FUROSEMIDE- furosemide injection, solution

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

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Active ingredient:
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Available from:
General Injectables & Vaccines, Inc.
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. 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. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical. Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
Product summary:
Furosemide Injection, USP (10 mg/mL) Do not use if solution is discolored. Store at 20° to 25°C (68° to 77°F) ; excursions permitted to 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature] Protect from light. Baxter Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213, India Issue date: 2018-10-27 1400007271
Authorization status:
Abbreviated New Drug Application
Authorization number:
52584-284-25

FUROSEMIDE- furosemide injection, solution

General Injectables & Vaccines, Inc.

----------

FUROSEMIDE INJECTION, USP

10 mg/mL

Rx Only

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

Furosemide is a diuretic which is an anthranilic acid derivative.

Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid.

Furosemide Injection 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and

intramuscular injection.

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 structural formula is as follows:

Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium

Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3.

CLINICAL PHARMACOLOGY

Investigations into the mode of action of furosemide have utilized micropuncture studies is 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 reabsorption 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 this 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 intravenous administration is within 5 minutes and somewhat later after

intramuscular administration. The peak effect occurs within the first half hour. The duration of diuretic

effect is approximately 2 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 intravenous 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 (60-70 years of age) is statistically significantly smaller than in younger

healthy male subjects (20-35 years of age). The intial diuretic effect of furosemide in older subjects is

decreased relative to younger subjects. (See

PRECAUTIONS: Geriatric Use .)

INDICATIONS AND USAGE

Parenteral therapy should be reserved for patients unable to take oral medication or for patients in

emergency clinical situations.

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.

Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration

of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.

If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide

is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral

furosemide as soon as practical.

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.)

Pediatric Use: In premature neonates with respiratory distress syndrome, diuretic treatment with

furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus

(PDA), possibly through a prostaglandin-E-mediated process.

Literature reports indicate that premature infants with post conceptual age (gestational plus postnatal)

less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which

could be associated with potential toxic effects including ototoxicity.

Hearing loss in neonates has been associated with the use of furosemide injection (see WARNINGS,

above).

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 the

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 diseases,

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.

Furosemide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Potentiation

occurs with ganglionic or peripheral adrenergic blocking drugs.

Furosemide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still

be used effectively.

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.

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 hyperuricemia 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.

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: Teratogenic Effects: 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

oral 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

fetal 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 oral dose of 600 mg/day). In another study, a dose of

50 mg/kg (4 times the maximal recommended human oral 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 an oral 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 treated dams as compared with the incidence of 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.

Renal calcifications (from barely visible on x-ray to staghorn) have occurred in some severely

premature infants treated with intravenous furosemide for edema due to patent ductus arteriosus and

hyaline membrane disease. The concurrent use of chlorothiazide has been reported to decrease

hypercalcinuria and dissolve some calculi.

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 reactions (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.Exfoliative dermatitis

2.Bullous pemphigoid

3.Erythema multiforme

4.Purpura

5.Photosensitivity

6.Urticaria

7.Rash

8.Pruritus

9.Stevens-Johnson Syndrome

10.Toxic epidermal necrolysis

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.Transient injection site pain following intramuscular injection

10.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

LD50exceeded 1000 mg/kg body weight, while the intravenous LD50 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

Adults: Parenteral therapy with Furosemide Injection should be used only in patients unable to take oral

medication or in emergency situations and should be replaced with oral therapy as soon as practical.

Edema

The usual initial dose of furosemide is 20 to 40 mg given as a single dose, injected intramuscularly or

intravenously. The intravenous dose should be given slowly (1 to 2 minutes). Ordinarily a prompt

diuresis ensues. If needed, another dose may be administered in the same manner 2 hours later or the

dose may be increased. The dose may be raised by 20 mg and given not sooner than 2 hours after the

previous dose until the desired diuretic effect has been obtained. This individually determined single

dose should then be given once or twice daily. Therapy should be individualized according to patient

response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that

response. Close medical supervision is necessary.

When furosemide is given for prolonged periods, careful clinical observation and laboratory

monitoring are particularly advisable. (See PRECAUTIONS: Laboratory Tests.)

If the physician elects to use high dose parenteral therapy, add the furosemide to either Sodium

Chloride Injection USP, Lactated Ringer's Injection USP, or Dextrose (5%) Injection USP after pH has

been adjusted to above 5.5, and administer as a controlled intravenous infusion at a rate not greater than 4

mg/min. Furosemide Injection is a buffered alkaline solution with a pH of about 9 and drug may

precipitate at pH values below 7. Care must be taken to ensure that the pH of the prepared infusion

solution is in the weakly alkaline to neutral range. Acid solutions, including other parenteral medications

(e.g., labetalol, ciprofloxacin, amrinone, milrinone) must not be administered concurrently in the same

infusion because they may cause precipitation of the furosemide. In addition, furosemide injection

should not be added to a running intravenous line containing any of these acidic products.

Acute Pulmonary Edema

The usual initial dose of furosemide is 40 mg injected slowly intravenously (over 1 to 2 minutes). If a

satisfactory response does not occur within 1 hour, the dose may be increased to 80 mg injected slowly

intravenously (over 1 to 2 minutes).

If necessary, additional therapy (e.g., digitalis, oxygen) may be administered concomitantly.

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: Parenteral therapy should be used only in patients unable to take oral medication or

in emergency situations and should be replaced with oral therapy as soon as practical.

The usual initial dose of Furosemide Injection (intravenously or intramuscularly) in pediatric patients is

1 mg/kg body weight and should be given slowly under close medical supervision. If the diuretic

response to the initial dose is not satisfactory, dosage may be increased by 1 mg/kg not sooner than 2

hours after the previous dose, until the desired diuretic effect has been obtained. Doses greater than 6

mg/kg body weight are not recommended.

Literature reports suggest that the maximum dose for premature infants should not exceed 1 mg/kg/day

(see WARNINGS, Pediatric Use).

Furosemide Injection should be inspected visually for particulate matter and discoloration before

administration.

HOW SUPPLIED

Furosemide Injection, USP (10 mg/mL)

Do not use if solution is discolored.

Store at 20° to 25°C (68° to 77°F) ; excursions permitted to 15˚ to 30˚C (59˚ to 86˚F) [see USP

Controlled Room Temperature]

Protect from light.

Baxter

Manufactured for:

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Manufactured by:

Baxter Pharmaceuticals India Private Ltd

Ahmedabad 382213, India

Issue date: 2018-10-27

1400007271

SAMPLE LABEL

FUROSEMIDE

furosemide injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:5258 4-28 4(NDC:36 0 0 0 -28 4)

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

FUROSEMIDE

10 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

General Injectables & Vaccines, Inc.

HYDRO CHLO RIC ACID (UNII: QTT1758 2CB)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:5258 4-28 4-25 1 in 1 BAG

0 8 /15/20 19

1

1 mL in 1 VIAL, GLASS; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 2747

0 8 /15/20 19

Labeler -

General Injectables & Vaccines, Inc. (108250663)

Revised: 8/2019

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