FURADANTIN- nitrofurantoin suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L)

Dostępny od:

Shionogi Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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

Status autoryzacji:

New Drug Application

Charakterystyka produktu

FURADANTIN- NITROFURANTOIN SUSPENSION
SHIONOGI INC.
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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