FUROSEMIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

New Horizon Rx Group, LLC

INN (International ime):

FUROSEMIDE

Sastav:

FUROSEMIDE 40 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Edema 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. Hypertension 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.

Proizvod sažetak:

Furosemide tablets, USP 40 mg are supplied as white to off-white, round tablets. 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 58517-400-30          Bottles of 30 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. Distributed by: New Horizon Rx Group, LLC Kenner, LA 70062 Manufactured by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India. Rev. 11/13

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FUROSEMIDE - FUROSEMIDE TABLET
NEW HORIZON RX GROUP, LLC
----------
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 40 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 C N 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
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