FUROSEMIDE (Page 2 of 2)

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
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

Systemic Hypersensitivity Reactions

1.
Severe anaphylactic or anaphylactoid reactions (e.g. with shock)
2.
Systemic vasculitis
3.
Interstitial nephritis
4.
Necrotizing angiitis

Central Nervous System Reactions

1.
Tinnitus and hearing loss
2.
Paresthesias
3.
Vertigo
4.
Dizziness
5.
Headache
6.
Blurred vision
7.
Xanthopsia

Hematologic Reactions

1.
Aplastic anemia
2.
Thrombocytopenia
3.
Agranulocytosis
4.
Hemolytic anemia
5.
Leukopenia
6.
Anemia
7.
Eosinophilia

Dermatologic-Hypersensitivity Reactions

1.
Exfoliative dermatitis
2.
Bullous pemphigoid
3.
Erythema multiforme
4.
Purpura
5.
Photosensitivity
6.
Urticaria
7.
Rash
8.
Pruritus
9.
Stevens-Johnson Syndrome
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
2.
Glycosuria
3.
Hyperuricemia
4.
Muscle spasm
5.
Weakness
6.
Restlessness
7.
Urinary bladder spasm
8.
Thrombophlebitis
9.
Transient injection site pain following intramuscular injection
10.
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Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.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 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 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 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 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 (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 should be inspected visually for particulate matter and discoloration before administration.

HOW SUPPLIED

Furosemide Injection, USP (10 mg/mL)

NDC 72572-190-25

4 mL single dose amber colored vials

Boxes of 25

Do not use if solution is discolored.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]

Protect from light.

civica-logo-2

Distributed by:
Civica, Inc.
Lehi, Utah 84043

Manufactured by:
Baxter Pharmaceuticals India Private Ltd
Ahmedabad 382213, India

Revised: March 2022

1400008284

PRINCIPAL PANEL DISPLAY

NDC 72572-190 -01 Rx Only

Furosemide
Injection, USP

40 mg/4 mL
(10 mg/mL)

For Intravenous or Intramuscular Use

4 mL Single Dose Vial

Dist by: Civica, Inc.
Lehi, UT 84043

Mfg by: Baxter
Pharmaceuticals
India Private Ltd

container-3
(click image for full-size original)

NDC 72572-190 -25 Rx Only

Furosemide Injection, USP

40 mg/4 mL
(10 mg/mL)

For Intravenous or Intramuscular Use

25 x 4 mL Single Dose Vials

carton-4
(click image for full-size original)
carton-5
(click image for full-size original)
container-3carton-4carton-5
FUROSEMIDE
furosemide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72572-190
Route of Administration INTRAVENOUS 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
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72572-190-25 25 VIAL, SINGLE-DOSE in 1 BOX contains a VIAL, SINGLE-DOSE
1 4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BOX (72572-190-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202747 09/23/2022
Labeler — Civica, Inc. (081373942)
Registrant — Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED 918603338 ANALYSIS (72572-190), STERILIZE (72572-190), LABEL (72572-190), MANUFACTURE (72572-190), PACK (72572-190)

Revised: 12/2023 Civica, Inc.

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