Overview
11 DESCRIPTION Hydroxychloroquine sulfate tablets, USP is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) with the molecular formula C 18 H 26 ClN 3 O•H 2 SO 4 . The molecular weight of hydroxychloroquine sulfate is 433.95.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial [see Microbiology (12.4) ] and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of hydroxychloroquine sulfate tablets in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known. 12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of hydroxychloroquine have not been fully characterized. 12.
Indications
- 1 INDICATIONS AND USAGE 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. ( 1.1 ) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1 ) Treatment of rheumatoid arthritis in adults. ( 1.2 ) Treatment of systemic lupus erythematosus in adults. ( 1.3 ) Treatment of chronic discoid lupus erythematosus in adults. ( 1.
Common Doses
- 400 mg
- 6.5 mg
- 600 mg
- 200 mg
Dosage
2 DOSAGE AND ADMINISTRATION Malaria in Adult and Pediatric Patients ( 2.2 ): ● 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. Rheumatoid Arthritis in Adults ( 2.
Contraindications
- 4 CONTRAINDICATIONS Hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Cardiomyopathy and Ventricular Arrhythmias [see Warnings and Precautions (5.1) ] Retinal Toxicity [see Warnings and Precautions (5.2) ] Serious Skin Reactions [see Warnings and Precautions (5.3) ] Worsening of Psoriasis [see Warnings and Precautions (5.4) ] Risks Associated with Use in Porphyria [see Warnings and Precautions (5.5) ] Hematologic Toxicity [see Warnings and Precautions (5.6) ] Hemolytic Anemia Associated with G6PD [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs. ( 7.1 ) See FPI for more important drug interactions. ( 7 ) 7.1 Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs Hydroxychloroquine sulfate tablets prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate tablets are used concomitantly with other arrhythmogenic drugs.