FUROSEMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ReadyMeds

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 20 mg

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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE TABLET
READYMEDS
----------
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 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 concentrations ranging from 1 to 400 mcg/mL
are 91 to 99% bound in healthy
ind