FUROSEMIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

Furosemide

Composition:

Furosemide 10 mg in 1 mL

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 Oral Solution USP, 10 mg/mL is supplied as orange-flavored liquid in plastic bottles of 2 fl oz (60 mL) accompanied by a graduated dropper and plastic bottles of 4 fl oz (120 mL) accompanied by a graduated dispensing spoon. 2 fl oz (60 mL)             NDC 60432-613-60 4 fl oz (120 mL)           NDC 60432-613-04 NOTE: Store at 25°C (77°F): excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in original or tight, light-resistant containers as defined in the USP with graduated dropper or graduated spoon (dropper graduated in 5 mg increments at 5, 10, 15, and 20 mg corresponding to 0.5, 1, 1.5, and 2 mL; dispensing spoon graduated in 20 mg increments at 20, 40, 60, and 80 mg corresponding to 2, 4, 6, and 8 mL). Discard opened bottle after 90 days. PROTECT FROM LIGHT

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE- FUROSEMIDE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
----------
FUROSEMIDE
ORAL SOLUTION USP,
10 MG/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 SCHEDULE MUST BE ADJUSTED TO THE INDIVIDUAL
PATIENT'S NEEDS. (SEE
DOSAGE AND ADMINISTRATION.)
DESCRIPTION
Each mL of Oral Solution for oral administration contains:
Furosemide, USP.....................................10 mg per mL
Alcohol ....................................................11.6%
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:
Furosemide Oral Solution, USP is available for oral administration
containing 10 mg per mL. The oral
solution contains the following inactive ingredients: Dehydrated
alcohol, D&C Yellow No. 10, FD&C
Yellow No. 6, glycerin, hydrochloric acid, natural and artificial
orange juice flavor, purified water,
sodium hydroxide and sorbitol solution. It may contain 10%
hydrochloric acid solution or 10% sodium
hydroxide solution for pH adjustment. The pH range is between 7.0 and
9.0.
CLINICAL PHARMACOLOGY
Investigations into the mode of action of furosemide 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 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 inhi