NITROFURANTOIN MACROCRYSTALS- nitrofurantoin macrocrystals capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

NuCare Pharmaceuticals,Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Nitrofurantoin Capsules USP (Macrocrystals) are 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 Capsules USP (Macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules USP (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

Ringkasan produk:

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 bottles of 100 (NDC 68071-4681-7) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

NITROFURANTOIN MACROCRYSTALS- NITROFURANTOIN MACROCRYSTALS CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
NITROFURANTOIN CAPSULES USP (MACROCRYSTALS)
RX ONLY
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 Capsules USP (Macrocrystals) are a synthetic chemical
of controlled crystal size. It is a
stable, yellow, crystalline compound. Nitrofurantoin Capsules USP
(Macrocrystals) are an antibacterial
agent for specific urinary tract infections.
Nitrofurantoin, USP (macrocrystals) is chemically designated as
2,4-Imidazolidinedione, 1-[[(5-nitro-2-
furanyl)methylene]amino]- and has the following structural formula:
C
H
N
O
(anhydrous) M.W. 238.16
Each capsule, for oral administration, contains 50 mg or 100 mg of
nitrofurantoin, USP (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, talc, titanium dioxide and colorant D&C Red No. 33.
CLINICAL PHARMACOLOGY
Nitrofurantoin macrocrystals are 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)
8
6
4
5
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 bet