NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- nitrofurantoin monohydrate/macrocrystalline capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Blenheim Pharmacal, Inc.

INN（国際名）:

NITROFURANTOIN

構図:

NITROFURANTOIN 25 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 othe

製品概要:

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 47781-303-01  bottle of 100 Store at controlled room temperature (59° to 86°F or 15° to 30°C). Meets USP Dissolution Test 2 Rx Only

認証ステータス:

New Drug Application

製品の特徴

NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE- NITROFURANTOIN
MONOHYDRATE/MACROCRYSTALLINE CAPSULE
BLENHEIM PHARMACAL, INC.
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NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES
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.
CLINICAL PHARMACOLOGY
Each nitrofurantoin monohydrate/macrocrystals 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 nitrofurantoin
monohydrate/macrocrystals capsule are similar to those
of the 50 mg or 100 mg nitrofurantoin macrocrystals capsule.
Approximately 20-25% of a single dose
of nitrofurantoin is recovered from the urine unchanged over 24 hours.
Plasma nitrofurantoin concentrations after a single oral dose of the
100 mg nitrofurantoin
monohydrate/macrocrystals capsules are low, with peak levels usually
less than 1 mcg/mL.
Nitrofurantoin is highly soluble in urine, to which it may impart a
brown color. When nitrofurantoin
monohydrate/macrocrystals capsules are administered with food, the
bioavailability of nitrofurantoin is
increased by approximately 40%.
MICROBIOLOGY
Nitrofurantoin is a nitrofuran antimicrobial agent with activity
against certain Gram-positive and Gram-
negative bacteria.
MECHANISM OF ACTION
The mechanism of the antimicrobial action of nitrofurantoin is unusual
among antibacterials.
Nitrofurantoin is reduced by bacterial flavoproteins to reactive
interme