Hydroxychloroquine Sulfate
Hydroxychloroquine Sulfate Prescribing Information
| Warnings and Precautions, Risks Associated with Use in Porphyria ( 5.5 Risks Associated with Use in Porphyria Administration of hydroxychloroquine sulfate to patients with porphyria may exacerbate porphyria. Avoid hydroxychloroquine sulfate in patients with porphyria. Hepatotoxicity Associated with Porphyria Cutanea Tarda Cases of hepatotoxicity have been reported when hydroxychloroquine was used in patients with porphyria cutanea tarda (PCT). Patients received dosages ranging from 200 mg twice weekly to 400 mg daily. Most of the PCT-related cases presented with marked elevations in transaminases (>20 times upper limit of the reference range) within days to a month of hydroxychloroquine initiation. In some cases, PCT was diagnosed only after the occurrence of treatment-induced liver injury, when hydroxychloroquine was prescribed for an approved indication. Some of the cases were associated with other risk factors for hepatic injury (e.g., alcohol use, concomitant hepatotoxic medications). Measure liver tests promptly in patients who report symptoms that may indicate liver injury, such as fatigue, rash, nausea, dark urine, or jaundice. In this clinical context, if the patient is found to have abnormal serum liver tests (e.g., ALT level greater than three times the upper limit of the reference range, total bilirubin greater than two times the upper limit of the reference range), interrupt treatment with hydroxychloroquine sulfate, and investigate further to establish the probable cause. The safety and effectiveness of hydroxychloroquine sulfate for the treatment of PCT have not been established and hydroxychloroquine sulfate is not approved for this use. | 07/2023 |
| Warnings and Precautions, Neuropsychiatric Reactions Including Suicidality ( 5.9 Neuropsychiatric Reactions Including Suicidality Suicidal behavior, suicidal ideation, and other neuropsychiatric adverse reactions have been reported in patients treated with hydroxychloroquine sulfate [see Adverse Reactions ]. Neuropsychiatric adverse reactions typically occurred within the first month afterthe start of treatment with hydroxychloroquine and have been reported in patients with and without a prior history of psychiatric disorders. The risks and benefits of continued treatment with hydroxychloroquine sulfate should be assessed for patients who develop these symptoms. Given the long half-life of the drug, some patients may require several weeks off drug for symptoms to partially or fully abate. Advise patients to contact their healthcare provider promptly if they experience new or worsening neuropsychiatric symptoms such as depression, suicidal thoughts or behavior, or mood changes. | 07/2023 |
Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the:
- Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin adult and pediatric patients. ()1.1 Malaria
Hydroxychloroquine sulfate tablet is indicated in adult and pediatric patients for the:
- Treatment of uncomplicated malaria due toPlasmodium falciparum, Plasmodium malariae, Plasmodium vivax,andPlasmodium ovale.
- Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:Hydroxychloroquine sulfate tablet is
notrecommended for:- Treatment of complicated malaria.
- Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains ofPlasmodiumspecies[see Microbiology ].
- Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when thePlasmodiumspecies has not been identified.
- Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
- Prevention of relapses ofP. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary[see Microbiology ].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1.
- Treatment of uncomplicated malaria due to
- Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ()1.1 Malaria
Hydroxychloroquine sulfate tablet is indicated in adult and pediatric patients for the:
- Treatment of uncomplicated malaria due toPlasmodium falciparum, Plasmodium malariae, Plasmodium vivax,andPlasmodium ovale.
- Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:Hydroxychloroquine sulfate tablet is
notrecommended for:- Treatment of complicated malaria.
- Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains ofPlasmodiumspecies[see Microbiology ].
- Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when thePlasmodiumspecies has not been identified.
- Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
- Prevention of relapses ofP. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary[see Microbiology ].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1.
- Treatment of uncomplicated malaria due to
- Treatment of rheumatoid arthritis in adults. ()
1 INDICATIONS AND USAGEHydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the:
- Treatment of uncomplicated malaria due toPlasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivaxin 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 (1.1):Hydroxychloroquine sulfate Tablets is
notrecommended for the:- Treatment of complicated malaria.
- Treatment of chloroquine or hydroxychloroquine-resistant strains ofPlasmodiumspecies.
- Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when thePlasmodiumspecies has not been identified.
- Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
- Prevention of relapses ofP. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary.
1.1 MalariaHydroxychloroquine sulfate tablet is indicated in adult and pediatric patients for the:
- Treatment of uncomplicated malaria due toPlasmodium falciparum, Plasmodium malariae, Plasmodium vivax,andPlasmodium ovale.
- Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:Hydroxychloroquine sulfate tablet is
notrecommended for:- Treatment of complicated malaria.
- Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains ofPlasmodiumspecies[see Microbiology ].
- Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when thePlasmodiumspecies has not been identified.
- Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
- Prevention of relapses ofP. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary[see Microbiology ].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1.
1.2 Rheumatoid ArthritisHydroxychloroquine sulfate tablet is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus ErythematosusHydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus ErythematosusHydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults.
- Treatment of uncomplicated malaria due to
- Treatment of systemic lupus erythematosus in adults. ()1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults.
- Treatment of chronic discoid lupus erythematosus in adults. ()1.4 Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults.
Hydroxychloroquine sulfate Tablets is
- Treatment of complicated malaria.
- Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodiumspecies.
- Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodiumspecies has not been identified.
- Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
- Prevention of relapses of P. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary.
Hydroxychloroquine sulfate is not recommended in pediatric patients less than 31 kg because the lowest available strength (200 mg) exceeds the recommended dose for these patients and it cannot be divided.
Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to the endemic area, on the same day every week, continuing the same weekly dose while in the endemic area, and for 4 weeks after leaving the endemic area. The recommended prophylaxis dosage is:
- Adult patients: 400 mg once a week
- Pediatric patients ≥ 31kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week
The dosages for the treatment of uncomplicated malaria are:
- Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2,000 mg).
- Pediatric patients ≥ 31 kg: Administer 13 mg/kg (up to 800 mg) initially; subsequently administer 6.5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg - up to 2,000 mg).
For radical cure of
- 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.
The recommended dosage is:
- Initial dosage: 400 mg to 600 mg daily as a single daily dose or two divided doses. The action of hydroxychloroquine is cumulative and may require weeks to months for maximum therapeutic effect. Daily doses exceeding 5 mg/kg (actual weight) of hydroxychloroquine sulfate increase the incidence of retinopathy[see Warnings and Precautions ].
- Chronic dosage: 200 mg once daily to 400 mg daily, as a single dose or two divided doses.
Corticosteroids, salicylates, and other antirheumatic agents may be used concomitantly with hydroxychloroquine sulfate.
- Initial dosage: 400 mg to 600 mg daily
- Chronic dosage: 200 mg once daily or 400 mg once daily (or in two divided doses)
The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses.
- 200 mg once daily or 400 mg once daily (or in two divided doses)
The recommended dosage is 200 mg given once daily, or 400 mg given once daily or in two divided doses.
- 200 mg once daily or 400 mg once daily (or in two divided doses)
Tablets: 200 mg of hydroxychloroquine sulfate, white to off-white, capsule-shaped, biconvex, film-coated tablets debossed with "ZC38" on one side and plain on other side.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate during pregnancy. Encourage patients to register by contacting 1-877-311-8972.
Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with hydroxychloroquine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data from published epidemiologic and clinical studies have not established an association with hydroxychloroquine sulfate use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels. No retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine
Hydroxychloroquine sulfate is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.