FUROSEMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, LLC dba Vangard Labs

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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: Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed. Store at 68° to 77°F (20° to 25°C); excursions permitted to 59º to 86º F (15º to 30º C) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
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 CAS Registry Number is 54-31-9.
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 con