NITROFURANTOIN- nitrofurantion macrocrystals capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Central Texas Community Health Centers

INN (International Name):

NITROFURANTOIN

Composition:

NITROFURANTOIN 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 urinar

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

NITROFURANTOIN - NITROFURANTION MACROCRYSTALS CAPSULE
CENTRAL TEXAS COMMUNITY HEALTH CENTERS
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NITROFURANTOIN MACROCRYSTALS CAPSULES
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.
DESCRIPTION
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.
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 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 pro