FUROSEMIDE tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Mylan Institutional Inc.

INN (Alþjóðlegt nafn):

FUROSEMIDE

Samsetning:

FUROSEMIDE 20 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

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 51079-072-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 40 mg tablets are white, round, scored tablets debossed with MYLAN over 216 on one side of the tablet and 40 on the other side. They are available as follows: NDC 51079-073-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 51079-527-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Exposure to light may cause a slight discoloration. Discolored tablets should not be dispensed. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12678 4/21

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FUROSEMIDE- FUROSEMIDE TABLET
MYLAN INSTITUTIONAL INC.
----------
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