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Primaquine 26.3 mg primaquine phosphate (equivalent to 15 mg base) Tablet
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Indications & Clinical Uses
- Primaquine (primaquine phosphate) 15 mg base tablets, marketed in the United States as Primaquine Phosphate Tablets, USP by Sanofi-aventis, are an 8-aminoquinoline antimalarial used for the radical cure (prevention of relapse) of vivax malaria.
- Primaquine is given together with a blood-stage antimalarial, usually chloroquine, because it does not treat the acute attack itself; it acts against the dormant liver-stage parasites (hypnozoites) that cause relapse.
- The standard adult regimen is one 15 mg base tablet daily for 14 days alongside chloroquine therapy.
- Primaquine is also used, in some countries under WHO-based national malaria programmes, as a single low dose to reduce transmission of P. falciparum malaria, though this specific use is not detailed on the US label.
- It is prescribed by a healthcare provider familiar with malaria treatment and is taken by mouth at home, not hospital-administered.
Side Effects
- Primaquine carries a boxed warning: it can cause severe, life-threatening haemolytic anaemia (destruction of red blood cells) in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency, an inherited condition that is more common in some African, Asian, Mediterranean and Middle Eastern populations.
- G6PD testing is required before starting treatment.
- Common side effects include nausea, vomiting, stomach cramps and headache, which are less likely if the tablet is taken with food.
- More serious effects to report urgently include unusual tiredness, pale skin, dark urine or yellowing of the skin or eyes (signs of haemolysis or methemoglobinemia), an irregular heartbeat, or a severe rash.
- Primaquine can also lower white blood cell counts in some people.
- Seek urgent medical help for dark urine, breathlessness, unusual paleness or a fast heartbeat while taking Primaquine.
Precautions & Warnings
- Primaquine must not be given to people with severe G6PD deficiency, and G6PD status should be checked before every course because haemolysis risk depends on the degree of deficiency.
- It is contraindicated in pregnancy, in breastfeeding when the infant's G6PD status is unknown or deficient, and in people taking quinacrine.
- Baseline and periodic blood counts are recommended during treatment.
- People who are poor or intermediate CYP2D6 metabolisers may not fully activate primaquine and can have a higher risk of vivax relapse; discuss this with your prescriber if relapse occurs despite treatment.
- Use caution in people with a history of methemoglobinemia, lupus erythematosus or rheumatoid arthritis, and consider an ECG in people with existing heart rhythm problems, because primaquine can prolong the QT interval.
- Primaquine tablets are taken by mouth; there is no injectable form.
Avoid Interactions
- Avoid taking Primaquine with quinacrine, which increases primaquine toxicity and is contraindicated in combination.
- Other drugs that themselves cause haemolysis in G6PD-deficient people, for example certain sulfonamides, dapsone or nitrofurantoin, increase the risk of severe anaemia when combined with primaquine.
- Strong CYP2D6 inhibitors, such as some antidepressants (for example paroxetine or fluoxetine) and quinidine, can reduce conversion of primaquine to its active metabolite and lower its effectiveness against relapse, so tell your prescriber about all psychiatric or heart medicines you take.
- Drugs that prolong the QT interval should be used cautiously alongside primaquine because of an added arrhythmia risk.
- Always tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter product and supplement you use before starting Primaquine, and do not start or stop any other medicine during treatment without medical advice.
References
Frequently Asked Questions
Primaquine (primaquine phosphate) treats vivax malaria by killing the dormant liver-stage parasites that cause relapse after the initial infection has cleared. It is given together with a blood-stage antimalarial such as chloroquine, which treats the acute attack, while Primaquine prevents the illness from coming back weeks or months later.
The usual adult dose is one 15 mg base Primaquine tablet by mouth once daily for 14 days, taken with food to reduce stomach upset, alongside a separate course of chloroquine or another blood-stage antimalarial. Complete the full 14 days, even if you feel better sooner, to prevent relapse.
Common Primaquine side effects are nausea, vomiting, stomach cramps and headache. Its most serious risk is severe haemolytic anaemia (red blood cell breakdown) in people with G6PD deficiency, a boxed warning on the label. Get urgent help for dark urine, unusual paleness, breathlessness or a fast heartbeat.
Avoid quinacrine, which is contraindicated with Primaquine, and other drugs that can cause haemolysis, such as certain sulfonamides or nitrofurantoin. Do not take Primaquine if you are pregnant or breastfeeding without confirming your baby's G6PD status. Tell your prescriber about antidepressants that inhibit CYP2D6.
Take the missed Primaquine dose as soon as you remember that same day, then continue your normal daily schedule; do not double up the next day. Completing all 14 days is essential, since stopping early can let the malaria relapse. Contact your prescriber if you miss more than one dose.
You need a G6PD (glucose-6-phosphate dehydrogenase) blood test before starting Primaquine, because people with this inherited deficiency can develop severe, sometimes life-threatening anaemia from the drug. Testing confirms it is safe to prescribe, and periodic blood counts may be checked during the 14-day course.
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