chloroquine (Rx)

Brand and Other Names:Chloroquine phosphate
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 500mg
  • NOTE: Chloroquine phosphate 16.6 mg is equivalent to 10 mg chloroquine base

Malaria

Prophylaxis

  • Indicated for prophylaxis of malaria in geographic areas where resistance to chloroquine is not present
  • 500 mg (300-mg base) weekly on the same day each week; begin 1-2 weeks before travel, during travel, and for 4 weeks after leaving endemic area (CDC 2018 [link https://www.cdc.gov/malaria/travelers/drugs.html])

Treatment

  • Indicated for acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum
  • Acute attack
    • 1 g (600-mg base) PO, THEN
    • 500 mg (300 mg-base) PO after 6-8 hr THEN
    • 500 mg (300 mg-base) PO at 24 hr and 48 hr after initial dose
    • Total dose of 2500 mg (1500 mg-base) in 3 days

Amebiasis, Extraintestinal

1 g (600 mg base) PO qDay for 2 days, THEN

500 mg (300 mg base) qDay for 14-21 days

Coronavirus Disease 2019 (COVID-19) (Off-label)

Data available as of June 15, 2020

FDA revoked the emergency use authorization (EUA) for chloroquine June 15, 2020

Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine is unlikely to be effective in treating COVID-19 for the authorized uses in the EUA; additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine no longer outweigh the known and potential risks for the EUA

While additional clinical trials may continue to evaluate potential benefit, the FDA determined the EUA was no longer appropriate

The NIH COVID-19 Treatment Guidelines recommend against the use of chloroquine or hydroxychloroquine and/or azithromycin for the treatment of COVID-19 in hospitalized patients and in nonhospitalized patients

For more information, see the FDA news release: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine

Additional Medscape COVID-19 references are available

Porphyria Cutanea Tarda (Off-label)

125-250 mg (75-150 mg base) PO twice weekly

Glioblastoma (Orphan)

Orphan designation for treatment of glioblastoma multiforme

Sponsor

  • DualTpharma B.V.; Boschstraat 111-D01; 6211 A W Maastricht; Netherlands

Dosage Modifications

Hepatic impairment

  • Chloroquine phosphate tablets may concentrate in the liver; use with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs

Dosing Considerations

Limitations of use

  • Do not use for the treatment of complicated malaria (high-grade parasitemia and/or complications [eg, cerebral malaria, acute renal failure])
  • Do not use for malaria prophylaxis in areas where chloroquine resistance occurs
  • Concomitant use with an 8-aminoquinoline drug is necessary for treatment of hypnozoite liver stage forms of P.vivax and P.ovale

Dosage Forms & Strengths

tablet

  • 500mg
  • NOTE: Chloroquine phosphate 16.6 mg is equivalent to 10 mg chloroquine base

Malaria

Prophylaxis

  • Indicated for prophylaxis of malaria in geographic areas where resistance to chloroquine is not present
  • 5 mg/kg PO q1Week, not to exceed 500 mg (300-mg base), on the same day each week; begin 1-2 weeks before travel, during travel, and for 4 weeks after leaving endemic area (CDC 2018 [link https://www.cdc.gov/malaria/travelers/drugs.html])

Treatment

  • Indicated for acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum for adults, infants, and children
  • Acute attack
    • Note: Dosing is based chloroquine base; chloroquine phosphate 16.6 mg is equivalent to 10 mg chloroquine base
    • First dose: 10 mg base/kg (not to exceed 600-mg base/dose)
    • Second dose: (6 hr after first dose) 5 mg base/kg (not to exceed 300 mg base/dose)
    • Third dose: (24 hr after first dose): 5 mg base/kg (not to exceed 300 mg base/dose)
    • Fourth dose (36 hr after first dose): 5 mg base/kg (not to exceed 300 mg base/dose)
    • Total dose of 25mg base/kg

Dosage Modifications

Hepatic impairment

  • Chloroquine phosphate tablets may concentrate in the liver; use with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs

Dosing Considerations

Limitations of use

  • Do not use for the treatment of complicated malaria (high-grade parasitemia and/or complications [eg, cerebral malaria, acute renal failure])
  • Do not use for malaria prophylaxis in areas where chloroquine resistance occurs
  • Concomitant use with an 8-aminoquinoline drug is necessary for treatment of hypnozoite liver stage forms of P.vivax and P.ovale
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Interactions

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            Adverse Effects

            Frequency Not Defined

            Ocular disorders: Maculopathy, macular degeneration, visual disturbances, nyctalopia, scotomatous vision with field defects of paracentral, pericentral ring types, typically temporal scotomas (eg, difficulty in reading with words tending to disappear, seeing half an object, misty vision, and fog before the eyes), reversible corneal opacities

            Immune system disorders: Urticaria, anaphylactic reaction (eg, angioedema)

            Ear and labyrinth disorders: Nerve type deafness, tinnitus, reduced hearing in patients with preexisting auditory damage

            Musculoskeletal and connective tissue-disorders: Sensorimotor disorders, skeletal muscle myopathy or neuromyopathy, depression of tendon reflexes, abnormal nerve conduction

            Gastrointestinal disorders: Hepatitis, increased liver enzymes, anorexia, nausea, vomiting, diarrhea, abdominal cramps

            Skin and subcutaneous tissue disorders: Erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, pleomorphic skin eruptions, skin and mucosal pigment changes, lichen planus-like eruptions, pruritus, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, hair loss

            Blood and lymphatic system disorders: Pancytopenia, aplastic anemia, reversible agranulocytosis, thrombocytopenia, neutropenia, hemolytic anemia in G6PD deficient patients

            Nervous system disorders: Convulsions, mild and transient headache, polyneuropathy, acute extrapyramidal disorders (eg, dystonia, dyskinesia, tongue protrusion, torticollis)

            Neuropsychiatric disorders: Psychosis, delirium, anxiety, agitation, insomnia, confusion, hallucinations, personality changes, depression, suicidal behavior

            Cardiac disorders: Hypotension, ECG changes (particularly, inversion or depression of the T-wave with widening of the QRS complex), cardiomyopathy, cardiac arrhythmias, conduction disorders (eg, bundle branch block / atrioventricular [AV] block, QT interval prolongation, torsade de pointes, ventricular tachycardia, ventricular fibrillation)

            Metabolic and nutritional disorders: Hypoglycemia

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            Warnings

            Contraindications

            Hypersensitivity to chloroquine, 4-aminoquinolones

            Psoriasis, porphyria, retinal or visual field changes

            Cautions

            Acute extrapyramidal disorders may occur; reactions usually resolve after treatment discontinuation and/or symptomatic treatment

            Not effective in most areas; CDC recommends mefloquine or atovaquone/proguanil - check CDC traveler information for specific recommendations for region

            May cause hemolysis in glucose-6 phosphate dehydrogenase (G-6-PD) deficiency; blood monitoring may be needed as hemolytic anemia may occur, in particular in association with other drugs that cause hemolysis

            Experimental data showed a potential risk of inducing gene mutations; there are insufficient data in humans to rule out an increased risk of cancer in patients receiving long-term treatment

            Cases of cardiomyopathy resulting in cardiac failure, in some cases with fatal outcome, have been reported in patients treated during long term therapy at high doses with chloroquine; monitor for signs and symptoms of cardiomyopathy and discontinue chloroquine if cardiomyopathy develops

            May cause conduction disorders (eg, bundle branch block / AV heart block) are diagnosed; if cardiotoxicity is suspected, prompt discontinuation of chloroquine may prevent life-threatening complications

            Monitor knee and ankle reflexes in patients on long-term therapy to detect any evidence of muscular weakness; if weakness occurs, discontinue therapy

            A number of fatalities have been reported following the accidental ingestion of chloroquine; advise to keep medication out of the reach of children because they are especially sensitive to the 4-aminoquinoline compounds

            Use in patients with psoriasis may precipitate a severe attack of psoriasis; may be exacerbated condition when used in patients with porphyria; do not use in these conditions unless the benefit to the patient outweighs the potential risks

            Shown to cause severe hypoglycemia including loss of consciousness that could be life-threatening in patients treated with or without antidiabetic medications; patients should be warned about risk of hypoglycemia and associated clinical signs and symptoms; patients presenting with clinical symptoms suggestive of hypoglycemia during treatment with chloroquine should have blood glucose level checked and treatment reviewed as necessary

            Caution with history of auditory damage

            Caution with hepatic disease, alcoholism, and coadministration with other hepatotoxic drugs

            May provoke seizures in patients with history of epilepsy

            QT prolongation

            • QT interval prolongation, torsade de pointes, and ventricular arrhythmias have been reported
            • The risk increases with higher doses chloroquine; fatal cases have been reported
            • Use with caution in patients with cardiac disease, a history of ventricular arrhythmias, uncorrected hypokalemia and/or hypomagnesemia, or bradycardia (<50 bpm)

            Retinopathy

            • Irreversible retinal damage observed
            • Significant risk factors for retinal damage include daily doses of chloroquine phosphate >2.3 mg/kg of actual body weight, durations of use >5 years, subnormal glomerular filtration, and concurrent macular disease
            • Perform baseline ophthalmological examination within the first year of starting chloroquine phosphate tablets
            • Baseline exam should include: best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain optical coherence tomography (SD-OCT)
            • Exams (including BCVA, VF and SD-OCT) should be monitored annually in individuals with significant risk factors and may be deferred up to 5 years for individuals without risk factors
            • In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees
            • Discontinue if ocular toxicity is suspected and closely monitor; retinal changes (and visual disturbances) may progress even after cessation of therapy

            Drug interaction overview

            • Plasma concentrations of chloroquine and desethylchloroquine (major metabolite of chloroquine) were negatively associated with log antibody titers; the recommended dose of chloroquine for malaria prophylaxis can reduce the antibody response to primary immunization with intradermal human diploid-cell rabies vaccine
            • Concomitant use of chloroquine with drugs known to induce retinal toxicity such as tamoxifen is not recommended
            • Effects of other drugs on chloroquine
              • Antacids and kaolin can reduce absorption of chloroquine; observe for at least 4 hr between intake of these agents and chloroquine
              • Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level; avoid use
            • Chloroquine effects on other drugs
              • As chloroquine may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or other antidiabetic drugs may be required.
              • Chloroquine significantly reduced the bioavailability of ampicillin; monitor at least 2 hr between intake of ampicillin and chloroquine
              • After introduction of chloroquine (oral form), a sudden increase in serum cyclosporine level has been reported; closely monitor of serum cyclosporine level and if necessary, discontinue chloroquine
              • May increase risk of inducing ventricular arrhythmias if chloroquine is used concomitantly with other arrhythmogenic drugs (eg, amiodarone, moxifloxacin)
              • In a single-dose interaction study, chloroquine has been reported to reduce the bioavailability of praziquantel
              • Coadministration of chloroquine and mefloquine may increase the risk of convulsions
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            Pregnancy & Lactation

            Pregnancy

            In humans, at recommended doses for prophylaxis and treatment of malaria, observational studies as well as a meta-analysis, including a small number of prospective studies with chloroquine exposure during pregnancy, have shown no increase in the rate of birth defects or spontaneous abortions

            Avoid use during pregnancy except in prophylaxis or treatment of malaria when benefit outweighs potential risk to fetus

            Animal data

            • In animal studies, embryofetal developmental toxicity was shown at doses ranging from 250-1500 mg/kg body weight; approximately 3-16x the maximum recommended therapeutic dose based on a body surface area comparison
            • Preclinical data showed a potential risk of genotoxicity in some test systems

            Lactation

            Owing to the potential for serious adverse reactions in nursing infants from chloroquine, a decision should be made whether to discontinue nursing or chloroquine, taking into account the potential clinical benefit of the drug to the mother

            Excretion of chloroquine and the major metabolite, desethylchloroquine, in breast milk was investigated in eleven lactating mothers following a single oral dose of chloroquine (600-mg base); maximum daily dose of the drug that the infant can receive from breastfeeding was about 0.7% of the maternal start dose of the drug in malaria

            Separate prophylaxis for the infant is required

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Active against erythrocytic forms of Plasmodium vivax & P. malariae and most strains of Plasmodium falciparum

            Precise mechanism not known

            Absorption

            Bioavailability: ~89%

            Peak plasma time: 1-2 hr

            Distribution

            Distributed widely in body tissues (eg, eyes, heart, kidneys, liver, lungs) where retention prolonged; crosses placenta; enters breast milk

            Metabolism

            Partially in liver

            Elimination

            Half-life: 3-5 days

            Excretion: urine (~70% as unchanged drug); acidification of urine increases elimination

            Small amounts may be present in urine months following discontinuation of therapy

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            chloroquine oral
            -
            250 mg tablet
            chloroquine oral
            -
            500 mg tablet
            chloroquine oral
            -
            500 mg tablet
            chloroquine oral
            -
            250 mg tablet
            chloroquine oral
            -
            500 mg tablet
            chloroquine oral
            -
            250 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            chloroquine oral

            CHLOROQUINE - ORAL

            (KLOR-oh-kwin)

            COMMON BRAND NAME(S): Aralen

            USES: Chloroquine is used to prevent or treat malaria caused by mosquito bites. Chloroquine belongs to a class of drugs known as antimalarials.The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.Chloroquine is also used to treat infection caused by a different type of parasite (ameba).Chloroquine is not recommended for coronavirus infection, also known as COVID-19, unless you are enrolled in a study. Talk to your doctor about the risks and benefits.

            HOW TO USE: Take this medication by mouth, usually with food to prevent stomach upset, exactly as directed by your doctor. The dosage and length of treatment are based on your medical condition and response to treatment. In children, dosage is also based on weight.To prevent malaria, take chloroquine as directed by your doctor, usually once a week on the same day each week. Mark a calendar to help you remember. This drug is usually started 1 to 2 weeks before entering the malarious area. Continue to take it weekly while in the area and for 4 to 8 weeks after leaving the area, or as directed by your doctor.To treat malaria or an ameba infection, follow your doctor's instructions.If you are also taking a certain drug for diarrhea (kaolin) or taking antacids (such as magnesium/aluminum hydroxide), take chloroquine at least 4 hours before or after these products. These products may bind with chloroquine, preventing your body from fully absorbing it.Use this medication regularly in order to get the most benefit from it. Take this medication exactly as prescribed. Do not stop taking it without talking with your doctor. It is important to continue taking this for the length of time prescribed. Stopping prevention or treatment too soon may lead to infection or a return of the infection.Tell your doctor if your condition lasts or gets worse. Chloroquine may not prevent malaria in all cases. If you experience fever or other symptoms of illness, get medical help right away (especially while in the malarious area and for 2 months after returning from the area). You may need a different medication. Avoid exposure to mosquitoes. (See also Notes section.)

            SIDE EFFECTS: Nausea, vomiting, abdominal cramps, headache, and diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: slow heartbeat, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), mental/mood changes (such as anxiety, depression, rare thoughts of suicide, hallucinations), hearing changes (such as ringing in the ears, hearing loss), easy bruising/bleeding, signs of liver disease (such as severe stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of kidney problems (such as change in the amount of urine), muscle weakness, unwanted/uncontrolled movements (including tongue/face twitching), hair loss, hair/skin color changes.This medication may cause low blood sugar (hypoglycemia). Tell your doctor right away if you develop symptoms of low blood sugar, such as sudden sweating, shaking, hunger, blurred vision, dizziness, or tingling hands/feet. If you have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication.Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, fast/irregular heartbeat, seizures.This medication may cause serious eye/vision problems. The risk for these side effects is increased with long-term use of this medication and with taking this medication in high doses. Get medical help right away if you have any symptoms of serious eye problems, including: sensitivity to light, vision changes (such as light flashes/streaks, blurred vision, difficulty reading, missing areas of vision).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking chloroquine, tell your doctor or pharmacist if you are allergic to it; or to hydroxychloroquine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain enzyme problem (glucose-6-phosphate dehydrogenase deficiency-G6PD), vision/eye problems, hearing problems, kidney disease, liver disease, regular alcohol use/abuse, skin problems (such as psoriasis), a certain blood disorder (porphyria), seizures.If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar (see Side Effects section). Your doctor may need to adjust your diabetes medication, exercise program, or diet.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Chloroquine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using chloroquine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using chloroquine safely.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: mefloquine, penicillamine, remdesivir.Many drugs besides chloroquine may affect the heart rhythm (QT prolongation). Some examples are amiodarone, azithromycin, disopyramide, dronedarone, pimozide, quinidine, among others.Certain vaccines (rabies vaccine, cholera vaccine) may not work as well if given while you are taking chloroquine. Ask your doctor for more details.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, fainting, slow/shallow breathing, unwanted/uncontrolled movements (including tongue/face twitching), seizures.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as eye exams, reflex tests, liver/kidney function, EKG, complete blood counts) should be done if you are taking chloroquine for a long time. Keep all medical and lab appointments. Consult your doctor for more details.When traveling in an area at risk for malaria, use protective clothing, insect repellent, and bed nets. Remain indoors or in well-screened areas when possible. If you are taking this medication to prevent or treat malaria, use it for your current travel or condition only. Do not use it later to prevent or treat another infection unless your doctor tells you to.

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

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

            Information last revised May 2022. Copyright(c) 2022 First Databank, Inc.

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

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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