Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
Aidarex Pharmaceuticals LLC
NITROFURANTOIN
NITROFURANTOIN 100 mg
ORAL
PRESCRIPTION DRUG
Nitrofurantoin Macrocrystals is 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 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 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 distribution of other therapeutic agents approved for urinary t
Nitrofurantoin Macrocrystals is available as follows: 100 mg opaque, yellow capsule imprinted with “MACRODANTIN 100 mg” and “52427-288”. NDC 33261-0226-13 bottle of 4 NDC 33261-0226-14 bottle of 14 Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistantclosure.
New Drug Application
NITROFURANTION MACROCRYSTALS- NITROFURANTION MACROCRYSTALS CAPSULE AIDAREX PHARMACEUTICALS LLC ---------- NITROFURANTOIN MACROCRYSTALS CAPSULES 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 (nitrofurantoin macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Macrocrystals is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione INACTIVE INGREDIENTS: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10. 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 (0-24 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 mechanism of the antimicrobial action of nitrofurantoin is unusual among antibacterials. Nitrofurantoin is reduced by bacterial flavoproteins to reactive intermediat Baca dokumen lengkap