MACROBID- nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

nitrofurantoin monohydrate (UNII: E1QI2CQQ1I) (nitrofurantoin - UNII:927AH8112L), nitrofurantoin, macrocrystalline (UNII: 927AH8112L) (nitrofurantoin - UNII:927AH8112L)

Disponível em:

Procter and Gamble Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

nitrofurantoin monohydrate and nitrofurantoin, macrocrystalline

Forma farmacêutica:

CAPSULE

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Macrobid is 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 Macrobid and other antibacterial drugs, Macrobid 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 urinary tract infections. Consequently, many patients who are treated with Macrobid are predisposed to persisten

Resumo do produto:

Macrobid is available as 100 mg opaque black and yellow capsules imprinted “Macrobid” on one half and “Norwich Eaton” on the other. NDC 0149-0710-01     bottle of 100 Store at controlled room temperature (59° to 86°F or 15° to 30°C). Meets USP Dissolution Test 2 Rx Only

Características técnicas

MACROBID- NITROFURANTOIN MONOHYDRATE AND NITROFURANTOIN,
MACROCRYSTALLINE CAPSULE
PROCTER AND GAMBLE PHARMACEUTICALS, INC.
----------
MACROBID
(NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS)
CAPS ULES
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of MACROBID and
other antibacterial drugs, MACROBID 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 MACROBID 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, FD&C Red No. 40,
gelatin, lactose, magnesium
stearate, povidone, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY:
Each MACROBID capsule 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, 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
MACROBID capsule are similar to those of the 50 mg or 100 mg
MACRODANTIN (nitrofurantoin
macrocrystals) capsule. Approximately 20-25% of a single dose of
nitrofurantoin is recovered from the
urine unchange