FUROSEMIDE injection, solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)

Доступно од:

Hospira, Inc.

Пут администрације:

INTRAMUSCULAR

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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.

Резиме производа:

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

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

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