Adverse reactions are categorized below by organ system and listed by decreasing severity.
Gastrointestinal System Reactions
Hepatic encephalopathy in patients with hepatocellular insufficiency
Jaundice (intrahepatic cholestatic jaundice)
Increased liver enzymes
Oral and gastric irritation
Systemic Hypersensitivity Reactions
Severe anaphylactic or anaphylactoid reactions (e.g., with shock)
Central Nervous System Reactions
Tinnitus and hearing loss
Toxic epidermal necrolysis
Drug rash with eosinophila and systemic symptoms
Acute generalized exanthematous pustulosis
Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics
Increase in cholesterol and triglyceride serum levels
Urinary bladder spasm
Transient injection site pain following intramuscular injection Fever
Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.
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 1,000 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.
Parenteral therapy with furosemide injection 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 is 20 to 40 mg given as a single dose, injected IM or IV. The IV dose should be given slowly (one to two minutes). Ordinarily a prompt diuresis ensues. If needed, another dose may be administered in the same manner two hours later or the dose may be increased. The dose may be raised by 20 mg and given not sooner than two 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.
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 Injection 5% USP, after pH has been adjusted to above 5.5, and administer as a controlled IV infusion at a rate not greater than 4 mg/min. Furosemide injection is a buffered alkaline solution with a pH of about 9 and the 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 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 IV (over one to two minutes). If a satisfactory response does not occur within one hour, the dose may be increased to 80 mg injected slowly IV (over one to two minutes).
If necessary, additional therapy (e.g., digitalis, oxygen) may be administered concomitantly.
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).
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 (IM or IV) 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 two 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 should be inspected visually for particulate matter and discoloration before administration. Do not use if solution is discolored.
Furosemide injection, USP
2 mL, 4 mL and 10 mL sizes are single dose vials, packaged 25 vials per tray.
Preservative Free. Discard unused portion.
Use only if solution is clear and seal intact.
PROTECT FROM LIGHT. Do not use if solution is discolored.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Lake Zurich, IL 60047 www.fresenius-kabi.us
Revised: March 2016
51662-1574-2 POUCH LABELING
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