Hydroxychloroquine
Generic Name: hydroxychloroquine
Brand Names:
Hydroxychloroquine
11 DESCRIPTION Hydroxychloroquine Sulfate, 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. Its structural formula is: Hydroxychloroquine Sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether.
Overview
11 DESCRIPTION Hydroxychloroquine Sulfate, 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. Its structural formula is: Hydroxychloroquine Sulfate is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether.
Uses
1 INDICATIONS AND USAGE Hydroxychloroquine sulfate is 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. ( 1.4 ) Limitations of Use ( 1.1 ): Hydroxychloroquine sulfate is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species.
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.
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 (5.7) ] Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.8) ] Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.9) ] Hypoglycemia [see Warnings and Precautions (5.10) ] Renal Toxic...
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 prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate is used concomitantly with other arrhythmogenic drugs. Therefore, hydroxychloroquine sulfate is not recommended in patients taking other drugs that have the potential to prolong the QT interval or are arrhythmogenic [see Warnings and Precautions (5.1) ]. 7.2 Insulin or Other Antidiabetic Drugs Hydroxychloroquine sulfate may enhance the effects of insulin and antidiabetic drugs, and consequently increase the hypoglycemic risk.
Warnings
5 WARNINGS AND PRECAUTIONS Cardiomyopathy and Ventricular Arrhythmias: Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. ( 5.1 ) Retinal Toxicity: Irreversible retinal damage is related to cumulative dosage and treatment duration. Baseline retinal exam and exams during treatment are recommended. ( 5.2 ) Serious Skin Reactions: Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported. ( 5.3 ) Worsening of Psoriasis: Avoid in patients with psoriasis. ( 5.4 ) Risks Associated with Use in Porphyria: Avoid in patients with porphyria. Hepatotoxicity was reported in patients with porphyria cutanea tarda ( 5.5 ). 4 CONTRAINDICATIONS hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4- aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds ( 4 )
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Hydroxychloroquine sulfate tablets, USP are white to off white, film coated oval shaped tablets, debossed with “CE” on one side and “173” on other side. The tablets are available in: Bottles of 90 tablets (NDC 62135-752-90) 16.2 Storage Dispense in a tight, light-resistant container as defined in the USP.
Frequently Asked Questions
What is Hydroxychloroquine used for?▼
1 INDICATIONS AND USAGE Hydroxychloroquine sulfate is 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. ( 1.4 ) Limitations of Use ( 1.1 ): Hydroxychloroquine sulfate is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species.
What are the side effects of Hydroxychloroquine?▼
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 (5.7) ] Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.8) ] Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.9) ] Hypoglycemia [see Warnings and Precautions (5.10) ] Renal Toxic...
What are the important warnings for Hydroxychloroquine?▼
5 WARNINGS AND PRECAUTIONS Cardiomyopathy and Ventricular Arrhythmias: Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. ( 5.1 ) Retinal Toxicity: Irreversible retinal damage is related to cumulative dosage and treatment duration. Baseline retinal exam and exams during treatment are recommended. ( 5.2 ) Serious Skin Reactions: Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported. ( 5.3 ) Worsening of Psoriasis: Avoid in patients with psoriasis. ( 5.4 ) Risks Associated with Use in Porphyria: Avoid in patients with porphyria. Hepatotoxicity was reported in patients with porphyria cutanea tarda ( 5.5 ). 4 CONTRAINDICATIONS hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4- aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.