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Consumer Medicine Information - Primacin®
1
CONSUMER MEDICINE INFORMATION
PRIMACIN® TABLETS
This leaflet answers some common questions about Primacin (primaquine) tablets. Please read this
leaflet carefully before you start taking the tablets. The leaflet does not contain all
the information
available on this medication. 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 Primacin
against the benefits he expects it will have for you. If
you have concerns about taking this medicine,
ask your doctor or your pharmacist for further
information. Keep this leaflet with your medicine. You
may need to read it again.
IDENTIFICATION
Primacin tablets contain primaquine phosphate 13.2mg
equivalent to 7.5mg of primaquine. The
excipients (inactive ingredients) contained in the tablets are lactose, wheat starch, purified talc,
gelatine, povidone, magnesium stearate and glycerol.
WHAT PRIMAQUINE IS USED FOR
Primaquine is registered in Australia for two uses:
1. To treat the vivax and ovale form of malaria following an attack
2. To aid in the treatment of falciparum malaria
by treating the malaria parasites in patients
resident in areas receptive to malaria.
BEFORE YOU USE PRIMAQUINE
Contraindications – Do not take primaquine if you have an allergic reaction to the drug.
Tell your doctor if you are pregnant or
intend to become pregnant. Tell your doctor if you are
breastfeeding or are intending to breastfeed.
If you have a condition known as glucose-6-phosphate dehydrogenase deficiency (G6PD) tell your
doctor. You may not know if you have this deficiency but your doctor can give you a quick blood test
to check this out.
If you ha
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製品の特徴
Product Information – Primacin®
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PRODUCT INFORMATION
PRIMACIN® TABLETS
NAME OF THE MEDICINE
Primaquine phosphate CAS 63-45-6
and enantiomer
C
15
H
21
N
3
O,2H
3
PO
4
455.3
[(RS)-4-amino-1-methylbutyl (6-methoxy-8-quinolyl) amine diorthophosphate]
DESCRIPTION
Primaquine phosphate is an orange crystalline powder
and melts at about 200°C with
decomposition. It is soluble in water
and practically insoluble in ethanol.
Primacin tablets contain lactose (53.6 mg), starch - wheat, povidone, gelatin, glycerol, magnesium
stearate and talc – purified as excipients.
PHARMACOLOGY
Primaquine is an antimalarial agent. It is used as a
schizontocide for the treatment of the
hypnozoite stage (in the liver) of
malaria. Primaquine is effective against exoerythrocytic stages
of _P. vivax_ and _P. ovale_ and against the primary exoerythrocytic stages of _P. falciparum_. It is also
effective against the sexual forms (gametocytes) of
plasmodia, especially _P. falciparum_,
disrupting transmission of
the disease by eliminating the reservoir from which the mosquito
carrier
is infected. Primaquine is more active against tissue forms and gametes than asexual
blood forms of plasmodia. The precise mechanism of
action is not known. There is some in vitro
evidence that some of the antiparasitic effect may be due
to the binding and inhibition of entry
of the parasite to the hepatoma cell.
_PHARMACOKINETICS _
_Absorption _
Primaquine is rapidly absorbed (T
max
about 2 hours) from the gastrointestinal
tract and the
_ _
concentration of the drug in the body is dose dependent. Oral
bioavailability studies (not
performed with this product) shows that primaquine is rapidly and almost completely absorbed.
_Distribution _
_ _
It is widely d
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