FUROSEMIDE (Page 3 of 4)

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 6. Oral and gastric irritation
hepatocellular insufficiency 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 3. Interstitial nephritis
reactions (e.g. with shock) 4. Necrotizing angiitis
2. Systemic vasculitis
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. Exfoliative dermatitis 6. Urticaria
2. Bullous pemphigoid 7. Rash
3. Erythema multiforme 8. Pruritus
4. Purpura 9. Stevens-Johnson Syndrome
5. Photosensitivity 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 7. Urinary bladder spasm
2. Glycosuria 8. Thrombophlebitis
3. Hyperuricemia 9. Transient injection site pain following
4. Muscle spasms intramuscular injection
5. Weakness 10. Fever
6. Restlessness

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 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

Adults

Parenteral therapy with furosemide injection, USP 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, USP 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, USP 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, USP (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, USP should be inspected visually for particulate matter and discoloration before administration.

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