Furosemide 80 MG Oral Tablet
WARNINGS
In patients with hepatic cirrhosis and ascites, furosemide tablets 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 tablets should be discontinued.
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported.
Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with 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 per minute has been used) (See PRECAUTIONS: Drug Interactions ).
DRUG INTERACTIONS
Drug Interactions Furosemide tablets 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 tablets should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity.
Patients receiving high doses of salicylates concomitantly with furosemide, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
There is a risk of ototoxic effects if cisplatin and furosemide tablets are given concomitantly.
In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide tablet is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.
Furosemide tablets have 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 tablets combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure.
An interruption or reduction in the dosage of furosemide tablets, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.
Furosemide may decrease arterial responsiveness to norepinephrine.
However, norepinephrine may still be used effectively.
Simultaneous administration of sucralfate and furosemide tablets may reduce the natriuretic and antihypertensive effects of furosemide.
Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.
The intake of furosemide and sucralfate should be separated by at least two hours.
In isolated cases, intravenous administration of furosemide within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure, and tachycardia.
Use of furosemide concomitantly with chloral hydrate is therefore not recommended.
Phenytoin interferes directly with renal action of furosemide tablets.
There is evidence that treatment with phenytoin leads to decrease intestinal absorption of furosemide tablets, and consequently to lower peak serum furosemide concentrations.
Methotrexate and other drugs that, like furosemide tablets, undergo significant renal tubular secretion may reduce the effect of furosemide tablets.
Conversely, furosemide tablets may decrease renal elimination of other drugs that undergo tubular secretion.
High- dose treatment of both furosemide tablets and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of furosemide tablets.
Furosemide tablets can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.
Concomitant use of cyclosporine and furosemide is associated with increased risk of gouty arthritis secondary to furosemide-induced hyperurecemia and cyclosporine impairment of renal urate excretion.
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 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 should be observed closely to determine if the desired diuretic and/or antihypertensive effect of furosemide is achieved.
OVERDOSAGE
The principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its 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 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
Furosemide is a diuretic which is an anthranilic acid derivative.
Furosemide tablets, USP for oral administration contain furosemide, USP as the active ingredient and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate.
Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid.
Furosemide, USP is available as white to off white round tablets for oral administration in dosage strengths of 20, 40 and 80 mg.
Furosemide, USP is a white to slightly yellow odorless crystalline powder.
It is practically insoluble in water, soluble in 15 parts of acetone, freely soluble in dimethylformamide and in solution of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; very slightly soluble in chloroform.
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 tabs-figure-01
HOW SUPPLIED
Furosemide tablets, USP 20 mg, 40 mg and 80 mg are supplied as white to off-white, round tablets.
Furosemide tablets, USP 20 mg are debossed with ‘RE22’ on one side and plain on the other side and are supplied as follows: NDC 63304-624-03 Bottles of 10 NDC 63304-624-01 Bottles of 100 NDC 63304-624-10 Bottles of 1000 NDC 63304-624-69 Blister unit-dose pack of 10 Furosemide tablets, USP 40 mg are debossed with ‘RE23’ on one side and break-line on the other side and are supplied as follows: NDC 63304-625-03 Bottles of 10 NDC 63304-625-01 Bottles of 100 NDC 63304-625-10 Bottles of 1000 NDC 63304-625-69 Blister unit-dose pack of 10 Furosemide tablets, USP 80 mg are debossed with ‘RE24’ on one side and break-line on the other side and are supplied as follows: NDC 63304-626-03 Bottles of 10 NDC 63304-626-01 Bottles of 100 NDC 63304-626-05 Bottles of 500 NDC 63304-626-10 Bottles of 1000 NDC 63304-626-69 Blister unit-dose pack of 10 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 1 Store at 20 – 25°C (68 – 77°F) [See USP Controlled Room Temperature].
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
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 .)
INDICATIONS AND USAGE
Edema Furosemide tablets, USP 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 is particularly useful when an agent with greater diuretic potential is desired.
Hypertension Furosemide tablets, USP 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 alone.
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 tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher birth weights.
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 precede 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.
NUSRING MOTHERS
Nursing Mothers Because it appears in breast milk, caution should be exercised when furosemide tablets are administered to a nursing mother.
Furosemide tablets may inhibit lactation.
INFORMATION FOR PATIENTS
Information for Patients Patients receiving furosemide tablets 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.
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 tablets, USP 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 (e.g., at 8 am and 2 pm).
The dose of furosemide tablets, USP 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 tablets, USP on 2 to 4 consecutive days each week.
When doses exceeding 80 mg/day are given for prolonged periods, careful clinical 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 furosemide tablets, USP 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, USP 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 tablets, USP are 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 tablets, USP are added to the regimen.
As the blood pressure falls under the potentiating effect of furosemide tablets, USP 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 ).