Dosing & Uses
Dosage Forms & Strengths
tablet
- 26.3mg
Prevention of relapse of P. vivax malaria
30 mg PO qDay for 14 days
Uncomplicated P. vivax and P. ovale malaria (off-label)
30 mg PO qDay for 14 days with chloroquine or hydroxychloroquine
Alternatively, for mild G6PD deficiency or as an alternative to daily regimen: 45 mg PO qWeek for 8 weeks (use only after consultation with an infectious disease/tropical medicine expert) (CDC 2013)
See also Dosing Considerations
Chemoprophylaxis (Off-label)
P. vivax and P. ovale maleria: 30 mg PO qDay for 14 days after departure from malaria-endemic area
P. Jiroveci Pneumonia (Orphan)
For use in combination with clindamycin in the treatment of P. Jiroveci pneumonia associated with AIDS
15-30 mg base PO qD for 21 days (with clindamycin IV or PO)
Orphan indication sponsor
- Sanofi Winthrop, Inc; 90 Park Avenue; New York, NY 10016
Dosing Considerations
Monitor: CBC
Because primaquine can cause hemolytic anemia in G6PD-deficient persons, G6PD screening must occur prior to starting treatment with primaquine
Dosage Forms & Strengths
tablet
- 26.3mg
Uncomplicated P. vivax and P. ovale malaria (Off-label)
0.5 mg/kg (30 mg/day maximum) qDay for 14 days with chloroquine or hydroxychloroquine
Chemoprophylaxis
0.5 mg/kg PO qDay (30 mg/day maximum); start 1-2 days prior to travel and continue for 7 days after departure from malaria endemic area
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Abdominal pain
Hemolytic anemia in G6PD deficiency
Nausea
Vomiting
<1-10%
Methemoglobinemia in NADH-methemoglobin reductase-deficient individuals
<1%
Agranulocytosis
Arrhythmias
Headache
Interference with visual accommodation
Leukopenia
Leukocytosis
Rash
Dizziness
Pruritus
Warnings
Contraindications
Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency
Coadministration with quinacrine in patients who have received quinacrine recently
Concurrent administration with other potentially hemolytic drugs or depressants of myeloid elements of the bone marrow
Acutely ill patients suffering from systemic disease manifested by tendency to granulocytopenia, such as rheumatoid arthritis and lupus erythematosus
Cautions
Since anemia, methemoglobinemia, and leukopenia may occur following administration of large doses of primaquine, do not exceed adult dosage of 1 tablet (= 15 mg base) daily for fourteen days; make routine blood examinations (particularly blood cell counts and hemoglobin determinations) during therapy; drug should be discontinued immediately if marked darkening of urine or sudden decrease in hemoglobin concentration or leukocyte count occurs
Observe patient for tolerance if primaquine phosphate is prescribed for an individual who has shown a previous idiosyncrasy to primaquine phosphate (as manifested by hemolytic anemia, methemoglobinemia, or leukopenia), an individual with a family or personal history of favism, or an individual with erythrocytic glucose-6-phosphate dehydrogenase (G-6-PD) deficiency or nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficiency; discontinue therapy immediately if marked darkening of the urine or sudden decrease in hemoglobin concentration or leukocyte count occurs
Due to potential for QT interval prolongation, monitor ECG when using primaquine in patients with cardiac disease, long QT syndrome, a history of ventricular arrhythmias, uncorrected hypokalemia and/or hypomagnesemia, or bradycardia (<50 bpm), and during concomitant administration with QT interval prolonging agents
Pregnancy & Lactation
Pregnancy
Contraindicated in pregnant women; even if a pregnant woman is G6PD normal, the fetus may not be; safe usage in pregnancy not established; use during pregnancy should be avoided except when in judgment of the physician benefit outweighs possible hazard
Sexually-active females of reproductive potential should have a pregnancy test prior to starting primaquine
Contraception
- Advise females of child bearing potential to use effective contraception (methods that result in less than 1% pregnancy rates) when receiving therapy and after stopping treatment until completion of an ongoing ovulatory cycle (eg, up to next menses)
- Advise treated males whose partners may become pregnant, to use a condom while on treatment and for 3 months after stopping treatment
Lactation
CDC recommends do not use in nursing women unless breast-fed infant has been determined not to have G6PD deficiency
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Disrupts Plasmodium mitochondria
Absorption
Absorption: Well absorbed
Peak Plasma Time: 1-2 hr
Metabolism
Metabolism: Hepatic to carboxyprimaquine (active)
Elimination
Half-life: 3.7-9.6 hr
Excretion: Urine (small amounts as unchanged drug)
Administration
Oral administration
Take without meals
If patient vomits within 30 minutes of taking a dose, then should repeat dose
Storage
Store at 25°C (77° F); excursions permitted to 15-30° C (59-86° F)
Dispense in tight, light-resistant container
Images
Patient Handout
Formulary
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