Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Morton Grove Pharmaceuticals, Inc.
Furosemide
Furosemide 10 mg in 1 mL
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 Oral Solution USP, 10 mg/mL is supplied as orange-flavored liquid in plastic bottles of 2 fl oz (60 mL) accompanied by a graduated dropper and plastic bottles of 4 fl oz (120 mL) accompanied by a graduated dispensing spoon. 2 fl oz (60 mL) NDC 60432-613-60 4 fl oz (120 mL) NDC 60432-613-04 NOTE: Store at 25°C (77°F): excursions permitted to 15°C to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in original or tight, light-resistant containers as defined in the USP with graduated dropper or graduated spoon (dropper graduated in 5 mg increments at 5, 10, 15, and 20 mg corresponding to 0.5, 1, 1.5, and 2 mL; dispensing spoon graduated in 20 mg increments at 20, 40, 60, and 80 mg corresponding to 2, 4, 6, and 8 mL). Discard opened bottle after 90 days. PROTECT FROM LIGHT
Abbreviated New Drug Application
FUROSEMIDE- FUROSEMIDE SOLUTION MORTON GROVE PHARMACEUTICALS, INC. ---------- FUROSEMIDE ORAL SOLUTION USP, 10 MG/ML 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 SCHEDULE MUST BE ADJUSTED TO THE INDIVIDUAL PATIENT'S NEEDS. (SEE DOSAGE AND ADMINISTRATION.) DESCRIPTION Each mL of Oral Solution for oral administration contains: Furosemide, USP.....................................10 mg per mL Alcohol ....................................................11.6% Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro-_N_-furfuryl- 5-sulfamoylanthranilic acid. 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: Furosemide Oral Solution, USP is available for oral administration containing 10 mg per mL. The oral solution contains the following inactive ingredients: Dehydrated alcohol, D&C Yellow No. 10, FD&C Yellow No. 6, glycerin, hydrochloric acid, natural and artificial orange juice flavor, purified water, sodium hydroxide and sorbitol solution. It may contain 10% hydrochloric acid solution or 10% sodium hydroxide solution for pH adjustment. The pH range is between 7.0 and 9.0. 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 inhi Lees het volledige document