Get your patient on Furosemide - Furosemide tablet (Furosemide)

Furosemide tablets are 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 tablets 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.

Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.

Adults -- The usual initial dose of furosemide tablets 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 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of furosemide tablets may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.

Edema may be most efficiently and safely mobilized by giving furosemide tablets on 2 to 4 consecutive days each week.

When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable (see PRECAUTIONS: Laboratory Tests ).

Geriatric patients -- In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use ).

Pediatric patients -- The usual initial dose of furosemide tablets 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.

Therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.

Adults -- The usual initial dose of furosemide tablets for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when furosemide tablets are used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50% when furosemide tablets are added to the regimen. As the blood pressure falls under the potentiating effect of furosemide tablets, 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 ).

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

1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock)
2. systemic vasculitis
3. interstitial nephritis
4. necrotizing angiitis

1. tinnitus and hearing loss
2. paresthesias
3. vertigo
4. dizziness
5. headache
6. blurred vision
7. xanthopsia

1. aplastic anemia
2. thrombocytopenia
3. agranulocytosis
4. hemolytic anemia
5. leukopenia
6. anemia
7. eosinophilia

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. pruritis
12. urticaria

1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates, or narcotics.
2. Increase in cholesterol and triglyceride serum levels

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.

To report SUSPECTED ADVERSE REACTIONS, contact Ipca at 1-888-472-2651 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 ).