Furosemide is used for treating fluid build-up and swelling caused by congestive heart failure, liver cirrhosis, or kidney disease.
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Category: Blood Pressure
Furosemide is used for treating fluid build-up and swelling caused by congestive heart failure, liver cirrhosis, or kidney disease.
Active Ingredient: furosemide
Furosemide as known as: Apo-furosemide, Diurin, Froop, Frusemide, Frusid, Frusol, Furorese, Furosemida, Furosemidum, Furoside, Fusid, Impugan, Myrosemide, Novosemide, Rusyde, Seguril, Tenkafruse, Uritol
Furosemide Tablets, USP 20 mg, 40 mg and 80 mg meet USP DISSOLUTION TEST 1.
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 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 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.
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.
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.CONTRAINDICATIONS
Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
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.
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.
Laboratory Tests: Serum electrolytes, (particularly potassium), CO 2 . 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.
Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity.
Furosemide has a tendency to antagonize the skeletal muscle relaxing effects of tubocurarine and may potentiate the action of succinylcholine.
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.
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.
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 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.
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.ADVERSE REACTIONS
Adverse reactions are categorized below by organ system and listed by decreasing severity.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 to 40 mg and given not sooner than 6 to 8 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 (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 .)
Infants and Children: The usual initial dose of oral furosemide in infants and children 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 infants and children, the dose should be adjusted to the minimum effective level. For ease of administration, and to allow maximum flexibility in dosing, the use of Furosemide Oral Solution is suggested.
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.HOW SUPPLIED
The 20 mg tablets are white, round, unscored, flat-bevel -edged tablets marked with M2. They are available as follows:
NDC 0378-0208-01 bottles of 100 tablets
NDC 0378-0208-10 bottles of 1000 tablets
The 40 mg tablets are white, round, scored, flat-bevel -edged tablets marked with MYLAN over 216 on one side and 40 on the other side. They are available as follows:
NDC 0378-0216-01 bottles of 100 tablets
NDC 0378-0216-10 bottles of 1000 tablets
The 80 mg tablets are white, round, scored, flat-bevel -edged tablets marked with MYLAN over 232 on one side and 80 on the other side. They are available as follows:
NDC 0378-0232-01 bottles of 100 tablets
NDC 0378-0232-05 bottles of 500 tablets
STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F).
Dispense in a tight, light -resistant container 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 MARCH 1998
Furosemide is a generic form of the drug Lasix®, and is a type of diuretic called a loop diuretic. Most simply, it works on the kidneys, causing them to release more urine than usual. This can have a beneficial effect for many conditions that cause water retention. Some of the main conditions for which furosemide is prescribed include congestive heart failure and many different forms of edema (water retention). The drug can also reduce blood pressure by reducing fluid volume.
There are two principal forms in which furosemide is available by prescription. It comes in a pill and also a solution form. The solution form is especially useful when treating children, as the drug is used often after surgeries for certain congenital heart defects. Dosing varies depending on age, size and condition, but it must be followed exactly.
Most people find, if given the option, that it is easier to take this medicine during the day because it usually causes a much greater need to urinate. Taking it at night, especially at bedtime, can either create nighttime accidents or interrupt sleep. The need to urinate usually slows down in about six hours, and the brand name Lasix® has been said to be short for “lasts six hours.”
While great benefit exists with drugs like furosemide, the medicine is not appropriate to everyone and can have mild to severe side effects, plus interactions with other drugs. The main risk of using this medication, especially without proper fluid intake, is that dehydration may result, and in severe cases, this can throw off electrolyte balance and cause illness that includes vomiting and severe confusion. People need to consult with their physicians about the proper amount of fluid intake needed while using the drug. The chief medical conditions that contraindicate use of furosemide are many forms of kidney disease, liver disease, pregnancy or nursing, diabetes, or gout.
Very adverse side effects of Lasix® include no urination, which can suggest severe kidney dysfunction. Symptoms of dehydration like confusion, nausea, weakness, dizziness, vomiting and extremely dry mouth should also be watched for. Sometimes a rash develops, or people get jaundice with yellow skin and yellow on the whites of the eyes. Furosemide may additionally result in allergic reaction. These side effects need immediate medical attention.
Milder side effects of furosemide are also noted. Some people get headaches or feel dizzy or numb when they take this medicine. The diuretic can cause stomach upset, and both constipation and diarrhea have been recorded as potential side effects. A few people experience changes in vision and especially report their vision as blurry. Should these side effects remain unchanged, people should consult their doctors.
There are many medicines that may interact with furosemide, including drugs like lithium, aspirin. and common steroids. Patients should discuss with their doctor or pharmacist how any medicine might have an effect that combines with Lasix® to produce negative results. Not only prescription drugs, but any over the counter drugs, herbs, and supplements should be mentioned in such a discussion.