Furosemide (Page 3 of 4)

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
6. oral and gastric irritation
7. cramping

2. pancreatitis

8. diarrhea

3. jaundice (intrahepatic cholestatic jaundice)

9. constipation

4. increased liver enzymes

10. nausea

5. anorexia

11. vomiting

Systemic Hypersensitivity Reactions

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

3. interstitial nephritis

2. systemic vasculitis

4. necrotizing angiitis

Central Nervous System Reactions

1. tinnitus and hearing loss

5. headache

2. paresthesias

6. blurred vision

3. vertigo

7. xanthopsia

4. dizziness

Hematologic Reactions

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

Dermatologic-Hypersensitivity Reactions

1. toxic epidermal necrolysis
7. bullous pemphigoid
2. Stevens-Johnson Syndrome
8. purpura
3. erythema multiforme
9. fever
4. drug rash with eosinophilia and systemic symptoms
10. rash
5. acute generalized exanthematous pustulosis
11. pruritus
6. exfoliative dermatitis
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
6. restlessness
2. glycosuria
7. urinary bladder spasm
3. hyperuricemia
8. thrombophlebitis
4. muscle spasm
9. fever
5. weakness

Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.

To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 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 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 tablets 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 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).

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