FUROSEMIDE tablet FUROSEMIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Furosemide Tablets, USP 20 mg tablets are supplied as white, flat tablets with beveled edges, product identification “54 840” debossed on one side. NDC 0054-8297-25: Unit-Dose (10 x 10) NDC 0054-4297-25: Bottle of 100 Tablets NDC 0054-4297-31: Bottle of 1000 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 0054-8299-25: Unit-Dose (10 x 10) NDC 0054-4299-25: Bottle of 100 Tablets NDC 0054-4299-31: Bottle of 1000 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 0054-8301-25: Unit-Dose (10 x 10) NDC 0054-4301-25: Bottle of 100 Tablets NDC 0054-4301-29: Bottle of 500 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. Furosemide Oral Solution, USP 10 mg per mL oral solution is supplied as a (orange-flavored) clear, orange-colored solution. NDC 0054-3294-46: Bottle of 60 mL Dispense only in this bottle and only with the calibrated oral syringe provided. NDC 0054-3294-50: Bottle of 120 mL Dispense only in this bottle. PROTECT FROM LIGHT. NOTE: DISCARD OPENED BOTTLE AFTER 90 DAYS. 40 mg per 5 mL oral solution is supplied as a (pineapple-peach flavored) clear, orange-colored solution. NDC 0054-3298-63: Bottle of 500 mL Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF PROTECT FROM LIGHT. Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000360/01 Revised October 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE TABLET
FUROSEMIDE- FUROSEMIDE SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
FUROSEMIDE TABLETS, USP AND FUROSEMIDE ORAL SOLUTION, USP
RX ONLY
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:
Each mL of Oral Solution for oral administration contains:
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; freely
soluble in acetone,
dimethylformamide and in solutions of alkali hydroxides; soluble in
methanol; sparingly
soluble in alcohol; slightly soluble in ether; very slightly soluble
in chloroform. The CAS
Registry Number is 54-31-9.
The structural formula is as follows:
Furosemide, USP . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg
Furosemide, USP . . . . . . . . . . . . . . . . 10 mg per mL or 8 mg
(40 mg per 5 mL)
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 ora