MACRODANTIN- nitrofurantoin macrocrystals capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Almatica Pharma LLC

INN (International Name):

NITROFURANTOIN

Composition:

NITROFURANTOIN 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 patients

Product summary:

Macrodantin (Nitrofurantoin Capsules, USP) (macrocrystals)  is available as follows: 25 mg opaque, white capsule imprinted with "MACRODANTIN 25 mg" and "52427-286". NDC 52427-286-01 bottle of 100 50 mg opaque, yellow and white capsule imprinted with "MACRODANTIN 50 mg" and "52427-287". NDC 52427-287-01 bottle of 100 100 mg opaque, yellow capsule imprinted with "MACRODANTIN 100 mg" and "52427-288". NDC 52427-288-01 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

MACRODANTIN- NITROFURANTOIN MACROCRYSTALS CAPSULE
ALMATICA PHARMA LLC
REFERENCE LABEL SET ID: 44FB3519-9B0D-4037-A6EA-CD237961B7A4
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MACRODANTIN (NITROFURANTOIN CAPSULES, USP) (MACROCRYSTALS)
Rx Only
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 Capsules, USP) (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. Each capsule contains 25
mg, 50 mg, or
100 mg of nitrofurantoin macrocrystals.
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
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
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 MACRODANTIN, 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.
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MECHANISM OF ACTION
The mechanism of the antimicrobial action of nitrofurantoin is unusual
among
antibacterials.
Nitrofurantoin is reduced by bacterial