Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
Nitrofurantoin macrocrystals capsules are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli , enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lac
Nitrofurantoin Capsules, USP (Macrocrystals) 100 mg are light yellow to yellow powder filled in size 2 empty hard gelatin capsules with blue opaque colored cap and blue opaque colored body imprinted with 560 in black ink and are supplied as follows: NDC 68071-4688-7 BOTTLES OF 14 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Dispense in a tight container (USP). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 11/18
Abbreviated New Drug Application
NITROFURANTOIN MACROCRYSTALS- NITROFURANTOIN MACROCRYSTALS CAPSULE NUCARE PHARMACEUTICALS,INC. ---------- NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS) RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION: Nitrofurantoin macrocrystals is a synthetic chemical of controlled crystal size. It is a stable, lemon-yellow, crystalline compound. Nitrofurantoin macrocrystals is an antibacterial agent for specific urinary tract infections. It is available in 50 mg and 100 mg capsules for oral administration. Nitrofurantoin macrocrystals is a lemon-yellow crystalline compound. It is soluble in dimethylformamide, very slightly soluble in water and in alcohol. Each nitrofurantoin capsules, USP (macrocrystals) intended for oral administration contains 50 mg and 100 mg of nitrofurantoin macrocrystals. In addition, each capsule contains the following inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally each 50 mg and 100 mg capsule shell contains FD & C Blue # 1, FD & C Red # 3 and sodium lauryl sulphate. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac. CLINICAL PHARMACOLOGY: Nitrofurantoin macrocrystals is a larger crystal form of nitrofurantoin. The absorption of nitrofurantoin macrocrystals is slower and its excretion somewhat less when compared to nitrofurantoin. Blood concentrations at therapeutic dosage are usually low. It is highly soluble in urine, to which it may impart a brown color. Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary drug recoveries (0 to 24 hours) on day 1 and day 7 were 37.9% and 35%. Unlike many drugs, the presence of food or agents delaying gas Прочитать полный документ