FUROSEMIDE solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Furosemide (UNII: 7LXU5N7ZO5) (Furosemide - UNII:7LXU5N7ZO5)

Tilgjengelig fra:

Precision Dose Inc.

INN (International Name):

Furosemide

Sammensetning:

Furosemide 40 mg in 4 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Furosemide Oral Solution USP

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FUROSEMIDE- FUROSEMIDE SOLUTION
PRECISION DOSE INC.
----------
FUROSEMIDE ORAL SOLUTION USP
R 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
Each mL of Oral Solution for oral administration contains:
FurosemideUSP
10mg per mL or 8 mg (40
mg per 5 mL)
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 slightly yellow,
crystalline powder. It is practically insoluble in water; freely
soluble in acetone,
dimethylformamide and in solutions of alkali hydroxides; soluble in
methanol; sparingly
soluble in alcohol; slightly soluble in ether; very slightly soluble
in chloroform. The CAS
Registry Number is 54-31-9.
The structural formula is as follows:
C
H
CLN O S M.W. 330.75
Furosemide Oral Solution USP is also available for oral administration
containing either 10
mg per mL or 40 mg per 5 mL. The oral solution contains the following
inactive
ingredients: D and C Yellow No. 10, FD and C Yellow No. 6, flavors,
potassium carbonate
1½ hydrate, propylene glycol, purified water and sorbitol solution.
The 10 mg/mL
solution is orange flavored and contains prosweet liquid and saccharin
sodium. The 40
X
12 11
2
5
mg/5 mL solution is pineapple-peach flavored and contains sweet tone.
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 acti