FUROSEMIDE- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

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 TABLETS 40 mg are supplied as white, round, scored tablets in Bottles of 30. The 40 mg tablets are debossed with EP 117 on one side and 40 on the other. NDC 68071-3273-3 BOTTLES OF 30 NDC 68071-3273-6 BOTTLES OF 60 Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed. 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
NUCARE 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
12
11
2
5
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