NITROFURANTOIN- nitrofurantoin macrocrystals capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Bryant Ranch Prepack

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Nitrofurantoin macrocrystals capsules 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 macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules 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 therapeut

제품 요약:

NDC: 71335-1069-1: 40 Capsules in a BOTTLE NDC: 71335-1069-2: 28 Capsules in a BOTTLE NDC: 71335-1069-3: 30 Capsules in a BOTTLE NDC: 71335-1069-4: 20 Capsules in a BOTTLE NDC: 71335-1069-5: 14 Capsules in a BOTTLE NDC: 71335-1069-6: 10 Capsules in a BOTTLE NDC: 71335-1069-7: 12 Capsules in a BOTTLE NDC: 71335-1069-8: 90 Capsules in a BOTTLE NDC: 71335-1069-9: 6 Capsules in a BOTTLE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

NITROFURANTOIN- NITROFURANTOIN MACROCRYSTALS CAPSULE
BRYANT RANCH PREPACK
----------
NITROFURANTOIN CAPSULES, USP
(MACROCRYSTALS)<BR><BR>RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
nitrofurantoin macrocrystals capsules and other antibacterial drugs,
nitrofurantoin
macrocrystals capsules 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) is a synthetic chemical
of controlled crystal
size. It is a stable, lemon-yellow, crystalline compound.
Nitrofurantoin capsules, USP
(macrocrystals) is an antibacterial agent for specific urinary tract
infections. It is available
in 50 mg and 100 mg capsules for oral administration.
1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione
Nitrofurantoin macrocrystals is a lemon-yellow crystalline compound.
It is soluble in
dimethylformamide, very slightly soluble in water and in alcohol.
Each nitrofurantoin capsules, USP (macrocrystals) intended for oral
administration
contains 50 mg and 100 mg of nitrofurantoin macrocrystals. In
addition, each capsule
contains the following inactive ingredients: gelatin, lactose
monohydrate, magnesium
stearate, pregelatinized starch, talc and titanium dioxide.
Additionally each 50 mg and
100 mg capsule shell contains FD & C Blue # 1, FD & C Red # 3 and
sodium lauryl
sulphate. The capsule is printed with black pharmaceutical ink which
contains black iron
oxide, potassium hydroxide, propylene glycol and shellac.
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