Furorese Long

Furosemide:

• Pharmacological action
• Pharmacokinetics
• Why is Furorese Long prescribed?
• Dosage and administration
• Furorese Long (Furosemide) side effects, adverse reactions
• Furorese Long contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Furorese Long drug interactions
• Furorese Long in case of emergency / overdose
• Furorese Long (Furosemide) reviews

Pharmacological action

Furorese Long is a loop diuretic. This medication violates the reabsorption of sodium and chlorine in the large segment of the ascending loop of Henle. Due to increasing separation of sodium ions occurs secondary (indirect osmotically bound water) increased excretion of water and increased secretion of potassium ions in the distal renal tubule. Simultaneously increased excretion of calcium and magnesium ions.

Furorese Long (Furosemide) has secondary effects caused by the release of neurotransmitters and intrarenal redistribution of intrarenal blood flow. On the background of a course of treatment does not occur the weakening effect.

When heart failure Furorese Long (Furosemide) quickly leads to a reduction of preload on the heart through the expansion of large veins. This drug exerts the hypotensive effect due to increased excretion of sodium chloride and reduction reactions of vascular smooth muscle to vasoconstrictor effects and by decreasing the BCC. Effect of Furorese Long (Furosemide) after IV injection occurs in 5-10 minutes; after oral administration within 30-60 minutes, a maximum of the action is after 1-2 hours, the duration of effect is 2-3 hours (if reduced kidney function - up to 8 hours).

Furorese Long (Furosemide) reduces the incidence of atrial natriuretic factor in the plasma, causing vasoconstriction.

Diuretic effect develops in 3-4 minutes after IV injection and lasts 1-2 h; after oral taking - 20-30 minutes, lasts up to 4 hours.

Pharmacokinetics

After oral administration absorption of Furorese Long (Furosemide) is 60-70%. In severe kidney disease or chronic heart failure, extent of absorption is reduced.

V_d is 0.1 L / kg. Binding to plasma proteins (mainly albumin) is 95-99%. Furorese Long (Furosemide) metabolized in the liver. Excreted by the kidneys is 88% with bile - 12%. T_1/2 in patients with normal renal function and liver is 0.5-1.5 h. When anuria T_1/2 can be increased up to 1.5-2.5 h, with concomitant renal and liver failure - up to 11-20 hours.

Why is Furorese Long prescribed?

Edematous syndrome of different genesis, including in chronic heart failure II-III stage, liver cirrhosis (portal hypertension syndrome), nephrotic syndrome. Pulmonary edema, cardiac asthma, cerebral edema, eclampsia, conducting forced diuresis, severe hypertension, some forms of hypertensive crisis, hypercalcemia.

Dosage and administration

Dosing regimen set individually, depending on the evidence, the clinical situation, the patient's age. The treatment dosing regimen is adjusted depending on the value of diuretic response and the dynamics of the patient.

When Furorese Long administered orally an initial dose for adults is 20-80 mg / day, further, if necessary, the dose gradually increased to 600 mg / day. For children a single dose is 1-2 mg / kg.

The maximum oral dose for children is 6 mg / kg.

For IV jet or IM administration the dose for adults is 20-40 mg 1 time / day, in some cases - 2 times / day. For children the starting daily dosage for parenteral use is 1 mg / kg.

Furorese Long (Furosemide) side effects, adverse reactions

Cardiovascular system: decreased blood pressure, orthostatic hypotension, collapse, tachycardia, arrhythmias, decreased BCC.

CNS and peripheral nervous system: dizziness, headache, myasthenia gravis, calf muscle cramps (tetany), paresthesia, apathy, weakness, fatigue, lethargy, drowsiness, confusion.

Senses: blurred vision and hearing.

Digestive system: anorexia, dry mouth, thirst, nausea, vomiting, constipation or diarrhea, cholestatic jaundice, pancreatitis (acute).

Urogenital system: oliguria, acute urinary retention (in patients with prostatic hypertrophy), interstitial nephritis, hematuria, reduced potency.

Hemopoietic system: leucopenia, thrombocytopenia, agranulocytosis, aplastic anemia.

Water and electrolyte metabolism: hypovolemia, dehydration (the risk of thrombosis and thromboembolism), hypokalemia, hyponatremia, chloropenia, hypocalcemia, hypomagnesemia, metabolic alkalosis.

Metabolism: hypovolemia, hypokalemia, hyponatremia, chloropenia, hypokalemic metabolic alkalosis (as a result of these violations - hypotension, dizziness, dry mouth, thirst, arrhythmias, muscle weakness, cramps), hyperuricemia (with the possible aggravation of gout), hyperglycemia.

Allergic reactions: purpura, urticaria, exfoliative dermatitis, erythema multiforme exudative, vasculitis, necrotizing vasculitis, pruritus, chills, fever, photosensitivity, anaphylactic shock.

Other: for optional IV injections - thrombophlebitis, renal calcinosis in preterm infants.

Furorese Long contraindications

Acute glomerulonephritis, stenosis of the urethra, obstruction of urinary tract stones, acute renal failure with anuria, hypokalemia, alkalosis, precomatose state, severe hepatic failure, hepatic coma and precoma, diabetic coma, hyperglycemic coma, hyperuricemia, gout, decompensated mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy, increased central venous pressure (greater than 10 mm Hg), hypotension, acute myocardial infarction, pancreatitis, impaired water-electrolyte metabolism (hypovolemia, hyponatremia, hypokalemia, chloropenia, hypocalcemia, hypomagnesemia), digitalis toxicity, increased sensitivity to Furorese Long (Furosemide).

Using during pregnancy and breastfeeding

In pregnancy, the use of Furorese Long is only possible within a short time only, when the intended use of therapy to the mother justifies the potential risk to the fetus.

As Furorese Long (Furosemide) may be excreted in breast milk and to suppress lactation, if necessary use during lactation, a breastfeeding should be discontinued.

Category effects on the fetus by FDA - C.

Special instructions

With careful use Furorese Long (Furosemide) with prostatic hyperplasia, SLE, hypoproteinemia (risk of ototoxicity), diabetes (impaired glucose tolerance), stenosing atherosclerosis of cerebral arteries on the background of long-term therapy cardiac glycosides, elderly patients with severe atherosclerosis, pregnancy (especially first half), during lactation.

Before the treatment by Furorese Long (Furosemide) it should be compensated for electrolyte disturbances. During treatment with Furorese Long (Furosemide) it is necessary to control blood pressure, electrolytes and glucose in the blood serum, liver and kidney function.

For the prevention of hypokalemia there is expedient to combine Furorese Long (Furosemide) with potassium-sparing diuretics. With the simultaneous administration of Furorese Long (Furosemide) and hypoglycemic agents it may be require dose adjustment of the latter.

There is not recommended to mix a solution of Furorese Long (Furosemide) in the same syringe with any other drugs.

Furorese Long drug interactions

Aminoglycosides, ethacrynic acid and cisplatin increases ototoxicity of this medication (especially when impaired renal function). Furorese Long (Furosemide) increases the danger of kidney damage with amphotericin B. if prescribed high doses of salicylates increases the risk of salicylism (competitive renal excretion), cardiac glycosides - hypokalemia and related arrhythmias, corticosteroids - an electrolyte imbalance. Furorese Long (Furosemide) reduces muscle relaxant activity of tubocurarine, potentiates the effect of succinylcholine. This drug reduces the renal clearance (and increases the likelihood of intoxication) lithium. Under the influence of Furorese Long (Furosemide) increases the effect of ACE inhibitors and antihypertensive agents, warfarin, diazoxide, theophylline, attenuated - antidiabetic drugs, norepinephrine. Sucralfate and indomethacin (by inhibiting the synthesis of PG, the level of violations of plasma renin and aldosterone excretion) reduce the effectiveness of Furorese Long (Furosemide) Atlantic Laboratories. Probenecid increases the concentration of this medicine in serum (blocking excretion).

Furorese Long in case of emergency / overdose

Symptoms: hypovolemia, dehydration, haemoconcentration expressed hypotension, reduction of BCC, collapse, shock, cardiac arrhythmias and conduction (including AV block, ventricular fibrillation), acute renal failure with anuria, thrombosis, thromboembolism, drowsiness, confusion, flaccid paralysis, apathy.

Treatment: correction of water and electrolyte balance and acid-base balance, supplementation of BCC, symptomatic therapy, the maintenance of vital functions. The specific antidote is unknown.

Furosemide Sodium:

• Warning
• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Furorese Long (Furosemide Sodium) reviews

WARNING

Furorese Long (Furosemide Sodium) 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.

DESCRIPTION

Furorese Long (Furosemide Sodium) is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furorese Long (Furosemide Sodium), USP is a white to slightly yellow 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 tablet for oral administration contains 20 mg, 40 mg or 80 mg of Furorese Long (Furosemide Sodium), USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch and stearic acid.

Furorese Long (Furosemide Sodium) Tablets, USP 20 mg, 40 mg and 80 mg meet USP DISSOLUTION TEST 1.

CLINICAL PHARMACOLOGY

Investigations into the mode of action of Furorese Long 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 Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) glucuronide is the only or at least the major biotransformation product of Furorese Long (Furosemide Sodium) in man. Furorese Long (Furosemide Sodium) 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 one 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 Furorese Long (Furosemide Sodium) from Furorese Long (Furosemide Sodium) tablets and Furorese Long (Furosemide Sodium) oral solution is 64% to 60%, respectively, of that from an intravenous injection of the drug. Although Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) is approximately 2 hours.

Significantly more Furorese Long (Furosemide Sodium) 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

Furorese Long (Furosemide Sodium) binding to albumin may be reduced in elderly patients. Furorese Long (Furosemide Sodium) is predominantly excreted unchanged in the urine. The renal clearance of Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) in older subjects is decreased relative to younger subjects.

INDICATIONS AND USAGE

Edema

Furorese Long 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. Furorese Long (Furosemide Sodium) is particularly useful when an agent with greater diuretic potential is desired.

Hypertension

Oral Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) alone.

CONTRAINDICATIONS

Furorese Long (Furosemide Sodium) is contraindicated in patients with anuria and in patients with a history of hypersensitivity to Furorese Long (Furosemide Sodium).

WARNINGS

In patients with hepatic cirrhosis and ascites, Furorese Long (Furosemide Sodium) 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, Furorese Long (Furosemide Sodium) should be discontinued.

Cases of tinnitus and reversible or irreversible hearing impairment have been reported. Usually, reports indicate that Furorese Long (Furosemide Sodium) ototoxicity is associated with rapid injection, severe renal impairment, doses exceeding several times the usual recommended dose, 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 Furorese Long (Furosemide Sodium) per minute has been used).

PRECAUTIONS

General

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and and possibly vascular thrombosis and embolism, particularly in elderly patients. As with any effective diuretic, electrolyte depletion may occur during Furorese Long therapy, especially in patients receiving higher doses and a restricted salt intake. Hypokalemia may develop with Furorese Long (Furosemide Sodium), especially with brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use of corticosteroids or ACTH. Digitalis therapy may exaggerate metabolic effects of hypokalemia, especially myocardial effects.

All patients receiving Furorese Long (Furosemide Sodium) 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.

Asymptomatic hyperuricemia can occur and gout may rarely be precipitated.

Patients allergic to sulfonamides may also be allergic to Furorese Long (Furosemide Sodium). 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 Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium).

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,, CO₂, creatinine and BUN should be determined frequently during the first few months of Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium), even in those suspected of latent diabetes.

Furorese Long (Furosemide Sodium) 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.

Drug Interactions

Furorese Long (Furosemide Sodium) may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life threatening situations, avoid this combination.

Furorese Long (Furosemide Sodium) should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with Furorese Long (Furosemide Sodium), as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.

Furorese Long (Furosemide Sodium) 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.

Furorese Long (Furosemide Sodium) may add to or potentiate the therapeutic effect of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Furorese Long (Furosemide Sodium) may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.

Simultaneous administration of sucralfate and Furorese Long (Furosemide Sodium) tablets may reduce the natriuretic and antihypertensive effects of Furorese Long (Furosemide Sodium). Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furorese Long (Furosemide Sodium) is achieved. The intake of Furorese Long (Furosemide Sodium) and sucralfate should be separated by at least 2 hours.

One study in six subjects demonstrated that the combination of Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) was used in conjunction with NSAIDs.

Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Furorese Long (Furosemide Sodium) is achieved.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Furorese Long 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.

Furorese Long (Furosemide Sodium) 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. Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) of chromosomal aberrations in mice were inconclusive. The urine of rats treated with this drug did not induce gene conversion in Saccharomyces cerevisiae.

Furorese Long (Furosemide Sodium) 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

Furorese Long 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. Furorese Long (Furosemide Sodium) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The effects of Furorese Long (Furosemide Sodium) on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits.

Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) is administered to a nursing mother.

Geriatric Use

Controlled clinical studies of Furorese Long (Furosemide Sodium) 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.

ADVERSE REACTIONS

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

Gastrointestinal System Reactions

• hepatic encephalopathy in patients with hepatocellular insufficiency
• pancreatitis
• 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
• thrombocytopenia
• agranulocytosis (rare)
• hemolytic anemia
• leukopenia
• anemia

Dermatologic-Hypersensitivity Reactions

• exfoliative dermatitis
• bullous pemphigoid
• 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
• thrombophlebitis
• fever

Whenever adverse reactions are moderate or severe, Furorese Long (Furosemide Sodium) dosage should be reduced or therapy withdrawn.

OVERDOSAGE

The principal signs and symptoms of overdosage with Furorese Long (Furosemide Sodium) are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action.

The acute toxicity of Furorese Long (Furosemide Sodium) has been determined in mice, rats and dogs. In all three, the oral LD₅₀ exceeded 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 Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) 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 Furorese Long is 20 mg 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 mg to 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 Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) 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.

Geriatric Patients

In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range.

Pediatric Patients

The usual initial dose of oral Furorese Long 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. For ease of administration, and to allow maximum flexibility in dosing, the use of Furorese Long (Furosemide Sodium) Oral Solution is suggested.

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 Furorese Long 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 Furorese Long (Furosemide Sodium) 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 Furorese Long (Furosemide Sodium) is added to the regimen. As the blood pressure falls under the potentiating effect of Furorese Long (Furosemide Sodium), 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.

HOW SUPPLIED

Furorese Long (Furosemide Sodium) Tablets, USP are available as tablets for oral administration. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of Furorese Long (Furosemide Sodium), USP.

The 20 mg tablets are white, round, unscored tablets debossed with M2. They are available as follows:

NDC 0378-0208-93

bottles of 30 tablets

NDC 0378-0208-01

bottles of 100 tablets

NDC 0378-0208-10

bottles of 1000 tablets

The 40 mg tablets are white, round, scored tablets debossed with MYLAN over 216 on one side and 40 on the other side. They are available as follows:

NDC 0378-0216-93

bottles of 30 tablets

NDC 0378-0216-01

bottles of 100 tablets

NDC 0378-0216-10

bottles of 1000 tablets

The 80 mg tablets are white, round, scored tablets debossed with MYLAN over 232 on one side and 80 on the other side. They are available as follows:

NDC 0378-0232-93

bottles of 30 tablets

NDC 0378-0232-01

bottles of 100 tablets

NDC 0378-0232-05

bottles of 500 tablets

Store at 20° to 25°C (68° to 77°F).

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Exposure to light may cause slight discoloration. Discolored tablets should not be dispensed.

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505

REVISED JULY 2008

FUR:R26

Furorese Long (Furosemide Sodium) 80mg Tablet

Structural Formula