NITROFURANTOIN capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

NITROFURANTOIN (UNII: 927AH8112L) (NITROFURANTOIN - UNII:927AH8112L), NITROFURANTOIN MONOHYDRATE (UNII: E1QI2CQQ1I) (NITROFURANTOIN - UNII:927AH8112L)

Boleh didapati daripada:

Bryant Ranch Prepack

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . 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 (monohydrate/ macrocrystals) and other antibacterial drugs,Nitrofurantoin Capsules, USP (monohydrate/ 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 th

Ringkasan produk:

Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) is available as 100 mg opaque yellowish brown and pale yellow capsules imprinted “101” on both cap and body. NDC 63629-9191-1 bottle of 100 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.] Rx Only

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

NITROFURANTOIN- NITROFURANTOIN CAPSULE
BRYANT RANCH PREPACK
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NITROFURANTOIN CAPSULES USP (MONOHYDRATE/MACROCRYSTALS)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness
of Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) and other
antibacterial
drugs, NitrofurantoinCapsules, USP (monohydrate/macrocrystals) should
be used only
to treat or prevent infections that are proven or strongly suspected
to be caused by
bacteria.
DESCRIPTION:
Nitrofurantoin is an antibacterial agent specific for urinary tract
infections.
Nitrofurantoin Capsules , USP (monohydrate/macrocrystals)is a hard
gelatin capsule
shell containing the equivalent of 100 mg of nitrofurantoin in the
form of 25 mg of
nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate.
The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-
furanyl]methylene]amino]-2,4- imidazolidinedione. The chemical
structure is the
following:
Molecular Weight: 238.16
The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-
furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The
chemical structure is
the following:
Molecular Weight: 256.17
INACTIVE INGREDIENTS: Each capsule contains carbomer 974P, colloidal
silicon dioxide,
D&C Yellow No. 10, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No. 6,
gelatin,
lactose, magnesium stearate, Opacode
black ink S-1-17843 (consist of shellac,
ferrosoferric oxide, butyl alcohol, propylene glycol, isopropyl
alcohol and ammonia),
povidone, pregelatinized starch, sodium lauryl sulfate, sucrose, talc,
titanium dioxide.
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY:
Each Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals)
contains two forms of
nitrofurantoin. Twenty-five percent is macrocrystalline
nitrofurantoin, which has slower
dissolution and absorption than nitrofurantoin monohydrate. The
remaining 75% is
nitrofurantoin monohydrate contained in a powder blend which, upon
exposure to
gastric and intestinal fluids