Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Hikma Pharmaceuticals USA 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 20 mg tablets are supplied as white, flat tablets with beveled edges, product identification “54 840” debossed on one side. NDC 0054-8297-25: Unit-Dose (10 x 10) NDC 0054-4297-25: Bottle of 100 Tablets NDC 0054-4297-31: Bottle of 1000 Tablets 40 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification “54 583” debossed on one side. NDC 0054-8299-25: Unit-Dose (10 x 10) NDC 0054-4299-25: Bottle of 100 Tablets NDC 0054-4299-31: Bottle of 1000 Tablets 80 mg tablets are supplied as white, flat tablets with beveled edges, scored on one side and product identification “54 533” debossed on one side. NDC 0054-8301-25: Unit-Dose (10 x 10) NDC 0054-4301-25: Bottle of 100 Tablets NDC 0054-4301-29: Bottle of 500 Tablets Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Note: Dispense in a tight, light-resistant, child-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. Furosemide Oral Solution, USP 10 mg per mL oral solution is supplied as a (orange-flavored) clear, orange-colored solution. NDC 0054-3294-46: Bottle of 60 mL Dispense only in this bottle and only with the calibrated oral syringe provided. NDC 0054-3294-50: Bottle of 120 mL Dispense only in this bottle. PROTECT FROM LIGHT. NOTE: DISCARD OPENED BOTTLE AFTER 90 DAYS. 40 mg per 5 mL oral solution is supplied as a (pineapple-peach flavored) clear, orange-colored solution. NDC 0054-3298-63: Bottle of 500 mL Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF PROTECT FROM LIGHT. Store and Dispense Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000360/01 Revised October 2023
Abbreviated New Drug Application
FUROSEMIDE- FUROSEMIDE TABLET FUROSEMIDE- FUROSEMIDE SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- FUROSEMIDE TABLETS, USP AND FUROSEMIDE ORAL SOLUTION, USP 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 slightly yellow, crystalline powder. It is practically insoluble in water; freely soluble in acetone, dimethylformamide and in solutions of alkali hydroxides; soluble in methanol; sparingly soluble in alcohol; slightly soluble in ether; very slightly soluble in chloroform. The CAS Registry Number is 54-31-9. The structural formula is as follows: Furosemide, USP . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg Furosemide, USP . . . . . . . . . . . . . . . . 10 mg per mL or 8 mg (40 mg per 5 mL) C H ClN O S M.W. 330.74 Furosemide Tablets, USP are available for oral administration containing 20 mg, 40 mg or 80 mg of Furosemide, USP. The tablets meet Dissolution Test 1. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, purified water, sodium lauryl sulfate, sodium starch glycolate and stearic acid. Furosemide Oral Solution, USP is also available for oral administration containing either 10 mg per mL or 40 mg per 5 mL. The oral solution contains the following inactive ingredients: D and C Yellow No. 10, FD and C Yellow No. 6, flavors, potassium carbonate 1½ hydrate, propylene glycol, purified water and sorbitol solution. The 10 mg/mL solution is ora Lugege kogu dokumenti