FUROSEMIDE tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

MedVantx, Inc.

INN (Isem Internazzjonali):

FUROSEMIDE

Kompożizzjoni:

FUROSEMIDE 40 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Furosemide Tablets USP are 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 USP 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.

Sommarju tal-prodott:

Furosemide Tablets USP, 20 mg are available as white, round, flat face, beveled edge, unscored tablets, debossed with "TEVA" on one side and "2908" on the other side, containing 20 mg of furosemide USP, packaged in bottles of 100 and 1000 tablets and unit-dose boxes of 100 tablets. Furosemide Tablets USP, 40 mg are available as white, round, flat face, beveled edge tablets, debossed with "TEVA" on one side and "2907" and a bisect on the other side, containing 40 mg of furosemide USP, packaged in bottles of 100 and 1000 tablets and unit-dose boxes of 100 tablets. Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required). Exposure to light may cause slight discoloration. Discolored tablets should not be dispensed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. F 4/2011

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

FUROSEMIDE- FUROSEMIDE TABLET
MEDVANTX, INC.
----------
FUROSEMIDE TABLETS USP
WARNING
FUROSEMIDE USP 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 USP is a diuretic which is an anthranilic acid derivative.
Chemically, it is 4-chloro-N-
furfuryl-5-sulfamoylanthranilic acid. Furosemide USP is a white to
slightly yellow, odorless,
crystalline powder. It is practically insoluble in water, sparingly
soluble in alcohol, freely soluble in
solutions of dilute alkali hydroxides and insoluble in dilute acids.
The structural formula is as follows:
C
H CIN O S M.W. 330.74
Each tablet, for oral administration, contains 20 mg or 40 mg
furosemide USP. In addition, each tablet
contains the following inactive ingredients: colloidal silicon
dioxide, corn starch, lactose monohydrate,
magnesium stearate, povidone and sodium starch glycolate.
Both strengths: 20 mg and 40 mg meet 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. Th