FUROSEMIDE- furosemide tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Apotheca Inc.

INN (Διεθνής Όνομα):

FUROSEMIDE

Σύνθεση:

FUROSEMIDE 20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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. They are supplied as follows: NDC 12634-416-00 Bottles of 10 NDC 12634-416-01 Bottles of 100 NDC 12634-416-09 Bottles of 35 NDC 12634-416-12 Bottles of 120 NDC 12634-416-18 Bottles of 180 NDC 12634-416-40 Bottles of 40 NDC 12634-416-42 Bottles of 42 NDC 12634-416-45 Bottles of 45 NDC 12634-416-50 Bottles of 50 NDC 12634-416-52 Blister Pack of 12 NDC 12634-416-54 Blister Pack of 14 NDC 12634-416-57 Blister Pack of 20 NDC 12634-416-59 Blister Pack of 30 NDC 12634-416-60 Bottles of 60 NDC 12634-416-61 Blister Pack of 10 NDC 12634-416-63 Blister Pack of 3 NDC 12634-416-66 Blister Pack of 6 NDC 12634-416-67 Blister Pack of 7 NDC 12634-416-69 Blister Pack of 9 NDC 12634-416-71 Bottles of 30 NDC 12634-416-74 Bottles of 24 NDC 12634-416-78 Bottles of 28 NDC 12634-416-79 Bottles of 25 NDC 12634-416-80 Bottles of 20 NDC 12634-416-81 Bottles of 21 NDC 12634-416-82 Bottles of 12 NDC 12634-416-84 Bottles of 14 NDC 12634-416-85 Bottles of 15 NDC 12634-416-90 Bottles of 90 NDC 12634-416-91 Blister Pack of 1 NDC 12634-416-92 Bottles of 2 NDC 12634-416-93 Bottles of 3 NDC 12634-416-94 Bottles of 4 NDC 12634-416-95 Bottles of 5 NDC 12634-416-96 Bottles of 6 NDC 12634-416-97 Bottles of 7 NDC 12634-416-98 Bottles of 8 NDC 12634-416-99 Bottles of 9 Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed. Tested by 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.]

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FUROSEMIDE - FUROSEMIDE TABLET
APOTHECA INC.
----------
FUROSEMIDE TABLETS, USP
RX ONLY
WARNING
FUROSEMIDE TABLETS 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: lactose anhydrous NF, magnesium stearate NF, starch NF,
microcrystalline cellulose NF,
sodium starch Glycolate NF, and colloidal silicon dioxide NF.
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
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 CAS Registry Number is 54-31-9.
It has a molecular formula of C
H
ClN
O
S and a molecular weight of 330.75.
The molecular structure 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
ext