfonylureas; theophyllines. Loop diuretics may be affected by the following drugs: Charcoal; cisplatin; clofibrate; hydantoins; NSAIDs; probenecid; salicylates; thiazide diuretics.
Drug/Food interactions: The bioavailability of furosemide is decreased and its degree of diuresis reduced when administered with food. Simultaneous food intake with torsemide delays the time to Cmax by about 30 minutes, but overall bioavailability and diuretic activity are unchanged.

Adverse Reactions
Adverse reactions associated with loop diuretics include nausea; vomiting; diarrhea; gastric irritation; headache; fatigue; dizziness; thrombocytopenia; rash; orthostatic hypotension; hyperuricemia; hyperglycemia; electrolyte imbalance (decreased chloride, potassium and sodium); dehydration.
Bumetanide: Adverse reactions may include impaired hearing, ear discomfort, dry mouth, pain, renal failure, weakness, arthritic pain, muscle cramps, ECG changes, chest pain, hives, pruritus, itching, sweating, hyperventilation.
Ethacrynic acid: Adverse reactions may include anorexia, pain, GI bleeding, severe neutropenia, agranulocytosis, fever, chills, confusion, fatigue, malaise, sense of fullness in the ears, blurred vision, tinnitus, hearing loss (irreversible), rash.
Furosemide: Adverse reactions may include anorexia, cramping, constipation, blurred vision, hearing loss, restlessness, fever, anemia, purpura, thrombocytopenia, agranulocytosis, photosensitivity, urticaria, pruritus, thrombophlebitis, muscle spasm, weakness.
Torsemide: Adverse reactions may include excessive urination.
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