国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Mylan Institutional Inc.
FUROSEMIDE
FUROSEMIDE 20 mg
ORAL
PRESCRIPTION DRUG
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.
Furosemide Tablets, USP are available as tablets for oral administration. Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP. The 20 mg tablets are white, round, unscored tablets debossed with M2 . They are available as follows: NDC 51079-072-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 40 mg tablets are white, round, scored tablets debossed with MYLAN over 216 on one side of the tablet and 40 on the other side. They are available as follows: NDC 51079-073-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 80 mg tablets are white, round, scored tablets debossed with MYLAN over 232 on one side of the tablet and 80 on the other side. They are available as follows: NDC 51079-527-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Exposure to light may cause a slight discoloration. Discolored tablets should not be dispensed. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12678 4/21
Abbreviated New Drug Application
FUROSEMIDE- FUROSEMIDE TABLET MYLAN INSTITUTIONAL INC. ---------- 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. Chemically, it is 4-Chloro- _N_-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is a white to slightly yellow 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 structural formula is as follows: Each tablet for oral administration contains 20 mg, 40 mg or 80 mg of furosemide, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid. 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 plasma proteins, mainly to albumin. Plasma concentrations ranging from 1 to 400 mcg/mL are 91% to 99% bound in healthy individuals. The unbound fraction averages 2.3% to 4.1% at therapeutic concentrations. The onset of diuresis following oral administration is within one 阅读完整的文件