FUROSEMIDE- furosemide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

FUROSEMIDE

Composition:

FUROSEMIDE 20 mg

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 NDC: 70518-0050-00 NDC: 70518-0050-01 NDC: 70518-0050-02 NDC: 70518-0050-03 NDC: 70518-0050-04 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOTTLE PLASTIC PACKAGING: 180 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FUROSEMIDE - FUROSEMIDE TABLET
REMEDYREPACK INC.
----------
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 to
plasma proteins, mainl