Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Furosemide Injection, USP (10 mg/mL) is a clear colorless solution filled in amber colored vials and is supplied as: NDC 70756-618-05 2 mL single-dose vials Carton of 5 NDC 70756-618-25 2 mL single-dose vials Carton of 25 NDC 70756-619-05 4 mL single-dose vials Carton of 5 NDC 70756-619-10 4 mL single-dose vials Carton of 10 NDC 70756-619-25 4 mL single-dose vials Carton of 25 NDC 70756-620-10 10 mL single-dose vials Carton of 10 NDC 70756-620-25 10 mL single-dose vials Carton of 25 Do not use if solution is discolored. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: September 2022, V-05; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-618-82 Furosemide Injection, USP 20 mg/2 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 2 mL Single-dose vial NDC 70756-619-85 Furosemide Injection, USP 40 mg/4 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 4 mL Single-dose vial NDC 70756-620-86 Furosemide Injection, USP 100 mg/10 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 10 mL Single-dose vial NDC 70756-618-05 Furosemide Injection, USP 20 mg/2 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 5 x 2 mL Single-dose vials NDC 70756-619-05 Furosemide Injection, USP 40 mg/4 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 5 x 4 mL Single-dose vials NDC 70756-619-10 Furosemide Injection, USP 40 mg/4 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 10 x 4 mL Single-dose vials NDC 70756-619-25 Furosemide Injection, USP 40 mg/4 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 25 x 4 mL Single-dose vials NDC 70756-620-10 Furosemide Injection, USP 100 mg/10 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 10 x 10 mL Single-dose vials NDC 70756-618-25 Furosemide Injection, USP 20 mg/2 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 25 x 2 mL Single-dose vials NDC 70756-620-25 Furosemide Injection, USP 100 mg/10 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 25 x 10 mL Single-dose vials 2 ml vial 4 ml vial 10 ml vial 5x2ml carton 5x 4ml 10X4ML 25x4ml 10x10ml 25x2ml 25x10ml
- HOW SUPPLIED Furosemide Injection, USP (10 mg/mL) is a clear colorless solution filled in amber colored vials and is supplied as: NDC 70756-618-05 2 mL single-dose vials Carton of 5 NDC 70756-618-25 2 mL single-dose vials Carton of 25 NDC 70756-619-05 4 mL single-dose vials Carton of 5 NDC 70756-619-10 4 mL single-dose vials Carton of 10 NDC 70756-619-25 4 mL single-dose vials Carton of 25 NDC 70756-620-10 10 mL single-dose vials Carton of 10 NDC 70756-620-25 10 mL single-dose vials Carton of 25 Do not use if solution is discolored. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: September 2022, V-05
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-618-82 Furosemide Injection, USP 20 mg/2 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 2 mL Single-dose vial NDC 70756-619-85 Furosemide Injection, USP 40 mg/4 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 4 mL Single-dose vial NDC 70756-620-86 Furosemide Injection, USP 100 mg/10 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 10 mL Single-dose vial NDC 70756-618-05 Furosemide Injection, USP 20 mg/2 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 5 x 2 mL Single-dose vials NDC 70756-619-05 Furosemide Injection, USP 40 mg/4 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 5 x 4 mL Single-dose vials NDC 70756-619-10 Furosemide Injection, USP 40 mg/4 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 10 x 4 mL Single-dose vials NDC 70756-619-25 Furosemide Injection, USP 40 mg/4 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 25 x 4 mL Single-dose vials NDC 70756-620-10 Furosemide Injection, USP 100 mg/10 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 10 x 10 mL Single-dose vials NDC 70756-618-25 Furosemide Injection, USP 20 mg/2 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 25 x 2 mL Single-dose vials NDC 70756-620-25 Furosemide Injection, USP 100 mg/10 mL (10 mg/mL) For Intravenous or Intramuscular Use Rx Only 25 x 10 mL Single-dose vials 2 ml vial 4 ml vial 10 ml vial 5x2ml carton 5x 4ml 10X4ML 25x4ml 10x10ml 25x2ml 25x10ml
Overview
Furosemide, USP 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 solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is freely soluble in acetone, in dimethylformamide, and in solutions of alkali hydroxides, soluble in methanol, sparingly soluble in alcohol, slightly soluble in ether, very slightly soluble in chloroform, practically insoluble in water. The structural formula is as follows: Molecular Formula: C 12 H 11 ClN 2 O 5 S Molecular Weight: 330.74 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. structure
Indications & Usage
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema: Furosemide 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 is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide 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 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 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. Discard unused portion.
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).
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 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 Exfoliative dermatitis Bullous pemphigoid Erythema multiforme Purpura Photosensitivity Urticaria Rash Pruritus Stevens-Johnson Syndrome Toxic epidermal necrolysis Cardiovascular Reaction 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. To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995- 4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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