MACROBID CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NITROFURANTOIN

Available from:

ALLERGAN INC

ATC code:

J01XE01

INN (International Name):

NITROFURANTOIN

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

NITROFURANTOIN 100MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

URINARY ANTI-INFECTIVES

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-08-12

Summary of Product characteristics

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