Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Primaquine phosphate
Boucher & Muir Pty Ltd
Medicine Registered
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 Read the complete document
Product Information – Primacin® 1 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 Read the complete document