The dosage for adults of low body weight and for infants and children should be determined as follows: First dose: 10 mg base per kg (but not exceeding a single dose of 600 mg base). FDA revoked the emergency use authorization (EUA) that chloroquine donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasibleBased 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 EUAWhile additional clinical trials may continue to evaluate potential benefit, the FDA determined the EUA was no longer appropriateOrphan designation for treatment of glioblastoma multiformeOcular 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 damageMusculoskeletal and connective tissue-disorders: Sensorimotor disorders, skeletal muscle myopathy or neuromyopathy, depression of tendon reflexes, abnormal nerve conductionGastrointestinal disorders: Hepatitis, increased liver enzymes, anorexia, nausea, vomiting, diarrhea, abdominal crampsSkin 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 lossBlood and lymphatic system disorders: Pancytopenia, aplastic anemia, reversible agranulocytosis, thrombocytopenia, neutropenia, hemolytic anemia in G6PD deficient patientsNervous 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 behaviorCardiac 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)Psoriasis, porphyria, retinal or visual field changesAcute extrapyramidal disorders may occur; reactions usually resolve after treatment discontinuation and/or symptomatic treatmentNot effective in most areas; CDC recommends mefloquine or atovaquone/proguanil - check CDC traveler information for specific recommendations for regionMay 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 hemolysisExperimental 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 treatmentCases 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 developsMay cause conduction disorders (eg, bundle branch block / AV heart block) are diagnosed; if cardiotoxicity is suspected, prompt discontinuation of chloroquine may prevent life-threatening complicationsMonitor knee and ankle reflexes in patients on long-term therapy to detect any evidence of muscular weakness; if weakness occurs, discontinue therapyA 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 compoundsUse 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 risksShown 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 necessaryCaution with hepatic disease, alcoholism, and coadministration with other hepatotoxic drugsMay provoke seizures in patients with history of epilepsyIn 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 abortionsAvoid use during pregnancy except in prophylaxis or treatment of malaria when benefit outweighs potential risk to fetusOwing 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 motherExcretion 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 malariaA: Generally acceptable.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. If you log out, you will be required to enter your username and password the next time you visit. Please see In a large randomized controlled trial of hospitalized patients in the United Kingdom, hydroxychloroquine did not decrease 28-day mortality when compared to the usual standard of care.

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