furosemide- Furosemide tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Watson Labs

INN (Nome Internazionale):

Furosemide

Forma farmaceutica:

TABLET

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 nephritic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Hypertension: 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.

Dettagli prodotto:

Furosemide Tablets 20 mg are supplied as white, round unscored tablets, debossed WATSON 300 on one side in bottles of 100 and 1000. Furosemide Tablets 40 mg are supplied as white, round, scored tablets debossed WATSON 301 on one side in bottles of 100 and 1000. Furosemide Tablets 80 mg are supplied as white, round, scored tablets debossed WATSON 302 on one side in bottles of 100 and 500. Note: Dispense in a tight, light-resistant container, as defined in USP, with child-resistant closure. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed. Store at controlled room temperature: 20°-25°C (68°-77°F). [See USP.] Protect from light. Watson Laboratories, Inc. Corona, CA 92880 USA 10055-13 Revised: September 2005

Scheda tecnica

FUROSEMIDE- FUROSEMIDE TABLET
WATSON LABS
----------
FUROS EMIDE
TABLETS USP
REVISED: SEPTEMBER 2005
RX 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
Furosemide is a diuretic which is an anthranilic acid derivative.
Furosemide 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 solutions and insoluble
in dilute acids. Chemically, it is 4-
chloro-_N_-furfuryl-5-sulfamoylanthranilic acid with the following
structural formula:
Furosemide is available in 20 mg, 40 mg and 80 mg tablets for oral
administration.
The inactive ingredients include corn starch, lactose monohydrate,
magnesium stearate, and
microcrystalline cellulose.
Tested by 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 fo