Classes
DEA Class; Rx
Common Brand Names; Plaquenil
- Antimalarials;
- DMARDs, Other;
- Immunosuppressants;
- Antimalarials, Aminoquinoline
Description
Oral disease-modifying antirheumatic drug (DMARD) with antimalarial properties
Used for rheumatoid arthritis, systemic lupus erythematosus, and malaria
Associated with ocular toxicity and cardiomyopathy
Indications
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
Contraindications
Hypersensitivity to 4-aminoquinoline derivatives
Adverse Effects
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
Warnings
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
Pregnancy and Lactation
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy
Maximum Dosage
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
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
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.
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.
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.
Safety and efficacy have not been established.
How supplied
Hydroxychloroquine sulfate
tablet
- 200mg