FUROSEMIDE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Blenheim Pharmacal, Inc.

INN (الاسم الدولي):

FUROSEMIDE

تركيب:

FUROSEMIDE 20 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Furosemide tablets, USP 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. Furosemide tablets, USP 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.

ملخص المنتج:

Furosemide tablets, USP 20 mg and 40 mg are supplied as white to off-white, round tablets. Furosemide tablets, USP 20 mg are debossed with 'RE22' on one side and plain on the other side and are supplied as follows: NDC 10544-131-30                 Bottles of 30 NDC 10544-131-90                Bottles of 90 Furosemide tablets, USP 40 mg are debossed with 'RE23' on one side and break-line on the other side and are supplied as follows: NDC 10544-584-30                Bottles of 30 NDC 10544-584-90                Bottles of 90 Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration.  Discolored tablets should not be dispensed. [Store at 20 – 25°C (68 – 77°F) [See USP Controlled Room Temperature]. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville , FL 32257 USA Manufactured by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India Packaged/ Marketed by: Blenheim Pharmacal, Inc. North Blenheim, New York (NY) 12131 January 2013

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FUROSEMIDE- FUROSEMIDE TABLET
BLENHEIM PHARMACAL, INC.
----------
FUROSEMIDE TABLETS, USP
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, USP for oral
administration contain furosemide, USP as the active ingredient and
the following inactive ingredients:
corn starch, lactose monohydrate, magnesium stearate, pregelatinized
starch, and sodium starch
glycolate. Chemically, it is
4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is
available as white to off white round tablets for oral administration
in dosage strengths of 20, 40 and 80
mg. Furosemide, USP is a white to slightly yellow odorless crystalline
powder. It is practically
insoluble in water, soluble in 15 parts of acetone, freely soluble in
dimethylformamide and in solution
of alkali hydroxides; soluble in methanol; sparingly soluble in
alcohol; very slightly soluble in
chloroform.
The CAS Registry Number is 54-31-9.
It has a molecular formula of C
H ClN O S and a molecular weight of 330.75.
Tested by USP Dissolution Test 1
The molecular structure is as follows:
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
12
11
2
5
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