País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)
Aphena Pharma Solutions - Tennessee, LLC
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.
Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Furosemide tablets, USP, for oral administration, are available as: 20 mg: round, white, scored tablets, debossed GG 21 on one side and plain on the reverse side, and supplied as: NDC 0781-1818-01 bottles of 100 NDC 0781-1818-05 bottles of 500 NDC 0781-1818-10 bottles of 1000 40 mg: round, white, scored tablets, debossed GG 201 on one side and plain on the reverse side, and supplied as: NDC 0781-1966-60 bottles of 60 NDC 0781-1966-01 bottles of 100 NDC 0781-1966-05 bottles of 500 NDC 0781-1966-10 bottles of 1000 80 mg: round, white, scored tablets, debossed GG 80 on one side and plain on the reverse side, and supplied as: NDC 0781-1446-01 bottles of 100 NDC 0781-1446-05 bottles of 500 Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed. Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.
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 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 structural formula is as follows: Furosemide is available in 20 mg, 40 mg and 80 mg tablets for oral administration. Inactive ingredients include lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and starch (corn). Meets USP Dissolution Test 1. 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 biotransformation product of furosemide in man. Furosemide is extensively bound to plasma proteins, mainly to albumin. Plasma concentrations ranging from 1 to 400 mcg/mL are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic concentrations. The onset of diuresis following oral administration is Leia o documento completo