Class: Antimalarials
VA Class: AP101
CAS Number: 50-63-5
Brands: Aralen
Medically reviewed by Drugs.com. Last updated on June 15, 2020.
Warning
Special Alerts:
For additional information on the use of this drug in patients with coronavirus disease 2019 (COVID-19), see the document “Assessment of Evidence for COVID-19-Related Treatments” on ASHP's COVID-19 Resource Center. To view this document, please click here: [Web]
Effective June 15, 2020, FDA has revoked the emergency use authorization (EUA) they had previously issued on March 28, 2020 to facilitate the availability of chloroquine and hydroxychloroquine for the treatment of certain hospitalized patients during the COVID-19 pandemic.230 Based on a review of new information and reevaluation of information available at the time the EUA was issued, FDA now concludes that the original criteria for issuance of the EUA for these drugs are no longer met.230 FDA states that the suggested chloroquine and hydroxychloroquine dosage regimens as detailed in the EUA fact sheets for healthcare providers are unlikely to produce an antiviral effect; earlier observations of decreased viral shedding with chloroquine or hydroxychloroquine treatment have not been consistently replicated and recent data from a randomized controlled trial assessing probability of negative conversion showed no difference between hydroxychloroquine and standard of care alone; current US treatment guidelines do not recommend the use of the chloroquine or hydroxychloroquine in hospitalized patients with COVID-19 outside of a clinical trial and the NIH guidelines now recommend against such use outside of a clinical trial; and recent data from a large, randomized, controlled trial showed no evidence of benefit in mortality or other outcomes such as hospital length of stay or need for mechanical ventilation for hydroxychloroquine treatment in hospitalized patients with COVID-19.230 FDA concluded that, based on the totality of scientific evidence available, it is unlikely that chloroquine and hydroxychloroquine may be effective in treating COVID-19 and, in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia in COVID-19 patients, the known and potential benefits of chloroquine and hydroxychloroquine do not outweigh the known and potential risks associated with the use authorized in the EUA.230 (For information on the EUA that has now been revoked, see Coronavirus Disease 2019 [COVID-19] under Uses.)
Serious adverse events and medication errors associated with chloroquine or hydroxychloroquine must be reported to the FDA MedWatch program at [Web].224 225 226
CDC issued a health advisory concerning inappropriate use of chloroquine and hydroxychloroquine.222 (See Inappropriate Use under Cautions.)
Introduction
Antimalarial; 4-aminoquinoline derivative.136
Uses for Chloroquine
Prevention of Malaria
Prevention (prophylaxis) of malaria caused by Plasmodium malariae, P. ovale, chloroquine-susceptible P. vivax, and chloroquine-susceptible P. falciparum.115 121 134 136
Can be used for prevention of malaria in individuals traveling to malarious areas where chloroquine-resistant P. falciparum malaria has not been reported.115 121 134 (See Chloroquine-resistant Plasmodium under Cautions.)
Risk of acquiring malaria varies substantially from traveler to traveler and from region to region (even within a single country) because of differences in intensity of malaria transmission within the various regions and season, itinerary, duration, and type of travel.115 121 Malaria transmission occurs in large areas of Africa, Central and South America, parts of the Caribbean, Asia (including South Asia, Southeast Asia, and the Middle East), Eastern Europe, and the South Pacific.115 Mosquito avoidance measures must be used in conjunction with prophylaxis since no drug is 100% effective in preventing malaria.115 121
Choice of antimalarial for prophylaxis depends on traveler’s risk of acquiring malaria in area(s) visited, risk of exposure to drug-resistant P. falciparum, other medical conditions (e.g., pregnancy), cost, and potential adverse effects.115 121 134
Active only against 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;115 134 136 terminal prophylaxis with a 14-day regimen of primaquine may be indicated in addition to chloroquine prophylaxis if travelers were exposed in areas where P. ovale or P. vivax is endemic.115 134 136
Information on risk of malaria in specific countries and mosquito avoidance measures and recommendations regarding whether prevention of malaria indicated and choice of antimalarials for prevention are available from CDC at [Web] and [Web].115
Treatment of Uncomplicated Malaria
Treatment of uncomplicated malaria caused by P. malariae, P. ovale, chloroquine-susceptible P. vivax, or chloroquine-susceptible P. falciparum.134 136 143 144
For treatment of uncomplicated malaria caused by chloroquine-susceptible P. falciparum, P. malariae, or P. knowlesi or treatment of uncomplicated malaria when plasmodial species not identified and infection was acquired in areas where chloroquine resistance not reported, CDC recommends chloroquine (or hydroxychloroquine).143 144 Alternatively, CDC states that any of the regimens recommended for treatment of uncomplicated chloroquine-resistant P. falciparum malaria (fixed combination of atovaquone and proguanil [atovaquone/proguanil], fixed combination of artemether and lumefantrine [artemether/lumefantrine], regimen of quinine in conjunction with doxycycline, tetracycline, or clindamycin) may be used if preferred, more readily available, or more convenient.143 144
Pediatric patients with uncomplicated malaria generally can receive same treatment regimens recommended for adults using age- and weight-appropriate drugs and dosages.143 144
Because chloroquine active only against asexual erythrocytic forms of Plasmodium (not exoerythrocytic stages), 14-day regimen of primaquine indicated to eradicate hypnozoites and prevent delayed primary attacks or relapse and provide a radical cure whenever chloroquine used for treatment of P. ovale or P. vivax malaria.134 143
Assistance with diagnosis or treatment of malaria 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
Coronavirus Disease 2019 (COVID-19)
Being investigated for and has been used in the management of coronavirus disease 2019 (COVID-19)† caused by the SARS-CoV-2 virus.194 195 196 200 211 215 220 221
Targeted for investigation based on evidence of in vitro activity against SARS-CoV-2 (see Actions and Spectrum)191 212 and on initial anecdotal reports and preliminary information from small trials.194 195 196 220 In addition, 4-aminoquinoline derivatives (chloroquine, hydroxychloroquine) have immunomodulatory activity that theoretically could contribute to anti-inflammatory responses in patients with viral infections.193 196 213 215
Although efficacy and safety not clearly established,220 224 chloroquine has been included in some guidelines as an option for treatment of COVID-19.211 220
Various clinical trials evaluating use of chloroquine (alone or in conjunction with other antivirals or other drugs) have been initiated in the US and other countries.194 200 221 Information on the status of some clinical trials evaluating chloroquine for treatment or prevention of COVID-19 is available at [Web].200
On March 28, 2020, FDA issued an emergency use authorization (EUA) that permits chloroquine and hydroxychloroquine to be distributed from the Strategic National Stockpile (SNS) to public health authorities to facilitate availability of the drugs during the COVID-19 pandemic for use only in hospitalized adults and adolescents weighing ≥50 kg for whom a clinical trial is not available or participation not feasible.224 FDA concluded that emergency use of chloroquine and hydroxychloroquine for treatment of COVID-19 met criteria for issuance of an EUA because SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness; based on the totality of scientific evidence available to FDA, it is reasonable to believe that the drugs may be effective in treating COVID-19 and, when used under EUA conditions, known and potential benefits outweigh known and potential risks; and there are no adequate, approved, and available alternatives to emergency use of chloroquine and hydroxychloroquine for treatment of COVID-19.224 To request chloroquine and/or hydroxychloroquine under the EUA, healthcare providers should contact their local or state health departments;225 226 distribution to states will be managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR) and Federal Emergency Management Agency (FEMA).229 To mitigate risks of this unapproved use, the EUA includes certain mandatory requirements (including adverse event reporting to the FDA MedWatch program).224 225 226 For additional information, consult the EUA,224 EUA fact sheets for healthcare providers,225 226 and EUA fact sheets for patients and parent/caregivers227 228 available at the FDA website.
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 regimen of choice for mild to moderate or severe intestinal amebiasis and for amebic hepatic abscess.134
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
Consider risk of severe and sometimes irreversible toxicity if used for prolonged periods in treatment of lupus erythematosus.a (See Cautions.)
Rheumatoid Arthritis
Has been used for treatment of rheumatoid arthritis†.a
When a disease-modifying antirheumatic drug (DMARD) indicated, other DMARDs (hydroxychloroquine, leflunomide, methotrexate, minocycline, sulfasalazine) recommended.103 104
Consider risk of severe and sometimes irreversible toxicity if used for prolonged periods in treatment of rheumatoid arthritis.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†.a
Sarcoidosis
Has been used with some success in the treatment of sarcoidosis†.188 189
Chloroquine Dosage and Administration
Administration
Oral Administration
Administration with a meal may minimize adverse GI effects.121 134
For prevention of malaria, give once weekly on same day each week.136
Dosage
Available as chloroquine phosphate;102 136 dosage expressed as chloroquine phosphate or as the base (chloroquine).102 136
Each 500-mg tablet of chloroquine phosphate contains 300 mg of chloroquine.102 136
Dosage in children is based on body weight.102 136
Pediatric Patients
Malaria
Prevention of Malaria in Areas without Chloroquine-resistant Plasmodium
Oral5 mg/kg (8.3 mg/kg of chloroquine phosphate) once weekly on same day each week.115 134 136
Initiate prophylaxis 1–2 weeks prior to entering malarious area and continue during stay and for 4 weeks after leaving the area.115
If exposure occurred in areas where P. ovale or P. vivax is endemic, terminal prophylaxis with a 14-day regimen of primaquine may be indicated;115 136 give during final 2 weeks of chloroquine prophylaxis or, if not feasible, give after chloroquine prophylaxis discontinued.115
Treatment of Uncomplicated Chloroquine-susceptible Malaria
OralInitial dose of 10 mg/kg of chloroquine (16.7 mg/kg of chloroquine phosphate) followed by 5 mg/kg (8.3 mg/kg of chloroquine phosphate) given at 6, 24, and 48 hours after initial dose.134 144
Adults
Malaria
Prevention of Malaria in Areas without Chloroquine-resistant Plasmodium
Oral300 mg (500 mg of chloroquine phosphate) once weekly on same day each week.134 115 136
Initiate prophylaxis 1–2 weeks prior to entering malarious area and continue during and for 4 weeks after leaving the area.115
If exposure occurred in areas where P. ovale or P. vivax is endemic, terminal prophylaxis with a 14-day regimen of primaquine may be indicated;115 136 give during final 2 weeks of chloroquine prophylaxis or, if not feasible, give after chloroquine prophylaxis discontinued.115
Treatment of Uncomplicated Chloroquine-susceptible Malaria
OralInitial dose of 600 mg of chloroquine (1 g of chloroquine phosphate) followed by 300 mg (500 mg of chloroquine phosphate) given at 6, 24, and 48 hours after initial dose.134 144
Prophylaxis of P. ovale or P. vivax When Primaquine Deferred during Pregnancy
Oral300 mg (500 mg of chloroquine phosphate) once weekly for duration of the pregnancy.143 144 Give after usual treatment regimen and continue until a 14-day regimen of primaquine can be given after delivery to provide a radical cure.143 144
Coronavirus Disease 2019 (COVID-19)†
Treatment of COVID-19†
OralEfficacy and safety not established;224 optimal dosage and duration of treatment not known.220 224
The EUA for hospitalized adults and adolescents weighing ≥50 kg (see Coronavirus Disease 2019 [COVID-19] under Uses) suggests 1 g on day 1, then 500 mg daily for 4–7 days of total treatment based on clinical evaluation.225
Various other dosage regimens recommended in other countries or being investigated are presented below:194 200 211
500 mg of chloroquine phosphate twice daily for 10 days.194
500 mg of chloroquine phosphate twice daily for 7 days in adults 18–65 years of age weighing more than 50 kg or 500 mg of chloroquine phosphate twice daily on days 1 and 2, then 500 mg once daily on days 3–7 in adults weighing less than 50 kg.211
Initial dose of 600 mg (of chloroquine) followed by 300 mg (of chloroquine) 12 hours later on day 1, then 300 mg (of chloroquine) twice daily on days 2–5.194
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
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
Rheumatoid Arthritis†
Oral
150 mg (250 mg of chloroquine phosphate) daily.a Reduce dosage after remission or maximum improvement occurs.a
Response may not occur until after >4–6 weeks of therapy.a Some clinicians recommend the drug be continued for 4 months before being considered ineffective for treatment of rheumatoid arthritis.a
Prescribing Limits
Pediatric Patients
Malaria
Prevention of Malaria in Areas Without Chloroquine-resistant Plasmodium
OralMaximum dose 300 mg (500 mg of chloroquine phosphate).115 134 136
Treatment of Uncomplicated Chloroquine-susceptible Malaria
OralMaximum dose 600 mg (1 g of chloroquine phosphate).134
Adults
Malaria
Treatment of Uncomplicated Chloroquine-susceptible Malaria
OralMaximum initial dose 600 mg (1 g of chloroquine phosphate); maximum subsequent doses 300 mg (500 mg of chloroquine phosphate).136
Special Populations
Hepatic Impairment
No specific recommendations available regarding need for dosage adjustment in individuals with hepatic impairment;136 use with caution.136 (See Hepatic Impairment under Cautions.)
Renal Impairment
No specific recommendations available regarding need for dosage adjustment in individuals with renal impairment;136 substantially eliminated by the kidneys.136 (See Renal Impairment under Cautions.)
Geriatric Patients
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.136
Cautions for Chloroquine
Contraindications
-
Hypersensitivity to 4-aminoquinoline derivatives.102
-
Retinal or visual field changes attributable to any etiology.102
Warnings/Precautions
Warnings
Inappropriate Use
CDC issued a health advisory concerning inappropriate use of chloroquine and hydroxychloroquine.222 At least 1 death reported in individuals who ingested non-pharmaceutical chloroquine (marketed for aquarium use) in an attempt to prevent or treat COVID-19.222 Advise patients and the public to not ingest aquarium products or any other chemical products that contain chloroquine since these products are not intended for human consumption and can lead to serious health consequences, including death.222
Advise patients and the public that chloroquine and hydroxychloroquine should be used only under supervision of a healthcare provider.222 Inappropriate uses of chloroquine and hydroxychloroquine include taking any commercially available non-pharmaceutical preparations of the drugs, taking the drugs without a prescription or without supervision by a healthcare provider, and taking additional doses of the drugs not recommended by a healthcare provider.222
Chloroquine-resistant Plasmodium
Chloroquine-resistant P. falciparum confirmed in all areas with P. falciparum malaria, except the Caribbean, Central America west of the Panama Canal, and some countries in the Middle East.115
High prevalence of chloroquine-resistant P. vivax confirmed in Papua New Guinea and Indonesia;115 143 also reported in Burma (Myanmar), India, and Central and South America.143
Do not use for prevention of malaria in individuals traveling to malarious areas where chloroquine-resistant P. falciparum or chloroquine-resistant P. vivax malaria reported.115 134 136
Do not use for treatment of uncomplicated P. falciparum malaria or uncomplicated malaria caused by unidentified plasmodial species if the infection was acquired in areas with chloroquine resistance.136 143 144
Malaria patients who do not respond to chloroquine treatment should be switched to a regimen recommended for chloroquine-resistant P. falciparum (e.g., atovaquone/proguanil, artemether/lumefantrine, regimen of quinine in conjunction with doxycycline, tetracycline, or clindamycin) or chloroquine-resistant P. vivax (e.g., quinine and doxycycline [or tetracycline] in conjunction with primaquine, atovaquone/proguanil in conjunction with primaquine, mefloquine in conjunction with primaquine).143
Cardiac Effects
Cardiomyopathy resulting in cardiac failure, fatal in some cases, reported in patients receiving chloroquine.102 Cardiac arrhythmias, conduction disorders such as bundle branch block/AV block, QT interval prolongation, torsades de pointes, ventricular tachycardia, and ventricular fibrillation reported with therapeutic dosages and overdosages of chloroquine.102 Hypotension and ECG changes (particularly inversion or depression of T wave and widening of QRS complex) reported.102
Use with caution in patients with cardiac disease, history of ventricular arrhythmias, uncorrected hypokalemia and/or hypomagnesemia, or bradycardia (<50 bpm), and in those receiving concomitant therapy with other drugs with potential to prolong QT interval.102
Consider chronic toxicity when conduction disorders (bundle branch block/AV heart block) or biventricular hypertrophy are diagnosed.102
Monitor for signs and symptoms of cardiomyopathy; discontinue the drug if cardiomyopathy develops.102
If cardiotoxicity suspected, prompt discontinuance of chloroquine may prevent life-threatening complications.102
Hypoglycemia
Severe hypoglycemia, including loss of consciousness that could be life-threatening, reported in patients receiving chloroquine who were or were not receiving treatment with antidiabetic agents.102
Advise patients about risk of hypoglycemia and associated clinical signs and symptoms.102 If clinical symptoms suggestive of hypoglycemia occur during chloroquine treatment, assess blood glucose and review treatment as clinically indicated.102 In patients already receiving insulin or other antidiabetic agents, consider that decreased dosage of these drugs may be required.102
Ocular Effects
Retinopathy and maculopathy (as well as macular degeneration) reported, especially in patients receiving long-term treatment or high chloroquine dosage.136 May be irreversible in some patients.136
Visual disturbances reported in patients receiving chloroquine include blurred vision and difficulty in focusing or accommodation.136 Nyctalopia,136 scotomatous vision with field defects of paracentral, pericentral ring types, and typically temporal scotomas (e.g., difficulty reading with words tending to disappear, seeing half an object, misty vision, fog before the eyes), 136 and reversible corneal opacities136 also reported.
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.a
Risk factors for development of retinopathy during chloroquine treatment include age, duration of treatment, and high daily and/or cumulated dosage.136
Whenever long-term treatment contemplated, perform initial (base line) and periodic ophthalmologic examinations, including visual acuity, slit-lamp, funduscopic, and visual field tests.136
Immediately discontinue chloroquine 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
Neuropsychiatric and Nervous System Effects
Mild and transient headache,136 polyneuritis,136 fatigue,a nervousness,a anxiety,136 apathy,a irritability,a agitation,136 aggressiveness,a confusion,136 insomnia,136 delirium,136 and hallucinations136 have occurred.
Acute extrapyramidal disorders (e.g., dystonia, dyskinesia, tongue protrusion, torticollis) may occur;136 usually resolve after drug discontinued and/or patient receives symptomatic treatment.136
Seizures reported; advise patients with a history of epilepsy about the risk.136
Neuropsychiatric events, including psychosis, delirium, anxiety, agitation, insomnia, confusion, hallucinations, personality changes, depression, and suicidal behavior, reported in patients receiving chloroquine.102
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; test knee and ankle reflexes.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 risks.136
May exacerbate porphyria.136 Use in patients with porphyria only if potential benefits outweigh risks.136
Sensitivity Reactions
Hypersensitivity Reactions
Erythema multiforme,136 Stevens-Johnson syndrome,136 toxic epidermal necrolysis,136 exfoliative dermatitis,136 and similar desquamation-type adverse events136 reported rarely.
Urticaria,136 anaphylactic/anaphylactoid reaction including angioedema,136 and drug rash with eosinophilia and systemic symptoms (DRESS syndrome)136 also reported.
General Precautions
Hematologic Effects
Aplastic anemia, pancytopenia, 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 and 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, usually irreversible, reported after prolonged therapy with high dosage.136 a Tinnitus and reduced hearing reported 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
Hepatic Effects
Hepatitis and increased liver enzymes reported.136
Specific Populations
Pregnancy
Category C.c
Has been used for prophylaxis and treatment of malaria in pregnant women without evidence of adverse effects on the fetus.107 108 109 115 121
Manufacturer states avoid during pregnancy, except for prevention or treatment of malaria when clinician determines that possible benefits of the drug outweigh potential risks to fetus.136
CDC states pregnancy not a contraindication when chloroquine indicated for prevention or treatment of malaria.115 143
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.143
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.143 144
Lactation
Distributed into milk.122 123 124 136 Discontinue nursing or the drug.136
Amount of drug present in milk does not appear to be harmful to nursing infants, but is insufficient to provide adequate protection against malaria in these infants.115 When prevention of malaria indicated, such infants should receive recommended dosages of appropriate antimalarial agent(s).115
Pediatric Use
Pediatric patients are especially sensitive to 4-aminoquinoline derivatives.136 Fatalities 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; possible increased risk of toxicity 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
Renal Impairment
Substantially eliminated by kidneys; possible increased risk of toxicity in patients with impaired renal function.
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
Drugs that Prolong QT Interval
Concomitant use with drugs known to prolong QT interval may increase risk of QT interval prolongation and ventricular arrhythmias;102 if concomitant use necessary, use caution.102
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Ampicillin |
Possible reduced ampicillin bioavailability136 |
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 |
Antidiabetic agents (insulin, other antidiabetic agents) |
Possible enhanced hypoglycemic effects102 |
May need to decrease dosage of insulin or other antidiabetic agents102 |
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 |
Mefloquine |
Serious ECG abnormalities, including QTc interval prolongation, may occur; increased risk for torsades de pointes or other serious ventricular arrhythmias190 |
Do not administer mefloquine until ≥12 hours after last dose of chloroquine190 |
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 US)116 117 136 182 |
Although intradermal HDCV no longer commercially available in US, consider that individuals traveling outside of US who are exposed to rabies may receive postexposure prophylaxis regimens that include rabies vaccines not commercially available in US182 |
Tamoxifen |
Possible increased risk of retinal damage102 |
Concomitant use not recommended102 |
Typhoid vaccine |
Oral live typhoid vaccine (Vivotif): Potential interference with immune response to the vaccine;173 no evidence of altered anti-S. typhi immune response in healthy adults173 |
Chloroquine 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.122 123 124 136
Plasma Protein Binding
50–65%.106
Elimination
Metabolism
Partially metabolized; 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 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 susceptible 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 gametocytes of P. falciparum.a
-
Chloroquine-resistant P. falciparum confirmed in all areas where P. falciparum malaria occurs, except the Caribbean, Central America west of the Panama Canal, and some countries in the Middle East.115
-
High prevalence of chloroquine-resistant P. vivax confirmed in Papua New Guinea and Indonesia.115 143 145 154 156 Chloroquine-resistant P. vivax also documented in Burma (Myanmar), India, and Central and South America.143
-
To date, no widespread evidence of chloroquine resistance in P. malariae, P. ovale, or P. knowlesi.143 161
-
Chloroquine-resistant P. falciparum also are resistant to hydroxychloroquine109 and may be cross-resistant to pyrimethamine or quinine.a Cross-resistance between chloroquine and mefloquine reported in P. falciparum and P. vivax in vitro.152 153
-
Active in vitro against the trophozoite form of Entamoeba histolytica.a Acts as a tissue amebicide.a
-
Has in vitro activity against various viruses, including coronaviruses.191 192 193 213 214
-
Evidence of in vitro activity against SARS-CoV-1 (causative agent of severe acute respiratory syndrome [SARS]),192 199 MERS-CoV (causative agent of Middle East respiratory syndrome [MERS]),195 and SARS-CoV-2 (causative agent of COVID-19).191 194 In addition to in vitro activity in Vero E6 cells infected with SARS-CoV-2, there is some evidence the drug may block infection when uninfected cells are exposed to SARS-CoV-2.191 194 212
-
Has anti-inflammatory activity.a
Mechanism(s) of action in the treatment of rheumatoid arthritis and lupus erythematosus not determined.a
Advice to Patients
-
Importance of keeping chloroquine out of reach of children since they are especially sensitive to 4-aminoquinoline derivatives.136
-
For prevention of malaria, necessity of starting chloroquine prophylaxis 1–2 weeks before arriving in an area with malaria and continuing during stay and for 4 weeks after leaving the area.115
-
Necessity of taking protective measures to reduce contact with mosquitoes (protective clothing, insect repellents, mosquito nets, remaining in air-conditioned or well-screened areas).115 121 134
-
Possibility of contracting malaria during travel, regardless of prophylactic regimen used.115 121 134
-
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.115 121 134
-
Advise patients with a history of epilepsy about the risk of seizures.136
-
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.136 (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
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Tablets, film-coated |
250 mg (150 mg of chloroquine base)* |
Chloroquine Phosphate Tablets |
|
500 mg (300 mg of chloroquine base)* |
Chloroquine Phosphate Tablets |
AHFS DI Essentials™. © Copyright 2021, Selected Revisions June 15, 2020. 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
Only references cited for selected revisions after 1984 are available electronically.
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