Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Furosemide Injection, USP is a sterile, non-pyrogenic, clear colorless solution and is available as follows: 20 mg per 2 mL (10 mg/mL) 2 mL Single-Dose Amber Colored Vials in a Carton of 25 NDC 55150-322-25 40 mg per 4 mL (10 mg/mL) 4 mL Single-Dose Amber Colored Vials in a Carton of 25 NDC 55150-323-25 100 mg per 10 mL (10 mg/mL) 10 mL Single-Dose Amber Colored Vials in a Carton of 25 NDC 55150-324-25 Do not use if solution is discolored. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. The vial stopper is not made with natural rubber latex. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 55150-322-25 2 mL Single-Dose Amber Colored Vials in a Carton of 25 NDC 0404-9864-02 1 2 mL Single-Dose Vial in a bag (Vial bears NDC 55150-322-01) 20 mg per 2 mL (10 mg/mL) Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialties Limited Hyderabad - 500032 India Revised: June 2023; SAMPLE PACKAGE LABEL Label1.jpg
- HOW SUPPLIED Furosemide Injection, USP is a sterile, non-pyrogenic, clear colorless solution and is available as follows: 20 mg per 2 mL (10 mg/mL) 2 mL Single-Dose Amber Colored Vials in a Carton of 25 NDC 55150-322-25 40 mg per 4 mL (10 mg/mL) 4 mL Single-Dose Amber Colored Vials in a Carton of 25 NDC 55150-323-25 100 mg per 10 mL (10 mg/mL) 10 mL Single-Dose Amber Colored Vials in a Carton of 25 NDC 55150-324-25 Do not use if solution is discolored. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. The vial stopper is not made with natural rubber latex. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 55150-322-25 2 mL Single-Dose Amber Colored Vials in a Carton of 25 NDC 0404-9864-02 1 2 mL Single-Dose Vial in a bag (Vial bears NDC 55150-322-01) 20 mg per 2 mL (10 mg/mL) Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialties Limited Hyderabad - 500032 India Revised: June 2023
- SAMPLE PACKAGE LABEL Label1.jpg
Overview
Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection USP, 10 mg/mL is a sterile, non-pyrogenic, clear colorless solution in vials for intravenous and intramuscular injection. Furosemide USP is a white to slightly yellow, crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows: Each mL contains: Furosemide USP 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3. Formula1.jpg
Indications & Usage
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide Injection is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Injection is particularly useful when an agent with greater diuretic potential is desired. Furosemide Injection is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of Furosemide Injection is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, Furosemide Injection is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.
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 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 Injection 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 Injection 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.
Warnings & Precautions
WARNINGS In patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used). (See PRECAUTIONS, Drug Interactions .) Pediatric Use: In premature neonates with respiratory distress syndrome, diuretic treatment with furosemide in the first few weeks of life may increase the risk of persistent patent ductus arteriosus (PDA), possibly through a prostaglandin-E-mediated process. Literature reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity. Hearing loss in neonates has been associated with the use of furosemide injection (see WARNINGS , above).
Boxed Warning
BOXED WARNING WARNING Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient’s needs. (See DOSAGE AND ADMINISTRATION.)
Contraindications
Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
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 Reactions 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 spasms 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.
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