Primaquine

Indications

INDICATIONS AND USAGE Primaquine phosphate Tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Primaquine phosphate Tablets are recommended only for the radical cure of vivax malaria, the prevention of relapse in vivax malaria, or following the termination of chloroquine phosphate suppressive therapy in an area where vivax malaria is endemic. Patients suffering from an attack of vivax malaria or having parasitized red blood cells should receive a course of chloroquine phosphate, which quickly destroys the erythrocytic parasites and terminates the paroxysm. Primaquine phosphate Tablets should be administered concurrently to eradicate the exoerythrocytic parasites in adults at a dosage of 1 tablet (equivalent to 15 mg base) daily for 14 days.

Contraindications

CONTRAINDICATIONS Known hypersensitivity reactions to primaquine phosphate, other 8-aminoquinolones, or to any component in Primaquine phosphate Tablets. Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (see WARNINGS , Hemolytic Anemia ). Pregnant women (see WARNINGS , Pregnancy ). Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown (see WARNINGS , Nursing Mothers ).

Warnings and precautions

WARNINGS Hemolytic Anemia Hemolytic reactions (moderate to severe) may occur in individuals with G6PD deficiency and in individuals with a family or personal history of favism. Areas of high prevalence of G6PD deficiency are Africa, Southern Europe, Mediterranean region, Middle East, South-East Asia, and Oceania. People from these regions have a greater tendency to develop hemolytic anemia due to a congenital deficiency of erythrocytic G6PD while receiving primaquine and related drugs.

Storage and supply

HOW SUPPLIED Primaquine phosphate Tablets USP are solid oral formulation round purple tablet debossed "BY4" available in 26.3 mg (=15 mg base) and 100 count. Available in bottles of 100 tablets. (NDC 76385-102-01) Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F) .

Source: Primaquine Phosphate (Primaquine Phosphate) — US FDA prescribing information, 2026-02-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.