FUROSEMIDE- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Safecor Health, LLC

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone. Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Product summary:

Furosemide tablets, USP, for oral administration, are available as: 40 mg: round, white, scored tablets, debossed GG 201 on one side and plain on the reverse side, and supplied as: Box of 100, Unit Dose Robot-Rx®1 Pouches NDC 48433-314-10 (Unit-Dose NDC# 48433-314-01) This package is not child resistant. For institutional use only. Packaging meets USP specifications for light resistance.

Authorization status:

New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE TABLET
SAFECOR HEALTH, LLC
----------
FUROSEMIDE TABLETS, USP
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 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:
Furosemide is available in 20 mg, 40 mg and 80 mg tablets for oral
administration.
Inactive ingredients include lactose monohydrate, magnesium stearate,
pregelatinized starch (corn) and
starch (corn).
Meets USP Dissolution Test 1.
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 absorption 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 the 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 mcg/mL
are 91 to 99% bound in healthy
individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic
concentrations.
The onset of diuresis following oral administration is within 1 hour.
The pe