FUROSEMIDE- furosemide tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Quality Care Products LLC

INN (International Name):

FUROSEMIDE

구성:

FUROSEMIDE 20 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

FUROSEMIDE TABLET 20 mg are supplied as white, round tablets. The 20 mg tablets are imprinted with "EP 116" on one side and plain on the other. 55700-461-30 FUROSEMIDE TABLETS 40 mg are supplied as white, round, scored tablets.  The 40 mg tablets are imprinted with "EP 117" on one side and "40" on the other. FUROSEMIDE TABLETS 80 mg are supplied as white, round, scored tablets.  The 80 mg tablets are imprinted with "EP 118" on one side and "80" on the other. Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed. Meets 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.] Rev. 02 03/16

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

FUROSEMIDE - FUROSEMIDE TABLET
QUALITY CARE PRODUCTS LLC
----------
FUROSEMIDE TABLETS, USP
20 mg, 40 mg, and 80 mg
Rx only
WARNING
FUROSEMIDE TABLET 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: corn starch, lactose anhydrous,
magnesium stearate,
pregelatinized starch, microcrystalline cellulose, sodium starch
Glycolate, and colloidal
silicon dioxide. 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 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 CAS Registry Number is 54-31-9.
The structural formula 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
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