Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Hospira, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. 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. Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.
Furosemide Injection, USP 10 mg/mL is supplied as follows: Unit of Sale Concentration NDC 0409-9631-04 Bundle Containing 10 Single‑dose ANSYR Syringes 40 mg/4 mL (10 mg/mL) NDC 0409-1639-10 Bundle Containing 10 Single‑dose ANSYR Syringes 100 mg/10 mL (10 mg/mL) Do not use if solution is discolored or contains particulate. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.] Protect from light. Do not remove the Ansyr syringe from carton until ready to use. Discard unused portion. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1453-1.0 Revised: 09/2022
Abbreviated New Drug Application
FUROSEMIDE- FUROSEMIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- FUROSEMIDE Injection, USP (10 MG/ML) Ansyr™ Plastic Syringe RX ONLY 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 SCHEDULE MUST BE ADJUSTED TO THE INDIVIDUAL PATIENT’S NEEDS(SEE DOSAGE AND ADMINISTRATION). DESCRIPTION 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 an Ansyr™ plastic syringe for intravenous and intramuscular injection. Furosemide 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 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. The plastic syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material. Contains no preservative. CLINICAL PHARMACOLOGY Investigations into the mode of action of furosemide have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. It has been demonstrated that furosemide inhibits primarily the reabsorption of sodium and chloride not only in the proximal and distal tubules but also in the loop of Henle. The high degree o Lees het volledige document