FUROSEMIDE- furosemide injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Furosemide (UNII: 7LXU5N7ZO5) (Furosemide - UNII:7LXU5N7ZO5)

Available from:

General Injectables & Vaccines, Inc.

INN (International Name):

Furosemide

Composition:

Furosemide 10 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Furosemide Injection is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Product summary:

Furosemide Injection, USP 10 mg/mL is supplied as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Do not use if solution is discolored or contains particulate. Protect from light. Do not remove from carton until ready for use. Discard unused portion. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1025-3.0 Revised: 05/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE - FUROSEMIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
----------
FUROSEMIDE INJECTION, USP
(10 MG/ML)
FLIPTOP VIAL
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
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 identified as 4-
chloro-_N_-furfuryl-5-sulfamoylanthranilic acid.
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. It has the following structural formula:
Molecular formula: C
H
Cl N O S
Molecular weight: 330.75
Furosemide Injection, USP is a sterile solution intended for
intramuscular or intravenous
administration. Each mL contains furosemide 10 mg and sodium chloride
sufficient to
render solution isotonic in water for injection. Contains sodium
hydroxide and may
contain hydrochloric acid for pH adjustment. pH 9.0 (8.0 to 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.
12
11
2
5
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
reabsorpti