primaquine (Rx)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

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  

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Interactions

Interaction Checker

and primaquine

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            Contraindicated (1)

            • lefamulin

              lefamulin will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.

            Serious - Use Alternative (30)

            • abametapir

              abametapir will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • apalutamide

              apalutamide will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • carbamazepine

              carbamazepine will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ceritinib

              ceritinib and primaquine both increase QTc interval. Avoid or Use Alternate Drug.

            • chloroquine

              chloroquine and primaquine both increase QTc interval. Avoid or Use Alternate Drug.

            • citalopram

              citalopram and primaquine both increase QTc interval. Avoid or Use Alternate Drug.

            • clarithromycin

              clarithromycin will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              clarithromycin and primaquine both increase QTc interval. Avoid or Use Alternate Drug.

            • crizotinib

              crizotinib and primaquine both increase QTc interval. Avoid or Use Alternate Drug.

            • dapsone topical

              primaquine, dapsone topical. unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration of dapsone topical with oral dapsone or antimalarial medications because of the potential for hemolytic reactions.

            • deferiprone

              deferiprone, primaquine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

            • desflurane

              desflurane and primaquine both increase QTc interval. Avoid or Use Alternate Drug.

            • entrectinib

              primaquine and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • enzalutamide

              enzalutamide will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and primaquine both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.

              fexinidazole will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • glasdegib

              primaquine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • grapefruit

              grapefruit will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • idelalisib

              idelalisib will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • ivosidenib

              ivosidenib will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • lonafarnib

              primaquine will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to or continue lonafarnib at starting dose. During coadministration, closely monitor for arrhythmias and events (eg, syncope, heart palpitations).

            • mifepristone

              mifepristone will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • pirfenidone

              primaquine will increase the level or effect of pirfenidone by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Use of strong CYP1A2 inhibitors should be discontinued before initiating pirfenidone and avoided during treatment; if strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended

            • pitolisant

              primaquine and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • pomalidomide

              primaquine increases levels of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug.

            • primidone

              primidone will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • quinacrine

              quinacrine increases levels of primaquine by unspecified interaction mechanism. Avoid or Use Alternate Drug.

            • rifampin

              rifampin will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • stiripentol

              primaquine will decrease the level or effect of stiripentol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If unable to avoid coadministration of stiripentol with strong CYP3A4 inducers, increase stiripentol dose.

            • tucatinib

              tucatinib will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • voxelotor

              voxelotor will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (57)

            • acalabrutinib

              acalabrutinib, primaquine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

            • albuterol

              albuterol and primaquine both increase QTc interval. Use Caution/Monitor.

            • alfuzosin

              alfuzosin and primaquine both increase QTc interval. Use Caution/Monitor.

            • apomorphine

              apomorphine and primaquine both increase QTc interval. Use Caution/Monitor.

            • arformoterol

              arformoterol and primaquine both increase QTc interval. Use Caution/Monitor.

            • aripiprazole

              aripiprazole and primaquine both increase QTc interval. Use Caution/Monitor.

            • artemether

              artemether and primaquine both increase QTc interval. Use Caution/Monitor.

            • artemether/lumefantrine

              artemether/lumefantrine and primaquine both increase QTc interval. Use Caution/Monitor.

            • atogepant

              primaquine will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • atomoxetine

              atomoxetine and primaquine both increase QTc interval. Use Caution/Monitor.

            • avapritinib

              primaquine will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • axitinib

              primaquine increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • bosentan

              bosentan will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • bupivacaine implant

              primaquine, bupivacaine implant. Either increases effects of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.

            • cenobamate

              cenobamate will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • clozapine

              clozapine and primaquine both increase QTc interval. Use Caution/Monitor.

            • crofelemer

              crofelemer increases levels of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

            • dabrafenib

              dabrafenib will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • darunavir

              darunavir will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dasatinib

              dasatinib and primaquine both increase QTc interval. Use Caution/Monitor.

            • degarelix

              degarelix and primaquine both increase QTc interval. Use Caution/Monitor.

            • deutetrabenazine

              deutetrabenazine and primaquine both increase QTc interval. Use Caution/Monitor.

            • efavirenz

              efavirenz will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • elagolix

              elagolix decreases levels of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • eluxadoline

              primaquine increases levels of eluxadoline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. As a precautionary measure due to incomplete information on the metabolism of eluxadoline, use caution when coadministered with strong CYP1A2 inhibitors.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

            • encorafenib

              encorafenib, primaquine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • etravirine

              etravirine will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • finerenone

              primaquine will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

            • flibanserin

              primaquine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

            • fostemsavir

              primaquine and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • ifosfamide

              ifosfamide, primaquine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Ifosfamide may enhance the toxicities of myelosuppressive agents. Monitor for increased risk of myelosuppression.

            • iloperidone

              iloperidone increases levels of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

            • isavuconazonium sulfate

              primaquine will increase the level or effect of isavuconazonium sulfate by affecting hepatic enzyme CYP2E1 metabolism. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • itraconazole

              itraconazole will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lemborexant

              primaquine will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

            • lorlatinib

              lorlatinib will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • midazolam intranasal

              primaquine will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

            • mitotane

              mitotane decreases levels of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • nafcillin

              nafcillin will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • osilodrostat

              osilodrostat and primaquine both increase QTc interval. Use Caution/Monitor.

            • oxaliplatin

              oxaliplatin will increase the level or effect of primaquine by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • pentoxifylline

              primaquine will increase the level or effect of pentoxifylline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • phenobarbital

              phenobarbital will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • rifabutin

              rifabutin will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifapentine

              rifapentine will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • stiripentol

              stiripentol, primaquine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • tasimelteon

              primaquine will increase the level or effect of tasimelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Avoid coadministration; potentially large increase in tasimelteon exposure and greater risk of adverse reactions with strong CYP1A2 inhibitors

            • tazemetostat

              tazemetostat will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • terbinafine

              primaquine will increase the level or effect of terbinafine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • tetracaine

              tetracaine, primaquine. Other (see comment). Use Caution/Monitor. Comment: Monitor for signs of methemoglobinemia when methemoglobin-inducing drugs are coadministered.

            • tinidazole

              primaquine will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • triclabendazole

              triclabendazole and primaquine both increase QTc interval. Use Caution/Monitor.

            • zidovudine

              primaquine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            Minor (10)

            • chloroquine

              primaquine, chloroquine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hemolysis in G6PD deficient pts.

            • dapsone

              primaquine, dapsone. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hemolysis in G6PD deficient pts.

            • isoniazid

              primaquine, isoniazid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hemolysis in G6PD deficient pts.

            • probenecid

              primaquine, probenecid. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hemolysis in G6PD deficient pts.

            • quinine

              primaquine, quinine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hemolysis in G6PD deficient pts.

            • ribociclib

              ribociclib will increase the level or effect of primaquine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ruxolitinib

              primaquine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • sulfadiazine

              primaquine, sulfadiazine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hemolysis in G6PD deficient pts.

            • sulfamethoxazole

              primaquine, sulfamethoxazole. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hemolysis in G6PD deficient pts.

            • sulfisoxazole

              primaquine, sulfisoxazole. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Risk of hemolysis in G6PD deficient pts.

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            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

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            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

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            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.

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            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)

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            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

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            primaquine oral
            -
            26.3 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            primaquine oral

            PRIMAQUINE PHOSPHATE - ORAL

            (PRIM-uh-kwin FOSS-fate)

            COMMON BRAND NAME(S): Primaquine

            USES: Primaquine is used with other medications to prevent and treat malaria caused by mosquito bites in countries where malaria is common. Malaria parasites can enter the body through these mosquito bites, and then live in body tissues such as red blood cells or the liver. Primaquine is used after other medications (such as chloroquine) have killed the malaria parasites living inside red blood cells. Primaquine then kills the malaria parasites living in other body tissues. This prevents the return of the infection. Both drugs are needed for a complete cure. Primaquine phosphate belongs to a class of drugs known as antimalarials.The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.

            HOW TO USE: Take this medication by mouth, usually once daily with food to prevent stomach upset, or as directed by your doctor. Follow your doctor's directions exactly. Primaquine is usually taken for 2 weeks after you have left the malarious area. It is started during the last 1-2 weeks of your other malaria treatment or immediately after you have finished your other treatment. Primaquine should not be taken for more than 14 days for malaria treatment.Dosage is based on the kind of infection you have and your response to treatment. Take this medication regularly. To help you remember, take it at the same time every day.It is very important to continue taking this medication exactly as prescribed by your doctor. Do not take more or less of this drug than prescribed. Do not stop taking it before completing treatment, even if you feel better, unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause prevention/treatment to be ineffective, cause the amount of parasite to increase, make the infection more difficult to treat (resistant), or worsen side effects.It is important to prevent mosquito bites (such as by using appropriate insect repellents, wearing clothes that cover most of the body, remaining in air-conditioned or well-screened areas, using mosquito nets, using insect-killing spray). Buy insect repellent before traveling. The most effective insect repellents contain diethyltoluamide (DEET). Ask your doctor or pharmacist to recommend the appropriate strengths of mosquito repellent for you/your children.No drug treatment is completely effective in preventing malaria. Seek immediate medical attention if you develop symptoms of malaria (such as fever, chills, headache, other flu-like symptoms), especially while in the malarious area and even after completing this prescription. Quick treatment of malaria infection is needed to prevent serious, possibly fatal, outcomes.When using primaquine phosphate for treatment of infection, tell your doctor if your condition persists or worsens.

            SIDE EFFECTS: Nausea, vomiting, dizziness, stomach upset, and abdominal cramps may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these rare but very serious side effects occur: signs of serious infection (such as high fever, severe chills, persistent sore throat), signs of a sudden loss of red blood cells (such as severe tiredness, brown urine, pale lips/nails/skin, fast heartbeat/breathing with usual activities), signs of a certain blood problem (methemoglobinemia, including bluish skin/lips/nails, headache, shortness of breath, lightheadedness, weakness, confusion, chest pain, sudden pounding heartbeat).Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking primaquine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system disease (such as lupus, rheumatoid arthritis), blood problems (such as low white blood cell counts, anemia), history of blood problems due to primaquine (such as hemolytic anemia, methemoglobinemia), personal/family history of favism, low levels of certain blood enzymes (glucose-6-phosphate dehydrogenase-G6PD, NADH methemoglobin reductase).Your doctor may order a blood test to see if you have any enzyme deficiency before starting primaquine.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Primaquine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using primaquine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using primaquine safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).This medication must not be used during pregnancy. It may harm an unborn baby. Women of child-bearing age should have a pregnancy test before starting this medication. It is important to prevent pregnancy during and after treatment with primaquine. Men and women must use reliable forms of birth control (such as condoms, birth control pills) during treatment. Men should continue to use birth control for at least 3 months after the end of treatment. Women should continue to use birth control for at least 1 menstrual cycle after the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor right away. While you are pregnant, traveling to an area with malaria puts you and your infant at a much higher risk for death and other problems. The CDC recommends continuing your other malaria treatment (such as chloroquine) throughout pregnancy until delivery to prevent harm to your unborn baby (hemolytic anemia). After delivery, you may finish treatment with primaquine. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk and the effect on a nursing infant is unknown. The doctor should test your infant for G6PD deficiency before breast-feeding. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: penicillamine, quinacrine, drugs that may cause decreased blood cells (such as trimethoprim, zidovudine, pyrimethamine, azathioprine).

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, seizures, fast/irregular heartbeat.

            NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as G6PD blood test, blood cell counts) should be performed at the start of treatment and periodically to monitor your progress or check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.