MACRODANTIN 100mg Capsule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nitrofurantoin, Quantity: 100 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oral

Units in package:

30 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 1 JANUARY 1991 : 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: A hard-shell, no. 2, locking, gelatin capsule, opaque yellow cap and opaque yellow body, "Eaton 009" is printed on both cap and body in black edible ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1997-05-29

Patient Information leaflet

MACRODANTIN
®
_Nitrofurantoin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
MACRODANTIN. This leaflet
answers some common questions
about MACRODANTIN. 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 MACRODANTIN 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 MACRODANTIN
IS USED FOR
MACRODANTIN is used to treat
infections of the urinary system
caused by bacteria, for example,
bladder infections.
MACRODANTIN 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
MACRODANTIN for another
reason. Ask your doctor if you have
any questions about why
MACRODANTIN has been
prescribed for you.
These medicines are only available
with a doctor's prescription.
BEFORE YOU TAKE
MACRODANTIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MACRODANTIN IF:
1.
you have an allergy to
MACRODANTIN 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
MACRODANTIN.
Do not take MACRODANTIN if the
packaging is torn or shows signs of
tampering.
Do not take it after the expiry date
(EXP) printed on the pack.
_BEFORE YOU START TAKING IT_
YOU MUST TELL YOUR DOCTOR IF:
1.
you are pregnant or intend to
become pregnant. Your doctor
will discuss the risks and benefits
of ta

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION –
MACRODANTIN
® (NITROFURANTOIN)
1.
NAME OF THE MEDICINE
Nitrofurantoin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MACRODANTIN is available in 50 mg and 100 mg capsules.
NOTE:
MACRODANTIN
(nitrofurantoin
macrocrystals)
is
a
larger
crystal
form
of
nitrofurantoin.
The
absorption
of
MACRODANTIN
is
slower
and
the
excretion
of
MACRODANTIN is somewhat less, when the two are compared. The reduced
incidence of
gastrointestinal intolerance with MACRODANTIN is probably due to
delayed and decreased
absorption; this however does not significantly reduce clinical
effectiveness. A number of
patients who cannot tolerate nitrofurantoin tablets can take
MACRODANTIN capsules without
nausea.
EXCIPIENT WITH KNOWN EFFECT:
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
50 mg capsules: yellow/white, marked EATON 008
100 mg capsules: yellow, marked EATON 009
4.
CLINICAL PARTICULARS
4.1 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.
4.2 DOSE 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 nocte.
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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.
Nitrofurantoin should not be administered to infants under one month
of age.
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 g