FUROSEMIDE- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tablets are particularly useful when an agent with greater diuretic potential is desired. Oral 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 tablets alone. Furosemide tablets are contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Product summary:

Furosemide tablets 20 mg are supplied as white to off-white, round, flat face beveled edge, compressed tablets, debossed "EP" and "116" on one side and plain on the other side in bottles of 100 (NDC 69315-116-01), and 1000 (NDC 69315-116-10). Furosemide tables 40 mg are supplied as white to off-white, round, flat face beveled edge, bisected compressed tablets, debossed "EP" above bisect and "117" below bisect on one side, and "40" on the other side in bottles of 100 (NDC 69315-117-01) and 1000 (NDC 69315-117-10). Furosemide tablets 80 mg are supplied as white to off-white, round, flat face beveled edge, bisected compressed tablets, debossed "EP" above bisect and "118" below bisect on one side, and "80" on the other side in bottles of 100 (NDC 69315-118-01) and 500 (NDC 69315-118-05). Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed. Meets USP Dissolution Test 2 Store at 20° -25° C (68° -77° F) [ See USP Controlled Room Temperature]. Protect from light. Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev. 05 12/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE - FUROSEMIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
FUROSEMIDE TABLETS, USP
20 MG, 40 MG AND 80 MG
WARNING
FUROSEMIDE TABLETS ARE 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 tablets are a diuretic which is an anthranilic acid
derivative. Furosemide tablets for oral
administration contain furosemide as the active ingredient and the
following inactive ingredients: corn
starch, lactose anhydrous, magnesium stearate, pregelatinized starch,
microcrystalline cellulose, sodium
starch glycolate, and colloidal silicon dioxide. Chemically, it is
4-chloro-N-furfuryl- 5-
sulfamoylanthranilic acid. Furosemide tablets are available as white
tablets for oral administration in
dosage strengths of 20, 40 and 80 mg. 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:
CLINICAL PHARMACOLOGY
Investigations into the mode of action of Furosemide tablets 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 tablets 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 t