VA Class: AP101
CAS Number: 50-63-5
Brands: Aralen Phosphate
Antimalarial; 4-aminoquinoline derivative.136
Uses for Chloroquine Phosphate
Prevention (prophylaxis) of malaria caused by Plasmodium malariae, P. ovale, chloroquine-susceptible P. vivax, or chloroquine-susceptible P. falciparum.136 174 176 178 Recommended by CDC and others as drug of choice for prevention of malaria caused by susceptible Plasmodium; should be used whenever malaria prophylaxis is indicated in individuals traveling to malarious areas where chloroquine-resistant P. falciparum malaria has not been reported.140 147 148 149 162 163 164 166 174 175 176 177 178 (See Chloroquine-resistant Plasmodium under Cautions.)
Treatment of uncomplicated malaria caused by susceptible P. falciparum.191 Recommended by CDC and others as the drug of choice for treatment of uncomplicated P. falciparum malaria acquired in areas where chloroquine resistance has not been reported.174 183 191 (See Chloroquine-resistant Plasmodium under Cautions.)
Treatment of uncomplicated malaria caused by P. malariae, P. ovale, or chloroquine-susceptible P. vivax.136 174 183 191 Recommended by CDC and others as the drug of choice for treatment of uncomplicated malaria caused by these Plasmodium;174 183 191 do not use for P. vivax malaria acquired in Papua New Guinea or Indonesia.183 191 (See Chloroquine-resistant Plasmodium under Cautions.)
Active only against the asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages) and cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria or provide a radical cure; primaquine usually also indicated to eradicate hypnozoites and prevent relapse in patients exposed to or being treated for P. ovale or P. vivax malaria.176 183
Detailed recommendations regarding prevention of malaria available from CDC 24 hours a day from the voice information service (877-394-8747) or at .176
Assistance with diagnosis or treatment of malaria available from CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.191
Has been used for treatment of extraintestinal amebiasis136 (including liver abscess) caused by Entamoeba histolytica.
Ineffective for treatment of intestinal amebiasis.a
A nitroimidazole derivative (metronidazole, tinidazole) followed by a luminal amebicide (iodoquinol, paromomycin, diloxanide furoate) is usual regimen of choice for mild to moderate or severe intestinal disease and for amebic hepatic abscess.174 178
No longer a recommended disease-modifying antirheumatic drug (DMARD).a Other DMARDs generally preferred,105 106 especially since risk of severe and sometimes irreversible toxicity must be considered if chloroquine is used for prolonged periods in treatment of rheumatoid arthritis. (See Cautions.)a
Has been used as an adjunct to topical corticosteroid therapy in treatment of discoid lupus erythematosus† and as an adjunct to systemic corticosteroid and/or salicylate therapy in treatment of systemic lupus erythematosus†.a
If used for prolonged periods in the treatment of lupus erythematosus, the risk of serious and sometimes irreversible toxicity should be considered.a (See Cautions.)
Porphyria Cutanea Tarda and Polymorphous Light Eruptions
Has been effective in some cases when used in treatment of polymorphous light eruptions†.
Chloroquine Phosphate Dosage and Administration
Administration with meals may minimize adverse GI effects.a
Because tablets have a bitter taste, they have been pulverized and mixed with chocolate or cherry syrup for administration in children or, alternatively, enclosed in gelatin capsules for mixing in food or drink.a Outside the US, the drug is available in many countries as an oral suspension for use in children.176 However, the chloroquine concentration varies depending on the specific oral suspension, and parents should be instructed how to calculate the appropriate volume to be administered based on the child's body weight.176
For prevention of malaria, chloroquine is given once weekly and should be administered on the same day each week.136 148 163 166 If intolerable adverse GI effects occur despite administration with meals, the usual weekly dose can be divided into 2 doses and administered on separate days during the week.a
Dosage of chloroquine in children should be calculated in proportion to adult dosage based on body weight.136
Prevention of Malaria in Areas without Chloroquine-resistant PlasmodiumOral
Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.176
Treatment of Uncomplicated Chloroquine-susceptible MalariaOral
An initial dose of 10 mg/kg of chloroquine (16.7 mg/kg of chloroquine phosphate) followed by 5-mg/kg doses (8.3 mg/kg of chloroquine phosphate) given at 6, 24, and 48 hours after the initial dose.174 183 191
Prevention of Malaria in Areas without Chloroquine-resistant PlasmodiumOral
Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.176
Treatment of Uncomplicated Chloroquine-susceptible MalariaOral
An initial dose of 600 mg of chloroquine (1 g of chloroquine phosphate) followed by 300-mg doses (500 mg of chloroquine phosphate) given at 6, 24, and 48 hours after the initial dose.191
Prophylaxis of P. ovale or P. vivax When Primaquine Is Deferred during PregnancyOral
300 mg (500 mg of chloroquine phosphate) once weekly for the duration of the pregnancy.183 Given after the usual treatment regimen and continued until primaquine can be given to provide a radical cure after delivery.183
600 mg of chloroquine (1 g of chloroquine phosphate) once daily for 2 days, followed by 300 mg (500 mg of chloroquine phosphate) once daily for at least 2–3 weeks; usually used in conjunction with an intestinal amebicide.136
150 mg (250 mg of chloroquine phosphate) daily. After remission or maximum improvement occurs, dosage should be reduced.a
A response may not occur until after >4–6 weeks of therapy.a Some clinicians recommend that the drug be continued for 4 months before being considered ineffective for treatment of rheumatoid arthritis.a
150 mg (250 mg of chloroquine phosphate) daily.a
When used in conjunction with topical corticosteroids in treatment of discoid lupus erythematosus, skin lesions may regress within 3–4 weeks and new lesions may not appear.a When systemic and cutaneous manifestations of lupus erythematosus subside, reduce chloroquine dosage gradually over several months, and discontinue as soon as possible.a
Prevention of Malaria in Areas Without Chloroquine-resistant PlasmodiumOral
Cautions for Chloroquine Phosphate
Hypersensitivity to chloroquine or other 4-aminoquinoline derivatives.136
Retinal or visual field changes attributable to 4-aminoquinoline derivatives or to any other etiology.136 After weighing the possible benefits and risks to the patient, some clinicians may elect to use chloroquine in these patients for treatment of acute attacks of malaria caused by susceptible Plasmodium.136
For prevention of malaria, use only in individuals traveling to malarious areas where chloroquine-resistant P. falciparum malaria has not been reported.136 140 147 148 149 162 163 164 166 174 175 176 177 178 Malaria-related deaths have been reported in US citizens using chloroquine-containing regimens (i.e., chloroquine alone or in conjunction with proguanil) for malaria prevention in countries with chloroquine-resistant P. falciparum.118
Consider that chloroquine-resistant P. vivax has been reported with a high incidence in Papua New Guinea and Indonesia and rarely in Burma (Myanmar), India, and Central and South America.183 191 A treatment regimen effective against chloroquine-resistant P. vivax should be used in those who acquire P. vivax malaria in Papua New Guinea or Indonesia.174 183 191
Malaria patients who do not respond to chloroquine should be switched to a treatment recommended for chloroquine-resistant P. falciparum (e.g., quinine sulfate with doxycycline, tetracycline or clindamycin; fixed combination of atovaquone and proguanil; fixed combination of artemether and lumefantrine) or chloroquine-resistant P. vivax (e.g., quinine sulfate with doxycycline or tetracycline in conjunction with primaquine; mefloquine in conjunction with primaquine; fixed combination of atovaquone and proguanil in conjunction with primaquine).183 191
Dose-related retinopathy reported, which may progress even after the drug is discontinued.136 Retinal changes may be reversible if detected early, but usually are permanent and may rarely result in blindness.136
Whenever long-term therapy is contemplated, perform initial (base line) and periodic ophthalmologic examinations, including visual acuity, slit-lamp, funduscopic, and visual field tests.136
Discontinue drug immediately and closely observe patient for possible progression if there is any indication of abnormalities in visual acuity or visual field, abnormalities in the retinal macular area (such as pigmentary changes or loss of foveal reflex), or if any other visual symptoms (e.g., light flashes and streaks) occur which are not fully explainable by difficulties of accommodation or corneal opacities.136
Skeletal muscle myopathy or neuromyopathy occur rarely; neuromyopathy is manifested as slowly progressing weakness which first affects proximal muscles of lower extremities.136
Patients receiving prolonged therapy should be questioned and examined periodically for evidence of muscular weakness; knee and ankle reflexes should be tested.136
Discontinue chloroquine if muscular weakness occurs.136
Patients with Psoriasis or Porphyria
Aplastic anemia, reversible agranulocytosis, thrombocytopenia, and neutropenia reported rarely.136
Periodically monitor CBCs in patients receiving prolonged treatment.136 Consider discontinuing chloroquine if any severe blood disorder occurs which is not attributable to the disease being treated.136
Use with caution in patients with G-6-PD deficiency.136
Nerve-type deafness, tinnitus, and reduced hearing reported rarely in patients with pre-existing auditory damage.136
Seizures may occur; advise patients with a history of epilepsy about the risk.136
Avoid use during pregnancy unless the clinician determines that the benefits of prevention or treatment of malaria outweigh the risks.136
Has been used for prophylaxis and treatment of malaria in pregnant women without evidence of adverse effects on the fetus.176
CDC states that the benefits of chloroquine prophylaxis in pregnant women exposed to malaria outweigh the potential risks to the fetus.176
Because malaria infection in pregnant women is associated with high risks of maternal and perinatal morbidity and mortality (e.g., miscarriage, premature delivery, low birth weight, congenital infection and/or perinatal death), CDC recommends prompt chloroquine treatment in pregnant women with uncomplicated malaria caused by P. malariae, P. ovale, chloroquine-susceptible P. falciparum, or chloroquine-susceptible P. vivax.183
Because use of primaquine should be deferred during pregnancy, CDC recommends that pregnant women being treated for P. ovale or P. vivax malaria receive chloroquine prophylaxis for the duration of the pregnancy (after the initial chloroquine treatment regimen) until primaquine can be given after delivery to provide a radical cure.183 191
Amount of drug present in human milk does not appear to be harmful to nursing infants, but is insufficient to provide adequate protection against malaria in these infants.176 When chemoprophylaxis is necessary in such infants, they should receive recommended dosages of the appropriate antimalarial agent(s).176
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.136
Substantially eliminated by kidneys; risk of toxicity may be greater in patients with impaired renal function.136 Select dosage with caution and assess renal function periodically since geriatric patients are more likely to have renal impairment.136
Concentrates in the liver; use with caution in patients with hepatic disease or alcoholism and in those receiving known hepatotoxic drugs.136
Common Adverse Effects
Ocular effects; skeletal muscle myopathy or neuromyopathy; GI effects (anorexia, nausea, vomiting, diarrhea, abdominal cramps); dermatologic effects (pleomorphic skin eruptions, skin and mucosal pigmentary changes).136
Interactions for Chloroquine Phosphate
Possible reduced bioavailability of ampicillin136
Administer chloroquine at least 2 hours before or after ampicillin136
Possible reduced GI absorption of chloroquine136
Administer chloroquine at least 4 hours before or after antacids136
Possible inhibition of chloroquine metabolism resulting in increased concentrations of the antimalarial136
Avoid concomitant use136
Possible increased cyclosporine concentrations136
Closely monitor serum cyclosporine concentrations; if necessary, discontinue chloroquine136
Possible decreased praziquantel concentrations184
Complete preexposure intradermal vaccination with HDCV (no longer commercially available in the US) before initiating chloroquine malaria prophylaxis or administer the vaccine IM in those receiving chloroquine 176 182
Sulfadoxine and pyrimethamine
Possible increased incidence and severity of adverse effects when used concomitantly with chloroquine compared with use of sulfadoxine and pyrimethamine alone190
Chloroquine Phosphate Pharmacokinetics
Widely distributed into body tissues.a
Chloroquine binds to melanin-containing cells in the eyes and skin; skin concentrations of the drug are considerably higher than plasma concentrations.a Also concentrates in erythrocytes and binds to platelets and granulocytes.a
Plasma Protein Binding
Chloroquine and its metabolites are slowly excreted by the kidneys; unabsorbed drug is excreted in feces.a
Up to 70% of a dose is excreted unchanged in urine and up to 25% of dose may be excreted in urine as desethylchloroquine.a Small amounts of chloroquine may be present in urine for weeks, months, and occasionally years after the drug is discontinued.a
Usually 72–120 hours.a
Serum concentrations decline in a biphasic manner and terminal half-life increases with increasing doses.a Terminal half-life is 3.1 hours after a single 250-mg oral dose, 42.9 hours after a single 500-mg oral dose, and 312 hours after a single 1-g oral dose.a
25°C (may be exposed to 15–30°C) in tight container.136
Actions and Spectrum
A blood schizonticidal agent active against asexual erythrocytic forms of most strains of Plasmodium malariae, P. ovale, P. vivax, and many strains of P. falciparum.a Not active against preerythrocytic or exoerythrocytic forms of plasmodia.a Gametocytocidal for P. malariae and P. vivax, but has no direct activity against the gametocytes of P. falciparum.a
Chloroquine-resistant P. falciparum also are resistant to hydroxychloroquine and may be cross-resistant to pyrimethamine or quinine.a Chloroquine-resistant P. falciparum may be susceptible to quinine or the fixed combination of sulfadoxine and pyrimethamine, but P. falciparum resistant to both chloroquine and sulfadoxine and pyrimethamine are widespread in certain areas.176
Has anti-inflammatory activity; mechanism(s) of action in the treatment of rheumatoid arthritis and lupus erythematosus has not been determined.a
Advice to Patients
Importance of keeping chloroquine out of reach of children since they are especially sensitive to 4-aminoquinoline derivatives.136
Advise patients with a history of epilepsy about the risk of seizures.136
Necessity of taking protective measures to reduce contact with mosquitoes (protective clothing, insect repellents, mosquito nets, remaining in air-conditioned or well-screened areas).140 162 163 164 165 166 176
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.162 163 166 176
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.136
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.136
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
150 mg (of chloroquine)*
Chloroquine Phosphate Tablets
300 mg (of chloroquine)*
Chloroquine Phosphate Tablets
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Aralen 500MG Tablets (SANOFI-AVENTIS U.S.): 25/$190.00 or 75/$545.96
Chloroquine Phosphate 250MG Tablets (GLOBAL PHARMACEUTICAL CORP): 30/$72.99 or 90/$205.97
Chloroquine Phosphate 500MG Tablets (WEST-WARD): 7/$36.99 or 21/$108.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions January 1, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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