FUROSEMIDE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Aphena Pharma Solutions - Tennessee, LLC

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Edema 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. Hypertension 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.

leaflet_short:

Furosemide Tablets USP 20 mg tablets are supplied as white, flat tablets with beveled edges, product identification “54 840” debossed on one side. NDC 51407-113-90: Bottle of 90 Tablets NDC 51407-113-01: Bottle of 100 Tablets NDC 51407-113-10: Bottle of 1000 Tablets NDC 51407-113-51: ​Bottle of 5000 Tablets 40 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification “54 583” debossed on one side. NDC 51407-114-90: Bottle of 90 Tablets NDC 51407-114-01: Bottle of 100 Tablets NDC 51407-114-10: Bottle of 1000 Tablets NDC 51407-114-51: ​Bottle of 5000 Tablets 80 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification “54 533” debossed on one side. NDC 51407-115-01: Bottle of 100 Tablets NDC 51407-115-05: Bottle of 500 Tablets NDC 51407-115-10: ​Bottle of 1000 Tablets Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Note: Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. Exposure to light may cause slight discoloration. Discolored tablets should not be dispensed. Protect From Moisture. PROTECT FROM LIGHT. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 4052002//12 Revised July 2017 Marketed/Packaged by: GSMS, Inc Camarillo, CA 91304 U.S.A.

authorization_status:

Abbreviated New Drug Application

SPC

FUROSEMIDE- FUROSEMIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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FUROSEMIDE TABLETS USP
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
Each tablet for oral administration contains:
Furosemide USP . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg
Each mL of Oral Solution for oral administration contains:
Furosemide USP . . . . . . . . . . . . . . . . 10 mg per mL or 8 mg
(40 mg per 5 mL)
Furosemide is a diuretic which is an anthranilic acid derivative.
Chemically, it is 4-chloro- _N_-furfuryl-
5-sulfamoylanthranilic acid. Furosemide is a white to slightly yellow,
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:
C
H
ClN
O
S M.W. 330.74
Furosemide Tablets USP are available for oral administration
containing 20 mg, 40 mg or 80 mg of
Furosemide USP. The tablets meet Dissolution Test 1. Each tablet
contains the following inactive
ingredients: colloidal silicon dioxide, corn starch, lactose
monohydrate, microcrystalline cellulose,
pregelatinized starch, purified water, sodium lauryl sulfate, sodium
starch glycolate and stearic acid.
Furosemide Oral Solution USP is also available for oral administration
containing either 10 mg per mL
or 40 mg per 5 mL. The oral solution contains the following inactive
ingredients: D and C Yellow No.
10, FD and C Yellow No. 6, flavors, potassium carbonate 1½ hydrate,
propylene glycol, purified water
and sorbitol solution. The 10 mg/mL solution is orange flavored and
contains prosweet liquid and
saccharin sodium. The 40 mg/5 mL solution is pineapple-peach flavored
and contains sweet tone.
CLINICAL PHARMACOLOGY
In