NITROFURANTOIN MACROCRYSTALS- nitrofurantoin capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

DIRECT RX

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Nitrofurantoin Macrocrystals 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 and other antibacterial drugs, Nitrofurantoin Macrocrystals 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 t

Přehled produktů:

Nitrofurantoin Macrocrystals is available as follows: 25 mg opaque, white capsule imprinted with “MACRODANTIN 25 mg” and “52427-286”. NDC 47781-306-01 bottle of 100 50 mg opaque, yellow and white capsule imprinted with “MACRODANTIN 50 mg” and“52427-287”. NDC 47781-307-01 bottle of 100 100 mg opaque, yellow capsule imprinted with “MACRODANTIN 100 mg” and “52427-288”. NDC 47781-308-01 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.

Stav Autorizace:

New Drug Application

Charakteristika produktu

NITROFURANTOIN MACROCRYSTALS- NITROFURANTOIN CAPSULE
DIRECT RX
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NITROFURANTOIN MACROCRYSTALS
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Nitrofurantoin Macrocrystals and other antibacterial drugs,
Nitrofurantoin Macrocrystals
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
Nitrofurantoin Macrocrystals is a synthetic chemical of controlled
crystal size. It is a
stable, yellow, crystalline compound. Nitrofurantoin Macrocrystals is
an antibacterial
agent for specific urinary tract infections. It is available in 25 mg,
50 mg, and 100 mg
capsules for oral administration.
[structure]
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.
Nitrofurantoin Macrocrystals is a larger crystal form of
nitrofurantoin. The absorption of
Nitrofurantoin Macrocrystals 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
(0-24 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,
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
intermediates which
inactivate or alter bacterial ribosomal proteins and other
acromolecules. As a result of
such inactivations,