14-PANEL TOXICOLOGY MEDICATED COLLECTION SYSTEM- furosemide kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Morkin Companies, Inc DBA Medical Technologies, Inc

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. In premature infants Furosemide tablets may precipitate nephrocalcinosis/nephrolithiasis. Nephrocalcinosis/ nephrolithiasis has also been observed in children under 4 years of age with no history of prematurity who have been treated chronically with Furosemide tablets. Monitor renal functi

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 1 (NDC 70529-062-01). 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” STORAGE Store at 20° to 25ºC (68º to 77ºF) 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

14-PANEL TOXICOLOGY MEDICATED COLLECTION SYSTEM- FUROSEMIDE
MORKIN COMPANIES, INC DBA MEDICAL TECHNOLOGIES, INC
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14-PANEL POC TOXICOLOGY MEDICATED COLLECTION SYSTEM
FUROSEMIDE TABLETS, USP 20 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
biotran