LASIX- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LASIX 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.  LASIX is particularly useful when an agent with greater diuretic potential is desired. Oral LASIX 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 LASIX alone. LASIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Product summary:

LASIX (furosemide) Tablets 20mg are supplied as white, oval, monogrammed tablets in Bottles of 100 (NDC 30698-067-01) and 1000 (NDC 30698-067-10).  The 20mg tablets are imprinted with “Lasix ® ” on one side.  LASIX Tablets 40mg are supplied as white, round, monogrammed, scored tablets in Bottles of 100 (NDC 30698-060-01), 500 (NDC 30698-060-50), and 1000 (NDC 30698-060-10). The 40mg tablets are imprinted with “Lasix ® 40” on one side. LASIX Tablets 80mg are supplied as white, round, scored, monogrammed, facetted-edge tablets in Bottles of 50 (NDC 30698-066-05) and 500 (NDC 30698-066-50).  The 80mg tablets are imprinted with “Lasix ® 80” on one side.  Note:   Dispense in well-closed, light-resistant containers.  Exposure to light might cause a slight discoloration.  Discolored tablets should not be dispensed. Tested by USP Dissolution Test 2 Store at 68º to 77ºF (20º to 25ºC); excursions permitted to 59º to 86ºF (15º to 30ºC) [See USP Controlled Room Temperature]. Manufactured for and Distributed by: Validus Pharmaceuticals LLC 119 Cherry Hill Road, Suite 310 Parsippany, NJ 07054 [e-mail] www.validuspharma.com 1-866-982-5438 (1-866-9VALIDUS) Product of Canada © 2018 Validus Pharmaceuticals LLC 60031-05  August 2018

Authorization status:

New Drug Application

Summary of Product characteristics

LASIX- FUROSEMIDE TABLET
REMEDYREPACK INC.
----------
LAS IX
LASIX (FUROSEMIDE) TABLETS 20, 40, AND 80MG
RX ONLY
WARNING
LASIX (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
LASIX
is a diuretic which is an anthranilic acid derivative. LASIX tablets
for oral administration
contain furosemide as the active ingredient and the following inactive
ingredients: lactose monohydrate
NF, magnesium stearate NF, starch NF, talc USP, and colloidal silicon
dioxide NF. Chemically, it is 4-
chloro-N-furfuryl-5-sulfamoylanthranilic acid. LASIX is available as
white tablets for oral
administration in dosage strengths of 20, 40 and 80mg. 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 CAS Registry Number is 54-31-9.
The structural formula is as follows:
CLINICAL PHARMACOLOGY
Investigations into the mode of action of LASIX 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 LASIX inhibits primarily the absorption of sodium
and chloride not only in the
proximal and distal tubu 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 μg/mL to 400
μg/mL are 91% to 99% bound in
healthy indivi