FUROSEMIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Gland Pharma Limited

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 (10 mg/mL) Do not use if solution is discolored. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Protect from light.  Manufactured by: Gland Pharma Limited  Hyderabad 500043, India Revised Date: February, 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE - FUROSEMIDE INJECTION, SOLUTION
GLAND PHARMA LIMITED
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FUROSEMIDE INJECTION, USP 10 MG/ML RX ONLY
BOXED 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 USP, 10 mg/mL is a sterile, non-pyrogenic
solution in vials for intravenous and
intramuscular injection.
Furosemide, USP 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:
Molecular formula: C
H ClN O S
Molecular weight: 330.75
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
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11
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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