FUROSEMIDE- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 40 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 40 mg white, scored tablets (Identified 54 583). Bottle of 30 - 68788-1966-3 Bottle of 60 - 68788-1966-6 Bottle of 90 - 68788-1966-9 Bottle of 100 - 68788-1966-1   Store and Dispense: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Note: Dispense in a tight, light-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.   Roxane Laboratories, Inc. Columbus, Ohio 43216   4052002//09 Revised April 2012 © RLI, 2012 Repackaged by Preferred Pharmaceuticals, Inc.

Authorization status:

New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
FUROSEMIDE TABLETS USP, 20 MG, 40 MG, 80 MG
FUROSEMIDE ORAL SOLUTION USP, 40 MG PER 5 ML AND 10 MG PER ML
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 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.
The structural formula is as follows:
C H CLN O S M.W. 330.74
Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of
furosemide. The tablets meet
USP Dissolution Test 1. Furosemide Oral Solution is available in two
strengths: 40 mg per 5 mL, and
10 mg per mL.
_Inactive Ingredients:_
The tablets contain colloidal silicon dioxide, corn starch, lactose
monohydrate, microcrystalline
cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch
glycolate and stearic acid.
The oral solutions contain D and C Yellow No. 10, FD and C Yellow No.
6, flavors, potassium
carbonate 1 1/2 hydrate, propylene glycol, sorbitol solution and
water. The 10 mg/mL solution is orange
flavored and the 40 mg/5 mL solution is pineapple-peach flavored. The
10 mg/mL oral solution also
contains saccharin sodium.
Furosemide . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg
Furosemide . . . . . . . . . . . . . . . . 10 mg, or 8 mg (40 mg per 5
mL)
12
11
2
5
CLINICAL PHARMACOLOGY
Investigations into the mode of action of furosemide have uti