MACRODANTIN- nitrofurantoin, macrocrystalline capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

nitrofurantoin, macrocrystalline (UNII: 927AH8112L) (nitrofurantoin - UNII:927AH8112L)

Available from:

Procter & Gamble Pharmaceuticals

INN (International Name):

nitrofurantoin, macrocrystalline

Pharmaceutical form:

CAPSULE

Composition:

25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Macrodantin 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 Macrodantin and other antibacterial drugs, Macrodantin 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 tract infections. Consequently, many patient

Product summary:

Macrodantin is available as follows: 25 mg opaque, white capsule imprinted with one black line encircling the capsule and coded "MACRODANTIN 25 mg" and "0149-0007."* NDC 0149-0007-05      bottle of 100 50 mg opaque, yellow and white capsule imprinted with two black lines encircling the capsule and coded "MACRODANTIN 50 mg" and "0149-0008."* NDC 0149-0008-05      bottle of 100 NDC 0149-0008-67      bottle of 1000 100 mg opaque, yellow capsule imprinted with three black lines encircling the capsule and coded "MACRODANTIN 100 mg" and "0149-0009."* NDC 0149-0009-05      bottle of 100 NDC 0149-0009-67      bottle of 1000 *Capsule design, registered trademark of Procter & Gamble Pharmaceuticals. Rx Only

Summary of Product characteristics

MACRODANTIN- NITROFURANTOIN, MACROCRYSTALLINE CAPSULE
PROCTER & GAMBLE PHARMACEUTICALS
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MACRODANTIN (NITROFURANTOIN MACROCRYSTALS)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of MACRODANTIN
and other antibacterial drugs, MACRODANTIN should be used only to
treat or prevent infections that are
proven or strongly suspected to be caused by bacteria.
DESCRIPTION:
MACRODANTIN (nitrofurantoin macrocrystals) is a synthetic chemical of
controlled crystal size. It is a
stable, yellow, crystalline compound. MACRODANTIN is an antibacterial
agent for specific urinary tract
infections. It is available in 25 mg, 50 mg, and 100 mg capsules for
oral administration.
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:
MACRODANTIN is a larger crystal form of FURADANTIN (nitrofurantoin).
The absorption of MACRODANTIN
is slower and its excretion somewhat less when compared to FURADANTIN.
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 MACRODANTIN, presumably by allowing better
dissolution in gastric juices.
MICROBIOLOGY: Nitrofurantoin is bactericidal in urine at therapeutic
doses. 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 macromolecules. As a result of such inactivations, the vital
biochemical processes of protein
synthesis, aerobic energy metabolism, DNA synthesis, RNA synthesis,
and cell wall synthesis are
inhibited. The broad-