FUROSEMIDE- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Furosemide 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. 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 is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Product summary:

Furosemide Tablets, USP are available as tablets for oral administration. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP. The 20 mg tablets are white, round, unscored tablets debossed with M2 . They are available as follows: NDC 0378-0208-01 bottles of 100 tablets NDC 0378-0208-10 bottles of 1000 tablets The 40 mg tablets are white, round, scored tablets debossed with MYLAN over 216 on one side and the tablet and 40 on the other side. They are available as follows: NDC 0378-0216-01 bottles of 100 tablets NDC 0378-0216-10 bottles of 1000 tablets The 80 mg tablets are white, round, scored tablets debossed with MYLAN over 232 on one side of the tablet and 80 on the other side. They are available as follows: NDC 0378-0232-01 bottles of 100 tablets NDC 0378-0232-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Exposure to light may cause a slight discoloration. Discolored tablets should not be dispensed. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 6/2018 FUR:R29

Authorization status:

New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE TABLET
REMEDYREPACK INC.
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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.
Chemically, it is 4-Chloro- _N_-furfuryl-
5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly
yellow 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:
Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of
furosemide, USP and the
following inactive ingredients: colloidal silicon dioxide, lactose
monohydrate, microcrystalline
cellulose, pregelatinized starch (corn) and stearic acid.
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 individuals. The unbound fraction averages 2.3% to 4.1% at
therapeutic concentrations.
The onset of diuresis following oral administration is within one
hour.