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Chloroquine Phosphate

Pronunciation

Class: Antimalarials
VA Class: AP101
CAS Number: 50-63-5
Brands: Aralen Phosphate

Introduction

Antimalarial; 4-aminoquinoline derivative.136

Uses for Chloroquine Phosphate

Malaria

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.)

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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

Extraintestinal Amebiasis

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

Rheumatoid Arthritis

Has been used for treatment of rheumatoid arthritis in patients whose symptoms progress despite an adequate regimen of nonsteroidal anti-inflammatory agents (NSAIAs).a

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

Lupus Erythematosus

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 used with some success in treatment of porphyria cutanea tarda.185 186 187 (See Patients with Psoriasis or Porphyria under Cautions.)

Has been effective in some cases when used in treatment of polymorphous light eruptions.

Sarcoidosis

Has been used with some success in the treatment of sarcoidosis.188 189

Chloroquine Phosphate Dosage and Administration

Administration

Administer orally.136

Oral 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

Available as chloroquine phosphate;136 dosage usually expressed in terms of chloroquine.136 Each 100 mg of chloroquine phosphate is equivalent to 60 mg of chloroquine.136

Dosage of chloroquine in children should be calculated in proportion to adult dosage based on body weight.136

Pediatric Patients

Malaria
Prevention of Malaria in Areas without Chloroquine-resistant Plasmodium
Oral

5 mg/kg (8.3 mg/kg of chloroquine phosphate) once weekly on the same day each week.136 163 174 176

Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.176

Terminal prophylaxis with primaquine may be indicated during the final 2 weeks of chloroquine prophylaxis if exposure occurred in areas where P. ovale or P. vivax are endemic.174 176

Treatment of Uncomplicated Chloroquine-susceptible Malaria
Oral

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

Adults

Malaria
Prevention of Malaria in Areas without Chloroquine-resistant Plasmodium
Oral

300 mg (500 mg of chloroquine phosphate) once weekly.136 163 174 176

Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.176

Terminal prophylaxis with primaquine may be indicated during the final 2 weeks of chloroquine prophylaxis if exposure occurred in areas where P. ovale or P. vivax are endemic.174 176

Treatment of Uncomplicated Chloroquine-susceptible Malaria
Oral

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 Pregnancy
Oral

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

Extraintestinal Amebiasis
Oral

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

Rheumatoid Arthritis
Oral

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

Lupus Erythematosus
Oral

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

Prescribing Limits

Pediatric Patients

Malaria
Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium
Oral

Maximum dosage of 300 mg (500 mg of chloroquine phosphate) daily, regardless of weight.136 174 176

Cautions for Chloroquine Phosphate

Contraindications

  • 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

Warnings/Precautions

Warnings

Chloroquine-resistant Plasmodium

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

For prevention or treatment of malaria, consider that chloroquine-resistant P. falciparum have been reported in many areas where malaria occurs.140 143 144 174 176 183

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

Ocular Effects

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

Neuromuscular Effects

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

May exacerbate psoriasis and precipitate a severe attack in patients with the disease.136 Use in psoriasis patients only if potential benefits outweigh the risks.136

May exacerbate porphyria.136 Use in patients with porphyria only if potential benefits outweigh the risks.136

General Precautions

Hematologic Effects

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

Otic Effects

Nerve-type deafness, tinnitus, and reduced hearing reported rarely in patients with pre-existing auditory damage.136

Use with caution in patients with preexisting auditory damage.136 Discontinue chloroquine immediately and closely observe patient if any hearing defects occur.136

CNS Effects

Seizures may occur; advise patients with a history of epilepsy about the risk.136

Specific Populations

Pregnancy

Category C.c

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

Lactation

Distributed into milk.122 123 124 Discontinue nursing or the drug.136

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

Pediatric Use

Pediatric patients are especially sensitive to 4-aminoquinoline derivatives.136 Fatalities have been reported following accidental ingestion of relatively small doses.136

Geriatric Use

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

Hepatic Impairment

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

Specific Drugs

Drug

Interaction

Comments

Ampicillin

Possible reduced bioavailability of ampicillin136

Administer chloroquine at least 2 hours before or after ampicillin136

Antacids

Possible reduced GI absorption of chloroquine136

Administer chloroquine at least 4 hours before or after antacids136

Cimetidine

Possible inhibition of chloroquine metabolism resulting in increased concentrations of the antimalarial136

Avoid concomitant use136

Cyclosporine

Possible increased cyclosporine concentrations136

Closely monitor serum cyclosporine concentrations; if necessary, discontinue chloroquine136

Praziquantel

Possible decreased praziquantel concentrations184

Rabies vaccine

Possible interference with immune response to intradermally administered human diploid-cell rabies vaccine (HDCV) (no longer commercially available in the US)116 117 176 182

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

Absorption

Bioavailability

Rapidly and almost completely absorbed from GI tract following oral administration;a 136 peak plasma concentrations generally attained within 1–2 hours.a

Food

Bioavailability of chloroquine is greater when administered with food;a rate of absorption is unaffected but peak plasma concentrations and AUCs are higher.a

Distribution

Extent

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

Crosses placenta in mice.136 Distributed into milk.122 123 124

Plasma Protein Binding

50–65%.104

Elimination

Metabolism

Partially metabolized; the major metabolite is desethylchloroquine.122 123 124 136 147 Desethylchloroquine also has antiplasmodial activity, but is slightly less active than chloroquine.114

Elimination Route

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

Half-life

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

Stability

Storage

Oral

Tablets

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

  • Active in vitro against the trophozoite form of Entamoeba histolytica.a Acts as a tissue amebicide.a

  • 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

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

Preparations

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

Chloroquine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

150 mg (of chloroquine)*

Chloroquine Phosphate Tablets

Global, West-Ward

300 mg (of chloroquine)*

Aralen Phosphate

Sanofi-Aventis

Chloroquine Phosphate Tablets

West-Ward

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. 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

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions January 1, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

Only references cited for selected revisions after 1984 are available electronically.

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