FUROSEMIDE- furosemide tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Available from:
Aphena Pharma Solutions - Tennessee, LLC
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Edema Furosemide 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 Oral furosemide 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. Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
Product summary:
Furosemide Tablets USP 20 mg tablets are supplied as white, flat tablets with beveled edges, product identification “54 840” debossed on one side. NDC 51407-113-90: Bottle of 90 Tablets NDC 51407-113-01: Bottle of 100 Tablets NDC 51407-113-10: Bottle of 1000 Tablets NDC 51407-113-51: ​Bottle of 5000 Tablets 40 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification “54 583” debossed on one side. NDC 51407-114-90: Bottle of 90 Tablets NDC 51407-114-01: Bottle of 100 Tablets NDC 51407-114-10: Bottle of 1000 Tablets NDC 51407-114-51: ​Bottle of 5000 Tablets 80 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification “54 533” debossed on one side. NDC 51407-115-01: Bottle of 100 Tablets NDC 51407-115-05: Bottle of 500 Tablets NDC 51407-115-10: ​Bottle of 1000 Tablets Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Note: Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. Exposure to light may cause slight discoloration. Discolored tablets should not be dispensed. Protect From Moisture. PROTECT FROM LIGHT. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 4052002//12 Revised July 2017 Marketed/Packaged by: GSMS, Inc Camarillo, CA 91304 U.S.A.
Authorization status:
Abbreviated New Drug Application
Authorization number:
71610-305-60, 71610-305-80, 71610-308-30, 71610-308-45, 71610-308-53, 71610-308-60, 71610-308-80, 71610-309-30, 71610-309-45, 71610-309-53, 71610-309-60, 71610-309-80, 71610-309-92

FUROSEMIDE- furosemide tablet

Aphena Pharma Solutions - Tennessee, LLC

----------

FUROSEMIDE Tablets USP

WARNING

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 must be adjusted to the individual patient’s needs (See DOSAGE

AND ADMINISTRATION).

DESCRIPTION

Each tablet for oral administration contains:

Furosemide USP . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg

Each mL of Oral Solution for oral administration contains:

Furosemide USP . . . . . . . . . . . . . . . . 10 mg per mL or 8 mg (40 mg per 5 mL)

Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro- N-furfuryl-

5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow, 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.

The structural formula is as follows:

S M.W. 330.74

Furosemide Tablets USP are available for oral administration containing 20 mg, 40 mg or 80 mg of

Furosemide USP. The tablets meet Dissolution Test 1. Each tablet contains the following inactive

ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, microcrystalline cellulose,

pregelatinized starch, purified water, sodium lauryl sulfate, sodium starch glycolate and stearic acid.

Furosemide Oral Solution USP is also available for oral administration containing either 10 mg per mL

or 40 mg per 5 mL. The oral solution contains the following inactive ingredients: D and C Yellow No.

10, FD and C Yellow No. 6, flavors, potassium carbonate 1½ hydrate, propylene glycol, purified water

and sorbitol solution. The 10 mg/mL solution is orange flavored and contains prosweet liquid and

saccharin sodium. The 40 mg/5 mL solution is pineapple-peach flavored and contains sweet tone.

CLINICAL PHARMACOLOGY

Investigations into the mode of action of furosemide 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 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 mcg/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 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 Tablets 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).

INDICATIONS AND USAGE

Edema

Furosemide 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.

Hypertens ion

Oral furosemide 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.

CONTRAINDICATIONS

Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to

furosemide.

WARNINGS

In patients with hepatic cirrhosis and ascites, furosemide 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 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).

PRECAUTIONS

General

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and

possibly vascular thrombosis and embolism, particularly in elderly patients. As with any effective

diuretic, electrolyte depletion may occur during furosemide therapy, especially in patients receiving

higher doses and a restricted salt intake. Hypokalemia may develop with furosemide, especially with

brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use

of corticosteroids, ACTH, licorice in large amounts, or prolonged use of laxatives. Digitalis therapy

may exaggerate metabolic effects of hypokalemia, especially myocardial effects.

All patients receiving furosemide therapy should be observed for these signs or 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, 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.

As with many other drugs, patients should be observed regularly for the possible occurrence of blood

dyscrasias, liver or kidney damage, or other idiosyncratic reactions.

Information for Patients

Patients receiving furosemide 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.

Laboratory Tests

Serum electrolytes (particularly potassium), CO

, creatinine and BUN should be determined frequently

during the first few months of furosemide therapy and periodically thereafter. Serum and urine

electrolyte determinations are particularly important when the patient is vomiting profusely or receiving

parenteral fluids. Abnormalities should be corrected or the drug temporarily withdrawn. Other

medications may also influence serum electrolytes.

Reversible elevations of BUN may occur and are associated with dehydration, which should be

avoided, particularly in patients with renal insufficiency.

Urine and blood glucose should be checked periodically in diabetics receiving furosemide, even in

those suspected of latent diabetes.

Furosemide may lower serum levels of calcium (rarely cases of tetany have been reported) and

magnesium. Accordingly, serum levels of these electrolytes should be determined periodically.

In premature infants furosemide may precipitate nephrocalcinosis/nephrolithiasis, therefore renal

function must be monitored and renal ultrasonography performed (See PRECAUTIONS: Pediatric Use).

Drug Interactions

Furosemide 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 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 are given concomitantly. In addition,

nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if furosemide is not given in

lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin

treatment.

Furosemide 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 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, 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. There is evidence that treatment with

phenytoin leads to decrease intestinal absorption of furosemide, and consequently to lower peak serum

furosemide concentrations.

Methotrexate and other drugs that, like furosemide, undergo significant renal tubular secretion may

reduce the effect of furosemide. Conversely, furosemide may decrease renal elimination of other drugs

that undergo tubular secretion. High-dose treatment of both furosemide 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.

Furosemide 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.

High doses (>80 mg) of furosemide may inhibit the binding of thyroid hormones to carrier proteins and

result in transient increase in free thyroid hormones, followed by an overall decrease in total thyroid

hormone levels.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Furosemide was tested for carcinogenicity by oral administration in one strain of mice and one strain of

rats. A small but significantly increased incidence of mammary gland carcinomas occurred in female

mice at a dose 17.5 times the maximum human dose of 600 mg. There were marginal increases in

uncommon tumors in male rats at a dose of 15 mg/kg (slightly greater than the maximum human dose) but

not at 30 mg/kg.

Furosemide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested

in the presence or absence of an in vitro metabolic activation system, and questionably positive for gene

mutation in mouse lymphoma cells in the presence of rat liver S9 at the highest dose tested. Furosemide

did not induce sister chromatid exchange in human cells in vitro, but other studies on chromosomal

aberrations in human cells in vitro gave conflicting results. In Chinese hamster cells it induced

chromosomal damage but was questionably positive for sister chromatid exchange. Studies on the

induction by furosemide of chromosomal aberrations in mice were inconclusive. The urine of rats

treated with this drug did not induce gene conversion in Saccharomyces cerevisiae.

Furosemide produced no impairment of fertility in male or female rats, at 100 mg/kg/day (the maximum

effective diuretic dose in the rat and 8 times the maximal human dose of 600 mg/day).

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 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 (two times the maximal recommended human dose of 600 mg/day). In another study, a dose of 50

mg/kg (four 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.

Nursing Mothers

Because it appears in breast milk, caution should be exercised when furosemide is administered to a

nursing mother.

Furosemide may inhibit lactation.

Pediatric Use

In premature infants furosemide may precipitate nephrocalcinosis/nephrolithiasis.

Nephrocalcinosis/nephrolithiasis has also been observed in children under 4 years of age with no

history of prematurity who have been treated chronically with furosemide. Monitor renal function, and

renal ultrasonography should be considered, in pediatric patients receiving furosemide.

If furosemide is administered to premature infants during the first weeks of life, it may increase the risk

of persistence of patent ductus arteriosus.

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).

ADVERSE REACTIONS

Adverse reactions are categorized below by organ system and listed by decreasing severity.

Gastrointestinal System Reactions

1. hepatic encephalopathy in patients with hepatocellular insufficiency

2. pancreatitis

3. jaundice (intrahepatic cholestatic jaundice)

4. increased liver enzymes

5. anorexia

6. oral and gastric irritation

7. cramping

8. diarrhea

9. constipation

10. nausea

11. vomiting

Systemic Hypersensitivity Reactions

1. severe anaphylactic or anaphylactoid reations (e.g. with shock)

2. systemic vasculitis

3. interstitial nephritis

4. necrotizing angiitis

Central Nervous System Reactions

1. tinnitus and hearing loss

2. paresthesias

3. vertigo

4. dizziness

5. headache

6. blurred vision

7. xanthopsia

Hematologic Reactions

1. aplastic anemia

2. thrombocytopenia

3. agranulocytosis

4. hemolytic anemia

5. leukopenia

6. anemia

7. eosinophilia

Dermatologic-Hypersensitivity Reactions

1. toxic epidermal necrolysis

2. Stevens-Johnson Syndrome

3. erythema multiforme

4. drug rash with eosinophilia and systemic symptoms

5. acute generalized exanthematous pustulosis

6. exfoliative dermatitis

7. bullous pemphigoid

8. purpura

9. photosensitivity

10. rash

11. pruritus

12. urticaria

Cardiovascular Reaction

1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.

2. Increase in cholesterol and triglyceride serum levels

Other Reactions

1. hyperglycemia

2. glycosuria

3. hyperuricemia

4. muscle spasm

5. weakness

6. restlessness

7. urinary bladder spasm

8. thrombophlebitis

9. fever

Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy

withdrawn.

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

exceeded 1000 mg/kg body weight, while the intravenous LD

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.

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 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 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 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).

the dosing range (See PRECAUTIONS: Geriatric Use).

Pediatric Patients

The usual initial dose of oral furosemide 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.

Hypertens ion

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 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 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 is added to the

regimen. As the blood pressure falls under the potentiating effect of furosemide, 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).

HOW SUPPLIED

Furosemide Tablets USP

20 mg tablets are supplied as white, flat tablets with beveled edges, product identification “54

840” debossed on one side.

NDC 51407-113-90: Bottle of 90 Tablets

NDC 51407-113-01: Bottle of 100 Tablets

NDC 51407-113-10: Bottle of 1000 Tablets

NDC 51407-113-51:

Bottle of 5000 Tablets

40 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and

product identification “54 583” debossed on one side.

NDC 51407-114-90: Bottle of 90 Tablets

NDC 51407-114-01: Bottle of 100 Tablets

NDC 51407-114-10: Bottle of 1000 Tablets

NDC 51407-114-51:

Bottle of 5000 Tablets

80 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and

product identification “54 533” debossed on one side.

NDC 51407-115-01: Bottle of 100 Tablets

NDC 51407-115-05: Bottle of 500 Tablets

NDC 51407-115-10:

Bottle of 1000 Tablets

Store and Dispense

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Note: Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. Exposure

to light may cause slight discoloration. Discolored tablets should not be dispensed.

Protect From Moisture.

PROTECT FROM LIGHT.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

4052002//12

Revised July 2017

Marketed/Packaged by:

GSMS, Inc

Camarillo, CA 91304 U.S.A.

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This

drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged

configuration and repackaged in full compliance with all applicable cGMP regulations. The package

configurations available from Aphena are listed below:

Count 20 mg 40 mg 80 mg

71610-

309-

71610-

308-

71610-

309-

71610-

308-

71610-

309-53

71610-

308-53

71610-

309-

71610-

308-

71610-

305-

71610-

309-

71610-

309-

71610-

305-

71610-

309-

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-

resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20190717JH

PRINCIPAL DISPLAY PANEL - 20 mg

NDC 71610-309 - Furosemide, USP 20 mg Tablets - Rx Only

PRINCIPAL DISPLAY PANEL - 40 mg

NDC 71610-308 - Furosemide, USP 40 mg Tablets - Rx Only

PRINCIPAL DISPLAY PANEL - 80 mg

NDC 71610-305 - Furosemide, USP 80 mg Tablets - Rx Only

FUROSEMIDE

furosemide tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:716 10 -30 9 (NDC:5140 7-113)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FURO SEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)

FUROSEMIDE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

54;8 40

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:716 10 -30 9 -

30 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/17/20 19

2

NDC:716 10 -30 9 -

45 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/17/20 19

3

NDC:716 10 -30 9 -

6 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/17/20 19

4

NDC:716 10 -30 9 -

9 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/17/20 19

5

NDC:716 10 -30 9 -

18 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/17/20 19

6

NDC:716 10 -30 9 -

270 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/17/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 8 23

11/10 /19 8 3

FUROSEMIDE

furosemide tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:716 10 -30 8 (NDC:5140 7-114)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FURO SEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)

FUROSEMIDE

40 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

Flavor

Imprint Code

54;58 3

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:716 10 -30 8 -30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/16 /20 19

2

NDC:716 10 -30 8 -45

45 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/16 /20 19

3

NDC:716 10 -30 8 -53

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/17/20 19

4

NDC:716 10 -30 8 -6 0

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/16 /20 19

5

NDC:716 10 -30 8 -8 0

18 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/16 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 18 8 23

11/10 /19 8 3

FUROSEMIDE

furosemide tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:716 10 -30 5(NDC:5140 7-115)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

FURO SEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)

FUROSEMIDE

8 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

54;533

Contains

Aphena Pharma Solutions - Tennessee, LLC

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:716 10 -30 5-

9 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/16 /20 19

2

NDC:716 10 -30 5-

18 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/16 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 70 0 8 6

0 1/24/19 8 6

Labeler -

Aphena Pharma Solutions - T ennessee, LLC (128385585)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Aphena Pharma So lutio ns - Tennessee, LLC

128 38 558 5

REPACK(716 10 -30 5, 716 10 -30 8 , 716 10 -30 9 )

Revised: 7/2019

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