Daraprim Tablets

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

pyrimethamine, Quantity: 25 mg

Mevcut itibaren:

Arrotex Pharmaceuticals Pty Ltd

Farmasötik formu:

Tablet, uncoated

Kompozisyon:

Excipient Ingredients: maize starch; magnesium stearate; lactose monohydrate; docusate sodium

Uygulama yolu:

Oral

Paketteki üniteler:

50 tablets

Sınıf:

Medicine Registered

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

Daraprim in combination with a sulphonamide is effective in the treatment of congenital and acquired infections.

Ürün özeti:

Visual Identification: White, round, biconvex tablets. The obverse side is scored in the middle, with GS and A3A imprinted above and below the score mark respectively. The reverse side is plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2003-11-11

Bilgilendirme broşürü

1
DARAPRIM
®
TABLETS
_Pyrimethamine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet
carefully before you take
Daraprim tablets.
This leaflet answers some
common questions about
Daraprim tablets. It does not
contain all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the expected benefits
of you taking Daraprim tablets
against the risks this medicine
could have for you.
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 ARE DARAPRIM TABLETS
USED FOR?
Daraprim tablets are used:
•
to treat toxoplasmosis
infections when taken with
another antibiotic called a
sulphonamide together
with a folic acid
supplement.
Daraprim belongs to a group of
medicines called
antiprotozoals, which are used
against infections of the blood
caused by the parasites called
_Plasmodium_ which causes a
disease called toxoplasmosis.
Daraprim tablets work by
disrupting the way that proteins
and genetic material are made
inside the parasites.
Your doctor may have
prescribed Daraprim tablets for
another reason. Please ask
your doctor why Daraprim has
been prescribed for you.
Daraprim tablets are not
addictive.
BEFORE YOU TAKE DARAPRIM
TABLETS
_ _
_DO NOT TAKE IF: _
You must not take Daraprim
tablets if:
•
you have ever had an
allergic reaction to
pyrimethamine or any of the
ingredients listed toward the
end of this leaflet. (See
“Ingredients”).
•
THE EXPIRY DATE (EXP)
PRINTED ON THE PACK HAS
PASSED.
•
THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
_TELL YOUR DOCTOR IF: _
You must tell your doctor if:
•
YOU ARE ALLERGIC TO FOODS,
DYES, PRESERVATIVES OR ANY
OTHER MEDICINES.
•
YOU HAVE KIDNEY, LIVER OR
BLOOD DISEASE (ANAEMIA).
•
YOU HAVE PREVIOUSLY BEEN
DIAGNOSED AS HAVING A LOW
LEVEL OF FOLIC ACID IN YOUR
BLOOD.
•
YOU ARE TAKING OR LIKELY TO
BE TAKING ANY OF THE
FOLLOWING MEDI

Ürün özellikleri

1
PRODUCT INFORMATION
DARAPRIM TABLETS
NAME OF THE MEDICINE:
Pyrimethamine
The chemical name of pyrimethamine is
5-(4-Chlorophenyl)-6-ethyl-2,4-pyrimidinediamine,
with a molecular formula C
12
H
13
ClN
4
and a molecular weight of 248.7. It is practically
insoluble in water; slightly soluble in ethanol and dilute HCl. The
chemical structure is:
CAS NUMBER – 58-14-0
DESCRIPTION:
Each
tablet
contains
pyrimethamine
25mg
as
the
active
ingredient
plus
the
inactive
ingredients: lactose, maize starch, hydrolysed starch, docusate sodium
and magnesium
stearate.
PHARMACOLOGY:
Pyrimethamine is an inhibitor of the enzyme dihydrofolate reductase
(DHFR). It blocks the
reduction of dihydrofolic acid to tetrahydrofolic acid which is an
essential coenzyme in the
production of nucleic acids, thereby leading to disruption of protein
synthesis and nuclear
division. The affinity of pyrimethamine for protozoal DHFR is much
greater than that for the
mammalian enzyme. Sulphonamides act synergistically with pyrimethamine
by arresting
production
of
dihydrofolic
acid
from
para-aminobenzoic
acid.
This
results
in
sequential
blockade of the folate pathway of Toxoplasma which, in contrast to
man, is unable to utilise
preformed folate.
PHARMACOKINETICS:
Peak plasma levels are found between 2 and 4 hours after oral
administration of a 100 mg
dose
of
pyrimethamine
and
the
plasma
half-life
is
approximately
90
hours.
87%
of
pyrimethamine is bound to plasma proteins and its pKa is 7.34.
Pyrimethamine is secreted in breast milk.
2
INDICATIONS:
TOXOPLASMOSIS: Daraprim in combination with a sulphonamide is
effective in the treatment of
congenital and acquired infections.
CONTRAINDICATIONS:
Daraprim should not be given to individuals with a history of
pyrimethamine sensitivity or any
of the components of the preparation.
Daraprim should not generally be used during the first trimester of
pregnancy (see Use in
Pregnancy section)
Since Daraprim is to be taken in conjuction with another drug for the
indications listed, the
relevant prescribing information