FUROSEMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 80 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Edema Furosemide tablets are 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 Furosemide tablets 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 tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Product summary:

Furosemide Tablets, USP 20 mg, 40 mg and 80 mg are supplied as white to off-white, round tablets. Furosemide Tablets, USP 20 mg are debossed with ‘RE22’ on one side and plain on the other side. Furosemide Tablets, USP 40 mg are debossed with ‘RE23’ on one side and break-line on the other side. Furosemide Tablets, USP 80 mg are debossed with ‘RE24’ on one side and break-line on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: 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 1 Store at 20 – 25° C (68 – 77° F). (See USP Controlled Room Temperature). Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE - FUROSEMIDE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
FUROSEMIDE TABLETS, 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
Furosemide is a diuretic which is an anthranilic acid derivative.
Furosemide tablets, USP for oral
administration contain furosemide, USP as the active ingredient and
the following inactive ingredients:
corn starch NF, lactose monohydrate NF, magnesium stearate NF,
pregelatinized starch NF and sodium
starch glycolate NF. Chemically, it is
4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is
available as white to off white round tablets for oral administration
in dosage strengths of 20, 40 and 80
mg. Furosemide is a white to off-white granular 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 structural formula is as follows:
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 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
extensively bound to