FUROSEMIDE- furosemide tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

REMEDYREPACK INC.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Furosemide tablets 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 tablets are 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 tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Каталог на резюме:

Furosemide Tablets, USP 20 mg: White-off white, oval, debossed "3169" on one side and debossed "V" on the reverse side, available as follows: 40 mg: White-off white, round, scored, debossed "3170" over "V" on one side and plain on the reverse side, available as follows: 80 mg: White-off white, round, scored, debossed "3171" over "V" on one side and plain on the reverse side, available as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

FUROSEMIDE- FUROSEMIDE TABLET
REMEDYREPACK INC.
----------
FUROSEMIDE TABLETS, USP 20, 40, AND 80 MG
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 Tablets for oral administration contain furosemide as the
active ingredient
and the following inactive ingredients: corn starch NF, lactose
monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and
talc USP.
Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid.
Furosemide is available as white-off white tablets for oral
administration in dosage
strengths of 20, 40 and 80 mg. 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:
Tested by 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
hea