Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)
Shionogi Inc.
ORAL
PRESCRIPTION DRUG
Furadantin 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Furadantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Furadantin , other therapeutic agents with broader tissue distribution should be selected. In considering the use of Furadantin , lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development
Furadantin Oral Suspension is available in: NDC 59630-450-08 glass amber bottle of 230 mL Avoid exposure to strong light which may darken the drug. It is stable when stored between 20°-25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, plastic (PET) or glass container. Use within 30 days. Keep out of reach of children. Rx only
New Drug Application
FURADANTIN- NITROFURANTOIN SUSPENSION SHIONOGI INC. ---------- FURADANTIN (NITROFURANTOIN) ORAL SUSPENSION DESCRIPTION FURADANTIN (nitrofurantoin), a synthetic chemical, is a stable, yellow, crystalline compound. Furadantin is an antibacterial agent for specific urinary tract infections. FURADANTIN is available in 25mg/5mL liquid suspension for oral administration. 1-[[(5-NITRO-2-FURANYL)METHYLENE]AMINO]-2, 4 -IMIDAZOLIDINEDIONE INACTIVE INGREDIENTS FURADANTIN Oral Suspension contains carboxymethylcellulose sodium, citric acid, flavors, glycerin, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium citrate, and sorbitol. CLINICAL PHARMACOLOGY Orally administered FURADANTIN is readily absorbed and rapidly excreted in urine. 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 42.7% and 43.6%. Unlike many drugs, the presence of food or agents delaying gastric emptying can increase the bioavailability of FURADANTIN, presumably by allowing better dissolution in gastric juices. MICROBIOLOGY Mode of Action Nitrofurantoin is reduced by a wide range of enzymes including bacterial flavoproteins to reactive intermediates which are damaging to macromolecules such as DNA and proteins. Cross-Resistance Although cross-resistance with other antimicrobials may occur, cross resistance with sulfonamides has not been observed. Interaction with Other Antimicrobials Antagonism has been demonstrated _in vitro_ between nitrofurantoin and quinolone antimicrobial agents. ® Nitrofurantoin, in the form of nitrofurantoin oral suspension, has been shown to be active against most of the following bacteria both _in vitro_ and in clinical infections :(See INDICATIONS AND USAGE). GRAM-POSITIVE AEROBES _Staphylococcus aureus_ _Enterococcus species_ GRAM-NEGATIVE AEROBES _Escherichia coli_ NOTE: Some strains of _Enterobact Կարդացեք ամբողջական փաստաթուղթը