Hydroxychloroquine Sulfate

What it is and how it works

Mechanism of Action Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of hydroxychloroquine in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known.

Indications

Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the: • Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale , and Plasmodium vivax in adult and pediatric patients. • 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. Limitations of Use : Hydroxychloroquine sulfate tablets are not recommended for the: • Treatment of complicated malaria. • Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. • Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. • Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. • Prevention of relapses of P. vivax or P.

Dosage and administration (summary)

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 - 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.

Contraindications

Hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. • Patients with hypersensitivity to 4-aminoquinoline compounds

Warnings and precautions

• Cardiomyopathy and Ventricular Arrhythmias : Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. • Retinal Toxicity : Irreversible retinal damage is related to cumulative dosage and treatment duration. Baseline retinal exam and exams during treatment are recommended. • Serious Skin Reactions : Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported. • Worsening of Psoriasis : Avoid in patients with psoriasis.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine during pregnancy. Encourage patients to register by contacting 1-877-311-8972.

Storage and supply

How Supplied Hydroxychloroquine sulfate tablets, USP contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of base). White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘J2’ on one side and plain on the other side.

Source: Hydroxychloroquine Sulfate (Hydroxychloroquine Sulfate) — US FDA prescribing information, 2024-01-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.