NITROFURANTOIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

NITROFURANTOIN

Composition:

NITROFURANTOIN 25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitrofurantoin oral suspension 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 oral suspension 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 nitrofurantoin oral suspension 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 nitrofurantoin oral suspension, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin oral suspension, lower eradication rates sho

Product summary:

Nitrofurantoin oral suspension, USP (a clear, yellow colored, tutti frutti flavored suspension) containing 25 mg nitrofurantoin, USP in each teaspoonful (5 mL) is available as follows: 230 mL in an 8 oz  amber bottle. NDC 65162-689-88 Avoid exposure to strong light which may darken the drug. It is stable when stored between 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Shake vigorously. Dispense in tight, light-resistant, amber glass bottles. Use within 30 days. Keep out of reach of children. Rx only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2021-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN- NITROFURANTOIN SUSPENSION
AMNEAL PHARMACEUTICALS LLC
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NITROFURANTOIN ORAL SUSPENSION USP, 25 MG/5 ML
DESCRIPTION
Nitrofurantoin oral suspension USP, a synthetic chemical, is a stable,
yellow, crystalline
compound. Nitrofurantoin oral suspension, USP is an antibacterial
agent for specific
urinary tract infections. Nitrofurantoin oral suspension, USP is
available in 25 mg/5 mL
liquid suspension for oral administration.
INACTIVE INGREDIENTS
Nitrofurantoin oral suspension, USP contains anhydrous citric acid,
artificial fruit flavor,
carboxymethylcellulose sodium, glycerin, magnesium aluminum silicate,
methylparaben,
propylparaben, purified water, saccharin insoluble, sodium citrate,
and sorbitol solution
CLINICAL PHARMACOLOGY
Orally administered nitrofurantoin oral suspension 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
to 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 nitrofurantoin oral suspension,
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
_St