NITROFURANTOIN MACROCRYSTALS capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

NITROFURANTOIN

Composition:

NITROFURANTOIN 50 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 urina

Product summary:

Nitrofurantoin Macrocrystals Capsules USP are available as pink opaque/white opaque capsules, imprinted with , “Zenith 50 mg” on the cap and “2130”, underlined with a double bar, on the body, in black ink, containing 50 mg nitrofurantoin macrocrystals, packaged in Nitrofurantoin Macrocrystals Capsules USP are available as pink opaque capsules, imprinted with , “Zenith 100 mg” on the cap and “2131”, underlined with a triple bar, on the body, in black ink, containing 100 mg nitrofurantoin macrocrystals, packaged in Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROFURANTOIN MACROCRYSTALS - NITROFURANTOIN MACROCRYSTALS CAPSULE
PHYSICIANS TOTAL CARE, INC.
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NITROFURANTOIN CAPSULES USP (MACROCRYSTALS)
RX ONLY
2130
2131
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 chemically designated as
1-[[(5-nitro-2-furanyl)methylene]amino]-2,4-imidazolidinedione and has
the following structural formula:
C H N O M.W. 238.16
Each capsule, for oral administration, contains 50 mg or 100 mg of
nitrofurantoin macrocrystals. In
addition, each capsule contains the following inactive ingredients:
corn starch, edible black ink (black
iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum
Lake, FD&C Blue No. 2
Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol,
shellac glaze), gelatin, lactose
monohydrate, silicon dioxide, sodium lauryl sulfate, talc, titanium
dioxide and colorant D&C Red No.
33.
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 to 24 hours)
on day 1 and day 7 were 37.9% and 35%.
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.
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