País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
Almatica Pharma LLC
NITROFURANTOIN
NITROFURANTOIN 25 mg
ORAL
PRESCRIPTION DRUG
Macrodantin 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 Macrodantin and other antibacterial drugs, Macrodantin 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 tract infections. Consequently, many patients
Macrodantin (Nitrofurantoin Capsules, USP) (macrocrystals) is available as follows: 25 mg opaque, white capsule imprinted with "MACRODANTIN 25 mg" and "52427-286". NDC 52427-286-01 bottle of 100 50 mg opaque, yellow and white capsule imprinted with "MACRODANTIN 50 mg" and "52427-287". NDC 52427-287-01 bottle of 100 100 mg opaque, yellow capsule imprinted with "MACRODANTIN 100 mg" and "52427-288". NDC 52427-288-01 bottle of 100 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-resistant closure.
New Drug Application
MACRODANTIN- NITROFURANTOIN MACROCRYSTALS CAPSULE ALMATICA PHARMA LLC REFERENCE LABEL SET ID: 44FB3519-9B0D-4037-A6EA-CD237961B7A4 ---------- MACRODANTIN (NITROFURANTOIN CAPSULES, USP) (MACROCRYSTALS) Rx Only To reduce the development of drug-resistant bacteria and maintain the effectiveness of MACRODANTIN and other antibacterial drugs, MACRODANTIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION MACRODANTIN Nitrofurantoin Capsules, USP) (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. MACRODANTIN is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin macrocrystals. 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 MACRODANTIN is a larger crystal form of FURADANTIN (nitrofurantoin). The absorption of MACRODANTIN 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 MACRODANTIN, 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 Llegiu el document complet