FUROSEMIDE injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

General Injectables & Vaccines, Inc.

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Furosemide Injection, USP (10 mg/mL) Do not use if solution is discolored. Store at 20° to 25°C (68° to 77°F) ; excursions permitted to 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature] 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

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FUROSEMIDE- FUROSEMIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
----------
FUROSEMIDE INJECTION, USP
10 MG/ML
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, 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.
CLINICAL PHARMACOLOGY
Investigations into the mode of action of furosemide have utilized
micropuncture studies
is 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 of efficacy is largely due to
this unique site of
action. The action on the distal tubule is independent of any
inhibitory effect on carbonic
anhydrase and aldosterone.
Recent evidence suggests that furosemide glucuronide is the only or at
least the major
biotransformation product of furosemide in man. Furosemide is
extensively bound to
plasma proteins, mainly to albumin. Plasma concentrations ranging from
1 to 400 μg/mL
are 91 to 99% bound in healthy individuals. The unbound fraction
av