Product Elements:
Furosemide furosemide sodium starch glycolate type a potato starch, corn cellulose, microcrystalline anhydrous lactose silicon dioxide magnesium stearate furosemide furosemide ep;117;40
Drug Interactions:
Drug interactions furosemide tablet may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. except in life-threatening situations, avoid this combination. furosemide tablet should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. patients receiving high doses of salicylates concomitantly with furosemide tablet, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites. furosemide tablet has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. lithium generally should not be given with diuretics because they reduce lithium's renal clearance and add a high risk of lithium toxicity. furosemide tablet may add to or potentiate the therapeutic effect of other antihypertensive drugs. potentiation occurs with ganglionic or peripheral adrenergic blocking dr
Read more...ugs. furosemide tablet may decrease arterial responsiveness to norepinephrine. however, norepinephrine may still be used effectively. simultaneous administration of sucralfate and furosemide tablet may reduce the natriuretic and antihypertensive effects of furosemide tablet. patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide tablet is achieved. the intake of furosemide tablet and sucralfate should be separated by at least two hours. one study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. there are case reports of patients who developed increased bun, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with nsaids. literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide tablet (furosemide) in some patients by inhibiting prostaglandin synthesis. indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. patients receiving both indomethacin and furosemide tablet should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide tablet is achieved.
Indications and Usage:
Indications and usage edema furosemide tablet is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide tablet is particularly useful when an agent with greater diuretic potential is desired. hypertension oral furosemide tablet may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide tablets alone.
Warnings:
Warnings in patients with hepatic cirrhosis and ascites, furosemide tablet therapy is best initiated in the hospital. in hepatic coma and in 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, furosemide tablet should be discontinued. cases of tinnitus and reversible or irreversible hearing impairment have been reported. usually, reports indicate that furosemide tablet ototoxicity is associated with rapid injection, severe renal impairment, doses exceeding several times the usual recommended dose, or concomitant therapy wit
Read more...h aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. if the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide tablet per minute has been used).
Dosage and Administration:
Dosage and administration edema therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. adults the usual initial dose of furosemide tablet is 20 to 80 mg given as a single dose. ordinarily a prompt diuresis ensues. if needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. the dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. the individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). the dose of furosemide tablet may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states. edema may be most efficiently and safely mobilized by giving furosemide tablet on 2 to 4 consecutive days each week. when doses exceeding 80 mg/day are given for prolonged periods, careful clini
Read more...cal observation and laboratory monitoring are particularly advisable. (see precautions: laboratory tests. ) geriatric patients in general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see precautions: geriatric use ). pediatric patients the usual initial dose of oral furosemide tablet in pediatric patients is 2 mg/kg body weight, given as a single dose. if the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. doses greater than 6 mg/kg body weight are not recommended. for maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level. hypertension therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response. adults the usual initial dose of furosemide tablets for hypertension is 80 mg, usually divided into 40 mg twice a day. dosage should then be adjusted according to response. if response is not satisfactory, add other antihypertensive agents. changes in blood pressure must be carefully monitored when furosemide tablet is used with other antihypertensive drugs, especially during initial therapy. to prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when furosemide tablet is added to the regimen. as the blood pressure falls under the potentiating effect of furosemide tablet, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary. geriatric patients in general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see precautions: geriatric use ).
Contraindications:
Contraindications furosemide tablet is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
Adverse Reactions:
Adverse reactions adverse reactions are categorized below by organ system and listed by decreasing severity. gastrointestinal system reactions pancreatitis jaundice (intrahepatic cholestatic jaundice) anorexia oral and gastric irritation cramping diarrhea constipation nausea vomiting systemic hypersensitivity reactions systemic vasculitis interstitial nephritis necrotizing angiitis central nervous system reactions tinnitus and hearing loss paresthesias vertigo dizziness headache blurred vision xanthopsia hematologic reactions aplastic anemia (rare) thrombocytopenia agranulocytosis (rare) hemolytic anemia leukopenia anemia dermatologic-hypersensitivity reactions exfoliative dermatitis erythema multiforme purpura photosensitivity urticaria rash pruritus cardiovascular reaction orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. other reactions hyperglycemia glycosuria hyperuricemia muscle spasm weakness restlessness urinary bladder spasm thrombophle
Read more...bitis fever whenever adverse reactions are moderate or severe, furosemide tablet dosage should be reduced or therapy withdrawn.
Drug Interactions:
Drug interactions furosemide tablet may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. except in life-threatening situations, avoid this combination. furosemide tablet should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. patients receiving high doses of salicylates concomitantly with furosemide tablet, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites. furosemide tablet has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine. lithium generally should not be given with diuretics because they reduce lithium's renal clearance and add a high risk of lithium toxicity. furosemide tablet may add to or potentiate the therapeutic effect of other antihypertensive drugs. potentiation occurs with ganglionic or peripheral adrenergic blocking dr
Read more...ugs. furosemide tablet may decrease arterial responsiveness to norepinephrine. however, norepinephrine may still be used effectively. simultaneous administration of sucralfate and furosemide tablet may reduce the natriuretic and antihypertensive effects of furosemide tablet. patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide tablet is achieved. the intake of furosemide tablet and sucralfate should be separated by at least two hours. one study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. there are case reports of patients who developed increased bun, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with nsaids. literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of furosemide tablet (furosemide) in some patients by inhibiting prostaglandin synthesis. indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. patients receiving both indomethacin and furosemide tablet should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide tablet is achieved.
Use in Pregnancy:
Pregnancy pregnancy category c - furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4 and 8 times the maximal recommended human dose. there are no adequate and well-controlled studies in pregnant women. furosemide tablet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits. furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (2 times the maximal recommended human dose of 600 mg/day). in another study, a dose of 50 mg/kg (4 times the maximal recommended human dose of 600 mg/day) also caused maternal deaths and abortions when administered to rabbits between days 12 and 17 of gestation. in a third study, none of the pregnant rabbits survived a dose of 100 mg/kg. data from the above studies indicate fetal lethality that can p
Read more...recede maternal deaths. the results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses derived from the treated dams as compared with the incidence in fetuses from the control group.
Geriatric Use:
Geriatric use controlled clinical studies of furosemide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.(see precautions: general and dosage and administration .)
Overdosage:
Overdosage the principal signs and symptoms of overdose with furosemide tablet are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action. the acute toxicity of furosemide tablet 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 tablet in biological fluids associated with toxicity or death is not known. treatment of overdosage 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.
Description:
Description furosemide tablet is a diuretic which is an anthranilic acid derivative. furosemide tablet for oral administration contain furosemide as the active ingredient and the following inactive ingredients: lactose anhydrous nf, magnesium stearate nf, starch nf, microcrystalline cellulose nf, sodium starch glycolate nf, and colloidal silicon dioxide nf. chemically, it is 4-chloro-n-furfuryl-5-sulfamoylanthranilic acid. furosemide tablet is available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. furosemide is a white to off-white odorless crystalline powder. it is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. the cas registry number is 54-31-9. it has a molecular formula of c 12 h 11 cln 2 o 5 s and a molecular weight of 330.75. the molecular structure is as follows: furosemide structure
Clinical Pharmacology:
Clinical pharmacology investigations into the mode of action of furosemide tablet have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. it has been demonstrated that furosemide tablet inhibits primarily the absorption of sodium and chloride not only in the proximal and distal tubules but also in the loop of henle. the high degree of efficacy is largely due to the unique site of action. the action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone. recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide in man. furosemide is extensively bound to plasma proteins, mainly to albumin. plasma concentrations ranging from 1 to 400 µg/ml are 91 to 99% bound in healthy individuals. the unbound fraction averages 2.3 to 4.1% at therapeutic concentrations. the onset of diuresis following
Read more...oral administration is within 1 hour. the peak effect occurs within the first or second hour. the duration of diuretic effect is 6 to 8 hours. in fasted normal men, the mean bioavailability of furosemide from furosemide tablet and furosemide oral solution is 64% and 60%, respectively, of that from an intravenous injection of the drug. although furosemide is more rapidly absorbed from the oral solution (50 minutes) than from the tablet (87 minutes), peak plasma levels and area under the plasma concentration-time curves do not differ significantly. peak plasma concentrations increase with increasing dose but times-to-peak do not differ among doses. the terminal half-life of furosemide is approximately 2 hours. significantly more furosemide is excreted in urine following the iv injection than after the tablet or oral solution. there are no significant differences between the two oral formulations in the amount of unchanged drug excreted in urine. geriatric population furosemide binding to albumin may be reduced in elderly patients. furosemide is predominantly excreted unchanged in the urine. the renal clearance of furosemide after intravenous administration in older healthy male subjects (60 to 70 years of age) is statistically significantly smaller than in younger healthy male subjects (20 to 35 years of age). the initial diuretic effect of furosemide in older subjects is decreased relative to younger subjects. (see precautions:geriatric use .)
How Supplied:
How supplied furosemide tablets 40 mg are supplied as white, round, scored tablets in bottles of 100(ndc 68071-1809-1) the 40 mg tablets are imprinted with ep 117 on one side and 40 on the other. note: dispense in well-closed, light-resistant containers. exposure to light might cause a slight discoloration. discolored tablets should not be dispensed. tested by usp dissolution test 2 store at 25° c (77° f); excursions permitted to 15 to 30° c (59 to 86° f). [see usp controlled room temperature.]
Information for Patients:
Information for patients patients receiving furosemide tablet should be advised that they may experience symptoms from excessive fluid and/or electrolyte losses. the postural hypotension that sometimes occurs can usually be managed by getting up slowly. potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia. patients with diabetes mellitus should be told that furosemide may increase blood glucose levels and thereby affect urine glucose tests. the skin of some patients may be more sensitive to the effects of sunlight while taking furosemide. hypertensive patients should avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms.
Package Label Principal Display Panel:
Package label.principal display panel pdp