This information is not for clinical use. These highlights do not include all the information needed to use Primaquine safely and effectively. Before taking Primaquine please consult with your doctor. See full prescribing information for Primaquine.

Indications And Usage

Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.

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Contraindications

Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (see WARNINGS). Pregnant women (see WARNINGS, Usage in Pregnancy). Primaquine phosphate is contraindicated in acutely ill patients suffering from systemic disease manifested by tendency to granulocytopenia, such as rheumatoid arthritis and lupus erythematosus. The drug is also contraindicated in patients receiving concurrently other potentially hemolytic drugs or depressants of myeloid elements of the bone marrow. Because quinacrine hydrochloride appears to potentiate the toxicity of antimalarial compounds which are structurally related to primaquine, the use of quinacrine in patients receiving primaquine is contraindicated. Similarly, primaquine should not be administered to patients who have received quinacrine recently, as toxicity is increased.

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, please call Ingenus Pharmaceuticals NJ, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Gastrointestinal: Nausea, vomiting, epigastric distress, and abdominal cramps. Hematologic: Leukopenia, hemolytic anemia in G6PD deficient individuals, and methemoglobinemia in nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficient individuals. Cardiac: Cardiac arrhythmia and QT interval prolongation (see PRECAUTIONS, OVERDOSAGE). Nervous System: Dizziness. Skin and Soft Tissue: Rash, pruritus.

Drug Interactions

Drug Interactions Caution is advised if primaquine is used concomitantly with other drugs that prolong the QT interval (see PRECAUTIONS, ADVERSE REACTIONS, and OVERDOSAGE).