Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Physicians Total Care, Inc.
FUROSEMIDE
FUROSEMIDE 20 mg
ORAL
PRESCRIPTION DRUG
Furosemide tablets, USP 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. Furosemide tablets, USP 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.
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 and are supplied as follows: Furosemide tablets, USP 40 mg are debossed with ‘RE23’ on one side and break-line on the other side and are supplied as follows: Furosemide tablets, USP 80 mg are debossed with ‘RE24’ on one side and break-line on the other side and are supplied 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]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ipca Laboratories Limited 48, Kandivli Ind. Estate, Mumbai 400 067, India. June 2009
Abbreviated New Drug Application
FUROSEMIDE - FUROSEMIDE TABLET PHYSICIANS TOTAL CARE, INC. ---------- 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, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide, USP is available as white to off white round tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide, USP is a white to slightly yellow odorless crystalline powder. It is practically insoluble in water, soluble in 15 parts of acetone, freely soluble in dimethylformamide and in solution of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; very slightly soluble in chloroform. 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 molecular structure 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 biotransformatio Læs hele dokumentet