Nitrofurantoin BNM nitrofurantoin 100 mg hard capsule blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

nitrofurantoin, Quantity: 100 mg

Dostupno od:

Boucher & Muir Pty Ltd

Farmaceutski oblik:

Capsule, hard

Sastav:

Excipient Ingredients: titanium dioxide; lactose monohydrate; iron oxide yellow; maize starch; purified talc; purified water; Gelatin; sodium lauryl sulfate

Administracija rute:

Oral

Jedinice u paketu:

30 capsules

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

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.

Proizvod sažetak:

Visual Identification: Hard gelatin capsules with yellow cap and body, containing a yellow powder; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2021-10-08

Uputa o lijeku

Nitrofurantoin BNM
1
NITROFURANTOIN BNM
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING NITROFURANTOIN BNM?
Nitrofurantoin BNM contains the active ingredient nitrofurantoin.
Nitrofurantoin BNM is used to treat infections of the urinary
system caused by bacteria, for example, bladder infections.
For more information, see Section 1. Why am I taking Nitrofurantoin
BNM?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE NITROFURANTOIN BNM?
Do not take if you have ever had an allergic reaction to
nitrofurantoin or any of the ingredients listed at the end of the CMI.
Do not take Nitrofurantoin BNM if you are close to giving birth or
have severe kidney problems.
Do not give Nitrofurantoin BNM to infants under one month of age.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Nitrofurantoin BNM?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Nitrofurantoin BNM and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE NITROFURANTOIN BNM?
Follow all directions given to you by your doctor and other health
professionals carefully including:
• how many capsules to take each day (the usual dose is one capsule
of either the 50 mg or 100 mg strength taken four times
daily)
• take the capsules with or immediately after food, or with a glass
of milk.
More instructions can be found in Section 4. How do I take
Nitrofurantoin BNM?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING NITROFURANTOIN BNM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Nitrofurantoin BNM.
•
Tell your doctor if you have to have any urine or blood tests while
taking

Svojstava lijeka

NITROFURANTOIN BNM
1
AUSTRALIAN PRODUCT INFORMATION
-
NITROFURANTOIN BNM (NITROFURANTOIN) CAPSULE
1
NAME OF THE MEDICINE
Nitrofurantoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitrofurantoin BNM is available in 50 mg and 100 mg capsules.
NOTE:
Nitrofurantoin BNM (nitrofurantoin macrocrystals) is a larger crystal
form of
nitrofurantoin. The absorption of nitrofurantoin is slower and the
excretion of nitrofurantoin
is somewhat less, when the two are compared. The reduced incidence of
gastrointestinal
intolerance with nitrofurantoin 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 nitrofurantoin
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 cap/white body, containing a yellow powder
100 mg capsules: yellow cap and body, containing a yellow powder
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.
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 BNM
2
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 given
to