NITROFURANTOIN MACROCRYSTALS capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

PD-Rx Pharmaceuticals, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Nitrofurantoin macrocrystals capsules 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 capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules 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 t

Produktbesonderheiten:

Nitrofurantoin macrocrystals capsules is available as follows: 50 mg opaque, yellow and white capsule imprinted with “MACRODANTIN 50 mg” and “52427-287”. NDC 43063-675-28 bottle of 28 NDC 43063-675-40 bottle of 40 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.

Berechtigungsstatus:

New Drug Application

Fachinformation

NITROFURANTOIN MACROCRYSTALS- NITROFURANTOIN MACROCRYSTALS CAPSULE
PD-RX PHARMACEUTICALS, INC.
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NITROFURANTOIN MACROCRYSTALS CAPSULES
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
nitrofurantoin macrocrystals capsules and other antibacterial drugs,
nitrofurantoin
macrocrystals capsules should be used only to treat or prevent
infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION
Nitrofurantoin macrocrystals capsules is a synthetic chemical of
controlled crystal size.
It is a stable, yellow, crystalline compound. Nitrofurantoin
macrocrystals capsules 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 capsules is a larger crystal form of
nitrofurantoin. The
absorption of nitrofurantoin macrocrystals capsules is slower and its
excretion
somewhat less when compared to nitrofurantoin. 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 nitrofurantoin macrocrystals capsules,
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