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:

Heritage Pharmaceuticals Inc.

Administration route:

INTRAVENOUS

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

Product summary:

Furosemide Injection, USP is clear, colorless to slightly yellow solution. 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 Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) PremierPro RxTM is a trademark of Premier, Inc., used under license. Rev. 04/15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE INJECTION, SOLUTION
HERITAGE PHARMACEUTICALS INC.
----------
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:
Molecular Weight: 330.74
Molecular Formula: C
H ClN O S
Each mL contains: Furosemide USP 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 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 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,
12
11
2
5
mainly to albumin. Plasma concentrations ranging from 1 to 400
g/mL are 91 to 99% bound in healthy
individuals. T