देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
Aurobindo Pharma Limited
ORAL
PRESCRIPTION DRUG
INDICATIONS AND USAGE: Nitrofurantoin capsules (macrocrystals) 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 capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) 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 lack the broader tissue d
HOW SUPPLIED: Nitrofurantoin Capsules, USP (macrocrystals) are available as follows: 100 mg grey opaque cap/gray opaque body, hard gelatin capsule filled with yellow powder. The capsule printed with ‘NT 100’ with black ink on cap. Bottles of 100 NDC 59651-795-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature .] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 11/2023
Abbreviated New Drug Application
NITROFURANTOIN (MACROCRYSTALS) - NITROFURANTOIN (MACROCRYSTALS) CAPSULE AUROBINDO PHARMA LIMITED ---------- NITROFURANTOIN CAPSULES, USP (MACROCRYSTALS) 100 MG RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (macrocrystals) and other antibacterial drugs, nitrofurantoin (macrocrystals) 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 lemon-yellow crystals. Nitrofurantoin (macrocrystals) is an antibacterial agent for specific urinary tract infections. It is available in 100 mg capsules for oral administration. Each capsule contains 100 mg of nitrofurantoin USP (macrocrystals). 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione INACTIVE INGREDIENTS: Each capsule contains black iron oxide, corn starch, gelatin, lactose monohydrate, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac. CLINICAL PHARMACOLOGY: Nitrofurantoin (macrocrystals) is a larger crystal form of Furadantin (nitrofurantoin). The absorption of nitrofurantoin (macrocrystals) is slower and its excretion somewhat less when compared to Furadantin. 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 35.0%. Unlike many drugs, the presence of food or agents delaying gastric emptying can ® increase the bioavailability of nitrofurantoin (macrocrystals), presumably by allowing better dissolution in gastric juices. MICROBIOLOGY Nitrofurantoin is a nitrofuran antimicrobial agent with activity against certain Gram- positive and Gram-negative bacteria. MECHANISM OF ACTION The mech पूरा दस्तावेज़ पढ़ें