Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Furosemide Injection, USP (10 mg/mL) Protect from light. Baxter Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213, India Issue date: 2018-10-27 1400007271 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 36000-284-25 10 mL single dose amber colored vials Boxes of 25 NDC 0404-9862-10 1 10 mL single dose vial in a bag (Vial bears NDC 36000-284-25) 10 mg/mL NDC 36000-283-25 4 mL single dose amber colored vials Boxes of 25 NDC 0404-9863-04 1 4 mL single dose vial in a bag (Vial bears NDC 36000-283-25) 10 mg/mL Image1.jpg; Sample Package Label Label1.jpg
- HOW SUPPLIED Furosemide Injection, USP (10 mg/mL) Protect from light. Baxter Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213, India Issue date: 2018-10-27 1400007271 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 36000-284-25 10 mL single dose amber colored vials Boxes of 25 NDC 0404-9862-10 1 10 mL single dose vial in a bag (Vial bears NDC 36000-284-25) 10 mg/mL NDC 36000-283-25 4 mL single dose amber colored vials Boxes of 25 NDC 0404-9863-04 1 4 mL single dose vial in a bag (Vial bears NDC 36000-283-25) 10 mg/mL Image1.jpg
- 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 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide is a white to off-white odorless 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 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 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
Not available
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
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.) Rx Only
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 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.
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