NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- nitrofurantoin monohydrate/macrocrystalline capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Rebel Distributors Corp

INN (Международно Name):

NITROFURANTOIN

Композиция:

NITROFURANTOIN 25 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Nitrofurantoin Monohydrate/Macrocrystals Capsules 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 Monohydrate/Macrocrystals Capsules and other antibacterial drugs, Nitrofurantoin Monohydrate/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 therapeutic agents ap

Каталог на резюме:

Nitrofurantoin Monohydrate/Macrocrystals Capsules are available as 100 mg opaque black and yellow capsules imprinted “(band) Macrobid (band)” on one half and “52427-285” on the other. NDC 42254-064-14 bottle of 14 Store at controlled room temperature (59° to 86°F or 15° to 30°C). Meets USP Dissolution Test 2 Rx Only

Статус Оторизация:

New Drug Application

Данни за продукта

NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALLINE CAPSULE
REBEL DISTRIBUTORS CORP
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NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULE
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALS CAPSULES and other antibacterial drugs,
NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALS CAPSULES 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. The NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALS CAPSULES brand of nitrofurantoin 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:
The chemical name of nitrofurantoin monohydrate is
1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-
imidazolidinedione monohydrate. The chemical structure is the
following:
INACTIVE INGREDIENTS: Each capsule contains carbomer 934P, corn
starch, compressible sugar, D&C
Yellow No. 10, edible gray ink, FD&C Blue No. 1, FDC Red No. 40,
gelatin, lactose, magnesium
stearate, povidone, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
Each NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES contain 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,
forms a gel matrix that releases
nitrofurantoin over time. Based on urinary pharmacokinetic data, the
extent and rate of urinary excretion
of nitrofurantoin from the 100 mg NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALS CAPSULES are similar
to th