Hydroxychloroquine is a 4-aminoquinoline antimalarial and antirheumatic agent.

PLAQUENIL is indicated in adult and pediatric patients for the:
• Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale.
• Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. Treatment of rheumatoid arthritis in adults. Treatment of systemic lupus erythematosus in adults. Treatment of chronic discoid lupus erythematosus in adults.

Malaria in Adult and Pediatric Patients: Prophylaxis: Begin weekly doses 2 weeks prior to travel to the endemic area, continue weekly doses while in the endemic area, and continue the weekly doses for 4 weeks after leaving the endemic area: Adults: 400 mg once a week and Pediatric patients ≥ 31 kg: 6.5 mg/kg up to 400 mg, once a week. Treatment of Uncomplicated Malaria: See Full Prescribing Information (FPI) for complete dosing information. Rheumatoid Arthritis in Adults: Initial dosage: 400 mg to 600 mg daily. Chronic dosage: 200 mg once daily or 400 mg once daily (or in two divided doses.) Systemic Lupus Erythematosus in Adults: 200 mg once daily or 400 mg once daily (or in two divided doses.) Chronic Discoid Lupus Erythematosus in Adults: 200 mg once daily or 400 mg once daily (or in two divided doses.)

The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain.

PLAQUENIL is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

Precautions include Retinal Toxicity, Serious Skin Reactions, Worsening of Psoriasis, Risks Associated with Use in Porphyria, Hematologic Toxicity, Renal Toxicity, and fatal and life-threatening cases of cardiotoxicity, including cardiomyopathy, have been reported.