FUROSEMIDE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
25-09-2020

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Clinical Solutions Wholesale, LLC

INN (Jina la Kimataifa):

FUROSEMIDE

Tungo:

FUROSEMIDE 20 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

FUROSEMIDE TABLET 20 mg are supplied as white, round tablets in Bottles of 100 (NDC 69315-116-01), 1000 (NDC 69315-116-10), and blister packs of 30 (NDC 58118-0143-8). The 20 mg tablets are imprinted with "EP 116" on one side and plain on the other. FUROSEMIDE TABLETS 40 mg are supplied as white, round, scored tablets in Bottles of 100 (NDC 69315-117-01) and 1000 (NDC 69315-117-10). 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 in Bottles of 100 (NDC 69315-118-01) and 500 (NDC 69315-118-05).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

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                FUROSEMIDE- FUROSEMIDE TABLET
CLINICAL SOLUTIONS WHOLESALE, 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
                                
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