Quinbisul quinine bisulfate heptahydrate 300 mg tablet NF

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

quinine bisulfate heptahydrate, Quantity: 300 mg

متاح من:

Arrotex Pharmaceuticals Pty Ltd

INN (الاسم الدولي):

quinine bisulfate heptahydrate

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: pregelatinised maize starch; sodium starch glycollate; Carnauba Wax; magnesium stearate; lactose monohydrate; colloidal anhydrous silica; purified talc; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; macrogol 4000

طريقة التعاطي:

Oral

الوحدات في الحزمة:

30, 50

الفئة:

Medicine Registered

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Treatment of malaria due to strains of P. Falciparum resistant to chloroquine and the related 4-aminoquinolines.

ملخص المنتج:

Visual Identification: Plain, white, biconvex, film coated tablets; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

الوضع إذن:

Registered

تاريخ الترخيص:

2005-02-14

نشرة المعلومات

QUINBISUL
1
QUINBISUL
_quinine bisulfate heptahydrate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Quinbisul.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Quinbisul against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IT IS USED FOR
Quinbisul is used to treat malaria,
together with other medicines. It
works by interfering with the growth
of the parasite that causes malaria.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY QUINBISUL HAS
BEEN PRESCRIBED FOR YOU.
Your doctor, may have prescribed it
for another purpose.
Quinbisul is only available with a
doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE QUINBISUL IF YOU ARE
ALLERGIC TO:
•
medicines containing quinine
(e.g. Quinate)
•
tonic water or bitter lemon drinks
which contain quinine
•
any of the ingredients at the end
of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching, flushing of the skin, swelling
of the face, fever, shortness of breath,
ringing in the ears and changes in
vision.
DO NOT TAKE QUINBISUL IF YOU HAVE
OR HAVE EVER HAD:
•
a severe side effect caused by
quinine (such as unusual bruising
or bleeding or kidney problems)
•
myasthenia gravis - a condition
causing muscle weakness
•
tinnitus - ringing in the ears
•
optic neuritis - a disease of the
nerves of the eye, causing
blindness
•
glucose-6-phosphate
dehydrogenase (G-6-PD)
deficiency - an inherited
condition
•
blackwater fever.
DO NOT TAKE QUINBISUL IF THE EXPIRY
DATE (EXP.) PRINTED ON THE PACK HAS
PASSED.
If you take this medicine after the
expiry date, it may not work as well.

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION – QUINBISUL (QUININE
BISULFATE HEPTAHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Quinine bisulfate heptahydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each QUINBISUL tablet contains 300 mg of quinine bisulphate
heptahydrate.
QUINBISUL tablet also contains lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
QUINBISUL tablets are plain, white film coated, unscored, convex
tablet
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of malaria due to strains of _P. falciparum_ resistant to
chloroquine and the related 4-
aminoquinolines.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS_. _The typical oral dose of quinine in the treatment of
chloroquine-resistant _P. falciparum _
malaria is 600 mg three times daily after meals for 7 to 14 days, plus
75 mg pyrimethamine/1,500
mg sulfadoxine as a single dose on the second day of treatment.
In certain emergencies such as cerebral malaria, quinine should be
given by intravenous injection or
infusion. The dihydrochloride is employed and the injection should be
made very slowly, preferably
by IV infusion. The optimal daily dose is 10 to 20 mg/kg, usually
given as two separate infusions over
four hours each. Quinine bisulfate heptahydrate is unsuitable for use
in injections since its solution
decomposes on heating.
_Therapeutic range of serum levels: _2 to 5 microgram/mL.
2
PAEDIATRIC. For the treatment of chloroquine resistant malaria in
children, administer 10 mg/kg
quinine three times daily for 7 to 10 days, in combination with an
appropriate single dose of
pyrimethamine/sulfadoxine.
GERIATRIC. A study of the pharmacokinetics of quinine in elderly
(older than 65 years) and young (20
to 40 years) subjects indicated that a significantly higher peak
plasma concentration was achieved in
the elderly subjects following a standard oral dose of quinine
sulfate. This is probably influenced by
the decrease in plasma clearance observed in the elderly patients. In
view of this it may be