MACROBID CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

NITROFURANTOIN

から入手可能:

ALLERGAN INC

ATCコード:

J01XE01

INN（国際名）:

NITROFURANTOIN

投薬量:

100MG

医薬品形態:

CAPSULE

構図:

NITROFURANTOIN 100MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

URINARY ANTI-INFECTIVES

製品概要:

Active ingredient group (AIG) number: 0101480001; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2021-08-12

製品の特徴

1 of 19
PRODUCT MONOGRAPH
PR
MACROBID
®
Nitrofurantoin Capsules, USP
(nitrofurantoin monohydrate/macrocrystals)
100 mg
URINARY TRACT ANTIBACTERIAL
Allergan Inc.
500 – 85 Enterprise Blvd.
Markham, Ontario
L6G 0B5
www.allergan.ca
Date of Preparation:
October 17, 2018
Control #: 220205
MacroBID
®
is a registered trademark of Allergan Pharmaceuticals International
Limited,
used under license by Allergan Inc.
2 of 19
NAME OF DRUG
PR
MACROBID
®
Nitrofurantoin Capsules, USP
(nitrofurantoin monohydrate/macrocrystals)
THERAPEUTIC CLASSIFICATION
Urinary Tract Antibacterial
ACTIONS AND CLINICAL PHARMACOLOGY
Nitrofurantoin is reduced by bacterial flavoproteins to reactive
intermediates which inactivate or
alter bacterial ribosomal proteins and other macromolecules. As a
result of such inactivations,
the vital biochemical processes of protein synthesis, aerobic energy
metabolism, DNA
synthesis, RNA synthesis, and cell wall synthesis are inhibited. The
broad-based nature of this
mode of action may explain the lack of acquired bacterial resistance
to nitrofurantoin, as the
necessary multiple and simultaneous mutations of the target
macromolecules would likely be
lethal to the bacteria.
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.
Following a single 100 mg dose, the extent and rate of nitrofurantoin
excretion in the urine are
similar for 100 mg capsules of MacroBID and 50 or 100 mg capsules of
Macrodantin
(nitrofurantoin macrocrystals). Nitrofurantoin bioavailability can be
increased by as much as
40% when MacroBID is administered with food. Approximately 20-25% of a
single dose of
MacroBID is recovered in the urine unchanged over 24 hours and drug
concentrations inhibitory
of bacterial growt