ARX-Nitrofurantoin 100 mg capsule blister

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nitrofurantoin, Quantity: 100 mg

Available from:

Luminarie Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; purified talc; titanium dioxide; purified water; quinoline yellow; iron oxide yellow; Gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

Blister pack of 3 x 10 Capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. Nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.

Product summary:

Visual Identification: Size 2 opaque yellow cap & body hard gelatin capsule, imprinted with EM29 360 degrees, thin band, in black ink on cap filled with yellow powder; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-01-18

Patient Information leaflet

ARX-NITROFURANTOIN
®
1
ARX-NITROFURANTOIN
NITROFURANTOIN (MACROCRYSTALS) CAPSULE
_ _
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully
before
you
start
taking
ARX-
NITROFURANTOIN.
This
leaflet
answers
some
common questions about ARX-
NITROFURANTOIN. It does not
contain
all
the
available
information and it does not take
the
place
of
talking
to
your
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
this
medicine
against
the
expected benefits it will have
for you.
Take ARX-NITROFURANTOIN as
instructed and follow the advice
given in this leaflet.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
Keep
this
leaflet
with
the
medicine. You may need to read
it again.
What ARX-
NITROFURANTOIN is
used for
ARX-NITROFURANTOIN
is
used
to treat infections of the urinary
system caused by bacteria, for
example, bladder infections.
ARX-NITROFURANTOIN
is
an
antibiotic which belongs to a group
of medicines called nitrofurans. It
works
by
killing
or
stopping
the
growth of the bacteria and other
organisms causing these infections.
Your doctor may have prescribed
ARX-NITROFURANTOIN for another
reason. Ask your doctor if you have
any
questions
about
why
ARX-
NITROFURANTOIN
has
been
prescribed for you.
These medicines are only available
with a doctor's prescription.
Before you take ARX-
NITROFURANTOIN
_WHEN YOU MUST NOT TAKE IT _
DO
NOT
TAKE
ARX-
NITROFURANTOIN IF:
1.
You
have
an
allergy
to
ARX-
NITROFURANTOIN
or
any
other
nitrofuran,
or
to
any
of
the
ingredients listed at the end of this
leaflet.
Symptoms
of
an
allergic
reaction include skin rash, itching,
difficulty with breathing, fever and
chills.
2.
you
have
severe
kidney
problems
3.
you are pregnant and close to
giving birth.
Infants
under
one month
of
age
should
not
be
given
ARX-
NITROFURANTOIN.
Do
not
take
ARX-
NITROFURANTOIN
if
the
packaging is torn or shows signs of
tampering.
Do not take it after the expiry date
(EXP) printed on the pack.
Before

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION ARX- NITROFURANTOIN (NITROFURANTOIN MACROCRYSTALS CAPSULE)
1
NAME OF THE MEDICINE
ARX- Nitrofurantoin capsules 50 mg and 100 mg (nitrofurantoin
macrocrystals)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg and 100 mg of ARX- NITROFURANTOIN capsule contains 50 mg
and 100 mg of
Nitrofurantoin (macrocrystals) respectively.
Excipient with known effect: “lactose monohydrate”.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NITROFURANTOIN CAPSULES (MACROCRYSTALS) 50 MG: Size '3' opaque yellow
cap and opaque white
body hard gelatin capsule, imprinted with “EM28” with 360 degree
thin band, in black ink on
cap filled with yellow powder.
NITROFURANTOIN CAPSULES (MACROCRYSTALS) 100 MG: Size '2' opaque yellow
cap and opaque yellow
body hard gelatin capsule, imprinted with “EM29” with 360 degree
thin band, in black ink on
cap filled with yellow powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of urinary tract infections such as cystitis and pyelitis
when due to susceptible
pathogens. Nitrofurantoin does not reach effective levels in plasma
and consequently is not
indicated for cortical or perinephric abscesses and in cases of
prostatitis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
To be taken with food or milk.
Adults: 50-100 mg four times a day. DO NOT EXCEED 400 mg DAILY.
Prophylactic therapy: 50 mg or 100 mg night
Children: Should be calculated on the basis of 5-7 mg/kg body weight
per 24 hours to be given
in divided doses four times a day.
ARX- NITROFURANTOIN should not be administered to infants under one
month of age.
2
Therapy should be continued for at least one week and for at least 3
days after sterility of the
urine is obtained. Continued infection indicates the need for
re-evaluation. If the drug is to be
used for prophylactic or for long-term suppressive therapy,
consideration should be given to
finding the lowest effective dose.
4.3
C
ONTRAINDICATIONS
Anuria and oliguria or extensive impairment of rena