Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Preferred Pharmaceuticals, Inc.
FUROSEMIDE
FUROSEMIDE 40 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 40 mg white, scored tablets (Identified 54 583). Bottle of 30 - 68788-1966-3 Bottle of 60 - 68788-1966-6 Bottle of 90 - 68788-1966-9 Bottle of 100 - 68788-1966-1 Store and Dispense: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Note: Dispense in a tight, light-resistant container as defined in the USP/NF. Exposure to light may cause slight discoloration. Discolored tablets should not be dispensed. Protect From Moisture. PROTECT FROM LIGHT. Roxane Laboratories, Inc. Columbus, Ohio 43216 4052002//09 Revised April 2012 © RLI, 2012 Repackaged by Preferred Pharmaceuticals, Inc.
New Drug Application
FUROSEMIDE- FUROSEMIDE TABLET PREFERRED PHARMACEUTICALS, INC. ---------- FUROSEMIDE TABLETS USP, 20 MG, 40 MG, 80 MG FUROSEMIDE ORAL SOLUTION USP, 40 MG PER 5 ML AND 10 MG PER 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 AND DOSE SCHEDULE MUST BE ADJUSTED TO THE INDIVIDUAL PATIENT’S NEEDS. (SEE DOSAGE AND ADMINISTRATION.) DESCRIPTION Each tablet for oral administration contains: Each mL of Oral Solution for oral administration contains: 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: C H CLN O S M.W. 330.74 Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of furosemide. The tablets meet USP Dissolution Test 1. Furosemide Oral Solution is available in two strengths: 40 mg per 5 mL, and 10 mg per mL. _Inactive Ingredients:_ The tablets contain colloidal silicon dioxide, corn starch, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and stearic acid. The oral solutions contain D and C Yellow No. 10, FD and C Yellow No. 6, flavors, potassium carbonate 1 1/2 hydrate, propylene glycol, sorbitol solution and water. The 10 mg/mL solution is orange flavored and the 40 mg/5 mL solution is pineapple-peach flavored. The 10 mg/mL oral solution also contains saccharin sodium. Furosemide . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg Furosemide . . . . . . . . . . . . . . . . 10 mg, or 8 mg (40 mg per 5 mL) 12 11 2 5 CLINICAL PHARMACOLOGY Investigations into the mode of action of furosemide have uti Citiți documentul complet