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Hydroxychloroquine Sulfate

    Brands

    DEA Class; Rx

    Common Brand Names; Plaquenil

    • Antimalarials; 
    • DMARDs, Other; 
    • Immunosuppressants; 
    • Antimalarials, Aminoquinoline

    Oral disease-modifying antirheumatic drug (DMARD) with antimalarial properties
    Used for rheumatoid arthritis, systemic lupus erythematosus, and malaria
    Associated with ocular toxicity and cardiomyopathy

    Indicated for prophylaxis of malaria in geographic areas where chloroquine resistance is not reported

    Indicated for treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax

    Indicated for treatment of acute and chronic rheumatoid arthritis

    Indicated for treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus

    Hypersensitivity to 4-aminoquinoline derivatives

    Blood and lymphatic system disorders: Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia; hemolysis reported in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency

    Cardiac disorders: Cardiomyopathy, QT interval prolongation, and ventricular arrhythmias and torsade de pointes

    Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness

    Eye disorders: Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision)

    Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain

    General disorders and administration site conditions: Fatigue

    Hepatobiliary disorders: Liver function tests abnormal, hepatic failure acute

    Immune system disorders: Urticaria, angioedema, bronchospasm

    Metabolism and nutrition disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased

    Not effective against chloroquine-resistant strains of P falciparum

    Rare suicidal behavior has been reported

    May cause severe hypoglycemia including loss of consciousness that could be life-threatening in patients treated with or without antidiabetic medications; check blood glucose and adjust treatment if necessary

    Exercise caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs; a dosage reduction may be necessary in patients with hepatic or renal disease, as well as in those taking medicines known to affect these organs

    Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs; perform periodic blood cell counts if patients are given prolonged therapy; if any severe blood disorder (eg, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia) appears which is not attributable to the disease under treatment, consider discontinuing treatment

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy

    Adults

    800 mg/dose (620 mg base/dose) PO for malaria up to a total of 2,000 mg (1,550 mg base) PO in 48 hours; 400 mg/week (310 mg base/week) PO for malaria prophylaxis; 600 mg/day (465 mg base/day) PO for rheumatoid arthritis; 400 mg/day (310 mg base/day) PO for systemic lupus erythematosus and chronic discoid lupus erythematosus

    Geriatric

    800 mg/dose (620 mg base/dose) PO for malaria up to a total of 2,000 mg (1,550 mg base) PO in 48 hours; 400 mg/week (310 mg base/week) PO for malaria prophylaxis; 600 mg/day (465 mg base/day) PO for rheumatoid arthritis; 400 mg/day (310 mg base/day) PO for systemic lupus erythematosus and chronic discoid lupus erythematosus

    Adolescents

    weighing 31 kg or more: 13 mg/kg/dose (10 mg base/kg/dose) [Max: 800 mg (620 mg base)] PO for malaria up to a total of 32.5 mg/kg (25 mg base/kg) [Max: 2,000 mg (1,550 mg base)] PO in 48 hours; 6.5 mg/kg/week (5 mg base/kg/week) [Max: 400 mg/week (310 mg base/week)] PO for malaria prophylaxis.
    weighing less than 31 kg: 13 mg/kg/dose (10 mg base/kg/dose) PO for malaria up to a total of 32.5 mg/kg (25 mg base/kg) PO in 48 hours has been used off-label; 6.5 mg/kg/week (5 mg base/kg/week) PO for malaria prophylaxis has been used off-label.

    Children

    weighing 31 kg or more: 13 mg/kg/dose (10 mg base/kg/dose) [Max: 800 mg (620 mg base)] PO for malaria up to a total of 32.5 mg/kg (25 mg base/kg) [Max: 2,000 mg (1,550 mg base)] PO in 48 hours; 6.5 mg/kg/week (5 mg base/kg/week) [Max: 400 mg/week (310 mg base/week)] PO for malaria prophylaxis.
    weighing less than 31 kg: 13 mg/kg/dose (10 mg base/kg/dose) PO for malaria up to a total of 32.5 mg/kg (25 mg base/kg) PO in 48 hours has been used off-label; 6.5 mg/kg/week (5 mg base/kg/week) PO for malaria prophylaxis has been used off-label.

    Infants

    13 mg/kg/dose (10 mg base/kg/dose) PO for malaria up to a total of 32.5 mg/kg (25 mg base/kg) PO in 48 hours has been used off-label; 6.5 mg/kg/week (5 mg base/kg/week) PO for malaria prophylaxis has been used off-label.

    Neonates

    Safety and efficacy have not been established.

    Hydroxychloroquine sulfate

    tablet

    • 200mg