Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Aphena Pharma Solutions - Tennessee, LLC
ORAL
PRESCRIPTION DRUG
Edema 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. Hypertension 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 51407-113-90: Bottle of 90 Tablets NDC 51407-113-01: Bottle of 100 Tablets NDC 51407-113-10: Bottle of 1000 Tablets NDC 51407-113-51: Bottle of 5000 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 51407-114-90: Bottle of 90 Tablets NDC 51407-114-01: Bottle of 100 Tablets NDC 51407-114-10: Bottle of 1000 Tablets NDC 51407-114-51: Bottle of 5000 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 51407-115-01: Bottle of 100 Tablets NDC 51407-115-05: Bottle of 500 Tablets NDC 51407-115-10: Bottle of 1000 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. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 4052002//12 Revised July 2017 Marketed/Packaged by: GSMS, Inc Camarillo, CA 91304 U.S.A.
Abbreviated New Drug Application
FUROSEMIDE- FUROSEMIDE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- FUROSEMIDE TABLETS USP 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: Furosemide USP . . . . . . . . . . . . . . . . 20 mg, 40 mg and 80 mg Each mL of Oral Solution for oral administration contains: Furosemide USP . . . . . . . . . . . . . . . . 10 mg per mL or 8 mg (40 mg per 5 mL) 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, 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 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 orange flavored and contains prosweet liquid and saccharin sodium. The 40 mg/5 mL solution is pineapple-peach flavored and contains sweet tone. CLINICAL PHARMACOLOGY In Lugege kogu dokumenti