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Primaquine Phosphate

Class: Antimalarials
VA Class: AP101
CAS Number: 63-45-6

Medically reviewed on Jun 18, 2018

Introduction

Antimalarial; 8-aminoquinoline derivative.100 140

Uses for Primaquine Phosphate

Malaria

Treatment of malaria caused by Plasmodium vivax100 134 140 143 144 or P. ovale.134 140 143 144 Provides a radical cure to prevent relapse of malaria caused by these Plasmodium.100 140 143 144 Has only low activity against asexual erythrocytic forms of Plasmodium;140 a regimen that includes a blood schizonticidal agent (e.g., chloroquine [or hydroxychloroquine]; quinine with doxycycline or tetracycline; mefloquine; fixed-combination of atovaquone and proguanil [atovaquone/proguanil]; fixed combination of artemether and lumefantrine [artemether/lumefantrine]) is always used in conjunction with primaquine for treatment of P. ovale or P. vivax malaria.143 144

Presumptive antirelapse therapy (terminal prophylaxis) in travelers who received a suitable antimalarial for prevention of malaria but are returning from areas where P. vivax or P. ovale is endemic.100 115 134 If primaquine not used for terminal prophylaxis in individuals who may have been exposed to P. ovale or P. vivax malaria, delayed primary attacks or relapse caused by these Plasmodium can occur.115

Prevention of malaria (primary prophylaxis).115 134 Primaquine may be an option when other recommended antimalarials (choroquine [or hydroxychloroquine], atovaquone/proguanil, doxycycline, mefloquine) cannot be used for primary prophylaxis and is a good choice when travelers will be in areas with high incidence of P. vivax malaria.115 134 If primaquine is used for primary prophylaxis, primaquine presumptive antirelapse therapy is not needed.115

Assistance with diagnosis or treatment of malaria is available from CDC Malaria Hotline at 770-488-7788 or 855-856-4713 from 9:00 a.m. to 5:00 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours and on weekends and holidays.143 144

Information on risk of malaria in specific countries and mosquito avoidance measures and recommendations regarding whether prevention of malaria is indicated and choice of antimalarials for prevention are available from CDC at [Web] and [Web].115

Pneumocystis jirovecii Pneumonia

Treatment of Pneumocystis jirovecii (formerly Pneumocystis carinii) pneumonia (PCP); used in conjunction with clindamycin.109 110 112 113 114 116 117 119 122 123 124 130 134 440 441 Designated an orphan drug by FDA for use in conjunction with clindamycin for treatment of PCP associated with AIDS.132

Co-trimoxazole is drug of choice for treatment of mild, moderate, or severe PCP, including PCP in HIV-infected adults, adolescents, and children.134 440 441 CDC, NIH, and IDSA state that a regimen of primaquine and clindamycin is an alternative for treatment of mild, moderate, or severe PCP in HIV-infected adults and adolescents who have had an inadequate response to co-trimoxazole or when co-trimoxazole is contraindicated or not tolerated.440 Although data not available regarding use in children, CDC, NIH, IDSA, and AAP state that a regimen of primaquine and clindamycin also can be considered an alternative to co-trimoxazole for treatment of PCP in HIV-infected children based on data in adults.441

Not recommended for prevention of initial episodes (primary prophylaxis) of PCP in HIV-infected individuals because data insufficient to determine efficacy;440 441 not included in recommendations for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP.440 441 Co-trimoxazole is drug of choice for primary and secondary prophylaxis of PCP in HIV-infected adults, adolescents, and children.440 441

Primaquine Phosphate Dosage and Administration

General

  • Prior to use, perform appropriate laboratory tests to rule out glucose-6-phosphate dehydrogenase (G6PD) deficiency.100 115 143 440 (See Hemolytic Anemia and G6PD Deficiency under Cautions.)

Administration

Oral Administration

Administer orally;100 usually as a single daily dose at the same time each day.115

Take with food to decrease adverse GI effects (e.g., nausea, abdominal pain).115 134 161

Dosage

Available as primaquine phosphate;100 dosage usually expressed in terms of primaquine.100 134 144

Each 26.3-mg tablet of primaquine phosphate contains 15 mg of primaquine.100

Pediatric Patients

Malaria
Radical Cure of P. ovale or P. vivax Malaria
Oral

0.5 mg/kg (0.8 mg/kg of primaquine phosphate) once daily for 14 days.115 134 144

Presumptive Antirelapse Therapy (Terminal Prophylaxis) of P. ovale or P. vivax Malaria
Oral

0.5 mg/kg (0.8 mg/kg of primaquine phosphate) once daily for 14 days115 134 given after leaving malarious area.115

Individuals who received primary prophylaxis with chloroquine, hydroxychloroquine, doxycycline, or mefloquine: Administer primaquine presumptive antirelapse therapy during final 2 weeks of primary prophylaxis or, if not feasible, administer for 14 days after primary prophylaxis discontinued.115

Individuals who received primary prophylaxis with atovaquone/proguanil: Administer primaquine presumptive antirelapse therapy during final 7 days of primary prophylaxis and then for an additional 7 days or, if not feasible, administer for 14 days after primary prophylaxis discontinued.115

Primary Prophylaxis of Malaria
Oral

0.5 mg/kg (0.8 mg/kg of primaquine phosphate) once daily.115 134

Initiate prophylaxis 1–2 days prior to entering a malarious area and continue during stay and for 7 days after leaving the area.115

Pneumocystis jirovecii Pneumonia (PCP)
Treatment of PCP in HIV-infected Children
Oral

0.3 mg/kg (up to 30 mg) once daily for 21 days;134 441 used in conjunction with clindamycin (10 mg/kg [up to 600 mg] IV every 6 hours or 10 mg/kg [up to 300–450 mg] orally every 6 hours) given for 21 days.441

Treatment of Mild to Moderate PCP in HIV-infected Adolescents
Oral

30 mg once daily for 21 days;440 used in conjunction with oral clindamycin (450 mg every 6 hours or 600 mg every 8 hours) given for 21 days.440

Treatment of Moderate to Severe PCP in HIV-infected Adolescents
Oral

30 mg once daily for 21 days;440 used in conjunction with IV clindamycin (600 mg every 6 hours or 900 mg every 8 hours) or oral clindamycin (450 mg every 6 hours or 600 mg every 8 hours) given for 21 days.440

Adults

Malaria
Radical Cure of P. ovale or P. vivax Malaria
Oral

30 mg of primaquine (52.6 mg of primaquine phosphate) once daily for 14 days recommended by CDC and others.115 134 144 Although manufacturer recommends 15 mg of primaquine (26.3 mg of primaquine phosphate) once daily for 14 days,100 this dosage may be inadequate if malaria is acquired in Southeast Asia (particularly Indonesia and Oceania).140

As an alternative to the daily regimen or if used in patients with borderline G6PD deficiency, CDC recommends 45 mg of primaquine (79 mg of primaquine phosphate) once weekly for 8 weeks.143 144 Consultation with an expert in infectious disease and/or tropical medicine recommended if this regimen considered for individuals with borderline G6PD deficiency.143 144 (See Hemolytic Anemia and G6PD Deficiency under Cautions.)

Presumptive Antirelapse Therapy (Terminal Prophylaxis) of P. ovale or P. vivax Malaria
Oral

30 mg of primaquine (52.6 mg of primaquine phosphate) once daily for 14 days given after leaving malarious areas recommended by CDC and others.115 134 Although manufacturer recommends 15 mg of primaquine (26.3 mg of primaquine phosphate) once daily for 14 days,100 this dosage may be inadequate in areas with P. vivax that are relatively resistant to primaquine (e.g., Oceania).140

Individuals who received primary prophylaxis with chloroquine, hydroxychloroquine, doxycycline, or mefloquine: Administer primaquine presumptive antirelapse therapy during final 2 weeks of primary prophylaxis or, if not feasible, administer for 14 days after primary prophylaxis discontinued.115

Individuals who received primary prophylaxis with atovaquone/proguanil: Administer primaquine presumptive antirelapse therapy during final 7 days of primary prophylaxis and then for an additional 7 days or, if not feasible, administer for 14 days after primary prophylaxis discontinued.115

Primary Prophylaxis of Malaria
Oral

30 mg of primaquine once daily.115 134

Initiate prophylaxis 1–2 days prior to entering a malarious area and continue during stay and for 7 days after leaving the area.115

Pneumocystis jirovecii Pneumonia (PCP)
Treatment of Mild to Moderate PCP
Oral

30 mg once daily for 21 days;134 440 used in conjunction with oral clindamycin (450 mg every 6 hours or 600 mg every 8 hours) given for 21 days.440

Treatment of Moderate to Severe PCP
Oral

30 mg once daily for 21 days;134 440 used in conjunction with IV clindamycin (600 mg every 6 hours or 900 mg every 8 hours) or oral clindamycin (450 mg every 6 hours or 600 mg every 8 hours) given for 21 days.440

Prescribing Limits

Pediatric Patients

Malaria
Treatment or Prevention of Malaria
Oral

Do not exceed adult dosage.115 144

Adults

Malaria
Treatment or Prevention of Malaria
Oral

Manufacturer states do not exceed 15 mg of primaquine (26.3 mg of primaquine phosphate) once daily for 14 days;100 CDC and others recommend 30 mg of primaquine (52.6 mg of primaquine phosphate) once daily.115 134 144

Special Populations

Hepatic Impairment

No specific dosage recommendations.100

Renal Impairment

No specific dosage recommendations.100

Geriatric Adults

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.100

Cautions for Primaquine Phosphate

Contraindications

  • Severe G6PD deficiency.100 (See Hemolytic Anemia and G6PD Deficiency under Cautions.)

  • Pregnant women.100 (See Pregnancy under Cautions.)

  • Acutely ill patients who have systemic disease manifested by a tendency to develop granulocytopenia (e.g., rheumatoid arthritis, lupus erythematosus).100

  • Patients receiving other potentially hemolytic drugs or agents capable of depressing the myeloid elements of bone marrow.100

Warnings/Precautions

Warnings

Hemolytic Anemia and G6PD Deficiency

Hemolytic reactions (moderate to severe) may occur if used in individuals with G6PD deficiency100 115 140 or in individuals with family or personal history of favism.100 Hemolytic reactions can be fatal.115

Perform appropriate laboratory testing to rule out G6PD deficiency before initiating primaquine.100 115 143

Severe G6PD deficiency: Do not prescribe primaquine.100

Mild to moderate G6PD deficiency: Base decision to prescribe primaquine on an assessment of risks and benefits.100 If use of the drug is considered, evaluate baseline hematocrit and hemoglobin concentration before treatment and closely monitor hematologic parameters during treatment (e.g., at days 3 and 8).100

G6PD status unknown and G6PD testing unavailable: Base decision to prescribe primaquine on an assessment of risks and benefits.100 Assess risk factors for G6PD deficiency or favism.100 If use of the drug is considered, evaluate baseline hematocrit and hemoglobin concentration before treatment and closely monitor hematologic parameters during treatment (e.g., at days 3 and 8).100

Consider that residual risk of hemolysis exists despite G6PD testing because of limitations of the tests.100 Routine hematologic monitoring (particularly CBCs and hemoglobin concentrations) is advisable during primaquine therapy, even in G6PD-normal individuals.100

Do not exceed recommended dosage.100

Monitor closely if used in individuals who have had a previous idiosyncratic reaction to primaquine (as manifested by hemolytic anemia, methemoglobinemia, or leukopenia) or in individuals with a personal or family history of hemolytic anemia or nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficiency.100

Discontinue immediately if evidence of hemolytic anemia occurs (e.g., darkening of urine, marked fall in hemoglobin concentration or erythrocyte count) or if leukocyte count suddenly decreases.100

Ensure that adequate medical support and follow-up to manage hemolytic risk are available for all patients receiving primaquine.100

Cardiac Effects

Cardiac arrhythmia100 140 and prolonged QT interval100 reported.

Because of potential for QT interval prolongation, monitor ECG if used in patients with cardiac disease, long QT syndrome, history of ventricular arrhythmias, uncorrected hypokalemia and/or hypomagnesemia, or bradycardia (<50 bpm) and whenever used concomitantly with drugs that prolong the QT interval.100

Females and Males of Reproductive Potential

Sexually active females of reproductive potential: Perform pregnancy test prior to initiation of primaquine;100 pregnancy must be avoided during and after treatment until an ongoing ovulatory cycle has been completed.100 (See Pregnancy under Cautions.)

Sexually active males whose partners may become pregnant: Use condom during primaquine treatment and for 3 months after the drug discontinued.100 (See Pregnancy under Cautions.)

General Precautions

GI Effects

Nausea,100 vomiting,100 epigastric distress,100 and abdominal cramps100 reported; incidence and severity appear to be dose related.140

Adverse GI effects may be decreased by administration with food.115 134 140

Specific Populations

Pregnancy

Contraindicated during pregnancy.100 115 134 143 Safe use during pregnancy not established.100 In addition, transplacental transfer of the drug to a G6PD-deficient fetus potentially could cause hemolytic anemia in utero.115

In animals, has been associated with teratogenicity and injury to embryos and developing fetuses.100 Inform patients of potential for adverse genetic and reproductive effects.100

Test all sexually active females of reproductive potential for pregnancy prior to initiation of primaquine.100 Advise such women to use effective contraception (i.e., methods with pregnancy rates <1%) during and after primaquine therapy until an ongoing ovulatory cycle has been completed (up to next menses).100 Advise sexually active males whose partners may become pregnant to use a condom during and for 3 months after primaquine therapy.100

If a pregnant woman requires treatment of P. vivax or P. ovale malaria, CDC recommends use of oral chloroquine (300 mg once weekly) for prophylaxis for duration of the pregnancy and deferral of primaquine (to provide a radical cure) until after delivery and after the woman has been tested and determined not to have G6PD deficiency.143 144

Lactation

Distributed into milk in low concentrations.140

Manufacturer states discontinue nursing or the drug, taking into account importance of the drug to the mother.100

CDC states do not use in nursing women unless the woman and breast-fed infant have been determined not to have G6PD deficiency.115

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.100

Select dosage with caution (starting at the low end of dosage range) because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.100

Common Adverse Effects

Hematologic effects (hemolytic anemia, leukocytosis, leukopenia); GI effects (nausea, vomiting, epigastric distress, abdominal cramps).100

Interactions for Primaquine Phosphate

Specific Drugs

Drug

Interaction

Comments

Drugs that prolong QT interval

Use concomitantly with caution and monitor ECG100

Quinacrine

Quinacrine (not available in US) potentiates toxicity of antimalarials structurally related to primaquine100

Concomitant use contraindicated; do not use primaquine in individuals who recently received quinacrine100

Primaquine Phosphate Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed from GI tract.140 Peak plasma concentrations generally attained within 2–4 hours.140

Pharmacokinetics are altered during malaria infection; peak plasma concentrations may be higher in adults with malaria compared with healthy adults.140

Food

In healthy adults, administration with food (approximately 28 g of fat) resulted in 1.23-fold increase in peak plasma concentration and 1.12-fold increase in AUC compared with administration in fasting state.140

Distribution

Extent

Widely distributed following oral administration.101

Low concentrations distributed into milk.140

Elimination

Metabolism

Extensively and rapidly metabolized in the liver.101 140 The principal metabolite is carboxyprimaquine; plasma concentrations of the metabolite greatly exceed those of unchanged primaquine.101 140

Elimination Route

Only small amounts excreted unchanged in urine.101

Half-life

4–7 hours.115 140

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C);100 store in tight, light-resistant container.100

Actions and Spectrum

  • Antimalarial.100 140

  • Tissue schizonticidal agent active against the preerythrocytic and exoerythrocytic forms of Plasmodium falciparum, P. malariae, P. ovale, and P. vivax.140 Also gametocytocidal against P. falciparum and other Plasmodium.140

  • Has only low activity against the erythrocytic forms of Plasmodium.140

  • Primaquine-resistant and primaquine-tolerant P. vivax reported.140

  • Exact mechanism of antimalarial activity unknown;140 161 appears to cause morphologic and physiologic changes in plasmodial mitochondria.140 In the treatment of malaria caused by P. vivax, primaquine eliminates tissue (exoerythrocytic) infection thereby preventing development of blood (erythrocytic) forms of the parasite that are responsible for relapse of P. vivax malaria.100

  • Mechanism of action against P. jirovecii unknown.140

Advice to Patients

  • Necessity of taking protective measures to reduce contact with mosquitoes (protective clothing, insect repellents, mosquito nets, remaining in air-conditioned or well-screened areas).115 134

  • Possibility of contracting malaria during travel, regardless of prophylactic regimen used.115 134

  • Importance of seeking medical attention as soon as possible if febrile illness develops during or after return from a malaria-endemic area and of informing clinician of possible malaria exposure.115 134

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.100

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.100 115 143

  • Advise sexually active females and males of the importance of taking precautions to avoid pregnancy during and after primaquine therapy.100 (See Pregnancy under Cautions.)

  • Importance of advising patients of other important precautionary information.100 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Primaquine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

15 mg (of primaquine)*

Primaquine Phosphate Tablets

AHFS DI Essentials. © Copyright 2018, Selected Revisions June 18, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Sanofi-Aventis. Primaquine phosphate tablets, film-coated prescribing information. Bridgewater, NJ; 2017 Jul.

101. White NJ. Clinical pharmacokinetics of antimalarial drugs. Clin Pharmacokinet. 1985; 10:187-215. http://www.ncbi.nlm.nih.gov/pubmed/3893840?dopt=AbstractPlus

109. Ruf B, Pohle HD. Clindamycin/primaquine for Pneumocystis carinii pneumonia. Lancet. 1989; 2:626-7. http://www.ncbi.nlm.nih.gov/pubmed/2570324?dopt=AbstractPlus

110. Toma E, Fournier D, Poisson M et al. Clindamycin with primaquine for Pneumocystis carinii pneumonia. Lancet. 1989; 1:1046-8. http://www.ncbi.nlm.nih.gov/pubmed/2566001?dopt=AbstractPlus

112. Black JR, Feinberg J, Murphy RL et al. Clindamycin and primaquine as primary treatment for mild and moderately severe Pneumocystis carinii pneumonia in patients with AIDS. Eur J Clin Microbiol Infect Dis. 1991; 10:204-7. http://www.ncbi.nlm.nih.gov/pubmed/2060532?dopt=AbstractPlus

113. Joseph P, Marzouk J, Phelps R. Oral clindamycin plus primaquine for Pneumocystis carinii pneumonia. Sixth International Conference on AIDS. 1990:373. Abstract No. 2078.

114. Kay R, DuBois RE. Clindamycin/primaquine therapy and secondary prophylaxis against Pneumocystis carinii pneumonia in patients with AIDS. South Med J. 1990; 83:403-4. http://www.ncbi.nlm.nih.gov/pubmed/2321069?dopt=AbstractPlus

115. Centers for Disease Control and Prevention. CDC health information for international travel, 2018. Atlanta, GA: US Department of Health and Human Services. Updates may be available at CDC website. https://wwwnc.cdc.gov/travel/page/yellowbook-home

116. Ruf B, Rohde I, Pohle HD. Efficacy of clindamycin/primaquine versus trimethoprim/sulfamethoxazole in primary treatment of Pneumocystis carinii pneumonia. Eur J Clin Microbiol Infect Dis. 1991; 10:207-10. http://www.ncbi.nlm.nih.gov/pubmed/2060533?dopt=AbstractPlus

117. Toma E. Clindamycin/primaquine for treatment of Pneumocystis carinii pneumonia in AIDS. Eur J Clin Microbiol Infect Dis. 1991; 10:210-3. http://www.ncbi.nlm.nih.gov/pubmed/2060534?dopt=AbstractPlus

119. Reviewers’ comments (personal observations).

122. Vildé JL, Remington JS. Role of clindamycin with or without another agent for the treatment of pneumocystosis in patients with AIDS. J Infect Dis. 1992; 166:694-5. http://www.ncbi.nlm.nih.gov/pubmed/1500762?dopt=AbstractPlus

123. Smith D, Gazzard B. Treatment and prophylaxis of Pneumocystis carinii pneumonia. Drugs. 1991; 42:628-39. http://www.ncbi.nlm.nih.gov/pubmed/1723365?dopt=AbstractPlus

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128. Wyler DJ. Malaria: overview and update. Clin Infect Dis. 1993; 16:449-58. http://www.ncbi.nlm.nih.gov/pubmed/8513046?dopt=AbstractPlus

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132. Food and Drug Administration. List of orphan designations and approvals. From FDA web site. http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm

133. Fryauff DJ, Baird JK, Basri H et al. Randomised placebo-controlled trial of primaquine for prophylaxis of falciparum and vivax malaria. Lancet. 1995; 346:1190-3. http://www.ncbi.nlm.nih.gov/pubmed/7475658?dopt=AbstractPlus

134. . Drugs for parasitic infections. Treat Guidel Med Lett. 2013; 11:e1-31.

135. Weiss WR, Oloo AJ, Johnson A et al. Daily primaquine is effective for prophylaxis against falciparum malaria in Kenya: comparison with mefloquine, doxycycline, and chloroquine plus proguanil. J Infect Dis. 1995; 171:1569-75. http://www.ncbi.nlm.nih.gov/pubmed/7769294?dopt=AbstractPlus

140. Edstein MD, Shanks GD. Primaquine. In: Grayson ML, ed. Kucers' the use of antibiotics: a clinical review of antibacterial, antifungal, antiparasitic, and antiviral drugs. 7th ed. Boca Raton, FL: CRC Press; 2018: 3097-3109.

143. Centers for Disease Control and Prevention. CDC treatment guidelines: Treatment of malaria (guidelines for clinicians). 2013 Jul. From the CDC website. Accessed 2018 Mar 9. http://www.cdc.gov/malaria

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440. Panel on Opportunistic Infection in HIV-infected Adults and Adolescents, US Department of Health and Human Services (HHS). Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Accessed March 8, 2018. Updates may be available at HHS AIDS Information (AIDSinfo) website. http://www.aidsinfo.nih.gov

441. Panel on Opportunistic Infection in HIV-exposed and HIV-infected children, US Department of Health and Human Services (HHS). Guidelines for the prevention and treatment of opportunistic infections among HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. Accessed March 8, 2018. Updates may be available at HHS AIDS Information (AIDSinfo) website. http://www.aidsinfo.nih.gov

161. World Health Organization (WHO). Guidelines for the treatment of malaria. 2nd edition. Geneva, Switzerland: World Health Organization; 2010. Updates may be available at WHO website. http://www.who.int/malaria/publications/atoz/9789241547925/en/index.html

a. AHFS Drug Information 2018. McEvoy GK, ed. Primaquine Phosphate. Bethesda, MD: American Society of Health-System Pharmacists; 2018.

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