Prescription Drug Information: FUROSEMIDE (Page 2 of 2)

ADVERSE REACTIONS

Adverse reactions are categorized below by organ system and listed by decreasing severity.

Gastrointestinal System Reactions

Hepatic encephalopathy in patients with hepatocellular insufficiency
Pancreatitis
Jaundice (intrahepatic cholestatic jaundice)
Increased liver enzymes
Anorexia
Oral and gastric irritation
Cramping
Diarrhea
Constipation
Nausea
Vomiting

Systemic Hypersensitivity Reactions

Severe anaphylactic or anaphylactoid reactions (e.g., with shock)
Systemic vasculitis
Interstitial nephritis
Necrotizing angiitis

Central Nervous System Reactions

Tinnitus and hearing loss
Paresthesias
Vertigo
Dizziness
Headache
Blurred vision
Xanthopsia

Hematologic Reactions

Aplastic anemia
Thrombocytopenia
Agranulocytosis
Hemolytic anemia
Leukopenia
Anemia
Eosinophilia

Dermatologic-Hypersensitivity Reactions

Toxic epidermal necrolysis
Stevens-Johnson Syndrome
Erythema multiforme
Drug rash with eosinophila and systemic symptoms
Acute generalized exanthematous pustulosis
Exfoliative dermatitis
Bullous pemphigoid
Purpura
Photosensitivity
Rash
Pruritus
Urticaria

Cardiovascular Reactions

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

Other Reactions

Hyperglycemia
Glycosuria
Hyperuricemia
Muscle spasm
Weakness
Restlessness
Urinary bladder spasm
Thrombophlebitis
Transient injection site pain following intramuscular injection Fever

Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.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

DOSAGE & ADMINISTRATION

Adults

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.

Edema-

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.

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 (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.

HOW SUPPLIED

Furosemide injection, USP

HS
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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].

SPL UNCLASSIFIED

LOGO
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Lake Zurich, IL 60047 www.fresenius-kabi.us

45788F

Revised: March 2016

PRINCIPAL DISPLAY PANEL — 51662-1574-1 — SERIALIZED LABEL AND VIAL LABELING

SERIALIZED
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VIAL
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PRINCIPAL DISPLAY PANEL — 51662-1574-2 VIAL AND POUCH LABELING

VIAL LABELING

VIAL LABEL

51662-1574-2 POUCH LABELING

POUCH LABELING
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PRINCIPAL DISPLAY PANEL — 51662-1574-3 CASE LABELING AND SERIALIZED LABELING

51662-1574-3 CASE AND SERILIZED LABELING

CASE
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SERIALIZED CASE
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FUROSEMIDE furosemide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1574(NDC:63323-280)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FUROSEMIDE (FUROSEMIDE) FUROSEMIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM CHLORIDE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1574-1 4 mL in 1 VIAL None
2 NDC:51662-1574-3 25 POUCH in 1 CASE contains a POUCH (51662-1574-2)
2 NDC:51662-1574-2 1 VIAL in 1 POUCH This package is contained within the CASE (51662-1574-3) and contains a VIAL
2 4 mL in 1 VIAL This package is contained within a POUCH (51662-1574-2) and a CASE (51662-1574-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018902 06/28/2021
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1574)

Revised: 07/2021 HF Acquisition Co LLC, DBA HealthFirst

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