FUROSEMIDE- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FUROSEMIDE TABLET 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 TABLET is particularly useful when an agent with greater diuretic potential is desired. Oral FUROSEMIDE TABLET 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 TABLETS alone. FUROSEMIDE TABLET is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Product summary:

FUROSEMIDE TABLET 20 mg are supplied as white, round tablets in Bottles of: 30 Tablets NDC# 68788-6397-3 60 Tablets NDC# 68788-6397-6 90 Tablets NDC# 68788-6397-9 100 Tablets NDC# 68788-6397-1 Tested by USP Dissolution Test 2 Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
FUROSEMIDE TABLETS, USP
RX ONLY
WARNING
FUROSEMIDE TABLETS 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 TABLET is a diuretic which is an anthranilic acid
derivative. FUROSEMIDE
TABLET for oral administration contain furosemide as the active
ingredient and the following inactive
ingredients: lactose anhydrous NF, magnesium stearate NF, starch NF,
microcrystalline cellulose NF,
sodium starch Glycolate NF, and colloidal silicon dioxide NF.
Chemically, it is 4-chloro-N-furfuryl-5-
sulfamoylanthranilic acid. FUROSEMIDE TABLET is available as 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 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.
The molecular structure is as follows:
CLINICAL PHARMACOLOGY
Investigations into the mode of action of FUROSEMIDE TABLET 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 TABLET 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. F